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4521 lines
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<HTML lang="en-US">
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<!-- From FOATemplate.txt -->
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<TITLE>Expired RFA-AI-22-069: Cooperative Centers on Human Immunology (U19 Clinical Trial Optional)</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Cooperative Centers on Human Immunology (U19 Clinical Trial Optional) RFA-AI-22-069. NIAID">
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<META NAME="Keywords" CONTENT="RFA-AI-22-069: Cooperative Centers on Human Immunology (U19 Clinical Trial Optional)">
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<meta name="viewport" content="width=device-width, initial-scale=1.0">
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<link href="../guide_styles/css/bootstrap.min.css" rel="stylesheet">
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<link href="../guide_styles/css/style.css" rel="stylesheet">
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<link href="../guide_styles/css/FOAM_Style.css" rel="stylesheet">
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</HEAD>
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<BODY>
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<link type="text/css" href="../guide_styles/css/expired.css" rel="stylesheet" media="all">
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<div class="noticeBar">This notice has expired. Check the <a href="https://grants.nih.gov/funding/searchguide/">NIH Guide</a> for active opportunities and notices.</div>
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<div id="watermark_background">
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<p id="watermark_text">EXPIRED</p>
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</div>
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<div class="container">
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<div class="row">
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<div class="col-xs-12">
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<body lang=EN-US link=blue vlink=purple>
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<div class=WordSection1>
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<div class="heading1"><a name="_Toc258852634"></a>Department of Health and Human Services</div>
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<div class="heading1"><a name="_Toc258873264"></a><a
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name="_Part_1._Overview"></a>Part 1. Overview Information</div>
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<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
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<div class="row">
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<div class="col-md-4 datalabel">Participating Organization(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel"><a name="_Components_of_Participating"></a>Components
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of Participating Organizations</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>National Institute of Allergy and Infectious Diseases (<a
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href="https://www.niaid.nih.gov/" target="_blank">NIAID</a>)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Title</div>
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<div class="col-md-8 datacolumn"><p class="title">Cooperative Centers on Human Immunology
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(U19 Clinical Trial Optional)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Activity Code</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><a
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href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u19&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">U19</a>
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Research Program Cooperative Agreements</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Announcement Type</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>Reissue of <a
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href="https://grants.nih.gov/grants/guide/rfa-files/rfa-ai-17-040.html">RFA-AI-17-040</a></p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Related Notices</div>
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<div class="col-md-8 datacolumn">
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<p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-012.html">NOT-OD-23-012</a> Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
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</p>
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</div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Announcement (FOA) Number</div>
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<div class="col-md-8 datacolumn"><p class="title">RFA-AI-22-069</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Companion Funding Opportunity</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>None </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel"><a name="_Number_of_Applications"></a>Number of
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Applications</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>See <a href="#_3._Additional_Information">Section III. 3.
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Additional Information on Eligibility</a>.</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Assistance Listing Number(s)<sub> </sub></div>
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<div class="col-md-8 datacolumn"><p class=regulartext>93.855</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Purpose</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>This Funding Opportunity Announcement (FOA) seeks to
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solicit applications from interdisciplinary teams to participate in the
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Cooperative Centers on Human Immunology (CCHI) program. The program supports
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mechanistic and hypothesis-testing studies to discover novel molecules,
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mechanisms, or regulatory pathways governing function of the human immune
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system in both healthy and vulnerable populations (<em>i.e.</em>, across lifespan,
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organ/tissue transplant recipients, pregnant women). Studies of interest
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include immunity related to prevention or treatment of infectious diseases,
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immune-mediated pathogenesis/sequelae associated with infectious disease,
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and/or immune-mediated diseases. This FOA also supports technology
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development to advance studies of the human immune system. The overarching
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goal of the CCHI is to provide foundational information on human immune
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system function to support translation of immunology research into clinical
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benefits.</p></div>
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</div><!--end row-->
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</table>
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<div class="heading2" style="clear:both;">Key Dates</div>
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<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
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<div class="row">
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<div class="col-md-4 datalabel">Posted Date</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>November 15, 2022</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Open Date (Earliest Submission Date)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>March 7, 2023</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Letter of Intent Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>30 days prior to the application due date</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Application Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>April 7, 2023 </p>
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<p class=regulartext>All applications are due by 5:00 PM local time of
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applicant organization. All <a href="#Application Types Allowed">types of non-AIDS
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applications</a> allowed for this funding opportunity announcement are due on
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the listed date(s). Applicants are encouraged to apply early to allow
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adequate time to make any corrections to errors found in the application
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during the submission process by the due date.</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">AIDS Application Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Scientific Merit Review </div>
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<div class="col-md-8 datacolumn"><p class=regulartext><a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></a>October
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2023</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Advisory Council Review</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>January 2024</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Earliest Start Date</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>February 2024</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Expiration Date</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>April 8, 2023 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Due Dates for E.O. 12372 </div>
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<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
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</div><!--end row-->
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</table>
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<div class="heading4"><a name="_Required_Application_Instructions"></a>Required
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Application Instructions</div>
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<p class=regulartext>It is critical that applicants follow the Multi-Project (M)
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Instructions in the <a
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href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">SF424
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(R&R) Application Guide</a>, except where instructed to do otherwise (in
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this FOA or in a Notice from the <a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11164"><i>NIH
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Guide for Grants and Contracts</i></a>). Conformance to all requirements (both
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in the Application Guide and the FOA) is required and strictly enforced. Applicants
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must read and follow all application instructions in the Application Guide as
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well as any program-specific instructions noted in <a
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href="#_Section_IV._Application_1">Section IV</a>. When the program-specific
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instructions deviate from those in the Application Guide, follow the
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program-specific instructions. <b>Applications that do not comply with
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these instructions may be delayed or not accepted for review.</b></p>
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<br>
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<style>
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.assist_button {
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background-color: #4CAF50; /* Green */
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border: none;
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color: white;
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padding: 8px 16px;
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text-align: center;
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text-decoration: none;
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display: inline-block;
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font-size: 14px;
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}
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.important {
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color: #F00;
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font-weight: bold;
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font-size 14px;
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}
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</style>
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<div class="heading1">Table of Contents</div>
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<p class=regulartext><a href="#_Part_1._Overview">Part 1. Overview Information</a><br>
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<a href="#_Part_2._Full">Part 2. Full Text of the Announcement</a></p>
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<p class=regulartext><span class=P_SingleIndent><a href="#_Section_I._Funding">Section
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I. Funding Opportunity Description</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_II._Award_1">Section II. Award Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section III. Eligibility Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_IV._Application_1">Section IV. Application and Submission
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Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_V._Application">Section V. Application Review Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VI._Award">Section VI. Award Administration Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VII._Agency">Section VII. Agency Contacts</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VIII._Other">Section VIII. Other Information</a></span></p>
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<div class="heading1"><a name="_Toc258852635"></a><a
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name="_Toc258873265"></a><br>
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<a name="_Part_2._Full"></a>Part 2.
|
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Full Text of Announcement</div>
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<div class="heading2"><a name=IFundOppDesc></a><a
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name="_Toc258852636"></a><a name="_Toc258873266"></a><a
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name="_Section_I._Funding"></a>Section I. Funding Opportunity
|
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Description</div>
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<p class=regulartext><a name="_Toc258873267"> </a></p>
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<div class="heading4">Purpose</div>
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<p class=regulartext> </p>
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<p class=regulartext>This Funding Opportunity Announcement (FOA) seeks to solicit
|
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applications from interdisciplinary teams to participate in the Cooperative
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Centers on Human Immunology (CCHI) program. The program supports mechanistic
|
|
and hypothesis-testing studies to discover novel molecules, mechanisms, or
|
|
regulatory pathways governing function of the human immune system in both
|
|
healthy and vulnerable populations (i.e., across lifespan, organ/tissue
|
|
transplant recipients, pregnant women). Studies of interest include immunity
|
|
related to prevention or treatment of infectious diseases, immune-mediated
|
|
pathogenesis/sequelae associated with infectious disease, and/or immune-mediated
|
|
diseases. This FOA also supports technology development to advance studies of
|
|
the human immune system. The overarching goal of the CCHI is to provide
|
|
foundational information on human immune system function to support translation
|
|
of immunology research into clinical benefits.</p>
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<div class="heading4">Background</div>
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<p class=regulartext> </p>
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<p class=regulartext>It is more difficult to dissect mechanisms of immune
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response and regulation in humans than in animal model systems. Experimental
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approaches are more limited in humans, and genetic and environmental
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heterogeneity make it more difficult to draw definitive conclusions. Although
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much has been learned from animal models, not all aspects translate directly to
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human applications, making studies in humans essential. Furthermore, human
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immunological research can now be conducted using sophisticated methods that permit
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analysis of tissue-specific and systemic responses. The
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recent advances in "omics" technologies have enabled system biology
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approaches that provide deeper interrogation of the molecular changes in
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human immune responses to infection, vaccination, and immune-mediated diseases.
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Large datasets from human samples are available in public repositories and
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knowledgebases, providing opportunities for more hypothesis-driven studies to
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better understand the immune mechanisms. </p>
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<p class=regulartext>To foster research in human immunology, NIAID established
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the CCHI program in 2003. Complementary to other data-gathering and
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hypothesis-generating programs supported by NIAID such as the Human Immunology
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Project Consortium (HIPC), the CCHI focuses on understanding the mechanisms
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underlying human immune system functions and how these processes impact other
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physiological systems. NIAID expanded the scope of the initial CCHI program to
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address research needs in infectious diseases and immune-mediated diseases,
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operating as a tightly interactive and collaborative network of eight research
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centers. Each center supports a centralized infrastructure that promotes and
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coordinates multi-disciplinary research. CCHI investigators are actively
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contributing to a fundamental understanding of human immunology, particularly
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in the areas of immune activation and memory responses to infection and
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vaccinations, including those of SARS-CoV-2 infection and COVID-19 disease.
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They are also at the forefront of technology development, which includes tissue
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imaging techniques, cluster based TCR repertoire analysis methods, and
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development of organoids derived from human tissues that offer ex vivo
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platforms for dissecting immune response.</p>
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<p class=regulartext>The COVID-19 pandemic has highlighted the importance of
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understanding host immune responses against emerging pathogens. Many advances
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have been made in characterizing the immunopathogenesis of COVID-19, providing
|
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foundational information for the discovery of therapeutic targets. NIAID
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recently published its <a
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href="https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf">Pandemic
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Preparedness Plan</a> and hosted a workshop to introduce NIAID’s strategy and
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request feedback from the scientific community on prioritizing prototype
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pathogens within viral families of highest pandemic potential for medical
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countermeasure development. Studies of the human immune system are vital for
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preparing for future pandemics and are a key aspect of NIAID's mission.
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CCHI-supported studies will advance our understanding of the human immune
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system, enabling development of next generation vaccines and therapeutics to
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strengthen pandemic preparedness. </p>
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<div class="heading4">Objectives and Scope</div>
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<p class=regulartext> </p>
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<p class=regulartext>The primary objective of the CCHI program is to support
|
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research on human immune system regulation and function for the discovery and
|
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characterization of new principles of human immunology for the prevention and
|
|
treatment of infectious and immune-mediated diseases. This research may entail
|
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the development of new technologies to support studies of the human immune system.
|
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The program will include support of a centralized infrastructure needed to
|
|
coordinate multi-disciplinary research in human immunology; continuing
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recruitment of outstanding immunologists to the study of the human immune
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system; and promotion of public data access and the flexibility to support new
|
|
research opportunities as they arise. </p>
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<p class=regulartext>Each application is expected to be synergistic, with
|
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projects and cores being connected by a common theme that produces scientific
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gains beyond those achievable if each project were pursued independently. All
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applications must include at least one Research Project focused on
|
|
understanding host defenses to infectious diseases, pathogen-specific
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vaccination, or adjuvants. </p>
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<p class=regulartext>All applications must propose studies on primary human cells
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or tissues; animal studies may be included only to extend or guide mechanistic
|
|
analyses of human samples. This program will support clinical studies using U.
|
|
S. Food and Drug Administration (FDA)-approved interventions (e.g., licensed
|
|
vaccines) that are used per indications in the product label and are exempt by
|
|
regulatory authorities from needing an Investigational New Drug (IND)
|
|
application. </p>
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<p class=regulartext>This program will support clinical trials that either do not
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require IND application or are IND-exempt, and that and that will advance
|
|
discovery and characterization of new principles of human immunology related to
|
|
infectious and/or immune-mediated diseases. However, applications that include
|
|
clinical trials with high risk or disease-modifying interventions in human
|
|
subjects will be considered non-responsive and will not be reviewed. Proposing
|
|
a clinical trial is optional for this FOA. If a clinical trial will be proposed
|
|
in the application, potential applicants are strongly encouraged to consult
|
|
with the Scientific/Research Contact listed in this FOA during the early stages
|
|
of preparation of the application, as well as submit a Letter of Intent 30 days
|
|
prior to the application due date. To ensure eligibility for this program,
|
|
applicants should contact the FDA or the equivalent non-US regulatory authority
|
|
(if applicable) to discuss whether an IND (or equivalent) application or
|
|
exemption/waiver is required. NIAID reserves the right to decide whether a
|
|
proposed clinical trial is responsive to the FOA based on the definitions and
|
|
guidance provided herein. If an application is selected for NIAID funding, any
|
|
proposed clinical trials will be reviewed by the Project Scientist(s) assigned
|
|
by NIAID and the NIAID Division of Allergy, Immunology and Transplantation
|
|
(DAIT) Clinical Research Committee. Approved clinical protocols will be
|
|
developed collaboratively as per the NIAID clinical term of award. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>When clinical studies are a component of the research
|
|
proposed, NIAID policy requires that studies be <a
|
|
href="https://www.niaid.nih.gov/research/guidance-policies-and-standard-operating-procedures">monitored</a>
|
|
commensurate with the degree of risk to study subjects and the complexity of
|
|
the study. The full policy, including terms and conditions of award, is available
|
|
at: <a
|
|
href="https://www.niaid.nih.gov/grants-contracts/niaid-clinical-terms-award">https://www.niaid.nih.gov/grants-contracts/niaid-clinical-terms-award</a>.
|
|
<em>If an application is
|
|
selected for NIAID funding, any proposed clinical trials will be reviewed by
|
|
the Project Scientist(s) assigned by NIAID and the NIAID Division of Allergy,
|
|
Immunology and Transplantation (DAIT) Clinical Research Committee. Final
|
|
clinical protocols will be developed collaboratively. </em> </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Examples
|
|
of research areas of interest include, but are not limited to:</strong></p>
|
|
<ul>
|
|
<li>
|
|
Understanding of host immune responses to pathogens with pandemic
|
|
potential.</li>
|
|
<li>
|
|
Differential effects of natural infection versus vaccination as
|
|
primary antigen exposure on immune responses to subsequent exposures (in
|
|
adults, teens, and the elderly).</li>
|
|
<li>
|
|
Analyses of immune responses to infection and vaccination in the
|
|
presence of immune-modulating co-morbidities (<em>i.e.</em>, age, diabetes, obesity, autoimmunity,
|
|
transplant, and cancer) </li>
|
|
<li>
|
|
Mechanisms of induction and durability of immune memory.</li>
|
|
<li>
|
|
Mechanisms of adjuvant-guided adaptive immune responses,
|
|
promoting effector vs. long-term memory response.</li>
|
|
<li>
|
|
Studies of immune-mediated diseases to define critical regulatory
|
|
pathways and tolerance mechanisms that comprise a well-regulated functional
|
|
immune response.</li>
|
|
<li>
|
|
Identification of mechanisms of immune dysregulation that may
|
|
impact protective immunity against infection or vaccination.</li>
|
|
<li>
|
|
Development and utilization of unique human model systems, <em>i.e.</em>, human organoid
|
|
systems or computational modeling systems, to understand immune mediated
|
|
disorders or immune responses to infection or vaccination.</li>
|
|
<li>
|
|
Developing and applying spatial omics assays to dissect dynamic
|
|
changes in immune responses in tissues and organs.</li>
|
|
<li>
|
|
Computational tools for analyzing human immune responses and predicting
|
|
and modeling human responses from animal studies.</li>
|
|
<li>
|
|
Imaging technologies for analyses of <em>in vivo</em> immune responses.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext> </p>
|
|
|
|
<p class=regulartext><a name="_Hlk106198425"><strong>Applications meeting the following conditions will be
|
|
considered non-responsive and will not be reviewed:</strong></a></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Applications that are not focused on mechanisms of the activation
|
|
and regulation of human immune responses.</li>
|
|
<li>
|
|
Applications that do not include at least one Research Project
|
|
focused on understanding host defenses to infectious diseases,
|
|
pathogen-specific vaccination, or adjuvants.</li>
|
|
<li>
|
|
Applications that are focused on vaccine or product development
|
|
for infectious or immune-mediated disease indications.</li>
|
|
<li>
|
|
Applications that do not include the use of primary human cells,
|
|
fluids, or tissue in Research Projects.</li>
|
|
<li>
|
|
Applications that are focused on animal studies that do not
|
|
extend or guide mechanistic analyses of human samples.</li>
|
|
<li>
|
|
Applications that include clinical trials with high risk or
|
|
disease-modifying interventions in human subjects.</li>
|
|
<li>
|
|
Applications that require an IND or equivalent from the U.S. FDA.</li>
|
|
<li>
|
|
Applications that include large scale immune profiling studies to
|
|
generate hypotheses in the absence of mechanistic studies.</li>
|
|
<li>
|
|
Applications that include the discovery or validation of immune
|
|
epitopes recognized by T cells or antibodies as the primary focus.</li>
|
|
<li>
|
|
Applications that include clinical trials in which the primary
|
|
objective is to test the safety or efficacy of an investigational vaccine,
|
|
adjuvant, or other product.</li>
|
|
<li>
|
|
Applications that include HIV/SIV/AIDS studies.</li>
|
|
<li>
|
|
Applications that develop of new animal models.</li>
|
|
<li>
|
|
Applications that involve cancer studies, except those examining
|
|
immune responses to infectious diseases or pathogen-specific vaccines in cancer
|
|
patients.</li>
|
|
<li>
|
|
Applications that involve behavioral research or epidemiological
|
|
studies.</li>
|
|
<li>
|
|
Applications proposing clinical trial(s) that do not include a
|
|
Clinical Core.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext> </p>
|
|
|
|
<div class="heading4">CCHI Components</div>
|
|
|
|
<p class=regulartext> </p>
|
|
|
|
<p class=regulartext>Highly integrated and collaborative interdisciplinary teams
|
|
are encouraged for the CCHI program. The scope of this work requires
|
|
interdisciplinary teams that can pursue coordinated activities that bridge
|
|
scientific disciplines and expertise in immunology, infectious diseases, vaccinology,
|
|
immune-mediated diseases, omics technologies, and bioinformatics. Bringing
|
|
multidisciplinary groups together creates opportunities for synergy that would
|
|
rarely happen otherwise. The research teams within each center may be composed
|
|
of investigators located at one institution, or may be formed through a
|
|
consortium of different institutions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Administrative
|
|
Core (required):</strong> Each application must include an
|
|
Administrative Core, which is responsible for managing, coordinating, and
|
|
supervising the entire range of the center's activities; monitoring progress;
|
|
ensuring that the overall project management plan is implemented effectively
|
|
and within proposed timelines; and ensuring data sharing and regulatory
|
|
compliance.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Infrastructure
|
|
and Opportunity Fund (IOF) Management Core (required):</strong> To
|
|
capitalize on emerging opportunities consistent with the goals of the CCHI an
|
|
Infrastructure and Opportunities Fund (IOF) will be made available to one
|
|
institution chosen from successful applicants by NIH after award to manage for
|
|
the entire CCHI. This institution must agree to take responsibility for
|
|
managing the IOF, and includes establishing an administrative structure,
|
|
disbursement and tracking of funds, and reporting status. Examples of
|
|
activities supported by the IOF may/could include collaborative and
|
|
pilot/feasibility projects; resource development and sharing opportunities;
|
|
translational projects; early stage investigator projects; and development and
|
|
management of a website for CCHI activities. IOF projects must be within the
|
|
scope of this FOA and may be submitted by recipients or by outside
|
|
investigators.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Clinical
|
|
Core:</strong> A Clinical Core is <strong><em>optional</em></strong> for the
|
|
applications proposing clinical studies, and it is required
|
|
for applications that include clinical trials. It may provide
|
|
human cells/samples to projects and must be responsible for the conduct of
|
|
clinical trials (if proposed in the application). This Core will ensure a
|
|
standardized approach to the recruitment and clinical characterization of human
|
|
subjects in all studies that will be conducted by the CCHI center. In addition,
|
|
the Core will be responsible for implementing appropriate human subject
|
|
protection measures, including cGCP rules, across all studies. This will
|
|
require that the Core ensures appropriate training of personnel and monitors
|
|
all clinical study activities of the CCHI center. In this context, the Core
|
|
will conduct functions such as clinical protocol development, informed consent
|
|
form development, development of a manual of procedures for each clinical
|
|
protocol that the CCHI center will conduct, development of protocol-specific
|
|
case report forms, training of clinical personnel prior to protocol initiation
|
|
(both cGCP and protocol-specific training), preparing IRB applications and
|
|
other approval processes, preparing annual progress reports to the IRB and NIH,
|
|
monitoring of the clinical component of the study, capturing and reporting
|
|
adverse events related to any intervention or procedure, and handling protocol
|
|
deviations. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Service
|
|
Core(s) (optional):</strong> Service Cores may be included to provide
|
|
CCHI investigators with pre-existing technologies or services that have already
|
|
been validated and refined for use (<em>e.g.</em>,
|
|
assays, reagents, technologies, and services such as statistical, or
|
|
informatics). Each Service Core must support at least two of the projects.
|
|
Service Core activities must not overlap with each other or with the activities
|
|
of a project. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Research
|
|
Projects (2 required, including 1 infectious disease-related):</strong>
|
|
Each application must propose at least two milestone-driven and
|
|
hypothesis-testing mechanistic immunology Research Projects, anticipated to
|
|
advance understanding of the mechanisms regulating human immune responses. At
|
|
least one of the projects must be applicable to immunity to infectious
|
|
diseases, pathogen-specific vaccines, or adjuvants. A project on
|
|
immune-mediated disease is not a requirement but is permitted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Technology
|
|
Development Project (optional):</strong> The Technology Development
|
|
Project is intended to create, validate, and refine new or significantly
|
|
enhance existing technologies, assays, or computational tools for analyzing
|
|
human immune responses. A Technology Development Project may be included but is
|
|
not required.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Steering
|
|
Committee:</strong> NIAID will establish a Steering Committee with the
|
|
PD(s)/PI(s) of each award serving as the governing body of the CCHI. This
|
|
committee will promote scientific collaboration and exchange of scientific
|
|
findings among the centers. It will review and make recommendations for funding
|
|
of applications submitted to the CCHI IOF.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>External
|
|
Advisory Board (EAB):</strong> NIAID will convene an EAB to review and
|
|
evaluate the scientific progress of the individual CCHI recipients and the
|
|
Consortium as a whole. The EAB may make suggestions to NIAID for prioritizing
|
|
research of individual CCHI Centers or the Consortium as a whole. EAB members
|
|
will be selected by NIAID after award and should not be proposed or contacted
|
|
by applicants. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>External
|
|
Scientific Advisory Group (ESAG) (optional):</strong> An ESAG may be
|
|
formed after award at the discretion of the PD(s)/PI(s) to evaluate and advise
|
|
on scientific progress within the center. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Note:
|
|
</strong>The recipients will be expected to deposit data and data analyses
|
|
into <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a>, or other public data
|
|
portals as designated by NIAID. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Note:</strong>
|
|
Under a public health emergency, NIAID may re-direct funds or provide
|
|
additional funds to individual awards to support research of direct relevance
|
|
to the emergency.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Note:</strong>
|
|
Applicants are <em>strongly</em>
|
|
encouraged to consult with the Scientific/Research Contact listed in Section
|
|
VII during the early stages of preparation of the application, particularly for
|
|
applications proposing clinical trials.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>See <span class=P_SingleIndent><a href="#_Section_VIII._Other">Section VIII. Other
|
|
Information</a></span> for award authorities and regulations.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Section_II._Award_1"></a>Section II. Award Information</div>
|
|
|
|
|
|
|
|
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funding Instrument</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Cooperative Agreement: A support mechanism used when there
|
|
will be substantial Federal scientific or programmatic involvement.
|
|
Substantial involvement means that, after award, NIH scientific or program
|
|
staff will assist, guide, coordinate, or participate in project activities. See
|
|
Section VI.2 for additional information about the substantial involvement for
|
|
this FOA.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Application Types Allowed</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>New <br>
|
|
Renewal - Renewals will only be accepted from applicants funded under <a
|
|
href="https://grants.nih.gov/grants/guide/rfa-files/rfa-ai-17-040.html">RFA-AI-17-040</a></p>
|
|
|
|
<p class=regulartext>The <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER
|
|
Glossary</a> and the SF424 (R&R) Application Guide provide details on
|
|
these application types. Only those application types listed here are allowed
|
|
for this FOA.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Clinical Trial?</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Optional: Accepting applications that either propose or do
|
|
not propose clinical trial(s)</p>
|
|
|
|
<p class=regulartext><a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need
|
|
help determining whether you are doing a clinical trial?</a></p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funds Available and Anticipated Number of Awards</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>NIAID intends to commit $13.7 million in FY2024 to
|
|
fund 4-5 awards and includes direct costs of $0.9 million annually to support
|
|
an infrastructure and Opportunity Fund.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Budget</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Application budgets are not expected to exceed $2.5
|
|
million direct costs per year, which is anticipated to include $0.9 million
|
|
direct costs for the Infrastructure and Opportunity Fund (IOF) Management
|
|
Core. Application budgets need to reflect the actual needs of the proposed
|
|
project. </p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Project Period</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>The scope of the proposed project should determine the
|
|
project period. The maximum period is five years.</p></div>
|
|
</div><!--end row-->
|
|
</table>
|
|
|
|
|
|
|
|
<p> </p>
|
|
<p class="regulartext" style="clear:both;">NIH grants policies as
|
|
described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></a> will apply
|
|
to the applications submitted and awards made from this FOA.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873268"></a><a
|
|
name="_Section_III._Eligibility"></a>Section III. Eligibility
|
|
Information</div>
|
|
|
|
<div class="heading3">1. Eligible Applicants</div>
|
|
|
|
|
|
|
|
<div class="heading4">Eligible Organizations</div>
|
|
|
|
<p class=regulartext>Higher Education Institutions</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Public/State Controlled Institutions of Higher Education </li>
|
|
<li>
|
|
Private Institutions of Higher Education </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>The following types of Higher Education Institutions
|
|
are always encouraged to apply for NIH support as Public or Private
|
|
Institutions of Higher Education: </p>
|
|
|
|
<ul>
|
|
<ul>
|
|
<li>
|
|
Hispanic-serving Institutions</li>
|
|
<li>
|
|
Historically Black Colleges and Universities (HBCUs)</li>
|
|
<li>
|
|
Tribally Controlled Colleges and Universities (TCCUs) </li>
|
|
<li>
|
|
Alaska Native and Native Hawaiian Serving Institutions</li>
|
|
<li>
|
|
Asian American Native American Pacific Islander Serving Institutions
|
|
(AANAPISIs)</li>
|
|
</ul>
|
|
</ul>
|
|
|
|
<p class=regulartext>Nonprofits Other Than Institutions of Higher Education</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
|
|
Higher Education) </li>
|
|
<li>
|
|
Nonprofits without 501(c)(3) IRS Status (Other than Institutions
|
|
of Higher Education) </li>
|
|
</ul>
|
|
|
|
<p class=regulartext>For-Profit Organizations</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Small Businesses</li>
|
|
<li>
|
|
For-Profit Organizations (Other than Small Businesses)</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Governments</p>
|
|
|
|
<ul>
|
|
<li>
|
|
State Governments </li>
|
|
<li>
|
|
County Governments</li>
|
|
<li>
|
|
City or Township Governments</li>
|
|
<li>
|
|
Special District Governments</li>
|
|
<li>
|
|
Indian/Native American Tribal Governments (Federally Recognized) </li>
|
|
<li>
|
|
Indian/Native American Tribal Governments (Other than Federally
|
|
Recognized)</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Federal Government</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Eligible Agencies of the Federal Government</li>
|
|
<li>
|
|
U.S. Territory or Possession</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Other</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Independent School Districts</li>
|
|
<li>
|
|
Public Housing Authorities/Indian Housing Authorities</li>
|
|
<li>
|
|
Native American Tribal Organizations (other than Federally
|
|
recognized tribal governments)</li>
|
|
<li>
|
|
Faith-based or Community-based Organizations</li>
|
|
<li>
|
|
Regional Organizations</li>
|
|
</ul>
|
|
|
|
<div class="heading4">Foreign Institutions</div>
|
|
|
|
<p class=regulartext>Non-domestic (non-U.S.) Entities (Foreign Institutions) <b>are
|
|
not</b> eligible to apply.</p>
|
|
<p class=regulartext>Non-domestic (non-U.S.) components of U.S. Organizations <b>are not</b> eligible
|
|
to apply.</p>
|
|
|
|
<p class=regulartext>Foreign components, as <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in
|
|
the <i>NIH Grants Policy Statement</i></a>, <b>are </b> allowed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Required Registrations</div>
|
|
|
|
<p class=regulartext><strong>Applicant
|
|
Organizations</strong></p>
|
|
|
|
<p class=regulartext>Applicant organizations must complete and maintain the
|
|
following registrations as described in the SF 424 (R&R) Application Guide
|
|
to be eligible to apply for or receive an award. All registrations must be
|
|
completed prior to the application being submitted. Registration can take 6
|
|
weeks or more, so applicants should begin the registration process as soon as
|
|
possible. The <a
|
|
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html">NIH
|
|
Policy on Late Submission of Grant Applications</a> states that failure to
|
|
complete registrations in advance of a due date is not a valid reason for a
|
|
late submission.</p>
|
|
|
|
<ul>
|
|
<li>
|
|
<a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for
|
|
Award Management (SAM)</a> Applicants must complete and maintain an active
|
|
registration, <b>which requires renewal at least annually</b>. The renewal
|
|
process may require as much time as the initial registration. SAM registration
|
|
includes the assignment of a Commercial and Government Entity (CAGE) Code for
|
|
domestic organizations which have not already been assigned a CAGE Code.
|
|
<ul>
|
|
<li>
|
|
<a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO
|
|
Commercial and Government Entity (NCAGE) Code</a> Foreign organizations must
|
|
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. </li>
|
|
<li>
|
|
Unique Entity Identifier (UEI)- A UEI is issued as part of the
|
|
SAM.gov registration process. The same UEI must be used for all registrations,
|
|
as well as on the grant application.</li>
|
|
</ul>
|
|
</li>
|
|
<li>
|
|
<a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA
|
|
Commons</a> - Once the unique organization identifier is established,
|
|
organizations can register with eRA Commons in tandem with completing their
|
|
full SAM and Grants.gov registrations; all registrations must be in place by
|
|
time of submission. eRA Commons requires organizations to identify at least one
|
|
Signing Official (SO) and at least one Program Director/Principal Investigator
|
|
(PD/PI) account in order to submit an application. </li>
|
|
<li>
|
|
<a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82300">Grants.gov</a>
|
|
Applicants must have an active SAM registration in order to complete the
|
|
Grants.gov registration. </li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Program
|
|
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
|
|
|
|
<p class=regulartext>All PD(s)/PI(s) must have an eRA Commons account.
|
|
PD(s)/PI(s) should work with their organizational officials to either
|
|
create a new account or to affiliate their existing account with the applicant
|
|
organization in eRA Commons.If the PD/PI is also the organizational Signing
|
|
Official, they must have two distinct eRA Commons accounts, one for each role.
|
|
Obtaining an eRA Commons account can take up to 2 weeks.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Eligible Individuals (Program Director/Principal
|
|
Investigator)</div>
|
|
|
|
<p class=regulartext>Any individual(s) with the skills, knowledge, and resources
|
|
necessary to carry out the proposed research as the Program Director(s)/Principal
|
|
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
|
|
develop an application for support. Individuals from diverse backgrounds,
|
|
including underrepresented racial and ethnic groups, individuals with
|
|
disabilities, and women are always encouraged to apply for NIH support.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For institutions/organizations proposing multiple PDs/PIs, visit
|
|
the Multiple Program Director/Principal Investigator Policy and submission
|
|
details in the Senior/Key Person Profile (Expanded) Component of the SF424
|
|
(R&R) Application Guide. </p>
|
|
|
|
<p class=regulartext><br>
|
|
Note that the multiple PD(s)/PI(s) option may be used only for the Overall
|
|
Program. Projects are limited to a single project lead per project and a single
|
|
core lead per core within the multi-component application.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>An investigator can serve as a PD/PI on only one CCHI award
|
|
or application. This includes all PD(s)/PI(s) of a multiple-PD/PI application.</p>
|
|
|
|
|
|
|
|
<div class="heading3">2. Cost Sharing</div>
|
|
|
|
<p class=regulartext>This FOA does not require cost sharing as defined in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11126"><i>NIH
|
|
Grants Policy Statement</i>.</a></p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</div>
|
|
|
|
<div class="heading4">Number of Applications</div>
|
|
|
|
<p class=regulartext>Applicant organizations may submit more than one application,
|
|
provided that each application is scientifically distinct. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>The NIH will not accept duplicate or highly overlapping
|
|
applications under review at the same time per 2.3.7.4 Submission of
|
|
Resubmission Application.". This means that the NIH will not accept:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
A new (A0) application that is submitted before issuance of the
|
|
summary statement from the review of an overlapping new (A0) or resubmission
|
|
(A1) application.</li>
|
|
<li>
|
|
A resubmission (A1) application that is submitted before issuance
|
|
of the summary statement from the review of the previous new (A0) application.</li>
|
|
<li>
|
|
An application that has substantial overlap with another
|
|
application pending appeal of initial peer review (see <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.9_application_receipt_information_and_deadlines.htm#Similar,">2.3.9.4
|
|
Similar, Essentially Identical, or Identical Applications</a>).</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><a name="_Toc258873269"></a><a
|
|
name="_Section_IV._Application"></a>Note that the current FOA will not allow
|
|
foreign clinical trial sites. However, foreign components that will be allowed
|
|
include mechanistic projects, observational studies, specialized assays, etc. </p>
|
|
|
|
<div class="heading2"><a name="_Section_IV._Application_1"></a>Section IV. Application and Submission Information</div>
|
|
|
|
<div class="heading3">1. Requesting an
|
|
Application Package</div>
|
|
|
|
<p class=regulartext>The application forms package specific to this opportunity
|
|
must be accessed through ASSIST or an institutional system-to-system solution. A
|
|
button to apply using ASSIST is available in <a
|
|
href="#_Required_Application_Instructions">Part 1</a> of this FOA. See your
|
|
administrative office for instructions if you plan to use an institutional
|
|
system-to-system solution.</p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_2._Content_and"></a>2. Content and Form of Application Submission</div>
|
|
|
|
|
|
|
|
<p class=regulartext>It is critical that applicants follow the Multi-Project (M) Instructions
|
|
in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">SF424
|
|
(R&R) Application Guide</a>, except where instructed in this funding
|
|
opportunity announcement to do otherwise and where instructions in the
|
|
Application Guide are directly related to the Grants.gov downloadable forms
|
|
currently used with most NIH opportunities. Conformance to the requirements in
|
|
the Application Guide is required and strictly enforced. Applications that are
|
|
out of compliance with these instructions may be delayed or not accepted for
|
|
review.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Letter of Intent </div>
|
|
|
|
<p class=regulartext>Although a letter of intent is not required, is not binding,
|
|
and does not enter into the review of a subsequent application, the information
|
|
that it contains allows IC staff to estimate the potential review workload and
|
|
plan the review. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>By the date listed in <a href="#_Part_1._Overview">Part 1. Overview
|
|
Information</a>, prospective applicants are asked to submit a letter of intent
|
|
that includes the following information:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Descriptive title of proposed activity</li>
|
|
<li>
|
|
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li>
|
|
<li>
|
|
Names of other key personnel</li>
|
|
<li>
|
|
Participating institution(s)</li>
|
|
<li>
|
|
Number and title of this funding opportunity</li>
|
|
</ul>
|
|
<p class=regulartext>The letter of intent should be sent to: </p>
|
|
|
|
<p class=P_SingleIndent>Anuja Mathew, Ph.D. <br>
|
|
Telephone: 301-761-6911 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#b6d7d8c3dcd798dbd7c2ded3c1f6d8dfde98d1d9c0"><span class="__cf_email__" data-cfemail="d3b2bda6b9b2fdbeb2a7bbb6a493bdbabbfdb4bca5">[email protected]</span></a> </p>
|
|
|
|
|
|
|
|
<div class="heading4">Page Limitations</div>
|
|
|
|
|
|
|
|
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0>
|
|
<thead>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext><strong>Available
|
|
Component Types </strong></p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext><strong>Research
|
|
Strategy/Program Plan Page Limits</strong></p>
|
|
</td>
|
|
</tr>
|
|
</thead>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Overall</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>12 pages</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Admin Core</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext> 6 pages</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Core (use for Infrastructure and Opportunity Fund
|
|
Management Core, Clinical Core, and Service Core)</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext> 6 pages each</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Project (use for Research Project, Technology Development
|
|
Project) </p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>12 pages each</p>
|
|
</td>
|
|
</tr>
|
|
</table>
|
|
|
|
|
|
|
|
<p class=regulartext>Additional page limits described in the SF424 Application
|
|
Guide and the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of
|
|
Page Limits</a> must be followed.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Instructions for the Submission of Multi-Component
|
|
Applications</div>
|
|
|
|
<p class=regulartext>The following section supplements the instructions found in
|
|
the SF424 (R&R) Application Guide, and should be used for preparing a
|
|
multi-component application. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The application should consist of the following components:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Overall: required</li>
|
|
<li>
|
|
Administrative Core; required; 1</li>
|
|
<li>
|
|
Infrastructure and Opportunity Fund Management Core: required; 1</li>
|
|
<li>
|
|
Clinical Core: optional for applications proposing clinical
|
|
studies, but required for applications proposing clinical trials; maximum of 1</li>
|
|
<li>
|
|
Service Core(s): optional; maximum of 3</li>
|
|
<li>
|
|
Research Projects: required; minimum of 2, maximum of 3</li>
|
|
<li>
|
|
Technology Development Project: optional; maximum of 1 </li>
|
|
</ul>
|
|
|
|
<div class="heading4">Overall Component</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type
|
|
Overall .</p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Overall)</div>
|
|
|
|
<p class=regulartext>Complete entire form. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Overall)</div>
|
|
|
|
<p class=regulartext>Note: Human Embryonic Stem Cell
|
|
lines from other components should be repeated in cell line table in Overall
|
|
component. </p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Research & Related Other
|
|
Project Information (Overall)</div>
|
|
|
|
<p class=regulartext>Follow standard instructions. </p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Project/Performance Site
|
|
Location(s) (Overall)</div>
|
|
|
|
<p class=regulartext>Enter primary site only. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=regulartext><i>A summary of Project/Performance
|
|
Sites in the Overall section of the assembled application image in eRA Commons
|
|
compiled from data collected in the other components will be generated upon
|
|
submission.</i></p>
|
|
|
|
<p class=P_SingleIndent><em> </em></p>
|
|
|
|
<div class="heading4">Research & Related
|
|
Senior/Key Person Profile (Overall)</div>
|
|
|
|
<p class=regulartext>Include only the Project
|
|
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
|
|
this FOA) for the entire application. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Provide evidence that demonstrates the PD(s)'/PI(s)'
|
|
abilities to provide leadership, guidance, and direction over the proposed
|
|
project. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><i>A summary of Senior/Key Persons
|
|
followed by their Biographical Sketches in the Overall section of the assembled
|
|
application image in eRA Commons will be generated upon submission.</i></p>
|
|
|
|
<p class=P_SingleIndent><em> </em></p>
|
|
|
|
<div class="heading4">Budget (Overall)</div>
|
|
|
|
<p class=regulartext>The only budget information
|
|
included in the Overall component is the Estimated Project Funding section of
|
|
the SF424 (R&R) Cover. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><i>A budget summary in the Overall
|
|
section of the assembled application image in eRA Commons compiled from
|
|
detailed budget data collected in the other components will be generated upon
|
|
submission.</i></p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Research Plan (Overall)</div>
|
|
|
|
<p class=regulartext><strong> </strong></p>
|
|
|
|
<p class=regulartext><b>Specific Aims: </b>Describe the
|
|
central scientific theme of the proposed research, and list in priority order
|
|
the broad, long-range objectives and goals of the center. </p>
|
|
|
|
<p class=regulartext><b> </b></p>
|
|
|
|
<p class=regulartext><b>Research Strategy: </b>Summarize
|
|
the overall research plan for the CCHI center application and explain how the
|
|
proposed program supports the study of mechanisms by which the human immune
|
|
system is activated and regulated. Describe the central theme of the proposed program
|
|
and explain how the proposed Research Projects and Technology Development Project
|
|
(if applicable) are synergistic and fit under the overarching program theme.
|
|
The CCHI application should be viewed as an alliance of interrelated projects,
|
|
each capable of standing on its own scientific merit, but complementary to one
|
|
another. This is an important section for it provides the group of
|
|
investigators an opportunity to convey the conceptual wholeness of the overall
|
|
program. Therefore, it should contain a statement of the scientific goals and
|
|
lay out a broad strategy to achieve these goals. As the strategy develops, each
|
|
project and core should be cited briefly as to its place in the overall scheme.
|
|
Briefly describe the human populations and the rationale for their selection
|
|
for each project and core and explain how the study of these populations will
|
|
enhance the goals of the overall center. Include a schematic overview (figure)
|
|
of the interactions, synergy, and collaborations among all the components. If
|
|
there was no prior experience of collaboration among the investigators, explain
|
|
how the proposed investigator collaborations will result in synergy. </p>
|
|
<p class=P_SingleIndent><b>Letters of Support:</b> Provide any institutional
|
|
letters of support specific to the Overall Component.</p>
|
|
<p class=P_SingleIndent><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=P_SingleIndent>Note: Effective for due dates on or after January 25,
|
|
2023, the Data Management and Sharing Plan will be attached in the Other
|
|
Plan(s) attachment in FORMS-H application forms packages.</p>
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed, with the following additional instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
<li>
|
|
Recipients are expected to deposit data and data analyses into
|
|
ImmPort (<a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">https://www.immport.org/home</a>)
|
|
or other public data portal as designated by NIAID.</li>
|
|
</ul>
|
|
<p class=regulartext><b>Appendix:</b></p>
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
<p class=heading4Indent>PHS Human Subjects and Clinical
|
|
Trials Information (Overall)</p>
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent>If you answered Yes to the question Are Human
|
|
Subjects Involved? on the R&R Other Project Information form, there must
|
|
be at least one human subjects study record using the<strong> Study Record: PHS Human Subjects and
|
|
Clinical Trials Information</strong> form or a <strong>Delayed Onset Study</strong>
|
|
record within the application. The study record(s) must be included in the
|
|
component(s) where the work is being done, unless the same study spans multiple
|
|
components. To avoid the creation of duplicate study records, a single study
|
|
record with sufficient information for all involved components must be included
|
|
in the Overall component when the same study spans multiple components. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424
|
|
(R&R) Application Guide must be followed.</p>
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).</p>
|
|
|
|
<p class=regulartext>All instructions in the SF424
|
|
(R&R) Application Guide must be followed. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS Assignment Request
|
|
Form (Overall)</div>
|
|
|
|
<p class=regulartext>All instructions in the SF424
|
|
(R&R) Application Guide must be followed. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">Administrative Core</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Admin
|
|
Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Administrative
|
|
Core)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Administrative
|
|
Core)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in
|
|
each relevant component.</p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Research & Related Other
|
|
Project Information (Administrative Core)</div>
|
|
|
|
<p class=regulartext><b>Human Subjects:</b> Answer only
|
|
the Are Human Subjects Involved? and 'Is the Project Exempt from Federal
|
|
regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Vertebrate Animals:</b> Answer
|
|
only the Are Vertebrate Animals Used? question.</p>
|
|
<p class=regulartext><b>Project Narrative: </b>Do not
|
|
complete. Note: ASSIST screens will show an asterisk for this attachment
|
|
indicating it is required. However, eRA systems only enforce this requirement
|
|
in the Overall component and applications will not receive an error if omitted
|
|
in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site
|
|
Location(s) (Administrative Core)</div>
|
|
|
|
<p class=regulartext>List all performance sites that
|
|
apply to the specific component.</p>
|
|
<p class=regulartext><i>Note: The Project Performance
|
|
Site form allows up to 300 sites, prior to using additional attachment for
|
|
additional entries.</i></p>
|
|
<div class="heading4">Research & Related
|
|
Senior/Key Person Profile (Administrative Core)</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
<li>
|
|
For institutions/organizations proposing a single PD/PI, the PD/PI
|
|
must serve as the Administrative Core Lead. For institutions/organizations
|
|
proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the
|
|
Administrative Core Lead. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Administrative Core)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the
|
|
specific component will be included in the application package.</p>
|
|
<p class=regulartext><i>Note: The R&R Budget form
|
|
included in many of the component types allows for up to 100 Senior/Key Persons
|
|
in section A and 100 Equipment Items in section C prior to using attachments
|
|
for additional entries. All other SF424 (R&R) instructions apply.</i></p>
|
|
<div class="heading4">PHS 398 Research Plan (Administrative
|
|
Core)</div>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Specific Aims:</b><strong> </strong>List in priority
|
|
order the activities and services of the Administrative Core. Describe the work
|
|
to be completed to address issues of program coordination, communication, and
|
|
management. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Research Strategy: </b> Provide
|
|
a staffing and administrative plan that includes a discussion of the structure
|
|
and roles of administrative and scientific staff for the core, and the
|
|
functions to be performed; how resources will be prioritized, allocated, and
|
|
managed; and how to enable compliance with the data sharing and other resource
|
|
sharing policies. Provide a management plan for fiscal accountability,
|
|
communication within the program, including group meetings and teleconferences.
|
|
Provide a plan for coordination, problem identification and resolution, and the
|
|
establishment of a strong collaborative environment for the center.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Optionally, an External Scientific
|
|
Advisory Group (ESAG) may be formed after award at the discretion of the
|
|
PD(s)/PI(s) to evaluate and advise on scientific progress within the center.
|
|
For renewal applications: identify any current or former ESAG members. New
|
|
applications should <em>not</em>
|
|
name, recruit or contact potential ESAG members until after an award is made. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=P_SingleIndent>Note: Effective for due dates on or after January 25,
|
|
2023, the Data Management and Sharing Plan will be attached in the Other
|
|
Plan(s) attachment of the Overall component in FORMS-H application forms
|
|
packages.</p>
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed, with the following additional instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Appendix:</b> </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix.Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information
|
|
(Administrative Core)</div>
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
<p class=P_SingleIndent>If you answered Yes to the question Are Human
|
|
Subjects Involved? on the R&R Other Project Information form, you must
|
|
include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and
|
|
Clinical Trials Information</strong><strong> </strong>form or a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424
|
|
(R&R) Application Guide must be followed.</p>
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
|
|
Application Guide must be followed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Infrastructure and Opportunity Fund Management Core</div>
|
|
|
|
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Infrastructure and Opportunity
|
|
Fund Management Core)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Infrastructure and
|
|
Opportunity Fund Management Core)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Research & Related Other Project Information (Infrastructure
|
|
and Opportunity Fund Management Core)</div>
|
|
|
|
<p class=regulartext><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site Location(s) (Infrastructure and
|
|
Opportunity Fund Management Core)</div>
|
|
|
|
<p class=regulartext>List all performance sites that apply to the specific
|
|
component.</p>
|
|
<p class=regulartext>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">Research & Related Senior/Key Person Profile (Infrastructure
|
|
and Opportunity Fund Management Core)<br>
|
|
<br>
|
|
</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used.</li>
|
|
<li>
|
|
Multiple Core Leads are NOT permitted for IOF Management Core. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Infrastructure and Opportunity Fund Management Core)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>The budget for Infrastructure and Opportunity Fund (IOF) Management
|
|
Core is not expected to exceed $900,000 direct costs per year, of which
|
|
$150,000 may be budgeted for management of the core. IOF Management Core
|
|
application budgets must include the following costs:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
A maximum of 1.2 person months' salary for the IOF Management
|
|
Leader. </li>
|
|
<li>
|
|
A minimum of 6 person months' salary for an IOF administrator and
|
|
a maximum of 6 person months for Information Technology staff (if required) to
|
|
be included in the Other Personnel category. </li>
|
|
<li>
|
|
IT computing supplies, if required. </li>
|
|
<li>
|
|
Costs for pilot/feasibility projects per year to be included in
|
|
the Other Direct Costs category for the remaining funds. </li>
|
|
<li>
|
|
IOF travel for either the IOF administrator or IT staff member to
|
|
attend the annual program Steering Committee meeting (one-day meeting) in
|
|
Bethesda/Rockville, Maryland area. </li>
|
|
<li>
|
|
Include travel funds for the core lead and up to one (1)
|
|
additional staff member to participate in the CCHI annual face-to-face meeting,
|
|
to be held in the Bethesda/Rockville, MD area (two days per annual meeting).</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Research Plan (Infrastructure and Opportunity
|
|
Fund Management Core)</div>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Specific
|
|
Aims:</strong><strong> </strong>List
|
|
in priority order the proposed activities and services of the IOF Management
|
|
Core. Concisely and realistically describe the work to be completed to address
|
|
issues of program coordination, communication, and fiscal management. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research Strategy: </strong>The
|
|
IOF management plan is expected to include:</p>
|
|
<ul>
|
|
<li>
|
|
an administrative structure; </li>
|
|
<li>
|
|
plans for the logistics for solicitation, review, and award of
|
|
pilot projects, including receipt of applications; </li>
|
|
<li>
|
|
proposed procedures to support the Steering Committee in the
|
|
timely award of consortium agreements, including the time interval for
|
|
establishment and renewal or consortium agreements</li>
|
|
<li>
|
|
tracking and monitoring of timely submission and payment of
|
|
invoices, and plans for handling consortium agreement administration delays; </li>
|
|
<li>
|
|
plans for interacting with the institutions that will receive IOF
|
|
funds; </li>
|
|
<li>
|
|
reporting on the status of the funds and consortium agreements
|
|
awarded;</li>
|
|
<li>
|
|
providing an administrative assistant to coordinate these activities
|
|
with the NIAID, Steering Committee and the institution’s grants and contracts
|
|
staff; </li>
|
|
<li>
|
|
providing IT support for the maintenance and/or development of an
|
|
internal website, if required; </li>
|
|
<li>
|
|
include a statement of commitment from the Institution’s signing
|
|
official agreeing to take fiscal responsibility for the management of the
|
|
Infrastructure and Opportunities Funds, if chosen by NIAID to administer the
|
|
fund. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>This section should only include information about
|
|
the management of the IOF and should NOT include any IOF proposed research
|
|
projects.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=P_SingleIndent>Note: Effective for due dates on or after January 25,
|
|
2023, the Data Management and Sharing Plan will be attached in the Other
|
|
Plan(s) attachment of the Overall component in FORMS-H application forms
|
|
packages.</p>
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed, with the following additional instructions:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=Bullet><strong>Appendix:
|
|
</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information (Infrastructure
|
|
and Opportunity Fund Management Core)</div>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<p class=regulartext>When involving human subjects research, clinical research,
|
|
and/or NIH-defined clinical trials follow all instructions for the PHS Human
|
|
Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If you answered Yes to the question Are Human Subjects
|
|
Involved? on the R&R Other Project Information form, you must include at
|
|
least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials
|
|
Information </strong>form or a <strong>Delayed
|
|
Onset Study</strong> record.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
|
|
Application Guide must be followed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Clinical Core</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Clinical Core)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Clinical Core)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Research & Related Other Project Information (Clinical
|
|
Core)</div>
|
|
|
|
<p class=regulartext><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site Location(s) (Clinical Core)</div>
|
|
|
|
<p class=regulartext>List all performance sites that apply to the specific
|
|
component.</p>
|
|
<p class=regulartext>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
<div class="heading4">Research & Related Senior/Key Person Profile (Clinical
|
|
Core)<br>
|
|
<br>
|
|
</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Clinical Core)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Include funds to support all functions of this core including
|
|
clinical protocol development, informed consent form development, development
|
|
of a manual of procedures for each clinical protocol that the CCHI will
|
|
conduct, development of protocol-specific case report forms, training of
|
|
clinical personnel prior to protocol initiation (both cGCP and
|
|
protocol-specific training), monitoring of the clinical component of the study,
|
|
capturing and reporting adverse events related to any intervention or procedure
|
|
and handling protocol deviations. </li>
|
|
<li>
|
|
Include travel funds for the Core Lead and up to three (3)
|
|
additional scientific staff to participate in the CCHI annual face-to-face
|
|
meeting, to be held in the Bethesda/Rockville, MD area (two days per annual
|
|
meeting).</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
<div class="heading4">PHS 398 Research Plan (Clinical Core)</div>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=regulartext><strong>Specific
|
|
Aims:</strong><strong> </strong>List
|
|
in priority order the proposed activities and services of the Clinical Core.
|
|
Describe the work to be completed indicating the core’s relationship to the
|
|
program’s goals. The Clinical Core must support the activities of at least two
|
|
of the projects.<strong> </strong></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research Strategy: </strong></p>
|
|
<ul>
|
|
<li>
|
|
Explain how the core will serve the proposed research projects.
|
|
For example, describe core activities to provide a uniform screening and
|
|
characterization of potential participants in the studies proposed by each of
|
|
the center’s research projects. </li>
|
|
<li>
|
|
Describe the clinical outcomes that will be captured and the
|
|
methodologies that will be used. </li>
|
|
<li>
|
|
Describe processes and procedures for clinical protocol
|
|
development, informed consent form development, development of a manual of
|
|
procedures for each clinical protocol that the center will conduct, development
|
|
of protocol-specific case report forms, training of clinical personnel prior to
|
|
protocol initiation (both cGCP and protocol-specific training), preparing IRB
|
|
applications and other approval processes, preparing annual progress reports to
|
|
the IRB and NIH, monitoring of the clinical component of the study, capturing
|
|
and reporting adverse events related to any intervention or procedure, and
|
|
handling protocol deviations.</li>
|
|
<li>Describe and justify any incentives provided to subjects
|
|
to participate in the proposed study, if in addition to those under the parent
|
|
clinical trial. <strong> </strong></li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Letters
|
|
of Support: </strong>Provide any institutional letters of support
|
|
specific to the Clinical Core.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=MsoCommentText><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment of the Overall component in FORMS-H application forms packages.</p>
|
|
<p class=MsoCommentText>All instructions in the SF424
|
|
(R&R) Application Guide must be followed, with the following additional
|
|
instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Appendix:
|
|
</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Only limited items are allowed in the Appendix. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application
|
|
Guide; any instructions provided here are in addition to the SF424 (R&R)
|
|
Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Include the following:</p>
|
|
<ul>
|
|
<li>
|
|
blank informed consent forms for the parent clinical trial(s)</li>
|
|
<li>
|
|
blank informed consent forms for the proposed additional studies,
|
|
if different from the parent trial(s)</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>It is recommended that applications submitted under this FOA
|
|
have clear language in the informed consent form(s) that distinguishes proposed
|
|
immune profiling studies from the clinical trials with which they are linked.
|
|
It is also recommended that the following items be clarified in the consent
|
|
form: 1) additional blood or tissue that will be collected as part of the
|
|
proposed profiling study; 2) the right of the subjects to refuse to participate
|
|
in the proposed profiling study and still participate in the parent clinical
|
|
trial; 3) that no charges to the subject for participation in the proposed
|
|
profiling study are incurred; and 4) agreement to share the subject s
|
|
de-identified data obtained from the immune profiling study as well as the
|
|
parent trial. </p>
|
|
|
|
|
|
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information (Clinical
|
|
Core)</div>
|
|
<p class=regulartext>When involving human subjects research, clinical research,
|
|
and/or NIH-defined clinical trials follow all instructions for the PHS Human
|
|
Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If you answered Yes to the question Are Human Subjects
|
|
Involved? on the R&R Other Project Information form, you must include at
|
|
least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials
|
|
Information </strong>form or a <strong>Delayed
|
|
Onset Study</strong> record.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For all clinical research or trial protocols and procedures
|
|
that span multiple Research Projects, enter requested information in the PHS
|
|
Human Subjects and Clinical Trials Information section associated with the
|
|
Clinical Core, not the Overall component. Do not duplicate information
|
|
requested under the PHS Human Subjects and Clinical Trials Information Forms
|
|
across components. Human subject details that are specific to a particular
|
|
Research Project should be entered in the PHS Human Subjects and Clinical
|
|
Trials Information Forms in the appropriate Research Project component. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>The materials from the independently-funded clinical trials
|
|
should identify the Research Projects they will provide with tissue samples. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start). All instructions in the SF424 (R&R)
|
|
Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<div class="heading4">Service Core</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Service Core)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Service Core)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
<p class=heading4Indent> </p>
|
|
|
|
<div class="heading4">Research & Related Other Project Information (Service
|
|
Core)</div>
|
|
|
|
<p class=regulartext><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site Location(s) (Service Core)</div>
|
|
|
|
<p class=regulartext>List all performance sites that apply to the specific
|
|
component.</p>
|
|
<p class=regulartext><em>Note: The
|
|
Project Performance Site form allows up to 300 sites, prior to using additional
|
|
attachment for additional entries.</em></p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">Research & Related Senior/Key Person Profile (Service
|
|
Core)</div>
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Service Core)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the specific component will be
|
|
included in the application package.</p>
|
|
<ul>
|
|
<li>
|
|
Include travel funds for the Service Core Lead and up to two
|
|
additional scientific staff to participate in the CCHI annual face-to-face
|
|
meeting, to be held in the Bethesda/Rockville, MD area (two days per annual
|
|
meeting).</li>
|
|
<li>
|
|
For cores obtaining samples from independently funded clinical
|
|
trials, include the following costs, when such costs are not included in the
|
|
Projects: additional clinical trial-related activities such as the costs of
|
|
re-consenting study participants, preparation of protocol or IND amendments,
|
|
and additional sample collection, preparation, and shipping.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
<div class="heading4">PHS 398 Research Plan (Service Core)</div>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Specific
|
|
Aims:</strong><strong> </strong> List
|
|
in priority order the activities and services of the Service Core. In addition,
|
|
state the core’s relationship to the center’s goals and how it will support the
|
|
research proposed by two or more individual research projects in the
|
|
application. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research Strategy: </strong>Indicate
|
|
the specific projects to be served by the core and explain why the Core
|
|
resources are not otherwise available. Describe the reagents, resources,
|
|
technologies, or other services to be provided by the core. Describe how it
|
|
will serve multiple projects and explain how requests will be prioritized and
|
|
coordinated. Any proposed development of new technologies, assays, etc. must be
|
|
presented within a research/technology development project and not in a Service
|
|
Core.</p>
|
|
<p class=P_SingleIndent>If the Service Core proposes
|
|
clinical studies designed only to collect and provide samples for two or more
|
|
research projects, this section must describe the following aspects of the
|
|
proposed trial(s)/study(ies):</p>
|
|
<ul>
|
|
<li>
|
|
Discuss the role of the study in the overall research strategy of
|
|
the application. Outline the objectives and concisely describe the design of
|
|
the proposed study, include rationale and process for the selection of the
|
|
participant population, choice of intervention (if applicable), choice of study
|
|
sites, and duration and schedule of events. </li>
|
|
<li>
|
|
Discuss the study's feasibility. If applicable, include general
|
|
concepts for sample size determinations and statistical methodologies, and
|
|
provide study-specific details in the PHS Human Subjects and Clinical Trial
|
|
Information Forms.</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>Note: Specific details for clinical
|
|
trials and clinical studies will be captured using the PHS Human Subjects and
|
|
Clinical Trials Information Form. Do not duplicate information requested under
|
|
the PHS Human Subjects and Clinical Trials Information Forms.</p>
|
|
<p class=P_SingleIndent>If the data management
|
|
activities are included in a Service Core, describe the data management infrastructure
|
|
that will support the proposed activities and how the services of this core
|
|
will support and advance the outcomes from the proposed research program.</p>
|
|
<p class=P_SingleIndent><em>Staffing Plan:</em> Include a description of a
|
|
staffing plan that will support the functions associated with this core,
|
|
including any professional staff or staff with specialized skills to fully
|
|
address the extent of core needs and submission of data, meta-data, and related
|
|
data analyses to the ImmPort database (or other appropriate public databases
|
|
designated by NIAID) (<a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">https://www.immport.org/home</a>).</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=regulartext><strong>Letters
|
|
of Support: </strong>Provide any institutional letters of support
|
|
specific to the Service Core.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=MsoCommentText><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment of the Overall component in FORMS-H application forms packages.</p>
|
|
<p class=MsoCommentText>All instructions in the SF424
|
|
(R&R) Application Guide must be followed, with the following additional
|
|
instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Appendix:
|
|
</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Only limited items are allowed in the Appendix. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application
|
|
Guide; any instructions provided here are in addition to the SF424 (R&R)
|
|
Application Guide instructions. </p>
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information (Service
|
|
Core)</div>
|
|
<p class=regulartext>When involving human subjects research, clinical research,
|
|
and/or NIH-defined clinical trials follow all instructions for the PHS Human
|
|
Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If you answered Yes to the question Are Human Subjects
|
|
Involved? on the R&R Other Project Information form, you must include at
|
|
least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials
|
|
Information </strong>form or a <strong>Delayed
|
|
Onset Study</strong> record.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
|
|
Application Guide must be followed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Research Project</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Project. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data
|
|
Management and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Research Project)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Research Project)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
<div class="heading4">Research & Related Other Project Information (Research
|
|
Project)</div>
|
|
|
|
<p class=regulartext><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site Location(s) (Research Project)</div>
|
|
|
|
<p class=regulartext>List all performance sites that apply to the specific
|
|
component.</p>
|
|
<p class=regulartext>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
<div class="heading4">Research & Related Senior/Key Person Profile (Research
|
|
Project)<br>
|
|
<br>
|
|
</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Project Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Research Project)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Include travel funds for the Project Lead and up to three (3)
|
|
additional scientific staff to participate in the CCHI annual face-to-face
|
|
meeting, to be held in the Bethesda/Rockville, MD area (two days per annual
|
|
meeting).</li>
|
|
<li>
|
|
If samples for the proposed studies are to be collected from a
|
|
CCHI-funded clinical trial or study include the following costs, when such
|
|
costs have not been included under a Service Core or Clinical Core: clinical
|
|
protocol development, informed consent form development, development of a
|
|
manual of procedures for each clinical protocol that the CCHI center will
|
|
conduct, development of protocol-specific case report forms, training of
|
|
clinical personnel prior to protocol initiation (both cGCP and
|
|
protocol-specific training), monitoring of the clinical component of the study,
|
|
and capturing and reporting adverse events related to any intervention or
|
|
procedure and handling protocol deviations.</li>
|
|
<li>
|
|
If samples for the proposed studies are to be collected from an
|
|
independently funded clinical trial include the following costs, when such
|
|
costs have not been included under a Service Core: the costs of re-consenting
|
|
study participants, preparation of protocol or IND amendments, and additional
|
|
sample collection, preparation, and shipping</li>
|
|
</ul>
|
|
<p class=regulartext>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Research Plan (Research Project)</div>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Specific
|
|
Aims:</strong><strong> </strong>List,
|
|
in priority order, the broad long-range objectives and goals of the proposed project.
|
|
Concisely describe the hypothesis or hypotheses to be tested. In addition,
|
|
state the individual research project's relationship to the center’s goals and
|
|
how it is related to other projects or cores to create synergy. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research Strategy: </strong>Describe
|
|
how the proposed studies will utilize primary human immune cells, fluids, or
|
|
tissues and, if needed, relevant animal models, to provide mechanistic insights
|
|
that will advance our understanding of human immune function or regulation
|
|
applicable to (1) the innate, adaptive, and mucosal immune responses to
|
|
infection, vaccination, and adjuvants, or (2) immune-mediated diseases (if
|
|
applicable).</p>
|
|
<ul>
|
|
<li>
|
|
Explain the rationale for selecting the methods and approaches to
|
|
accomplish the specific aims, including the selection of sample sources.</li>
|
|
<li>
|
|
State the biological significance of the research. Explain how
|
|
the Research Project addresses the common immunological theme of the
|
|
application and how the project contributes to the overall goals of the center.</li>
|
|
<li>
|
|
Include a data and/or statistical analysis plan that describes
|
|
how data will be analyzed. For clinical trials, applicants will provide
|
|
specific statistical design and power information under the PHS Human Subjects
|
|
and Clinical Trials Information, and these should not be duplicated under the
|
|
Research Strategy.</li>
|
|
<li>
|
|
Explain how animal studies will provide mechanistic insights into
|
|
immune function or regulation, and discuss how they will extend/complement the
|
|
findings of proposed human studies.</li>
|
|
</ul>
|
|
|
|
<p class=Bullet><em>Milestones and Timelines:</em>
|
|
In a clearly labeled section, describe annual milestones and timelines for the
|
|
Research Project. For clinical trials, applicants will provide specific
|
|
clinical trials timelines under the PHS Human Subjects and Clinical Trials
|
|
Information, and these should not be duplicated under the Research Strategy.</p>
|
|
<p class=regulartext><strong>Letters
|
|
of Support: </strong>Provide any institutional letters of support
|
|
specific to the Research Project, including a Memorandum of Understanding (MOU)
|
|
or Materials Transfer Agreement (MTA) that documents availability and/or access
|
|
to human materials for each source (<em>i.e.</em>,
|
|
sample availability corresponding to the outlined Milestones and Timelines).</p>
|
|
|
|
|
|
|
|
<p class=MsoCommentText><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment of the Overall component in FORMS-H application forms packages.</p>
|
|
<p class=MsoCommentText>All instructions in the SF424
|
|
(R&R) Application Guide must be followed, with the following additional
|
|
instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Appendix:
|
|
</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Only limited items are allowed in the Appendix. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application Guide;
|
|
any instructions provided here are in addition to the SF424 (R&R)
|
|
Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information (Research
|
|
Project)</div>
|
|
<p class=regulartext>When involving human subjects research, clinical research,
|
|
and/or NIH-defined clinical trials follow all instructions for the PHS Human
|
|
Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If you answered Yes to the question Are Human Subjects
|
|
Involved? on the R&R Other Project Information form, you must include at
|
|
least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials
|
|
Information </strong>form or a <strong>Delayed
|
|
Onset Study</strong> record.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Section
|
|
2 - Study Population Characteristics</strong></p>
|
|
|
|
<p class=regulartext><strong>2.7 -
|
|
Study Timeline</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>A study timeline is required for all studies utilizing human
|
|
biospecimens, including studies that are not clinical trials and selecting
|
|
exemption 4. For studies using human biospecimens collected from
|
|
independently-funded clinical research or clinical trials, provide a timeline
|
|
for obtaining these samples and implementing the proposed project.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
|
|
Application Guide must be followed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Technology Development Project</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Project. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment in FORMS-H application forms packages. If required, the Data Management
|
|
and Sharing (DMS) Plan must be provided in the Overall component.</p>
|
|
|
|
|
|
|
|
<div class="heading4">SF424 (R&R) Cover (Technology Development Project)</div>
|
|
|
|
<p class=regulartext>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
<div class="heading4">PHS 398 Cover Page Supplement (Technology Development
|
|
Project)</div>
|
|
|
|
<p class=regulartext>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
<div class="heading4">Research & Related Other Project Information (Technology
|
|
Development Project)</div>
|
|
|
|
<p class=regulartext><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Project /Performance Site Location(s) (Technology
|
|
Development Project)</div>
|
|
|
|
<p class=regulartext>List all performance sites that apply to the specific
|
|
component.</p>
|
|
<p class=regulartext>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">Research & Related Senior/Key Person Profile (Technology
|
|
Development Project)<br>
|
|
<br>
|
|
</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Project Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
<div class="heading4">Budget (Technology Development Project)</div>
|
|
|
|
<p class=regulartext>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Include travel funds for the Project Lead and up to three (3)
|
|
additional scientific staff to participate in the CCHI annual face-to-face
|
|
meeting, to be held in the Bethesda/Rockville, MD area (two days per annual
|
|
meeting).</li>
|
|
<li>
|
|
Include costs associated with the Project's submission of data
|
|
into the ImmPort (<a href="https://immport.niaid.nih.gov/home">https://immport.niaid.nih.gov/home</a>)
|
|
database or other publicly accessible database approved by NIAID (as
|
|
appropriate) when such costs are not included in the Administrative Core.</li>
|
|
</ul>
|
|
<p class=regulartext>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS 398 Research Plan (Technology Development Project)</div>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Specific
|
|
Aims:</strong><strong> </strong> List,
|
|
in priority order, the broad long-range objectives and goals of the proposed
|
|
project. Concisely describe the hypothesis or hypotheses to be tested, or the
|
|
rationale for technology development. In addition, state the individual
|
|
research project's relationship to the center’s goals and how it is relates to
|
|
other projects or cores to create synergy. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Research
|
|
Strategy: </strong>Describe how the proposed research will develop a new,
|
|
or significantly enhance, an existing technology(ies), assay(s) and/or
|
|
computational tool(s) relevant to the proposed Research Projects and the
|
|
rationale for selecting the methods to accomplish the specific aims. State the
|
|
biological significance of the research. Discuss how the proposed research will
|
|
address an unmet need that contributes to the common theme and the overall
|
|
goals of the center. Describe the potential benefit to the scientific community
|
|
at large and have a variety of biomedical research applications.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Milestones and Timelines:</em> In a clearly
|
|
labeled section, describe annual milestones and timelines for the project.</p>
|
|
<p class=P_SingleIndent>For clinical trials,
|
|
applicants will provide specific clinical trials timelines under the PHS Human
|
|
Subjects and Clinical Trials Information, and these should not be duplicated
|
|
under the Research Strategy.</p>
|
|
<p class=regulartext><strong>Letters
|
|
of Support: </strong>Provide any institutional letters of support
|
|
specific to the Research Project, including a Memorandum of Understanding (MOU)
|
|
or Materials Transfer Agreement (MTA) that documents availability and/or access
|
|
to human materials for each source (<em>i.e.</em>,
|
|
sample availability corresponding to the outlined Milestones and Timelines). </p>
|
|
|
|
<p class=Bullet> </p>
|
|
|
|
<p class=MsoCommentText><strong>Other
|
|
Plan(s):</strong></p>
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Management and Sharing Plan will be attached in the Other Plan(s)
|
|
attachment of the Overall component in FORMS-H application forms packages.</p>
|
|
<p class=MsoCommentText>All instructions in the SF424
|
|
(R&R) Application Guide must be followed, with the following additional
|
|
instructions:</p>
|
|
<ul>
|
|
<li>
|
|
All applicants planning research (funded or conducted in whole or
|
|
in part by NIH) that results in the generation of scientific data are required
|
|
to comply with the instructions for the Data Management and Sharing Plan. All
|
|
applications, regardless of the amount of direct costs requested for any one
|
|
year, must address a Data Management and Sharing Plan. The Data Management and
|
|
Sharing (DMS) Plan must be provided in the Overall component.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Appendix:
|
|
</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Only limited items are allowed in the Appendix. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application
|
|
Guide; any instructions provided here are in addition to the SF424 (R&R)
|
|
Application Guide instructions. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information (Technology
|
|
Development Project)</div>
|
|
<p class=P_SingleIndent>When involving human subjects
|
|
research, clinical research, and/or NIH-defined clinical trials follow all
|
|
instructions for the PHS Human Subjects and Clinical Trials Information form in
|
|
the SF424 (R&R) Application Guide, with the following additional
|
|
instructions:</p>
|
|
<p class=P_SingleIndent>If you answered Yes to the
|
|
question Are Human Subjects Involved? on the R&R Other Project
|
|
Information form, you must include at least one human subjects study record
|
|
using the <strong>Study Record:
|
|
PHS Human Subjects and Clinical Trials Information </strong>form or a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study Record: PHS Human Subjects and
|
|
Clinical Trials Information</strong></p>
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Section 2 - Study Population
|
|
Characteristics</strong></p>
|
|
|
|
<p class=P_SingleIndent><strong>2.7 - Study Timeline</strong></p>
|
|
<p class=P_SingleIndent>A study timeline is required
|
|
for all studies utilizing human biospecimens, including studies that are not
|
|
clinical trials and selecting exemption 4. For studies using human biospecimens
|
|
collected from independently-funded clinical research or clinical trials,
|
|
provide a timeline for obtaining these samples and implementing the proposed
|
|
project. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Delayed Onset Study</strong></p>
|
|
|
|
<p class=regulartext>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
|
|
Application Guide must be followed. </p>
|
|
|
|
|
|
|
|
<div class="heading3">3. Unique Entity Identifier
|
|
and System for Award Management (SAM)</div>
|
|
|
|
<p class=regulartext>See Part 1. Section III.1 for information regarding the
|
|
requirement for obtaining a unique entity identifier and for completing and
|
|
maintaining active registrations in System for Award Management (SAM), NATO
|
|
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
|
|
Grants.gov.</p>
|
|
|
|
<p class=regulartext> </p>
|
|
|
|
<div class="heading3">4. Submission Dates and
|
|
Times</div>
|
|
|
|
<p class=regulartext><a href="#_Part_1._Overview">Part I. Overview Information</a>
|
|
contains information about Key Dates and times. Applicants are encouraged to
|
|
submit applications before the due date to ensure they have time to make any
|
|
application corrections that might be necessary for successful submission. When
|
|
a submission date falls on a weekend or <a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82380">Federal
|
|
holiday</a>, the application deadline is automatically extended to the next
|
|
business day.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Organizations must submit applications to <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128"
|
|
target="_blank">Grants.gov</a> (the online portal to find and apply for grants
|
|
across all Federal agencies) using ASSIST or other electronic submission
|
|
systems. Applicants must then complete the submission process by tracking the
|
|
status of the application in the <a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123"
|
|
target="_blank">eRA Commons</a>, NIH’s electronic system for grants
|
|
administration. NIH and Grants.gov systems check the application against many
|
|
of the application instructions upon submission. Errors must be corrected and a
|
|
changed/corrected application must be submitted to Grants.gov on or before the
|
|
application due date and time. If a Changed/Corrected application is submitted
|
|
after the deadline, the application will be considered late. Applications that
|
|
miss the due date and time are subjected to the NIH Policy on Late Application
|
|
Submission. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Applicants
|
|
are responsible for viewing their application before the due date in the eRA
|
|
Commons to ensure accurate and successful submission. </strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Information on the submission process and a definition of
|
|
on-time submission are provided in the SF424 (R&R) Application Guide.</p>
|
|
|
|
|
|
|
|
<div class="heading3">5. Intergovernmental Review
|
|
(E.O. 12372)</div>
|
|
|
|
<p class=regulartext>This initiative is not subject to <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/html5/section_10/10.10.1_executive_orders.htm">intergovernmental
|
|
review.</a> </p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_5._Funding_Restrictions"></a>6. Funding Restrictions</div>
|
|
|
|
<p class=regulartext>All NIH awards are subject to the terms and conditions, cost
|
|
principles, and other considerations described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></a>. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Pre-award costs are allowable only as described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11143"><i>NIH
|
|
Grants Policy Statement</i></a>.</p>
|
|
|
|
|
|
|
|
<div class="heading3">7. Other Submission
|
|
Requirements and Information</div>
|
|
|
|
<p class=regulartext>Applications must be submitted electronically following the
|
|
instructions described in the SF424 (R&R) Application Guide. Paper
|
|
applications will not be accepted.</p>
|
|
<p class=regulartext>For information on how your application will be
|
|
automatically assembled for review and funding consideration after submission
|
|
go to: <a
|
|
href="//grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf">http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf</a>. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Applicants must complete all required registrations before
|
|
the application due date.</b> <span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section III.
|
|
Eligibility Information</a></span> contains information about registration.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For assistance with your electronic application or for more information on the electronic submission
|
|
process, visit <a
|
|
href="https://grants.nih.gov/grants/how-to-apply-application-guide.html">How to
|
|
Apply Application Guide</a>. If you encounter a system issue beyond your
|
|
control that threatens your ability to complete the submission process on-time,
|
|
you must follow the <a
|
|
href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm">Dealing
|
|
with System Issues</a> guidance. For assistance
|
|
with application submission, contact the Application Submission Contacts in <a
|
|
href="#_Section_VII._Agency">Section VII</a>.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Important reminders:</strong></p>
|
|
|
|
<p class=regulartext>All PD(s)/PI(s) and component
|
|
Project Leads must include their eRA Commons ID in the Credential field<b> </b>of
|
|
the Senior/Key Person Profile form<b>. </b>Failure to register in the Commons
|
|
and to include a valid PD/PI Commons ID in the credential field will prevent
|
|
the successful submission of an electronic application to NIH.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The applicant organization must
|
|
ensure that the unique entity identifier provided on the application is the
|
|
same identifier used in the organization’s profile in the eRA Commons and for
|
|
the System for Award Management. Additional information may be found in the
|
|
SF424 (R&R) Application Guide.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>See <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a>
|
|
for avoiding common errors.</p>
|
|
<p class=regulartext>Upon receipt, applications will be evaluated for
|
|
completeness and compliance with application
|
|
instructions by the Center for Scientific Review and responsiveness by
|
|
NIAID, NIH. Applications that are incomplete,
|
|
non-compliant and/or nonresponsive will not be reviewed.</p>
|
|
|
|
<div class="heading4"><a name="_Toc258873270"> </a></div>
|
|
|
|
<div class="heading4">Post Submission Materials</div>
|
|
|
|
<p class=regulartext>Applicants are required to follow the instructions for
|
|
post-submission materials, as described in <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82299">the policy</a>.
|
|
Any instructions
|
|
provided here are in addition to the instructions in the policy.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Section_V._Application"></a>Section V. Application Review Information</div>
|
|
|
|
<div class="heading3"><a name="_1._Criteria"></a>1.
|
|
Criteria</div>
|
|
|
|
<p class=regulartext>Only the review criteria described below will be considered
|
|
in the review process. Applications submitted to the NIH in support of the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a>
|
|
are evaluated for scientific and technical merit through the NIH peer review
|
|
system.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: Effective for due dates on or after January 25, 2023,
|
|
the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated
|
|
at time of review.</p>
|
|
|
|
|
|
|
|
<p class=regulartext> In addition, for applications involving clinical trials:</p>
|
|
|
|
|
|
|
|
<p class=regulartext>A proposed Clinical Trial application may include study
|
|
design, methods, and intervention that are not by themselves innovative but
|
|
address important questions or unmet needs. Additionally, the results of the
|
|
clinical trial may indicate that further clinical development of the
|
|
intervention is unwarranted or lead to new avenues of scientific investigation.
|
|
</p>
|
|
|
|
|
|
|
|
<div class="heading4">Overall Impact - Overall</div>
|
|
|
|
<p class=regulartext>Reviewers will provide an overall impact score to reflect
|
|
their assessment of the likelihood for the center to exert a sustained,
|
|
powerful influence on the research field(s) involved, in consideration of the
|
|
following review criteria and additional review criteria (as applicable for the
|
|
center proposed).</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_1"></a>Scored Review Criteria - Overall</div>
|
|
|
|
<p class=regulartext>Reviewers will consider each of the review criteria below in
|
|
the determination of scientific merit and give a separate score for each. An
|
|
application does not need to be strong in all categories to be judged likely to
|
|
have major scientific impact. For example, a center that by its nature is not
|
|
innovative may be essential to advance a field.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Significance</div>
|
|
|
|
<p class=regulartext>Does the center address an
|
|
important problem or a critical barrier to progress in the field? Is the prior research
|
|
that serves as the key support for the proposed center rigorous? If the aims
|
|
of the center are achieved, how will scientific knowledge, technical capability,
|
|
and/or clinical practice be improved? How will successful completion of the
|
|
aims change the concepts, methods, technologies, treatments, services, or
|
|
preventative interventions that drive this field? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Specific
|
|
to this FOA:</em></p>
|
|
<p class=P_SingleIndent>How adequately does the application
|
|
focus on the study of mechanisms by which the human immune system is activated
|
|
and regulated?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Are the scientific rationale and
|
|
need for a clinical trial to test the proposed hypothesis or intervention well
|
|
supported by preliminary data, clinical and/or preclinical studies, or
|
|
information in the literature or knowledge of biological mechanisms? For trials
|
|
focusing on clinical or public health endpoints, is this clinical trial necessary
|
|
for testing the safety, efficacy, or effectiveness of an intervention that
|
|
could lead to a change in clinical practice, community behaviors or health care
|
|
policy? For trials focusing on mechanistic, behavioral, physiological,
|
|
biochemical, or other biomedical endpoints, is this trial needed to advance
|
|
scientific understanding?</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_2"></a>Investigator(s)</div>
|
|
|
|
<p class=regulartext>Are the PD(s)/PI(s), collaborators,
|
|
and other researchers well suited to the center? If Early Stage Investigators
|
|
or those in the early stages of independent careers, do they have appropriate
|
|
experience and training? If established, have they demonstrated an ongoing
|
|
record of accomplishments that have advanced their field(s)? If the center is
|
|
collaborative or multi-PD/PI, do the investigators have complementary and
|
|
integrated expertise; are their leadership approach, governance and
|
|
organizational structure appropriate for the center? </p>
|
|
|
|
<p class=P_SingleIndent><strong> </strong></p>
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>With regard to the proposed leadership for the center,
|
|
do the PD/PI(s) and key personnel have the expertise, experience, and ability
|
|
to organize, manage and implement the proposed clinical trial and meet
|
|
milestones and timelines? Do they have appropriate expertise in study
|
|
coordination, data management and statistics? For a multicenter trial, is the
|
|
organizational structure appropriate and does the application identify a core
|
|
of potential center investigators and staffing for a coordinating center? </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_3"></a>Innovation</div>
|
|
|
|
<p class=regulartext>Does the application challenge and
|
|
seek to shift current research or clinical practice paradigms by utilizing
|
|
novel theoretical concepts, approaches or methodologies, instrumentation, or
|
|
interventions? Are the concepts, approaches or methodologies, instrumentation,
|
|
or interventions novel to one field of research or novel in a broad sense? Is a
|
|
refinement, improvement, or new application of theoretical concepts, approaches
|
|
or methodologies, instrumentation, or interventions proposed? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Does the design/research plan include innovative
|
|
elements, as appropriate, that enhance its sensitivity, potential for
|
|
information or potential to advance scientific knowledge or clinical practice? </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_4"></a>Approach</div>
|
|
|
|
<p class=regulartext>Are the overall strategy,
|
|
methodology, and analyses well-reasoned and appropriate to accomplish the
|
|
specific aims of the center? Have investigators included plans to address
|
|
weaknesses in the rigor of prior research that serves as the key support for
|
|
the proposed project? Have the investigators presented strategies to ensure a
|
|
robust and unbiased approach, as appropriate for the work proposed? Are
|
|
potential problems, alternative strategies, and benchmarks for success presented?
|
|
If the project is in the early stages of development, will the strategy
|
|
establish feasibility and will particularly risky aspects be managed? Have the
|
|
investigators presented adequate plans to address relevant biological
|
|
variables, such as sex, for studies in vertebrate animals or human subjects?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If the center involves human
|
|
subjects and/or NIH-defined clinical research, are the plans to address:</p>
|
|
|
|
<p class=regulartext> 1) the protection of human
|
|
subjects from research risks, and </p>
|
|
|
|
<p class=regulartext> 2) inclusion (or exclusion) of
|
|
individuals on the basis of sex/gender, race, and ethnicity, as well as the
|
|
inclusion or exclusion of individuals of all ages (including children and older
|
|
adults), justified in terms of the scientific goals and research strategy
|
|
proposed? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Specific
|
|
to this FOA: </em>How cohesive is the
|
|
application in terms of projects and cores fitting into a common theme? How
|
|
adequate is the coordination and synergy between the individual Research
|
|
Projects, Technology Development Project (if applicable), and Cores to achieve
|
|
the central objectives of the application? To what extent will the integration
|
|
of the individual Research Projects and Technology Development Project (if
|
|
applicable) into a single application be more beneficial than pursuing each
|
|
project independently?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Does the application adequately address the
|
|
following, if applicable</p>
|
|
<p class=P_SingleIndent><em>Study
|
|
Design</em></p>
|
|
<p class=P_SingleIndent>Is the study design justified and appropriate to
|
|
address primary and secondary outcome variable(s)/endpoints that will be clear,
|
|
informative and relevant to the hypothesis being tested? Is the scientific
|
|
rationale/premise of the study based on previously well-designed preclinical
|
|
and/or clinical research? Given the methods used to assign participants and
|
|
deliver interventions, is the study design adequately powered to answer the
|
|
research question(s), test the proposed hypothesis/hypotheses, and provide
|
|
interpretable results? Is the trial appropriately designed to conduct the
|
|
research efficiently? Are the study populations (size, gender, age, demographic
|
|
group), proposed intervention arms/dose, and duration of the trial, appropriate
|
|
and well justified?</p>
|
|
<p class=P_SingleIndent>Are potential ethical issues adequately addressed? Is
|
|
the process for obtaining informed consent or assent appropriate? Is the
|
|
eligible population available? Are the plans for recruitment outreach,
|
|
enrollment, retention, handling dropouts, missed visits, and losses to
|
|
follow-up appropriate to ensure robust data collection? Are the planned
|
|
recruitment timelines feasible and is the plan to monitor accrual adequate? Has
|
|
the need for randomization (or not), masking (if appropriate), controls, and
|
|
inclusion/exclusion criteria been addressed? Are differences addressed, if
|
|
applicable, in the intervention effect due to sex/gender and race/ethnicity?</p>
|
|
<p class=P_SingleIndent>Are the plans to standardize, assure quality of, and
|
|
monitor adherence to, the trial protocol and data collection or distribution
|
|
guidelines appropriate? Is there a plan to obtain required study agent(s)? Does
|
|
the application propose to use existing available resources, as applicable?</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent><em>Data
|
|
Management and Statistical Analysis</em></p>
|
|
<p class=P_SingleIndent>Are planned analyses and statistical approach
|
|
appropriate for the proposed study design and methods used to assign
|
|
participants and deliver interventions? Are the procedures for data management
|
|
and quality control of data adequate at clinical site(s) or at center
|
|
laboratories, as applicable? Have the methods for standardization of procedures
|
|
for data management to assess the effect of the intervention and quality
|
|
control been addressed? Is there a plan to complete data analysis within the
|
|
proposed period of the award? </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_5"></a>Environment</div>
|
|
|
|
<p class=regulartext>Will the scientific environment in
|
|
which the work will be done contribute to the probability of success? Are the
|
|
institutional support, equipment and other physical resources available to the
|
|
investigators adequate for the center proposed? Will the center benefit from
|
|
unique features of the scientific environment, subject populations, or
|
|
collaborative arrangements? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>If proposed, are the administrative, data
|
|
coordinating, enrollment and laboratory/testing centers, appropriate for the
|
|
trial proposed?</p>
|
|
<p class=P_SingleIndent>Does the application adequately address the
|
|
capability and ability to conduct the trial at the proposed site(s) or centers?
|
|
Are the plans to add or drop enrollment centers, as needed, appropriate?</p>
|
|
<p class=P_SingleIndent>If international site(s) is/are proposed, does the
|
|
application adequately address the complexity of executing the clinical trial?</p>
|
|
<p class=P_SingleIndent>If multi-sites/centers, is there evidence of the
|
|
ability of the individual site or center to (1) enroll the proposed numbers,
|
|
(2) adhere to the protocol, (3) collect and transmit data in an accurate and
|
|
timely fashion, and (4) operate within the proposed organizational structure? </p>
|
|
|
|
|
|
|
|
<div class="heading4">Overall Impact - Individual Research Projects, Technology
|
|
Development Project</div>
|
|
|
|
<p class=regulartext>Reviewers will provide an overall impact score to reflect
|
|
their assessment of the likelihood for the project to exert a sustained,
|
|
powerful influence on the research field(s) involved, in consideration of the
|
|
following review criteria and additional review criteria (as applicable for the
|
|
project proposed).</p>
|
|
|
|
|
|
|
|
<div class="heading4">Scored Review Criteria - Individual Research Projects,
|
|
Technology Development Project</div>
|
|
|
|
<p class=regulartext>Reviewers will consider each of the review criteria below in
|
|
the determination of scientific merit and give a separate score for each. An
|
|
application does not need to be strong in all categories to be judged likely to
|
|
have major scientific impact. For example, a project that by its nature is not
|
|
innovative may be essential to advance a field.</p>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Significance</p>
|
|
|
|
<p class=P_SingleIndent>Does the project address an important problem or a critical
|
|
barrier to progress in the field? Is the prior research that serves as the key
|
|
support for the proposed project rigorous? If the aims of the project are
|
|
achieved, how will scientific knowledge, technical capability, and/or clinical
|
|
practice be improved? How will successful completion of the aims change the
|
|
concepts, methods, technologies, treatments, services, or preventative
|
|
interventions that drive this field? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Specific
|
|
to this FOA: </em></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>For Research Projects and the Technology Development Project
|
|
(if applicable): How likely are new principles of human immunology to be
|
|
discovered through the proposed efforts? How relevant are the goals of the
|
|
Project to the primary theme of the overall application?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>For Research Projects: How likely are the proposed
|
|
mechanisms to play important roles in human immune activation and regulation?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>For the Technology Development Project (if applicable): How
|
|
compelling is the need for the new technology within the proposed center? What
|
|
potential benefit will this new technology bring to the scientific community at
|
|
large and how likely is it that the new technology will have a variety of
|
|
research applications?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Are the scientific rationale and need for a clinical trial
|
|
to test the proposed hypothesis or intervention well supported by preliminary
|
|
data, clinical and/or preclinical studies, or information in the literature or
|
|
knowledge of biological mechanisms? For trials focusing on clinical or public
|
|
health endpoints, is this clinical trial necessary for testing the safety,
|
|
efficacy or effectiveness of an intervention that could lead to a change in
|
|
clinical practice, community behaviors or health care policy? For trials
|
|
focusing on mechanistic, behavioral, physiological, biochemical, or other
|
|
biomedical endpoints, is this trial needed to advance scientific understanding?</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=heading4Indent>Investigator(s)</p>
|
|
|
|
<p class=P_SingleIndent>Are the PD(s)/PI(s), collaborators, and other researchers
|
|
well suited to the project? If Early Stage Investigators or those in the early
|
|
stages of independent careers, do they have appropriate experience and
|
|
training? If established, have they demonstrated an ongoing record of
|
|
accomplishments that have advanced their field(s)? If the project is
|
|
collaborative or multi-PD/PI , do the investigators have complementary and
|
|
integrated expertise; are their leadership approach, governance and
|
|
organizational structure appropriate for the project? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>With regard to the proposed leadership for the project, do
|
|
the PD/PI(s) and key personnel have the expertise, experience, and ability to
|
|
organize, manage and implement the proposed clinical trial and meet milestones
|
|
and timelines? Do they have appropriate expertise in study coordination, data
|
|
management and statistics? For a multicenter trial, is the organizational
|
|
structure appropriate and does the application identify a core of potential
|
|
center investigators and staffing for a coordinating center? </p>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Innovation</p>
|
|
|
|
<p class=P_SingleIndent>Does the application challenge and seek to shift current
|
|
research or clinical practice paradigms by utilizing novel theoretical
|
|
concepts, approaches or methodologies, instrumentation, or interventions? Are
|
|
the concepts, approaches or methodologies, instrumentation, or interventions
|
|
novel to one field of research or novel in a broad sense? Is a refinement,
|
|
improvement, or new application of theoretical concepts, approaches or
|
|
methodologies, instrumentation, or interventions proposed? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Does the design/research plan include innovative elements,
|
|
as appropriate, that enhance its sensitivity, potential for information or
|
|
potential to advance scientific knowledge or clinical practice? </p>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Approach</p>
|
|
|
|
<p class=P_SingleIndent>Are the overall strategy, methodology, and analyses
|
|
well-reasoned and appropriate to accomplish the specific aims of the project?
|
|
Have investigators included plans to address weaknesses in the rigor of prior
|
|
research that serves as the key support for the proposed project? Have the
|
|
investigators presented strategies to ensure a robust and unbiased approach, as
|
|
appropriate for the work proposed? Are potential problems, alternative
|
|
strategies, and benchmarks for success presented? If the project is in the
|
|
early stages of development, will the strategy establish feasibility and will
|
|
particularly risky aspects be managed? Have the investigators presented
|
|
adequate plans to address relevant biological variables, such as sex, for
|
|
studies in vertebrate animals or human subjects?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>If the project involves human subjects and/or NIH-defined
|
|
clinical research, are the plans to address:</p>
|
|
|
|
<p class=P_SingleIndent> 1) the protection of human subjects from research risks,
|
|
and </p>
|
|
|
|
<p class=P_SingleIndent> 2) inclusion (or exclusion) of individuals on the basis of
|
|
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
|
|
individuals of all ages (including children and older adults), justified in
|
|
terms of the scientific goals and research strategy proposed? </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Specific
|
|
to this FOA:</em></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Research Projects:</p>
|
|
<ul>
|
|
<li class="P_SingleIndent">
|
|
How adequate is the focus on hypothesis-testing, mechanistic
|
|
studies of the human immune system? Do the hypotheses address mechanisms of
|
|
human immune function or regulation?</li>
|
|
<li class="P_SingleIndent">
|
|
How adequate are the data and/or statistical analyses plans (for
|
|
non-clinical trial projects)?</li>
|
|
<li class="P_SingleIndent">
|
|
If animal studies are proposed, what is the potential of
|
|
extending the findings of human studies?</li>
|
|
<li class="P_SingleIndent">
|
|
How adequate are the annual milestones and timelines proposed?</li>
|
|
<li class="P_SingleIndent">
|
|
For those studies using de-identified human biospecimens
|
|
collected from independently-funded clinical research or clinical trials, how
|
|
adequate and feasible are the timeline and documentation to successfully obtain
|
|
the samples and implement the proposed project(s)?</li>
|
|
</ul>
|
|
<p class=P_SingleIndent>Technology Development Project (if applicable):</p>
|
|
<ul>
|
|
<li class="P_SingleIndent">
|
|
How likely will the proposed research develop a new or
|
|
significantly enhanced technology, assay, or computational tool?</li>
|
|
<li class="P_SingleIndent">
|
|
To what extent does the project address an unmet need that
|
|
contributes to the common immunological theme amongst all the proposed Research
|
|
Projects?</li>
|
|
<li class="P_SingleIndent">
|
|
How adequate are the annual milestones and timelines proposed?</li>
|
|
<li class="P_SingleIndent">
|
|
For those studies using de-identified human biospecimens
|
|
collected from independently-funded clinical research or clinical trials, how
|
|
adequate and feasible are the timeline and documentation to successfully obtain
|
|
the samples and implement the proposed project(s)?</li>
|
|
</ul>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Does the application adequately address the following, if
|
|
applicable?</p>
|
|
<p class=P_SingleIndent><em>Study
|
|
Design</em></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Is the study design justified and appropriate to address
|
|
primary and secondary outcome variable(s)/endpoints that will be clear,
|
|
informative, and relevant to the hypothesis being tested? Is the scientific
|
|
rationale/premise of the study based on previously well-designed preclinical
|
|
and/or clinical research? Given the methods used to assign participants and
|
|
deliver interventions, is the study design adequately powered to answer the
|
|
research question(s), test the proposed hypothesis/hypotheses, and provide
|
|
interpretable results? Is the trial appropriately designed to conduct the
|
|
research efficiently? Are the study populations (size, gender, age, demographic
|
|
group), proposed intervention arms/dose, and duration of the trial appropriate
|
|
and well justified?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Are potential ethical issues adequately addressed? Is the
|
|
process for obtaining informed consent or assent appropriate? Is the eligible
|
|
population available? Are the plans for recruitment outreach, enrollment,
|
|
retention, handling dropouts, missed visits, and losses to follow-up
|
|
appropriate to ensure robust data collection? Are the planned recruitment
|
|
timelines feasible and is the plan to monitor accrual adequate? Has the need for
|
|
randomization (or not), masking (if appropriate), controls, and
|
|
inclusion/exclusion criteria been addressed? Are differences addressed, if
|
|
applicable, in the intervention effect due to sex/gender and race/ethnicity?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Are the plans to standardize, assure quality of, and monitor
|
|
adherence to the trial protocol and data collection or distribution guidelines
|
|
appropriate? Is there a plan to obtain required study agent(s)? Does the
|
|
application propose to use existing available resources, as applicable?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><em>Data Management
|
|
and Statistical Analysis</em></p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Are planned analyses and the statistical approach
|
|
appropriate for the proposed study design and methods used to assign
|
|
participants and deliver interventions? Are the procedures for data management
|
|
and quality control of data adequate at clinical site(s) or at center
|
|
laboratories, as applicable? Have the methods for standardization of procedures
|
|
for data management to assess the effect of the intervention and quality
|
|
control been addressed? Is there a plan to complete data analysis within the
|
|
proposed period of the award?</p>
|
|
|
|
|
|
|
|
<div class="heading4">Environment</div>
|
|
|
|
<p class=regulartext>Will the scientific environment in which the work will be
|
|
done contribute to the probability of success? Are the institutional support,
|
|
equipment and other physical resources available to the investigators adequate
|
|
for the project proposed? Will the project benefit from unique features of the
|
|
scientific environment, subject populations, or collaborative arrangements? </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>If proposed, are the administrative, data coordinating,
|
|
enrollment, and laboratory/testing centers appropriate for the trial proposed?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Does the application adequately address the capability and
|
|
ability to conduct the trial at the proposed site(s) or centers? Are the plans
|
|
to add or drop enrollment centers, as needed, appropriate?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If international site(s) is/are proposed, does the
|
|
application adequately address the complexity of executing the clinical trial?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>If multi-sites/centers, is there evidence of the ability of the
|
|
individual site or center to (1) enroll the proposed numbers, (2) adhere to the
|
|
protocol, (3) collect and transmit data in an accurate and timely fashion, and
|
|
(4) operate within the proposed organizational structure?</p>
|
|
|
|
|
|
|
|
<div class="heading4">Overall Impact - Administrative Core, Service Core(s)</div>
|
|
|
|
<p class=regulartext>Reviewers will provide an overall impact score to reflect
|
|
their assessment of the likelihood for the core to meet its intended goals in
|
|
consideration of the following review criteria and additional review criteria
|
|
(as applicable for the core proposed).</p>
|
|
|
|
|
|
|
|
<div class="heading4">Review Criteria - Administrative Core, Service Core(s)</div>
|
|
|
|
<p class=regulartext>Reviewers will consider each of the review criteria below,
|
|
as appropriate for the individual Core, in the determination of scientific
|
|
merit and provide an overall impact score for each Core but will not give
|
|
separate scores for these items.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Administrative
|
|
Core</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
How adequate are the staffing and administrative plans to
|
|
facilitate attainment of the objectives of the proposed program?</li>
|
|
<li>
|
|
How adequate is the plan to organize communications, group
|
|
meetings, and teleconferences?</li>
|
|
<li>
|
|
How appropriate are the plans for coordination, problem
|
|
identification and resolution, and establishment of a strong collaborative
|
|
environment for the program?</li>
|
|
<li>
|
|
Are the plans for resource allocation within the program adequate
|
|
and appropriate?</li>
|
|
<li>
|
|
How appropriate is the management plan for fiscal accountability
|
|
and communication within the program?</li>
|
|
<li>
|
|
How sufficient are the designated personnel to enable compliance
|
|
with the data sharing and other resource sharing policy?</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Service
|
|
Core(s) (if applicable)</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
How adequate is the provision of the proposed core services to
|
|
the Research and Technology Development Projects?</li>
|
|
<li>
|
|
How well is the core connected to the central focus of the
|
|
overall center?</li>
|
|
<li>
|
|
How appropriate are the quality of the relevant facilities or
|
|
services provided (including procedures, techniques, quality control) and
|
|
criteria for prioritization and usage?</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Does the application adequately address the following, if applicable</p>
|
|
|
|
<p class=regulartext><em> </em></p>
|
|
|
|
<p class=regulartext><em>Study
|
|
Design</em></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Is the study design justified and appropriate to address
|
|
primary and secondary outcome variable(s)/endpoints that will be clear,
|
|
informative, and relevant to the hypothesis being tested? Is the scientific
|
|
rationale/premise of the study based on previously well-designed preclinical
|
|
and/or clinical research? Given the methods used to assign participants and
|
|
deliver interventions, is the study design adequately powered to answer the
|
|
research question(s), test the proposed hypothesis/hypotheses, and provide
|
|
interpretable results? Is the trial appropriately designed to conduct the
|
|
research efficiently? Are the study populations (size, gender, age, demographic
|
|
group), proposed intervention arms/dose, and duration of the trial appropriate and
|
|
well justified?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Are potential ethical issues adequately addressed? Is the
|
|
process for obtaining informed consent or assent appropriate? Is the eligible
|
|
population available? Are the plans for recruitment outreach, enrollment,
|
|
retention, handling dropouts, missed visits, and losses to follow-up
|
|
appropriate to ensure robust data collection? Are the planned recruitment
|
|
timelines feasible and is the plan to monitor accrual adequate? Has the need
|
|
for randomization (or not), masking (if appropriate), controls, and
|
|
inclusion/exclusion criteria been addressed? Are differences addressed, if
|
|
applicable, in the intervention effect due to sex/gender and race/ethnicity?</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Are the plans to standardize, assure quality of, and monitor
|
|
adherence to the trial protocol and data collection or distribution guidelines
|
|
appropriate? Is there a plan to obtain required study agent(s)? Does the
|
|
application propose to use existing available resources, as applicable?</p>
|
|
|
|
|
|
|
|
<p class=regulartext><em>Data
|
|
Management and Statistical Analysis</em></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Are planned analyses and statistical approach appropriate
|
|
for the proposed study design and methods used to assign participants and
|
|
deliver interventions? Are the procedures for data management and quality
|
|
control of data adequate at clinical site(s) or at center laboratories, as
|
|
applicable? Have the methods for standardization of procedures for data
|
|
management to assess the effect of the intervention and quality control been
|
|
addressed? Is there a plan to complete data analysis within the proposed period
|
|
of the award?</p>
|
|
|
|
|
|
|
|
<div class="heading4">Additional Review Criteria - Overall, Cores, Technology
|
|
Development Project and Research Projects</div>
|
|
|
|
<div class="heading4"> </div>
|
|
|
|
<p class=regulartext>As applicable for the cores or projects proposed, reviewers
|
|
will evaluate the following additional items while determining scientific and
|
|
technical merit, and in providing an overall impact score, but will not give
|
|
separate scores for these items.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Infrastructure and Opportunity Fund
|
|
(IOF) Management Core</strong></p>
|
|
<ul>
|
|
<li>
|
|
How adequate is the provision of the proposed services? How well
|
|
qualified are the personnel charged with managing the IOF? </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4">Study Timeline</div>
|
|
<p class=P_SingleIndent><strong>Specific to applications proposing
|
|
clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Is the study timeline described in detail, taking into
|
|
account start-up activities, the anticipated rate of enrollment, and planned
|
|
follow-up assessment? Is the projected timeline feasible and well justified?
|
|
Does the project incorporate efficiencies and utilize existing resources (e.g.,
|
|
CTSAs, practice-based research networks, electronic medical records,
|
|
administrative database, or patient registries) to increase the efficiency of
|
|
participant enrollment and data collection, as appropriate?</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Are potential challenges and corresponding solutions
|
|
discussed (e.g., strategies that can be implemented in the event of enrollment
|
|
shortfalls)? </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=humans></a>Protections
|
|
for Human Subjects</div>
|
|
|
|
<p class=regulartext>For research that involves human
|
|
subjects but does not involve one of the categories of research that are exempt
|
|
under 45 CFR Part 46, the committee will evaluate the justification for
|
|
involvement of human subjects and the proposed protections from research risk
|
|
relating to their participation according to the following five review
|
|
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
|
|
potential benefits to the subjects and others, 4) importance of the knowledge
|
|
to be gained, and 5) data and safety monitoring for clinical trials.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For research that involves human
|
|
subjects and meets the criteria for one or more of the categories of research
|
|
that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the
|
|
justification for the exemption, 2) human subjects involvement and
|
|
characteristics, and 3) sources of materials. For additional information on
|
|
review of the Human Subjects section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11175">Guidelines
|
|
for the Review of Human Subjects</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=inclusion></a>Inclusion
|
|
of Women, Minorities, and Individuals Across the Lifespan </div>
|
|
|
|
<p class=regulartext>When the proposed cores or projects
|
|
involves human subjects and/or NIH-defined clinical research, the committee
|
|
will evaluate the proposed plans for the inclusion (or exclusion) of individuals
|
|
on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
|
|
exclusion) of individuals of all ages (including children and older adults) to
|
|
determine if it is justified in terms of the scientific goals and research
|
|
strategy proposed. For additional information on review of the Inclusion
|
|
section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11174">Guidelines
|
|
for the Review of Inclusion in Clinical Research</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=animals></a>Vertebrate
|
|
Animals</div>
|
|
|
|
<p class=regulartext>The committee will evaluate the
|
|
involvement of live vertebrate animals as part of the scientific assessment
|
|
according to the following criteria: (1) description of proposed procedures
|
|
involving animals, including species, strains, ages, sex, and total number to
|
|
be used; (2) justifications for the use of animals versus alternative models
|
|
and for the appropriateness of the species proposed; (3) interventions to
|
|
minimize discomfort, distress, pain and injury; and (4) justification for
|
|
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
|
|
of Animals. Reviewers will assess the use of chimpanzees as they would any
|
|
other application proposing the use of vertebrate animals. For additional
|
|
information on review of the Vertebrate Animals section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11150">Worksheet
|
|
for Review of the Vertebrate Animal Section</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=biohazards></a>Biohazards</div>
|
|
|
|
<p class=regulartext>Reviewers will assess whether
|
|
materials or procedures proposed are potentially hazardous to research
|
|
personnel and/or the environment, and if needed, determine whether adequate protection
|
|
is proposed.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=resubmissions></a>Resubmissions</div>
|
|
|
|
<p class=regulartext>Not Applicable </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=renewals></a>Renewals</div>
|
|
|
|
<p class=regulartext>For Renewals, the committee will
|
|
consider the progress made in the last funding period</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=revisions></a>Revisions</div>
|
|
|
|
<p class=regulartext>Not Applicable </p>
|
|
|
|
|
|
|
|
<div class="heading4">Additional Review Considerations - Overall, Technology
|
|
Development Project and Research Projects </div>
|
|
|
|
<p class=regulartext>As applicable for the project proposed, reviewers will
|
|
consider each of the following items, but will not give scores for these items,
|
|
and should not consider them in providing an overall impact score.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=foreign></a>Applications
|
|
from Foreign Organizations</div>
|
|
|
|
<p class=regulartext>Not Applicable </p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=agents></a>Select Agent
|
|
Research</div>
|
|
|
|
<p class=regulartext>Reviewers will assess the
|
|
information provided in this section of the application, including 1) the
|
|
Select Agent(s) to be used in the proposed research, 2) the registration status
|
|
of all entities where Select Agent(s) will be used, 3) the procedures that will
|
|
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
|
|
for appropriate biosafety, biocontainment, and security of the Select Agent(s).</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=sharing></a>Resource
|
|
Sharing Plans</div>
|
|
|
|
<p class=regulartext>Reviewers will comment on whether
|
|
the Resource Sharing Plan(s) (i.e., <a
|
|
href="https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy#policy-overview">Sharing
|
|
Model Organisms</a>) or the rationale for not sharing the resources, is
|
|
reasonable.</p>
|
|
|
|
<div class="heading4"><br>
|
|
<a name=authentication></a>Authentication of Key Biological
|
|
and/or Chemical Resources</div>
|
|
|
|
<p class=regulartext>For projects involving key
|
|
biological and/or chemical resources, reviewers will comment on the brief plans
|
|
proposed for identifying and ensuring the validity of those resources.</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name=budget></a>Budget and
|
|
Period of Support</div>
|
|
|
|
<p class=regulartext>Reviewers will consider whether the
|
|
budget and the requested period of support are fully justified and reasonable
|
|
in relation to the proposed research.</p>
|
|
|
|
|
|
|
|
<div class="heading3">2. Review and Selection
|
|
Process </div>
|
|
|
|
<p class=regulartext>Applications will be evaluated for scientific and technical
|
|
merit by (an) appropriate Scientific Review Group(s), convened by the National
|
|
Institute of Allergy and Infectious Diseases in accordance with <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11154">NIH peer
|
|
review policy and procedures</a>, using the stated <a href="#_1._Criteria">review
|
|
criteria</a>. Assignment to a Scientific Review Group will be shown in the eRA
|
|
Commons. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>As part of the scientific peer review, all applications:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
May undergo a selection process in which only those applications
|
|
deemed to have the highest scientific and technical merit (generally the top
|
|
half of applications under review) will be discussed and assigned an overall impact
|
|
score. </li>
|
|
<li>
|
|
Will receive a written critique.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.4.2_appeals_of_initial_scientific_review.htm">Appeals</a>
|
|
of initial peer review will not be accepted for applications submitted in
|
|
response to this FOA.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Applications will be assigned to the appropriate NIH
|
|
Institute or Center. Applications will compete for available funds with all
|
|
other recommended applications submitted in response to this FOA. Following
|
|
initial peer review, recommended applications will receive a second level of
|
|
review by the National Advisory Allergy and Infectious Diseases Council. The
|
|
following will be considered in making funding decisions: </p>
|
|
|
|
<ul>
|
|
<li>
|
|
Scientific and technical merit of the proposed project as
|
|
determined by scientific peer review. </li>
|
|
<li>
|
|
Availability of funds. </li>
|
|
<li>
|
|
Relevance of the proposed project to program priorities. </li>
|
|
</ul>
|
|
|
|
<div class="heading3"><a name="_3._Anticipated_Announcement"></a>3. Anticipated Announcement and Award Dates</div>
|
|
|
|
<p class=regulartext>After the peer review of the application is completed, the
|
|
PD/PI will be able to access his or her Summary Statement (written critique)
|
|
via the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA
|
|
Commons</a>. Refer to Part 1 for dates for peer review, advisory council
|
|
review, and earliest start date.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Information regarding the disposition of applications is
|
|
available in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i>.</a> </p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873271"></a><a
|
|
name="_Section_VI._Award"></a>Section VI. Award
|
|
Administration Information</div>
|
|
|
|
<div class="heading3">1. Award Notices</div>
|
|
|
|
<p class=regulartext>If the application is under consideration for funding, NIH
|
|
will request "just-in-time" information from the applicant as
|
|
described in the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm"><i>NIH
|
|
Grants Policy Statement</i>.</a> </p>
|
|
|
|
|
|
|
|
<p class=regulartext>A formal notification in the form of a Notice of Award (NoA)
|
|
will be provided to the applicant organization for successful applications. The
|
|
NoA signed by the grants management officer is the authorizing document and
|
|
will be sent via email to the recipient’s business official. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Recipients must comply with any funding restrictions described
|
|
in <a href="#_5._Funding_Restrictions">Section IV.5. Funding Restrictions</a>. Selection
|
|
of an application for award is not an authorization to begin performance. Any
|
|
costs incurred before receipt of the NoA are at the recipient's risk. These
|
|
costs may be reimbursed only to the extent considered allowable pre-award costs.</p>
|
|
|
|
<p class=regulartext>Any application awarded in response to this FOA will be
|
|
subject to terms and conditions found on the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/part_ii_subpart_b.htm">Award
|
|
Conditions and Information for NIH Grants</a> website. This includes any
|
|
recent legislation and policy applicable to awards that is highlighted on this
|
|
website.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Individual awards are based on the application submitted to,
|
|
and as approved by, the NIH and are subject to the IC-specific terms and
|
|
conditions identified in the NoA. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>ClinicalTrials.gov: If an award provides for one or more
|
|
clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the
|
|
"responsible party" must register and submit results information for
|
|
certain applicable clinical trials on the ClinicalTrials.gov Protocol
|
|
Registration and Results System Information Website (<a
|
|
href="https://register.clinicaltrials.gov">https://register.clinicaltrials.gov</a>).
|
|
NIH expects registration and results reporting of all trials whether required
|
|
under the law or not. For more information, see <a
|
|
href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">https://grants.nih.gov/policy/clinical-trials/reporting/index.htm</a>
|
|
</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Institutional Review Board or Independent Ethics Committee
|
|
Approval: Grantee institutions must ensure that all protocols are reviewed by
|
|
their IRB or IEC. To help ensure the safety of participants enrolled in
|
|
NIH-funded studies, the awardee must provide NIH copies of documents related to
|
|
all major changes in the status of ongoing protocols. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Data and Safety Monitoring Requirements: The NIH policy for
|
|
data and safety monitoring requires oversight and monitoring of all
|
|
NIH-conducted or -supported human biomedical and behavioral intervention
|
|
studies (clinical trials) to ensure the safety of participants and the validity
|
|
and integrity of the data. Further information concerning these requirements is
|
|
found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the
|
|
application instructions (SF424 (R&R) and PHS 398). </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Investigational New Drug or Investigational Device Exemption
|
|
Requirements: Consistent with federal regulations, clinical research projects
|
|
involving the use of investigational therapeutics, vaccines, or other medical
|
|
interventions (including licensed products and devices for a purpose other than
|
|
that for which they were licensed) in humans under a research protocol must be
|
|
performed under a Food and Drug Administration (FDA) investigational new drug
|
|
(IND) or investigational device exemption (IDE). </p>
|
|
|
|
|
|
|
|
<div class="heading4">Prior Approval of Pilot Projects</div>
|
|
|
|
<p class=regulartext>All recipient-selected projects require prior approval by
|
|
NIH prior to initiation. </p>
|
|
|
|
<ul>
|
|
<li>
|
|
The recipient institution will comply with the NIH <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-128.html">Guidance
|
|
on Changes That Involve Human Subjects in Active Awards and That Will Require
|
|
Prior NIH Approval</a>. </li>
|
|
<li>
|
|
The recipient institution will provide NIH with specific plans
|
|
for data and safety monitoring, and will notify the IRB and NIH of serious
|
|
adverse events and unanticipated problems, consistent with <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=21600">NIH DSMP
|
|
policies</a>. </li>
|
|
</ul>
|
|
|
|
<div class="heading3">2. Administrative and
|
|
National Policy Requirements</div>
|
|
|
|
<p class=regulartext>All NIH grant and cooperative agreement awards include the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants
|
|
Policy Statement</a> as part of the NoA. For these terms of award, see the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157">NIH Grants
|
|
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:
|
|
General</a> and <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11159">Part II:
|
|
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
|
|
Specific Types of Grants, Recipients, and Activities</a>, including of note,
|
|
but not limited to:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
<a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_3/3.1_federalwide_standard_terms_and_conditions_for_research_grants.htm">Federalwide
|
|
Research Terms and Conditions</a> </li>
|
|
<li>
|
|
<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-041.html">Prohibition
|
|
on Certain Telecommunications and Video Surveillance Services or Equipment</a> </li>
|
|
<li>
|
|
<a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm">Acknowledgment of Federal Funding</a> </li>
|
|
</ul>
|
|
|
|
<p class=regulartext>If a recipient is successful and receives a Notice of Award,
|
|
in accepting the award, the recipient agrees that any activities under the
|
|
award are subject to all provisions currently in effect or implemented during
|
|
the period of the award, other Department regulations and policies in effect at
|
|
the time of the award, and applicable statutory provisions.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Should the applicant organization successfully compete for
|
|
an award, recipients of federal financial assistance (FFA) from HHS must
|
|
administer their programs in compliance with federal civil rights laws that
|
|
prohibit discrimination on the basis of race, color, national origin,
|
|
disability, age and, in some circumstances, religion, conscience, and sex
|
|
(including gender identity, sexual orientation, and pregnancy). This
|
|
includes ensuring programs are accessible to persons with limited English
|
|
proficiency and persons with disabilities. The HHS Office for Civil Rights
|
|
provides guidance on complying with civil rights laws enforced by HHS. Please
|
|
see <a
|
|
href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a>
|
|
<a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html</a></p>
|
|
<p class=regulartext>HHS recognizes that research projects are often limited in
|
|
scope for many reasons that are nondiscriminatory, such as the principal
|
|
investigator’s scientific interest, funding limitations, recruitment
|
|
requirements, and other considerations. Thus, criteria in research protocols
|
|
that target or exclude certain populations are warranted where nondiscriminatory
|
|
justifications establish that such criteria are appropriate with respect to the
|
|
health or safety of the subjects, the scientific study design, or the purpose
|
|
of the research. For additional guidance regarding how the provisions apply to
|
|
NIH grant programs, please contact the Scientific/Research Contact that is
|
|
identified in Section VII under Agency Contacts of this FOA.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=regulartext>Recipients of FFA must ensure that their programs are
|
|
accessible to persons with limited English proficiency. For guidance on
|
|
meeting the legal obligation to take reasonable steps to ensure meaningful
|
|
access to programs or activities by limited English proficient individuals see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html</a> and <a
|
|
href="https://www.lep.gov/">https://www.lep.gov</a>.</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
For information on an institution's specific legal obligations
|
|
for serving qualified individuals with disabilities, including reasonable
|
|
accomodations and making services accessible to them, see <a href="https://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.</li>
|
|
<li>
|
|
HHS funded health and education programs must be administered in
|
|
an environment free of sexual harassment, see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html</a>;
|
|
For information about NIH's commitment to supporting a safe and respectful work
|
|
environment, who to contact with questions or concerns, and what NIH's
|
|
expectations are for institutions and the individuals supported on NIH-funded
|
|
awards, please see <a href="https://grants.nih.gov/grants/policy/harassment.htm">https://grants.nih.gov/grants/policy/harassment.htm</a>.
|
|
</li>
|
|
<li>
|
|
For guidance on administering programs in compliance with
|
|
applicable federal conscience protection and associated anti-discrimination
|
|
laws see <a
|
|
href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>
|
|
and <a href="https://www.hhs.gov/conscience/religious-freedom/index.html">https://www.hhs.gov/conscience/religious-freedom/index.html</a>.
|
|
</li>
|
|
</ul>
|
|
<p class=regulartext>Please contact the HHS Office for Civil Rights for more
|
|
information about obligations and prohibitions under federal civil rights laws
|
|
at <a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a>
|
|
or call 1-800-368-1019 or TDD 1-800-537-7697. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>In accordance with the statutory provisions contained in
|
|
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
|
|
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
|
|
Awardee Performance and Integrity Information System (FAPIIS) requirements.
|
|
FAPIIS requires Federal award making officials to review and consider
|
|
information about an applicant in the designated integrity and performance
|
|
system (currently FAPIIS) prior to making an award. An applicant, at its
|
|
option, may review information in the designated integrity and performance
|
|
systems accessible through FAPIIS and comment on any information about itself
|
|
that a Federal agency previously entered and is currently in FAPIIS. The
|
|
Federal awarding agency will consider any comments by the applicant, in
|
|
addition to other information in FAPIIS, in making a judgement about the
|
|
applicant’s integrity, business ethics, and record of performance under Federal
|
|
awards when completing the review of risk posed by applicants as described in
|
|
45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk
|
|
posed by applicants. This provision will apply to all NIH grants and
|
|
cooperative agreements except fellowships.</p>
|
|
|
|
|
|
|
|
<p class=Heading4>Cooperative Agreement Terms and Conditions of Award</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The following special terms of award are in addition to, and
|
|
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
|
|
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
|
|
grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and
|
|
other HHS, PHS, and NIH grant administration policies. <br>
|
|
<br>
|
|
The administrative and funding instrument used for this program will be the
|
|
cooperative agreement, an "assistance" mechanism (rather than an
|
|
"acquisition" mechanism), in which substantial NIH programmatic
|
|
involvement with the recipients is anticipated during the performance of the
|
|
activities. Under the cooperative agreement, the NIH purpose is to support and
|
|
stimulate the recipients' activities by involvement in and otherwise working
|
|
jointly with the recipients in a partnership role; it is not to assume
|
|
direction, prime responsibility, or a dominant role in the activities.
|
|
Consistent with this concept, the dominant role and prime responsibility
|
|
resides with the recipients for the project as a whole, although specific tasks
|
|
and activities may be shared among the recipients and the NIH as defined below.
|
|
</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>The
|
|
PD(s)/PI(s) will have the primary responsibility for:</strong></p>
|
|
|
|
<ul>
|
|
<li>
|
|
Being a member of the Steering Committee, one voting member from
|
|
each center.</li>
|
|
<li>
|
|
Accepting and implementing policies approved by the Steering Committee.</li>
|
|
<li>
|
|
For clinical trials and other human subject research,
|
|
implementing current Good Clinical Practice guidelines and specific NIAID/DAIT
|
|
policies.</li>
|
|
<li>
|
|
Recipients will retain custody of and have primary rights to the
|
|
data and software developed under these awards, subject to Government rights of
|
|
access consistent with current DHHS, PHS, and NIH policies.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>NIH
|
|
staff have substantial programmatic involvement that is above and beyond the
|
|
normal stewardship role in awards, as described below:</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Coordinate NIAID staff assistance, including participation in
|
|
periodic on-site monitoring with respect to compliance with Federal
|
|
regulations, quality control, accuracy of data recording, sample accrual, etc.</li>
|
|
<li>
|
|
Facilitate collaborations with and access to other NIAID-supported
|
|
research resources and services.</li>
|
|
<li>
|
|
Provide oversight for human subjects protections and provide
|
|
monitoring for any studies that involve more than minimal risk for participants
|
|
or that involve vulnerable populations.</li>
|
|
<li>
|
|
Provide assistance to the Steering Committee in the development
|
|
of procedures for evaluating the performance of research studies and monitoring
|
|
any clinical trials developed via the IOF.</li>
|
|
<li>
|
|
Promote coordination of Steering Committee activities and
|
|
implementation of its recommendations, decisions, and policies.</li>
|
|
<li>
|
|
Establish an EAB to review and evaluate the scientific progress
|
|
of the individual CCHI recipients and the Consortium as a whole. </li>
|
|
<li>
|
|
Additionally, an agency program official or IC program director
|
|
will be responsible for the normal scientific and programmatic stewardship of
|
|
the award and will be named in the award notice.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong> </strong></p>
|
|
|
|
<p class=regulartext><strong>Areas
|
|
of Joint Responsibility include:</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext><em>Steering
|
|
Committee</em>: The Steering Committee will serve as the governing body
|
|
of the CCHI and will assist in making recommendations for applications
|
|
submitted for CCHI Infrastructure and Opportunities Fund (IOF).</p>
|
|
|
|
|
|
|
|
<p class=regulartext><em>Infrastructure
|
|
and Opportunities Fund</em>: The Steering Committee will oversee the
|
|
Infrastructure and Opportunities Fund, consistent with the goals of the
|
|
program. The Steering Committee will device and implement procedures,
|
|
practices, and subcommittees as needed, for the IOF solicitation, receipt,
|
|
review, development, evaluation, and recommendation of feasibility, pilot,
|
|
resource development, or collaborative projects or potential resource sharing
|
|
opportunities and other collaborative needs. The Steering Committee will also
|
|
assess additional professional and administrative staffing needs beyond the
|
|
administrative support provided as part of the requirements to manage the IOF
|
|
budget and activities (<em>e.g.,</em>
|
|
for review activities or IT needs as required) and provide recommendations to
|
|
the NIH Project Scientist. In addition, the Steering Committee will be
|
|
responsible for an annual report of progress of projects, status of funds, and
|
|
other activities funded by the IOF program, including outcomes of all completed
|
|
projects.</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Each CCHI center will be represented by one PD/PI as a voting
|
|
member of the Steering Committee. NIAID Project Scientists will be non-voting
|
|
members.</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>External
|
|
Scientific Advisory Group (ESAG)</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>The Administrative Core may support an External Scientific
|
|
Advisory Group, to be formed after award at the discretion of the PD(s)/PI(s).
|
|
The ESAG will evaluate scientific progress within the CCHI center and provide
|
|
advice to the center on an annual basis.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Dispute
|
|
Resolution:</strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Any disagreements that may arise in scientific or
|
|
programmatic matters (within the scope of the award) between award recipients
|
|
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
|
|
composed of three members will be convened. It will have three members: a
|
|
designee of the Steering Committee chosen without NIH staff voting, one NIH
|
|
designee, and a third designee with expertise in the relevant area who is
|
|
chosen by the other two; in the case of individual disagreement, the first
|
|
member may be chosen by the individual recipient. This special dispute
|
|
resolution procedure does not alter the recipient's right to appeal an adverse
|
|
action that is otherwise appealable in accordance with PHS regulation 42 CFR
|
|
Part 50, Subpart D and DHHS regulation 45 CFR Part 16.</p>
|
|
|
|
|
|
|
|
<div class="heading3">3. Data Management and Sharing</div>
|
|
|
|
|
|
|
|
<p class=regulartext>Note: The NIH Policy for Data Management and Sharing is
|
|
effective for due dates on or after January 25, 2023. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Consistent with the NIH Policy for Data Management and
|
|
Sharing, when data management and sharing is applicable to the award,
|
|
recipients will be required to adhere to the Data Management and Sharing
|
|
requirements as outlined in the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm#Data">NIH
|
|
Grants Policy Statement</a>. Upon the approval of a Data Management and Sharing
|
|
Plan, it is required for recipients to implement the plan as described.</p>
|
|
|
|
|
|
|
|
<div class="heading3">4. Reporting</div>
|
|
|
|
<p class=regulartext>When multiple years are involved, recipients will be
|
|
required to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report
|
|
(RPPR)</a> annually and financial statements as required in the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm"><i>NIH
|
|
Grants Policy Statement</i>.</a> </p>
|
|
|
|
|
|
|
|
<p class=regulartext><a name=SectionVII></a>A final RPPR, invention statement, and the expenditure data portion of the
|
|
Federal Financial Report are required for closeout of an award, as described in
|
|
the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.6_closeout.htm"><i>NIH
|
|
Grants Policy Statement</i></a>. NIH FOAs outline intended research goals and
|
|
objectives. Post award, NIH will review and measure performance based on the
|
|
details and outcomes that are shared within the RPPR, as described at 45 CFR
|
|
Part 75.301 and 2 CFR 200.301.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The Federal Funding Accountability and Transparency Act of
|
|
2006 (Transparency Act), includes a requirement for recipients of Federal
|
|
grants to report information about first-tier subawards and executive
|
|
compensation under Federal assistance awards issued in FY2011 or later. All recipients
|
|
of applicable NIH grants and cooperative agreements are required to report
|
|
to the Federal Subaward Reporting System (FSRS) available at <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11170">www.fsrs.gov</a>
|
|
on all subawards over the threshold. See the <a
|
|
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.8_federal_funding_accountability_and_transparency_act__ffata_.htm"><i>NIH
|
|
Grants Policy Statement</i></a> for additional information on this reporting
|
|
requirement. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>In accordance with the regulatory requirements provided at
|
|
45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2
|
|
CFR Part 200, recipients that have currently active Federal grants, cooperative
|
|
agreements, and procurement contracts from all Federal awarding agencies with a
|
|
cumulative total value greater than $10,000,000 for any period of time during
|
|
the period of performance of a Federal award, must report and maintain the
|
|
currency of information reported in the System for Award Management
|
|
(SAM) about civil, criminal, and administrative proceedings in connection
|
|
with the award or performance of a Federal award that reached final disposition
|
|
within the most recent five-year period. The recipient must also make
|
|
semiannual disclosures regarding such proceedings. Proceedings information
|
|
will be made publicly available in the designated integrity and performance
|
|
system (currently FAPIIS). This is a statutory requirement under section 872
|
|
of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section
|
|
3010 of Public Law 111-212, all information posted in the designated integrity
|
|
and performance system on or after April 15, 2011, except past performance
|
|
reviews required for Federal procurement contracts, will be publicly
|
|
available. Full reporting requirements and procedures are found in Appendix
|
|
XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for
|
|
Recipient Integrity and Performance Matters.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873272"></a><a
|
|
name="_Section_VII._Agency"></a>Section VII. Agency Contacts</div>
|
|
|
|
<p class=regulartext>We encourage inquiries concerning this funding opportunity
|
|
and welcome the opportunity to answer questions from potential applicants. <br>
|
|
<br>
|
|
</p>
|
|
|
|
<div class="heading4">Application Submission Contacts</div>
|
|
|
|
<p class=regulartext>eRA Service Desk (Questions
|
|
regarding ASSIST, eRA Commons, application errors and warnings, documenting
|
|
system problems that threaten submission by the due date, and post-submission
|
|
issues)</p>
|
|
<p class=regulartext>Finding Help Online: <a
|
|
href="https://grants.nih.gov/support/index.html">https://grants.nih.gov/support/index.html</a>(preferred
|
|
method of contact)<br>
|
|
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
|
|
<p class=regulartext>General Grants Information
|
|
(Questions regarding application instructions, application processes, and NIH
|
|
grant resources)<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#aee9dccfc0dadde7c0c8c1eec0c7c680c9c1d8"><span class="__cf_email__" data-cfemail="ce89bcafa0babd87a0a8a18ea0a7a6e0a9a1b8">[email protected]</span></a> (preferred
|
|
method of contact)<br>
|
|
Telephone: 301-945-7573</p>
|
|
<p class=regulartext>Grants.gov Customer Support (Questions regarding
|
|
Grants.gov registration and Workspace)<br>
|
|
Contact Center Telephone: 800-518-4726<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#05767075756a7771456277646b71762b626a73"><span class="__cf_email__" data-cfemail="daa9afaaaab5a8ae9abda8bbb4aea9f4bdb5ac">[email protected]</span></a><br>
|
|
<br>
|
|
</p>
|
|
|
|
<div class="heading4">Scientific/Research Contact(s)</div>
|
|
|
|
<p class=regulartext>Chao Jiang, Ph.D.<br>
|
|
National Institute of Allergy and Infectious Diseases (NIAID)<br>
|
|
Telephone: 301-761-7802 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#ceada6afa1e0a4a7afa0a98ea0a7a6e0a9a1b8"><span class="__cf_email__" data-cfemail="b8dbd0d9d796d2d1d9d6dff8d6d1d096dfd7ce">[email protected]</span></a> </p>
|
|
|
|
|
|
|
|
<div class="heading4">Peer Review Contact(s)</div>
|
|
|
|
<p class=regulartext>Anuja Mathew, Ph.D. <br>
|
|
National Institute of Allergy and Infectious Diseases (NIAID)<br>
|
|
Telephone: 301-761-6911<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#0c6d6279666d22616d7864697b4c626564226b637a"><span class="__cf_email__" data-cfemail="1e7f706b747f30737f6a767b695e70777630797168">[email protected]</span></a></p>
|
|
|
|
|
|
|
|
<div class="heading4">Financial/Grants Management Contact(s)</div>
|
|
|
|
<p class=regulartext>Nicole Guidetti <br>
|
|
National Institute of Allergy and Infectious Diseases (NIAID)<br>
|
|
Telephone: 301-761-6934 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#afc1c6ccc0c3ca81c8dac6cbcadbdbc6efc1c6c781c8c0d9"><span class="__cf_email__" data-cfemail="0e60676d61626b20697b676a6b7a7a674e60676620696178">[email protected]</span></a> <br>
|
|
<br>
|
|
</p>
|
|
|
|
<div class="heading2"><a name="_Toc258873273"></a><a
|
|
name="_Section_VIII._Other"></a>Section VIII. Other
|
|
Information</div>
|
|
|
|
<p class=regulartext>Recently issued trans-NIH <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11163">policy
|
|
notices</a> may affect your application submission. A full list of policy
|
|
notices published by NIH is provided in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11164"><i>NIH
|
|
Guide for Grants and Contracts</i></a>. All
|
|
awards are subject to the terms and conditions, cost principles, and other considerations
|
|
described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a>.</p>
|
|
<div class="heading4">Authority and Regulations</div>
|
|
|
|
<p class=regulartext>Awards are made under the authorization of Sections 301 and
|
|
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
|
|
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200. </p>
|
|
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