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<!-- From FOATemplate.txt -->
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<TITLE>Expired PA-18-495: Academic Research Enhancement Award in Diseases within the Mission of NIDDK (R15 - Clinical Trial Required)</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Academic Research Enhancement Award in Diseases within the Mission of NIDDK (R15 - Clinical Trial Required) PA-18-495. NIDDK">
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<META NAME="Keywords" CONTENT="PA-18-495: Academic Research Enhancement Award in Diseases within the Mission of NIDDK (R15 - Clinical Trial Required)">
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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="col-xs-12">
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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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<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">
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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</div>
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</div>
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<!--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">
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<p>National Institute of Diabetes and Digestive and Kidney
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Diseases (<a href="http://www.niddk.nih.gov">NIDDK</a>)<br>
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<br>
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</p>
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</div>
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</div>
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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">
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<p class="title">Academic Research Enhancement Award in
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Diseases within the Mission of NIDDK (R15 Clinical Trial Required) </p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r15&Search.x=0&Search.y=0&Search_Type=Activity">R15</a> Academic Research Enhancement Award (AREA) </p>
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</div>
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</div>
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<!--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">
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<p>New </p>
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</div>
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</div>
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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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<ul>
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<li><strong>December 17, 2018</strong> - Notice of Expiration for PA-18-495. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-DK-19-005.html">NOT-DK-19-005</a>.</li>
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<li><b>November 26, 2018</b> - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria
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for Research Grant Applications. See Notice <a href="/grants/guide/notice-files/NOT-OD-18-228.html">NOT-OD-18-228</a>.</li>
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</ul>
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</div>
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</div>
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<!--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">
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<p class="title">PA-18-495</p>
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</div>
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</div>
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<!--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">
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<p>None</p>
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</div>
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</div>
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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">
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<p>See <a href="#_3._Additional_Information">Section III. 3.
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Additional Information on Eligibility</a>. </p>
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</div>
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</div>
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<div class="row">
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<div class="col-md-4 datalabel">Catalog of Federal Domestic Assistance (CFDA) Number(s)<sub> </sub></div>
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<div class="col-md-8 datacolumn">
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<p>93.847 </p>
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</div>
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</div>
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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">
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<p>The purpose of the Academic Research Enhancement Award
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(AREA) program is to stimulate research in educational institutions that
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provide baccalaureate or advanced degrees for a significant number of the
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Nation's research scientists, but that have not been major recipients of NIH
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support. AREA grants create opportunities for scientists and institutions
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otherwise unlikely to participate extensively in NIH research programs to
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contribute to the Nation's biomedical and behavioral research effort. AREA grants
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are intended to support small-scale research projects proposed by faculty
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members of eligible, domestic institutions, to expose undergraduate and/or
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graduate students to meritorious research projects, and to strengthen the
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research environment of the applicant institution. The purpose of this FOA is
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to support AREA grants for clinical trials focused on diseases within the
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mission of NIDDK. </p>
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</div>
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</div>
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<div class="heading2" style="clear:both;">Key Dates</div>
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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">
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<p>December 11, 2017</p>
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</div>
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</div>
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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">
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<p>January 25, 2018</p>
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</div>
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</div>
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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">
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<p>Not Applicable</p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11111">Standard
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dates</a> apply, by 5:00 PM local time of applicant organization. All <a
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href="#Application Types Allowed">types of non-AIDS applications</a> allowed
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for this funding opportunity announcement are due on these dates.</p>
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<p>Applicants are encouraged to apply early to allow adequate
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time to make any corrections to errors found in the application during the
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submission process by the due date.</p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11112">Standard AIDS
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dates</a> apply, by 5:00 PM local time of applicant organization. All <a
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href="#Application Types Allowed">types of AIDS and AIDS-related applications</a> allowed for this funding opportunity announcement are due on these dates.</p>
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<p>The first AIDS due date for this FOA is May 7, 2018.</p>
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<p>Applicants are encouraged to apply early to allow adequate
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time to make any corrections to errors found in the application during the
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submission process by the due date.</p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard
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dates</a><a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></a> apply </p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard
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dates</a><a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></a> apply </p>
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</div>
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</div>
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<!--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">
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<p><a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard
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dates</a> apply </p>
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</div>
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</div>
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<!--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">
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<p><strong>New Date </strong>January 8, 2019 per issuance of <a href="//grants.nih.gov/grants/guide/notice-files/NOT-DK-19-005.html">NOT-DK-19-005</a>. (Original Expiration Date: January 8, 2021)</p>
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</div>
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</div>
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<!--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">
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<p>Not Applicable</p>
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</div>
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</div>
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<!--end row-->
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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>It is critical that applicants follow the Research (R) Instructions
|
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in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">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 href="//grants.nih.gov/grants/guide/"><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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</style>
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<div class="heading1">Table of Contents</div>
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<p><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><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="_Toc258873265"></a><a
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name="_Toc258852635"></a><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="_Toc258873266"></a><a
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name="_Toc258852636"></a><a name=IFundOppDesc></a><a name="_Section_I._Funding"></a>Section I. Funding Opportunity Description</div>
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<p><a name="_Toc258873267">This Funding Opportunity
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Announcement (FOA) invites applications for Academic Research Enhancement Award
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(AREA) grants proposing investigator-initiated clinical trials within the
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mission of the National Institute of Diabetes and Digestive and Kidney Diseases
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(NIDDK). NIDDK is committed to improving the health of people with diabetes and
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other endocrine and metabolic diseases; digestive diseases, nutritional
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disorders, and obesity; and kidney, urologic and hematologic diseases.
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Applications for clinical trials submitted under this FOA should be hypothesis
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driven, have clearly described aims and objectives, and have a high likelihood
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that the trial findings will lead to additional or larger studies that will improve
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understanding, diagnosis, prevention or treatment of the diseases studied. A
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major goal of this FOA is also to expose undergraduates and graduate students
|
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to clinical research.</a></p>
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<p>The purpose of the AREA program is to stimulate research at
|
|
educational institutions that provide baccalaureate and/or advanced degrees for
|
|
a significant number of the Nation's research scientists, but that have not
|
|
been major recipients of NIH support. AREA funds are intended to support new
|
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and renewal biomedical and behavioral research projects proposed by faculty
|
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members of eligible colleges, universities, schools, and components of domestic
|
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institutions.</p>
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<p>The objectives of the AREA program are to provide support
|
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for meritorious research, to strengthen the research environment of schools
|
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that have not been major recipients of NIH support, and to expose available undergraduate
|
|
and/or graduate students in such environments to meritorious research. The AREA
|
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program will enable qualified scientists to receive support for small-scale
|
|
research projects. These grants are intended to create a research opportunity
|
|
for scientists and institutions otherwise unlikely to participate extensively
|
|
in NIH programs that support the Nation's biomedical and behavioral research
|
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effort. It is anticipated that investigators supported under the AREA program
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will benefit from the opportunity to conduct independent research; that the
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grantee institution will benefit from a research environment strengthened
|
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through AREA grants and by participation in the diverse extramural programs of
|
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the NIH; and that undergraduate and/or graduate students at recipient
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institutions will benefit from exposure to and participation in scientific
|
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research in the biomedical and behavioral sciences so that they consider
|
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careers in biomedical and behavioral sciences.</p>
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<p>The research project must involve undergraduate (preferably,
|
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if available) and/or graduate students in the proposed research. Students
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involvement in research may include participation in the design of experiments
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and controls, collection and analysis of data, execution and troubleshooting of
|
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experiments, presentation at meetings, drafting journal articles, collaborative
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interactions, participation in lab meetings to discuss results and future
|
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experiments, etc. The AREA program is a research grant program, not a training
|
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or fellowship program. As such, applications should not include training plans
|
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such as didactic training plans or non-research activities relating to
|
|
professional development.</p>
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<p>An AREA application may include other investigators, such as
|
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collaborators or consultants, or other trainees such as high school students,
|
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post baccalaureate participants, postdoctoral fellows, or clinical fellows.
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However, involvement of such individuals does not fulfill the goal to expose
|
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undergraduate and/or graduate students in eligible environments to research.</p>
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<p>This FOA will support applications proposing to conduct
|
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clinical trials. AREA applications that do not involve human subjects research,
|
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or propose human subjects research not meeting the NIH definition of a clinical
|
|
trial may be submitted to the Parent R15 Clinical Trial Not Allowed program
|
|
announcement (i.e., the reissue of PA-16-200</p>
|
|
<p>(<a
|
|
href="https://grants.nih.gov/grants/guide/pa-files/PA-16-200.html">https://grants.nih.gov/grants/guide/pa-files/PA-16-200.html</a>).</p>
|
|
<p>NIH defines a clinical trial as a research study in which
|
|
one or more human subjects are prospectively assigned to one or more
|
|
interventions (which may include placebo or other control) to evaluate the
|
|
effects of those interventions on health-related biomedical or behavioral
|
|
outcomes" (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html</a>).
|
|
Applications submitted to this FOA may propose either therapeutic or
|
|
mechanistic clinical trials. A therapeutic trial has a goal of determining
|
|
clinical safety, tolerability, efficacy and/or effectiveness of an intervention
|
|
designed to prevent or treat a disease or condition. Such studies may be
|
|
pragmatic trials where the intervention is tested under the usual conditions in
|
|
which it will be applied, or explanatory trials where the intervention is
|
|
tested under standardized circumstances. Mechanistic trials are designed to
|
|
understand a biologic process, the pathophysiology of a disease, or the
|
|
mechanism of action of an intervention. </p>
|
|
<p><strong>This
|
|
FOA will only support research within the mission of NIDDK. Research
|
|
applications in areas that are primarily within the missions of other NIH
|
|
Institutes and Centers are not appropriate for this FOA and will not be
|
|
supported.</strong></p>
|
|
<p>NIDDK has a major interest in diabetes and its
|
|
complications, but research on most organ-specific diabetes complications, with
|
|
the exception of diabetic nephropathy, is generally not within the mission of NIDDK.
|
|
For example, research on diabetic retinopathy should not be submitted to NIDDK,
|
|
but may be appropriate for NEI. Research on cardiovascular disease,
|
|
cardiomyopathy, cardiac autonomic neuropathy, hypertension or dyslipidemia
|
|
should not be submitted to NIDDK, but may be appropriate for NHLBI. Research on
|
|
endocrine cancers should not be submitted to NIDDK, but may be appropriate for NCI.
|
|
Research focusing on the primary prevention or treatment of gestational
|
|
diabetes directed at the immediate pregnancy outcomes of women or their
|
|
newborns should not be submitted to NIDDK but may be appropriate for NICHD.
|
|
Reproductive endocrinology is not within the mission of NIDDK and studies on
|
|
this topic will not be supported under this announcement. </p>
|
|
<p>NIDDK has a major interest in obesity research, but research
|
|
on obesity-related endpoints outside of the mission of NIDDK should be
|
|
submitted to other NIH ICs. For example, research on the pathogenesis,
|
|
prevention, or treatment of obesity-related cardiovascular disease,
|
|
hypertension, asthma, or heart failure should not be submitted to NIDDK, but
|
|
may be appropriate for NHLBI; research on obesity-related musculoskeletal
|
|
disorders should not be submitted to NIDDK, but may be appropriate for NIAMS;
|
|
and research on use and abuse of alcohol after bariatric surgery should not be
|
|
submitted to NIDDK, but may be appropriate for NIAAA. NIDDK is also interested
|
|
in nutrition clinical trials that aim to treat diseases within the mission of
|
|
NIDDK or improve health.</p>
|
|
<p>NIDDK is interested in clinical trials with translational
|
|
potential and clinically meaningful endpoints for diseases of the alimentary
|
|
tract, liver, and pancreas. Trials for cancer should not be submitted to NIDDK,
|
|
but may be appropriate for NCI.</p>
|
|
<p>NIDDK is also interested in supporting clinical trials
|
|
leading to the identification and evaluation of possible treatments to prevent
|
|
the development and progression of kidney diseases and benign urological
|
|
conditions. Trials focused solely on non-renal outcomes and endpoints in
|
|
populations with kidney disease are not supported under this announcement and
|
|
should be submitted to the appropriate IC. Transplantation trials focused on
|
|
processes and mechanisms of acute or chronic rejection of kidneys, or on
|
|
immune-mediated diseases, where the kidney is not the focus of the investigation
|
|
should not be submitted to NIDDK, but may be appropriate for NIAID. Trials
|
|
involving malignant diseases of the kidney and urologic organs should not be
|
|
submitted to NIDDK, but may be appropriate for NCI. </p>
|
|
<p>Further information about research programs at NIDDK can be
|
|
found at: <a href="http://www.niddk.nih.gov">http://www.niddk.nih.gov</a>.</p>
|
|
<p>Further information about the AREA program, including FAQs,
|
|
is available at: <a href="https://area.nih.gov">https://area.nih.gov</a>/.</p>
|
|
<p>Applicants are reminded of the NIH policy on the use of a
|
|
single Institutional Review Board for multi-site research (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html</a>),
|
|
as well as the NIH policy on the registration and reporting of the results of
|
|
clinical trials (<a
|
|
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html</a>). </p>
|
|
<p><strong>Applications
|
|
involving only animal or in vitro studies are not appropriate for this FOA</strong>.
|
|
Applications proposing both animal work or in vitro studies and a clinical
|
|
trial in human participants may use this FOA; however, the non-trial work must
|
|
be complementary to the trial and not required as preliminary work for the
|
|
trial.</p>
|
|
<p><a name="_Section_II._Award_1"></a>See <a
|
|
href="#_Section_VIII._Other">Section
|
|
VIII. Other Information</a> for award authorities and regulations.</p>
|
|
<div class="heading2">Section II. Award
|
|
Information</div>
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funding Instrument</div>
|
|
<div class="col-md-8 datacolumn">
|
|
<p>Grant: A support mechanism providing money, property, or
|
|
both to an eligible entity to carry out an approved project or activity. </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>New <br>
|
|
Renewal <br>
|
|
Resubmission <br>
|
|
<br>
|
|
</p>
|
|
<p>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.</p>
|
|
</div>
|
|
</div>
|
|
<!--end row-->
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Clinical Trial?</div>
|
|
<div class="col-md-8 datacolumn">
|
|
<p>Required: Only accepting applications that propose
|
|
clinical trial(s)</p>
|
|
<p><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>The number of awards is contingent upon NIH appropriations
|
|
and the submission of a sufficient number of meritorious applications. </p>
|
|
</div>
|
|
</div>
|
|
<!--end row-->
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Budget</div>
|
|
<div class="col-md-8 datacolumn"><p>Applicants may request up to $300,000 in direct costs (exclusive
|
|
of subcontracts F&A) for the entire project period of up to three years. </p></div></div>
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Project Period</div>
|
|
<div class="col-md-8 datacolumn">
|
|
<p>The scope of the proposed project should determine the
|
|
project period. The maximum project period is three years. </p>
|
|
</div>
|
|
</div>
|
|
<!--end row-->
|
|
<p>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>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>
|
|
<li class="BulletDoubleIndent"> Hispanic-serving Institutions</li>
|
|
<li class="BulletDoubleIndent"> Historically Black Colleges and Universities (HBCUs)</li>
|
|
<li class="BulletDoubleIndent"> Tribally Controlled Colleges and Universities (TCCUs) </li>
|
|
<li class="BulletDoubleIndent"> Alaska Native and Native Hawaiian Serving Institutions</li>
|
|
<li class="BulletDoubleIndent"> Asian American Native American Pacific Islander Serving
|
|
Institutions (AANAPISIs)</li>
|
|
</ul>
|
|
<p>In addition, all organizations must meet the following two
|
|
criteria:</p>
|
|
<p>1. The applicant organization must be an accredited public
|
|
or non-profit private school that grants baccalaureate or advanced degrees in
|
|
biomedical or behavioral sciences</p>
|
|
<p>2. The applicant organization may not receive research
|
|
support from the NIH totaling more than $6 million per year (in both direct and
|
|
F&A/indirect costs) in each of 4 of the last 7 years.</p>
|
|
<p>Note that all activity codes are included except the
|
|
following: C06, S10, and all activity codes starting with a G.</p>
|
|
<p><strong>Institutions
|
|
with Health Professional Schools or Colleges</strong></p>
|
|
<p>For institutions composed of multiple academic components
|
|
(i.e., schools or colleges), the criterion of financial eligibility is based on
|
|
the amount of NIH research grant monies received, not by the institution
|
|
(university) as a whole, but by the individual health professional
|
|
school/college or by the sum of "Other Academic components" (as
|
|
defined in this section) where the PD/PI has a primary appointment (e.g.,
|
|
School of Arts and Science, School of Medicine, College of Nursing, School of
|
|
Pharmacy, etc.). Thus, each of the following is considered independently when
|
|
determining the financial eligibility of the applicant organization.</p>
|
|
<ul>
|
|
<li> Health professional school/college: Accredited public or
|
|
non-profit private school/college that grants a terminal health professional
|
|
degree (e.g., MD, DDS, DO, PharmD, DNP, DVM, DrPH, OD, DPT, DC, ND, DPM).</li>
|
|
<li> Accreditation must be provided by a body approved for such
|
|
purpose by the Secretary of Education.</li>
|
|
<li> Health professional schools/colleges that meet the above
|
|
requirements may include schools or colleges of medicine, dentistry,
|
|
osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry,
|
|
allied health, chiropractic, naturopathy and podiatry.</li>
|
|
<li> Other Academic component: Once the health professional
|
|
schools/colleges have been excluded, the financial eligibility of the Other
|
|
Academic component is determined by the sum of all remaining schools, colleges,
|
|
and free-standing institutes of the institution (university).</li>
|
|
</ul>
|
|
<div class="heading4">Additional Eligibility Guidance </div>
|
|
<p>To determine the financial eligibility of an institution, applicants
|
|
should consult the list of ineligible institutions on the <a
|
|
href="https://area.nih.gov/institutional-eligibility">AREA program website</a>.
|
|
If the name of the school does not appear on the list, it does not exceed the
|
|
limit of NIH support.</p>
|
|
<p>An AREA grant is permitted to have a subcontract to a
|
|
non-AREA-eligible institution. However, applicants should keep the goals of the
|
|
AREA program in mind when preparing the application, which include
|
|
strengthening the research environment of eligible institutions and exposing
|
|
students from eligible institutions to research. It is expected that the
|
|
majority of the research will be directed by the PD(s)/PI(s) at the grantee
|
|
institution.</p>
|
|
<p>Although foreign institutions are not eligible, applications
|
|
may include a foreign collaboration, component, or consortium.</p>
|
|
<div class="heading4">Foreign Institutions</div>
|
|
<p>Non-domestic (non-U.S.) Entities (Foreign Institutions) <b>are <strong>not</strong></b> eligible to apply.<br>
|
|
Non-domestic (non-U.S.) components of U.S. Organizations <b>are <strong>no</strong></b>t eligible to
|
|
apply.<br>
|
|
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"><a name="_Required_Registrations"></a>Required
|
|
Registrations</div>
|
|
<p><strong>Applicant
|
|
Organizations</strong></p>
|
|
<p>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="http://fedgov.dnb.com/webform" Title="Link to Non-U.S. Government Site">Dun and Bradstreet
|
|
Universal Numbering System (DUNS)</a> - All registrations require that
|
|
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
|
|
can begin both SAM and eRA Commons registrations. The same DUNS number must be
|
|
used for all registrations, as well as on the grant application.</li>
|
|
<li> <a href="https://www.sam.gov/portal/public/SAM/">System for Award Management (SAM)</a> (formerly CCR) Applicants must complete and maintain an active registration, <strong>which requires renewal at least
|
|
annually</strong>. 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. </li>
|
|
<li class="BulletDoubleIndent"> <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> <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Applicants
|
|
must have an active DUNS number and SAM registration in order to complete the
|
|
eRA Commons registration. Organizations can register with the eRA Commons as
|
|
they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the
|
|
Grants.gov registration. </li>
|
|
</ul>
|
|
<p><strong>Program
|
|
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
|
|
<p>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>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 underrepresented racial
|
|
and ethnic groups as well as individuals with disabilities are always
|
|
encouraged to apply for NIH support.</p>
|
|
<p>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>To be eligible for an AREA grant, the PD(s)/PI(s) must meet
|
|
the following additional criteria:</p>
|
|
<ul>
|
|
<li> The PD(s)/PI(s) must have a primary appointment at an AREA
|
|
eligible institution.</li>
|
|
<li> The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH
|
|
research grant, including another AREA grant, at the time of award of an AREA
|
|
grant, although he or she may be one of the Key Personnel for an active NIH
|
|
grant held by another PD/PI.</li>
|
|
<li> The PD(s)/PI(s) may not be awarded more than one AREA grant at a
|
|
time, although he or she may hold successive new or renewal grants.</li>
|
|
</ul>
|
|
<p>Note: These eligibility criteria only apply to the
|
|
PD(s)/PI(s) of the application, not to other Key Personnel such as
|
|
collaborators and consultants.</p>
|
|
<div class="heading3">2. Cost Sharing</div>
|
|
<p>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>Applicant organizations may submit more than one application,
|
|
provided that each application is scientifically distinct. </p>
|
|
<p>The NIH will not accept duplicate or highly overlapping
|
|
applications under review at the same time. 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="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>).</li>
|
|
</ul>
|
|
<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>Buttons to access the online ASSIST system or to download
|
|
application forms are 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>It is critical that applicants follow the Research (R) Instructions
|
|
in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
|
|
(R&R) Application Guide</a>, except where instructed in this funding
|
|
opportunity announcement to do otherwise. 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>
|
|
<p>For information on Application Submission and Receipt, visit <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=41137">Frequently
|
|
Asked Questions Application Guide, Electronic Submission of Grant
|
|
Applications</a>.</p>
|
|
<div class="heading4">Page Limitations</div>
|
|
<p>All page limitations 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 Application Submission</div>
|
|
<p>The following section supplements the instructions found in
|
|
the SF424 (R&R) Application Guide and should be used for preparing an
|
|
application to this FOA.</p>
|
|
<div class="heading4">SF424(R&R) Cover</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">SF424(R&R) Project/Performance Site Locations</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">SF424(R&R) Other Project Information</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
<p><strong>Facilities
|
|
& Other Resources</strong>: The following information must be
|
|
included:</p>
|
|
<ul>
|
|
<li> A profile of the students of the applicant institution/academic
|
|
component and any information or estimate of the number who have obtained a
|
|
baccalaureate degree and gone on to obtain an academic or professional doctoral
|
|
degree in the health-related sciences during the last five years.</li>
|
|
<li> A description of the special characteristics of the
|
|
institution/academic component that make it appropriate for an AREA grant,
|
|
where the goals of the AREA program are to: (1) provide support for meritorious
|
|
research; (2) strengthen the research environment of schools that have not been
|
|
major recipients of NIH support; and (3) expose available undergraduate and/or
|
|
graduate students in such environments to research.</li>
|
|
<li> Description of the likely impact of an AREA grant on the
|
|
PD(s)/PI(s).</li>
|
|
<li> Description of the likely impact of an AREA grant on the research
|
|
environment of the institution/academic component.</li>
|
|
<li> Although it is expected that the majority of the research will be
|
|
directed by the PD(s)/PI(s) and conducted at the grantee institution, limited
|
|
use of special facilities or equipment at another institution is permitted. For
|
|
any proposed research sites other than the applicant institution, provide a
|
|
brief description of the resources and access students will need and have to
|
|
these resources.</li>
|
|
<li> If relevant, a statement of institutional support for the
|
|
proposed research project (e.g., equipment, supplies, laboratory space, release
|
|
time, matching funds, etc.).</li>
|
|
</ul>
|
|
<div class="heading4">SF424(R&R) Senior/Key Person Profile </div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
<p><strong>Biographical
|
|
Sketch</strong>: The PD(s)/PI(s) should include a summary of his or her
|
|
previous and/or current experience supervising undergraduate and/or graduate
|
|
students in research in the Personal Statement. The PD(s)/PI(s) should indicate
|
|
which peer-reviewed publications or other research products involved
|
|
undergraduate and/or graduate students under his or her supervision.</p>
|
|
<div class="heading4">R&R or Modular Budget</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
<ul>
|
|
<li> The total budget for all years of the proposed project must be
|
|
requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are
|
|
not required and will not be accepted with the application.</li>
|
|
<li> Applicants submitting an application with direct costs of
|
|
$250,000 or less (total for all years, excluding consortium Facilities and
|
|
Administrative [F&A] costs) must use the Modular Budget.</li>
|
|
<li> Applicants submitting an application with direct costs of
|
|
$250,001 - $300,000 (total for all years, excluding consortium Facilities and
|
|
Administrative [F&A] costs) must use the R&R Budget.</li>
|
|
</ul>
|
|
<p class=heading4Indent><strong>Modular
|
|
Budget (direct costs of $250,000 or less):</strong></p>
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions:</p>
|
|
<p class=P_SingleIndent><strong>Budget
|
|
Period 1: Direct Costs</strong></p>
|
|
<ul>
|
|
<li> <em>Direct Costs
|
|
less Consortium F&A</em>: Select the appropriate dollar amount from
|
|
the drop-down list. This number must not exceed $250,000.</li>
|
|
</ul>
|
|
<p class=P_SingleIndent><strong>Budget
|
|
Justification:</strong></p>
|
|
<ul>
|
|
<li> <em>Personnel
|
|
Justification</em>: Since a primary objective of the AREA program is to
|
|
expose students to meritorious research, PD(s)/PI(s) must include undergraduate
|
|
students (preferably, if available from any academic component) and/or graduate
|
|
students from the applicant institution/applicant component in the proposed
|
|
research. Indicate aspects of the proposed research in which students will
|
|
participate. If participating students have not yet been individually
|
|
identified, the number and academic level of those to be involved should be
|
|
provided. If there are any Collaborators or Consultants for the project,
|
|
provide their names, organizational affiliations, and the services they will
|
|
perform.</li>
|
|
</ul>
|
|
<p class=heading4Indent>R&R Budget (direct costs of
|
|
$250,001 to $300,000):</p>
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed, with the following additional instructions:</p>
|
|
<p class=P_SingleIndent><strong>Budget
|
|
Period 1: Direct Costs</strong></p>
|
|
<ul>
|
|
<li> <em>Total Direct
|
|
Costs less Consortium F&A</em>: This number must not exceed
|
|
$300,000.</li>
|
|
</ul>
|
|
<p class=P_SingleIndent><strong>Budget
|
|
Justification:</strong></p>
|
|
<ul>
|
|
<li> <em>Personnel
|
|
Justification</em>: Since a primary objective of the AREA program is to
|
|
expose students to meritorious research, PD(s)/PI(s) must include undergraduate
|
|
students (preferably, if available from any academic component) and/or graduate
|
|
students from the applicant institution/applicant component in the proposed
|
|
research. Indicate aspects of the proposed research in which students will
|
|
participate. If participating students have not yet been individually
|
|
identified, the number and academic level of those to be involved should be
|
|
provided. If there are any Collaborators or Consultants for the project,
|
|
provide their names, organizational affiliations, and the services they will
|
|
perform.</li>
|
|
</ul>
|
|
<div class="heading4">R&R Subaward Budget</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS 398 Cover Page Supplement</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS 398 Research Plan</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions: </p>
|
|
<p><strong>Research
|
|
Strategy</strong>: Describe how undergraduate and/or graduate students
|
|
will be exposed to and supervised conducting hands-on research. Describe how
|
|
students will participate in research activities such as planning, execution
|
|
and/or analysis of research. Formal training plans (e.g., non-research
|
|
activities, didactic training, seminars) should not be provided.</p>
|
|
<p>A sound rationale should be offered as to why the approach
|
|
and the research team, including undergraduate and/or graduate students, are
|
|
appropriate to accomplish the specific aims and to make an important scientific
|
|
contribution.</p>
|
|
<p>The applicant must clearly articulate the significance of
|
|
the proposed study, including why the clinical trial is needed and what
|
|
evidence gap the trial will address. For therapeutic trials, this must include
|
|
a discussion of why there is clinical equipoise and how the results have the
|
|
potential to impact clinical care. For all trials, the discussion of the
|
|
trial’s potential impact must include consideration of the developmental
|
|
pathway of the intervention and delineate the next steps, beyond publication of
|
|
results. For therapeutic trials, this must include consideration of translation
|
|
and dissemination steps needed, if applicable, considering potential end-users
|
|
(e.g., health care providers, patients, healthcare systems and/or policy
|
|
makers).</p>
|
|
<p>The discussion of supporting data that provide the basis for
|
|
the trial’s design must address the adequacy and quality of previous studies. </p>
|
|
<p>The application must include a detailed description and
|
|
scientific rationale for the study design, addressing the intervention chosen,
|
|
the population to be studied and the outcomes being assessed. </p>
|
|
<p><strong>Resource
|
|
Sharing Plan</strong>: Individuals are required to comply with the
|
|
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
|
|
Application Guide.</p>
|
|
<p><strong>Appendix: </strong></p>
|
|
<p>Only limited Appendix materials are allowed. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application
|
|
Guide. </p>
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information</div>
|
|
<p>When involving NIH-defined human subjects research, clinical
|
|
research, and/or clinical trials (and when applicable, clinical trials research
|
|
experience) 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>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 <strong>Delayed
|
|
Onset Study</strong> record. </p>
|
|
<p><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<p><strong>Delayed
|
|
Onset Study</strong></p>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS Assignment Request Form</div>
|
|
<p>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>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>
|
|
<div class="heading3">4. Submission Dates and
|
|
Times</div>
|
|
<p><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>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). Applicants must then complete the submission
|
|
process by tracking the status of the application in the <a
|
|
href="//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><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>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>This initiative is not subject to <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11142">intergovernmental
|
|
review.</a> </p>
|
|
<div class="heading3"><a name="_5._Funding_Restrictions"></a>6. Funding Restrictions</div>
|
|
<p>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>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>Applications must be submitted electronically following the
|
|
instructions described in the SF424 (R&R) Application Guide. Paper
|
|
applications will not be accepted. </p>
|
|
<p><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>For assistance with your electronic application or for more information on the electronic submission
|
|
process, visit <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11144">Applying
|
|
Electronically</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="//grants.nih.gov/grants/ElectronicReceipt/support.htm#guidelines">Guidelines
|
|
for Applicants Experiencing System Issues</a>. For assistance with application
|
|
submission, contact the Application Submission Contacts in <a
|
|
href="#_Section_VII._Agency">Section VII</a>.</p>
|
|
<p class=P_SingleIndent><strong>Important
|
|
reminders:</strong></p>
|
|
<p class=P_SingleIndent>All PD(s)/PI(s) must include their eRA Commons ID in
|
|
the Credential field<b> </b>of the Senior/Key Person Profile Component of the
|
|
SF424(R&R) Application Package<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. See <a
|
|
href="#_Required_Registrations">Section III</a> of this FOA for information on
|
|
registration requirements.</p>
|
|
<p class=P_SingleIndent>The applicant organization must ensure that the DUNS
|
|
number it provides on the application is the same number 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=P_SingleIndent>See <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors. </p>
|
|
<p>Upon receipt, applications will be evaluated for
|
|
completeness and compliance with application instructions by the Center for
|
|
Scientific Review, NIH. Applications that are incomplete or non-compliant will
|
|
not be reviewed.</p>
|
|
<div class="heading4">Post Submission Materials</div>
|
|
<p>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>
|
|
|
|
<p>
|
|
<img src="/common14/images/new.gif"> <b>Important Update:</b> See <a href="/grants/guide/notice-files/NOT-OD-18-228.html">NOT-OD-18-228</a> for updated review language
|
|
for due dates on or after January 25, 2019.
|
|
</p>
|
|
|
|
<div class="heading3"><a name="_1._Criteria"></a>1.
|
|
Criteria</div>
|
|
<p>Only the review criteria described below will be considered
|
|
in the review process. As part of the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a>,
|
|
all applications submitted to the NIH in support of biomedical and behavioral
|
|
research are evaluated for scientific and technical merit through the NIH peer
|
|
review system.</p>
|
|
<p>For this particular announcement, note the following: </p>
|
|
<p>The objectives of the R15 program are to (1) provide support
|
|
for meritorious research, (2) strengthen the research environment of schools
|
|
that have not been major recipients of NIH support, and (3) expose available
|
|
undergraduate and graduate students in such environments to meritorious
|
|
research. Preliminary data are not required for an R15 application; however,
|
|
they may be included if available.</p>
|
|
<p>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 </div>
|
|
<p>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</div>
|
|
<p>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>
|
|
<div class="heading4Indent">Significance</div>
|
|
<p class=P_SingleIndent>Does the project address an important problem or a
|
|
barrier to progress in the field? Is there a strong scientific premise for the
|
|
project? 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? If
|
|
funded, will the AREA award have a substantial effect on the school/academic
|
|
component in terms of strengthening the research environment and exposing
|
|
students to research? </p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications proposing 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>
|
|
<div class="heading4Indent">Investigator(s)</div>
|
|
<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? Do the PD(s)/PI(s) have
|
|
suitable experience in supervising students in research? </p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications proposing 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>
|
|
<div class="heading4Indent">Innovation</div>
|
|
<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 proposing 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="heading4Indent">Approach</div>
|
|
<p class="P_SingleIndent">Are the overall strategy,
|
|
methodology, and analyses well-reasoned and appropriate to accomplish the
|
|
specific aims of the 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?
|
|
Does the application provide sufficient evidence that the project can stimulate
|
|
the interests of students so that they consider a career in the biomedical or
|
|
behavioral sciences? </p>
|
|
<p class="P_SingleIndent">If the project involves human
|
|
subjects and/or NIH-defined clinical research, are the plans to address 1) the
|
|
protection of human subjects from research risks, and 2) inclusion (or
|
|
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
|
|
well as the inclusion or exclusion of children, justified in terms of the
|
|
scientific goals and research strategy proposed? </p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications proposing 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 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="heading4Indent">Environment</div>
|
|
<p class=P_SingleIndent>Are the institutional support, equipment and other
|
|
physical resources available to the investigators adequate for the project
|
|
proposed? Does the application demonstrate the likely availability of
|
|
well-qualified students to participate in the research project? Does the
|
|
application provide sufficient evidence that students have in the past or are
|
|
likely to pursue careers in the biomedical or behavioral sciences? </p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications proposing 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">Additional Review Criteria</div>
|
|
<p>As applicable for the project 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=heading4Indent>Study Timeline </p>
|
|
<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="heading4Indent">Protections for Human Subjects</div>
|
|
<p class="P_SingleIndent">For research that involves human
|
|
subjects but does not involve one of the six 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="P_SingleIndent">For research that involves human
|
|
subjects and meets the criteria for one or more of the six 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="heading4Indent">Inclusion of Women, Minorities,
|
|
and Children </div>
|
|
<p class="P_SingleIndent">When the proposed project 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 children 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="heading4Indent">Vertebrate Animals</div>
|
|
<p class="P_SingleIndent">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="heading4Indent">Biohazards</div>
|
|
<p class="P_SingleIndent">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="heading4Indent">Resubmissions</div>
|
|
<p class="P_SingleIndent">For Resubmissions, the committee
|
|
will evaluate the application as now presented, taking into consideration the
|
|
responses to comments from the previous scientific review group and changes
|
|
made to the project. </p>
|
|
<div class="heading4Indent">Renewals</div>
|
|
<p class="P_SingleIndent">For Renewals, the committee will
|
|
consider the progress made in the last funding period. </p>
|
|
<div class="heading4Indent">Revisions</div>
|
|
<p class="P_SingleIndent">Not Applicable</p>
|
|
<div class="heading4">Additional Review Considerations</div>
|
|
<p>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="heading4Indent">Applications from Foreign
|
|
Organizations</div>
|
|
<p class="P_SingleIndent">Not Applicable</p>
|
|
<div class="heading4Indent">Select Agent Research</div>
|
|
<p class="P_SingleIndent">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="heading4Indent">Resource Sharing Plans</div>
|
|
<p class=P_SingleIndent>Reviewers will comment on whether the following
|
|
Resource Sharing Plans, or the rationale for not sharing the following types of
|
|
resources, are reasonable: (1) <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11151">Data Sharing
|
|
Plan</a>; (2) <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11152">Sharing
|
|
Model Organisms</a>; and (3) <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11153"> Genomic Data Sharing Plan (GDS)</a>. </p>
|
|
<div class="heading4Indent">Authentication of Key Biological
|
|
and/or Chemical Resources: </div>
|
|
<p class="P_SingleIndent">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="heading4Indent">Budget and Period of Support</div>
|
|
<p class="P_SingleIndent">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>Applications will be evaluated for scientific and technical
|
|
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
|
|
Scientific Review , 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>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>Applications will be assigned on the basis of established
|
|
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
|
|
will compete for available funds with all other recommended applications. Following
|
|
initial peer review, recommended applications will receive a second level of
|
|
review by the National Diabetes and Digestive and Kidney Diseases Advisory 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>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="//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>Information regarding the disposition of applications is
|
|
available in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11156"><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>If the application is under consideration for funding, NIH
|
|
will request "just-in-time" information from the applicant as
|
|
described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH
|
|
Grants Policy Statement</i></a>. </p>
|
|
<p>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 grantee’s business official. </p>
|
|
<p>Awardees 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>Any application awarded in response to this FOA will be
|
|
subject to terms and conditions found on the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">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>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>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 of all trials whether required under the law or not.
|
|
For more information, see <a href="//grants.nih.gov/ClinicalTrials_fdaaa/">http://grants.nih.gov/ClinicalTrials_fdaaa/</a>.</p>
|
|
<p>Institutional Review Board or Independent Ethics Committee
|
|
Approval: Grantee institutions must ensure that the application as well as 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. 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 <a
|
|
href="//grants.nih.gov/grants/policy/hs/data_safety.htm">http://grants.nih.gov/grants/policy/hs/data_safety.htm</a> and in the application instructions (SF424 (R&R) and PHS 398). </p>
|
|
<p>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="heading3">2. Administrative and
|
|
National Policy Requirements</div>
|
|
<p>All NIH grant and cooperative agreement awards include the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></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"><i>NIH
|
|
Grants Policy Statement</i> 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, Grantees, and Activities</a>. More information is
|
|
provided at <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award
|
|
Conditions and Information for NIH Grants</a>.</p>
|
|
<p>Recipients of federal financial
|
|
assistance (FFA) from HHS must administer their programs in compliance with
|
|
federal civil rights law. This means that recipients of HHS funds must ensure
|
|
equal access to their programs without regard to a person’s race, color,
|
|
national origin, disability, age and, in some circumstances, sex and religion.
|
|
This includes ensuring your programs are accessible to persons with limited
|
|
English proficiency. 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.</p>
|
|
<p>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. HHS provides
|
|
general guidance to recipients of FFA on meeting their legal obligation to take
|
|
reasonable steps to provide meaningful access to their programs by persons with
|
|
limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html.
|
|
The HHS Office for Civil Rights also provides guidance on complying with civil
|
|
rights laws enforced by HHS. Please see <a href="https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>;
|
|
and <a href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html">https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html</a>.
|
|
Recipients of FFA also have specific legal obligations for serving qualified
|
|
individuals with disabilities. Please see <a href="https://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.
|
|
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. Also note it is an HHS
|
|
Departmental goal to ensure access to quality, culturally competent care,
|
|
including long-term services and supports, for vulnerable populations. For
|
|
further guidance on providing culturally and linguistically appropriate
|
|
services, recipients should review the National Standards for Culturally and
|
|
Linguistically Appropriate Services in Health and Health Care at <a href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>. </p>
|
|
<p>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 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>Not Applicable</p>
|
|
<div class="heading3">3. Reporting</div>
|
|
<p>Progress reports for multi-year funded awards are due
|
|
annually on or before the anniversary of the budget/project period start date
|
|
of award. The reporting period for multi-year funded award progress report is
|
|
the calendar year preceding the anniversary date of the award. Information on
|
|
the content of the progress report and instructions on how to submit the report
|
|
using the RPPR are posted at <a
|
|
href="//grants.nih.gov/grants/policy/myf.htm">http://grants.nih.gov/grants/policy/myf.htm</a></p>
|
|
<p><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="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161"><i>NIH
|
|
Grants Policy Statement</i></a>.</p>
|
|
<p>The Federal Funding Accountability and Transparency Act of
|
|
2006 (Transparency Act), includes a requirement for awardees of Federal grants
|
|
to report information about first-tier subawards and executive compensation
|
|
under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11171"><i>NIH
|
|
Grants Policy Statement</i></a> for additional information on this reporting
|
|
requirement.</p>
|
|
<p>In accordance with the regulatory requirements provided at
|
|
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions 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>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>eRA Service Desk (Questions regarding ASSIST, eRA Commons
|
|
registration, submitting and tracking an application, documenting system
|
|
problems that threaten submission by the due date, post submission issues)<br>
|
|
Finding Help Online: <a href="//grants.nih.gov/support/">http://grants.nih.gov/support/</a> (preferred method of contact)<br>
|
|
Telephone: 301-402-7469 or 866-504-9552 (Toll Free) </p>
|
|
<p><a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82301">Grants.gov
|
|
Customer Support</a><strong> </strong>(Questions
|
|
regarding Grants.gov registration and submission, downloading forms and
|
|
application packages)<br>
|
|
Contact Center Telephone: 800-518-4726 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#196a6c6969766b6d597e6b78776d6a377e766f"><span class="__cf_email__" data-cfemail="6a191f1a1a05181e2a0d180b041e19440d051c">[email protected]</span></a> </p>
|
|
<p class=MsoCommentText>GrantsInfo
|
|
(Questions regarding application instructions and process, finding NIH grant
|
|
resources)<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#c88fbaa9a6bcbb81a6aea788a6a1a0e6afa7be"><span class="__cf_email__" data-cfemail="bcfbceddd2c8cff5d2dad3fcd2d5d492dbd3ca">[email protected]</span></a> (preferred method of contact)<br>
|
|
Telephone: 301-945-7573<br>
|
|
<br>
|
|
</p>
|
|
<div class="heading4">Scientific/Research Contact(s)</div>
|
|
<p> <br>
|
|
Henry Burch, M.D.<br>
|
|
Division of Diabetes, Endocrinology and Metabolic Diseases<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-827-0827<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#5f3d2a2d3c37373d1f31363771383029"><span class="__cf_email__" data-cfemail="7e1c0b0c1d16161c3e10171650191108">[email protected]</span></a></p>
|
|
<p>Aynur Unalp-Arida, MD, MSc, PhD<br>
|
|
Division of Digestive Diseases and Nutrition<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-594-8879<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#dcbda5b2a9aef2a9b2bdb0acf1bdaeb5b8bd9cb2b5b4f2bbb3aa"><span class="__cf_email__" data-cfemail="dabba3b4afa8f4afb4bbb6aaf7bba8b3bebb9ab4b3b2f4bdb5ac">[email protected]</span></a> </p>
|
|
<p>Tracy L. Rankin, PhD, MPH <br>
|
|
Division of Kidney, Urologic, and Hematologic Diseases<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-594-4748<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#4331222d282a2d37032e222a2f6d2d2a2b6d242c35"><span class="__cf_email__" data-cfemail="661407080d0f0812260b070f0a48080f0e48010910">[email protected]</span></a> </p>
|
|
<div class="heading4">Peer Review Contact(s)</div>
|
|
<p>Examine your eRA Commons account for review assignment and
|
|
contact information (information appears two weeks after the submission due
|
|
date).</p>
|
|
<div class="heading4">Financial/Grants Management Contact(s)</div>
|
|
<p>Todd Le (for the Division of Diabetes, Endocrinology and Metabolic
|
|
Diseases)<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-594-7794<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#9bcff4ffffb5d7fedbf5f2f3b5fcf4ed"><span class="__cf_email__" data-cfemail="d581bab1b1fb99b095bbbcbdfbb2baa3">[email protected]</span></a></p>
|
|
<p>Thuthuy Nguyen (for the Division of Digestive Diseases and
|
|
Nutrition)<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-594-8825<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#71051904051904081f160408141f311f1815151a5f1f18195f161e07"><span class="__cf_email__" data-cfemail="02766a77766a777b6c65777b676c426c6b6666692c6c6b6a2c656d74">[email protected]</span></a></p>
|
|
<p>Tommy Gunter (for the Division of Kidney, Urologic, and
|
|
Hematologic Diseases)<br>
|
|
National Institute of Diabetes and Digestive and Kidney
|
|
Diseases (NIDDK)<br>
|
|
Telephone: 301-451-3447<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#20744f4d4d590e47554e544552604e49480e474f56"><span class="__cf_email__" data-cfemail="41152e2c2c386f26342f352433012f28296f262e37">[email protected]</span></a></p>
|
|
<div class="heading2"><a name="_Toc258873273"></a><a
|
|
name="_Section_VIII._Other"></a>Section VIII. Other
|
|
Information</div>
|
|
<p>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>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. </p>
|
|
</div>
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<P>
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<HR>
|
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<A HREF="/grants/guide/WeeklyIndex.cfm?12-15-17">Weekly TOC for this Announcement</A><br>
|
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
|
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<hr>
|
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<div class="col-md-4"> <a href="/grants/oer.htm"><img src="/images7/nih-oer-logo.jpg" alt="NIH Office of Extramural Research Logo" usemap="#Map2" border="0"></a>
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<div style="float:left; padding: 5 5 5 70"> <a href="https://www.hhs.gov/"><img src="/images7/dhhs_sm.gif" width="36" height="37" border="0" alt="Department of Health and Human Services (HHS) - Home Page" long desc="Logo, circular in shape, depicting an American eagle in-flight with stylized profiles of human faces appearing on the trailing edge of the wings. The perimeter of the logo is encircled with the words 'Department of Health and Human Services U S A'"></a></div>
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<div style="padding: 5 5 5 5;">Department of Health<br>
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and Human Services (HHS)</div>
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</div>
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<div class="col-md-4">
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<div style="padding: 5 5 5 0" align="center"> <a href="https://www.usa.gov/"><img src="/images7/USA_Gov_logo.gif" border="0" alt="USA.gov - Government Made Easy" long desc="Logo,- the words 'USA.gov - Government Made Easy' with single streaking star above the logo"></a> </div>
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