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<TITLE>NOT-OD-01-003: APPROVAL PROCESS FOR THE DOCUMENTATION OF COMPLIANCE WITH NIH GUIDELINES ON THE USE OF HUMAN PLURIPOTENT STEM CELLS IN NIH RESEARCH PROPOSED FOR SUPPORT UNDER GRANTS AND COOPERATIVE AGREEMENTS</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: APPROVAL PROCESS FOR THE DOCUMENTATION OF COMPLIANCE WITH NIH GUIDELINES ON THE USE OF HUMAN PLURIPOTENT STEM CELLS IN NIH RESEARCH PROPOSED FOR SUPPORT UNDER GRANTS AND COOPERATIVE AGREEMENTS NOT-OD-01-003. NIH">
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<META NAME="Keywords" CONTENT="NOT-OD-01-003: APPROVAL PROCESS FOR THE DOCUMENTATION OF COMPLIANCE WITH NIH GUIDELINES ON THE USE OF HUMAN PLURIPOTENT STEM CELLS IN NIH RESEARCH PROPOSED FOR SUPPORT UNDER GRANTS AND COOPERATIVE AGREEMENTS">
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APPROVAL PROCESS FOR THE DOCUMENTATION OF COMPLIANCE WITH NIH GUIDELINES ON
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THE USE OF HUMAN PLURIPOTENT STEM CELLS IN NIH RESEARCH PROPOSED FOR SUPPORT
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UNDER GRANTS AND COOPERATIVE AGREEMENTS
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Release Date: November 21, 2000
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NOTICE: OD-01-003 (amended) (See <a href="/grants/guide/notice-files/NOT-OD-02-007.html">Notice OD-02-007</a> dated November 7, 2001)
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National Institutes of Health
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INTRODUCTION
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The only significant difference in this Notice and that published on October
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16, 2000, is that there are separate descriptions of the materials to be
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submitted for human pluripotent stem cells derived from embryos or fetal
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tissue. The documentation to be submitted and the timetable for submission
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have not changed. However, a separate discussion of the process for embryos
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or fetal tissue clarifies the compliance approval process.
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On August 23, 2000, the National Institutes of Health (NIH) published an
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outline of procedures for the approval of the use of human pluripotent stem
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cells in NIH supported intramural and extramural research
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(<a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html</a>). This
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second notice details the specific procedures that must be followed by
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extramural investigators proposing to use existing or seeking new NIH funds
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for research using human pluripotent stem cells derived from human embryos
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and human fetal tissue. These procedures are based on the NATIONAL
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INSTITUTES OF HEALTH GUIDELINES FOR RESEARCH USING HUMAN PLURIPOTENT STEM
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CELLS (<a href="http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp">http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp</a>),
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hereinafter referred to as the NIH GUIDELINES, published in the Federal Register
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(65 FR 51976) and effective on August 25, 2000. Because the GUIDELINES contain
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a few incorrect citations and other minor errors, a notice of correction
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(<a href="http://stemcells.nih.gov/news/newsArchives/fr21no00-104.asp">65 FR 69951</a>) is being published on November 21, 2000. The present notice details
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required procedures for research using pluripotent stem cells to be supported
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under grants and cooperative agreements.
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All research to be supported under NIH grants and cooperative agreements
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undergoes regular scientific peer review, including the customary two-stage
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process involving review by a Scientific Review Group (Study Section) and the
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Advisory Council of an Institute/Center. In addition, for research that
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proposes the use of human pluripotent stem cells, there will be a formal
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review of documentation of compliance with the NIH GUIDELINES. This latter
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review will be conducted by the Human Pluripotent Stem Cell Review Group
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(HPSCRG) which is a working group of the Center for Scientific Review
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Advisory Council (CSRAC). The process for documenting compliance with the
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NIH GUIDELINES is separate from the grant and cooperative agreement
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scientific review process. The two processes will take place in parallel in
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order to ensure that all aspects of scientific review and review of
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compliance are considered in a timely manner. Institutions and investigators
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proposing research using human pluripotent stem cells must be mindful of the
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requirements and deadlines for both processes in order to avoid delays in the
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potential funding of proposed research. NIH will not provide funds or allow
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existing funds to be used for research utilizing human pluripotent stem cells
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derived from human embryos or human fetal tissue until appropriate approvals
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have been obtained. Evidence of compliance with the NIH GUIDELINES does not
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affect the scientific merit review of a grant application nor does it ensure
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a favorable funding decision by the NIH.
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Review of compliance with the NIH GUIDELINES is a two-stage process. Any
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request proposing to use existing or seeking new NIH funds for research
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utilizing human pluripotent stem cells derived from human embryos or human
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fetal tissue must include the submission of compliance documentation to the
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NIH. The HPSCRG members will review the submitted documentation and forward
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their recommendation(s) to the CSRAC for final consideration. When the
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HPSCRG receives compliance documentation in support of a request for funds
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that proposes the use of a line of human pluripotent stem cells that has not
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been previously reviewed by HPSCRG and recommended to, and approved by, the
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CSRAC, the HPSCRG review will take place in a public meeting. Thus, although
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HPSCRG will review all requests for funds, the review of compliance
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documentation for the use of a cell line previously approved by the NIH will
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not take place in a public meeting of the HPSCRG. The final approval of
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documentation of compliance will always take place in a public meeting of the
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CSRAC.
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SUBMISSION OF DOCUMENTATION
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Timetable
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Documentation is to be submitted to the Office of Science Policy, Office of
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the Director, NIH, by institutions on behalf of principal investigators. An
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original and two copies of the documentation are to be submitted to:
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NIH Office of Science Policy
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Attention: HPSCRG
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Building 1, Room 218
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MSC 0166
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9000 Rockville Pike
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Bethesda, MD 20892
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(301) 594-7741
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The schedule for receipt and review by the HPSCRG and the CSRAC follows:
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!-------------------------------------------------------!
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!Submission Window !Materials !Review !Consideration !
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!of Competing !received by !by !on by CSRAC !
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!Applications(new, !Office of !HPSCRG ! !
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!continuation, !Science ! ! !
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!revised, !Policy ! ! !
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!supplements) ! ! ! !
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!------------------+------------+--------+--------------!
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!January 10 to !March 15 !April !May !
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!May 1 ! ! ! !
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!------------------+------------+--------+--------------!
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!May 10 to !July 15 !August !September !
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!September 1 ! ! ! !
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!------------------+------------+-----------------------!
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!September 10 to !November 15 !December!January !
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!January 2 ! ! ! !
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!-------------------------------------------------------!
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Packages of documentation received by the Office of Science Policy after the
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established deadlines will be held for the next cycle of HPSCRG and CSRAC
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consideration.
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To avoid delays, the required documentation of compliance with the NIH
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GUIDELINES may need to be submitted to the Office of Science Policy in
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advance of the submission of the actual grant application. Thus,
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institutions planning on submitting competing grant applications whether for
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standing receipt dates or special receipt dates (responses to Requests for
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Applications or special Program Announcements) between January 10 and May 1
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will need to submit the required documentation to the Office of Science
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Policy by March 15 in order to prevent delay in the consideration of the
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application. Specifically, institutions planning to submit small business
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applications on April 1, individual fellowship applications on April 5, or
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AIDS applications on May 1 should plan to submit the documentation to the
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Office of Science Policy by March 15 in order to avoid delays in the process.
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Likewise, planned submissions for August 1 (small business), August 5
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(fellowships), or September 1 (AIDS) need documentation submitted on July 15
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and planned submissions for December 1 (small business), December 5
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(fellowships), and January 2 (AIDS) by November 15. When institutions are
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submitting applications for RFAs and other special receipt dates, they must
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also consider the HPSCRG schedule and submit documentation accordingly. For
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administrative supplements to existing grants or proposals to use human
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pluripotent stem cells in studies funded as part of existing awards without a
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request for additional funds, institutions must comply with the NIH
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GUIDELINES and should also submit documentation for HPSCRG review.
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Investigators and institutions are advised that it may be prudent to first
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contact the awarding Institute or Center to discuss the proposed
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administrative supplement. If existing funds are to be used and the proposed
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research constitutes a change in scope of the funded project, the principal
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investigator must obtain prior approval for the change in scope from the
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funding Institute/Center at NIH (see the NIH Grants Policy Statement,
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(<a href="//grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#chgproj">http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#chgproj</a>) prior to
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the submission of compliance material to HPSCRG. Approval of the
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documentation of compliance with the NIH GUIDELINES does not ensure the
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approval of the Institute/Center of an administrative supplement or for a
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change in scope of the funded project.
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Materials to be submitted to NIH for research on human pluripotent stem cells
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derived from EMBRYOS and FETAL TISSUE are set forth below at parts I and II,
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respectively.
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I. HUMAN PLURIPOTENT STEM CELLS DERIVED FROM EMBRYOS
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A. MATERIALS TO BE SUBMITTED TO THE OFFICE OF SCIENCE POLICY
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1. Cover Page with the following information (See sample below)
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a. Name of the Principal Investigator (PI).
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b. Title of the grant or cooperative agreement application (See
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NIH GUIDELINES, Section II.A.1.f). If part of a multicomponent
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submission (for example a Program Project), include the name of
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the PI, the title of the overall application, and the title(s) of
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the project(s) involving the use of human pluripotent stem cells.
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If a competing continuation, revised application, administrative
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supplement, or existing award without a request for additional
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funds, also include the grant number (for example, R01 CA123456).
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c. Anticipated date of submission of the competing grant/cooperative
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agreement application.
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d. Name, title, telephone number, fax number, and e-mail address
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of the institutional official submitting the information.
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e. Signature of the institutional official.
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SAMPLE COVER PAGE
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Principal Investigator: Roberta Dilan, M.D.
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Title of Project: Use of Human Pluripotent Stem Cells to Treat
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XYZ Disease,
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Project 4 of Renewal of Program Project,
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Diagnosis and Therapy of XYZ Disease,
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Renewal of P01 ZZ123456
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(P01 Principal Investigator: James Blue, M.D., Ph.D.)
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Anticipated Submission Date of Grant Application: February 1, 2001
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Submitted by: University of Lakeview
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Institutional Official: Eileen Smith, Ph.D.
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Associate Provost for Research
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University of Lakeview
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555-555-1212 (voice)
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555-555-2121 (fax)
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<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="89fae4e0fde1ecc9e5e8e2ecffe0ecfea7ecedfc">[email protected]</a>
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2. Documentation of compliance with the NIH GUIDELINES specific to
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research using human pluripotent stem cells derived from HUMAN EMBRYOS.
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a. An assurance signed by the responsible institutional official that
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the pluripotent stem cells were derived from human embryos in
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accordance with the conditions set forth in Section II.A.2 of the
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NIH GUIDELINES and that the institution will maintain
|
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documentation in support of this assurance. The official’s
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signature will attest that the institution has documentation (or
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an assurance) from the person(s) who derived the human pluripotent
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stem cells stating that the derivation process was conducted in
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accordance with the NIH GUIDELINES (See NIH GUIDELINES Section
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II.A.1.a). Specifically, the institutional assurance should
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include a statement that the embryo(s) used to derive the
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pluripotent stem cells were created through in vitro fertilization
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for the purpose of fertility treatment and that the embryos had
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not reached the stage at which the mesoderm is formed at the time
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of donation. The assurance should also include statements that
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the donation of the embryo was voluntary; that the researcher who
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derived or proposed to derive the cells was a different person
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than the physician who provided fertility treatment; that the
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individuals undergoing fertility treatment were approached about
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consent for the donation of embryos to derive pluripotent stem
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cells only at the time of deciding the disposition of frozen
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embryos that were in excess of clinical need; that the donor
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placed no restrictions regarding the individual(s) who may be the
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recipients of transplants derived from the human embryo; and that
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the required informed consents and Institutional Review Board
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(IRB) approval were obtained.
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b. A sample of the informed consent document for the donation of the
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embryo(s) for the purpose of deriving the human pluripotent stem
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cells that was used in this research (with patient identifying
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information removed) (See NIH GUIDELINES, Section II.A.1.b). A
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description of the required elements in the informed consent
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process is set forth in Section II.A.2.e of the NIH GUIDELINES.
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c. An abstract of the scientific protocol that was used to derive the
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human pluripotent stem cells, obtained from the person(s) who
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derived the human pluripotent stem cells, describing the methods
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and materials used (See NIH GUIDELINES Section II.A.1.c). Note:
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This is not the abstract of the grant application.
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3. Other Documentation
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a. Documentation of the IRB approval of the derivation protocol (See
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NIH GUIDELINES, Section II.A.1.d).
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b. An assurance signed by the responsible institutional official that
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the human pluripotent stem cells to be used in the proposed
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research were, or will be, obtained through donation or through
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payment that does not exceed the reasonable costs associated with
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the transportation, processing, preservation, quality control, and
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storage of the stem cells (See NIH GUIDELINES, Section II.A.1.e).
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c. An assurance signed by the responsible institutional offical that
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the proposed use of human pluripotent stem cells is not a class of
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research that is ineligible for NIH funding as set forth in
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Section III of the NIH GUIDELINES (See NIH GUIDELINES, Section
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II.A.1.g).
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d. The Principal Investigator’s written consent to the disclosure of
|
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all material submitted as part of this documentation of
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compliance, as necessary to carry out the public review and other
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oversight procedures set forth in the NIH GUIDELINES (See NIH
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GUIDELINES, Section II.A.1.h).
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B. MATERIALS TO BE SUBMITTED TO THE CENTER FOR SCIENTIFIC REVIEW (CSR)
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A cover letter should accompany the submission of a competing grant
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application to the Division of Receipt and Referral, CSR (see
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instructions in the application form for complete address and
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application information), indicating that the documentation of
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compliance with the NIH GUIDELINES has been, or will be, provided to the
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NIH Office of Science Policy.
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C. DECISIONS
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HPSCRG may ask the institution to provide additional materials to
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clarify the documentation of compliance with the NIH GUIDELINES. This
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could delay the completion of the HPSCRG review. Following the meeting
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of the CSRAC, the NIH Office of Science Policy will convey the results
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of the compliance review to the principal investigator, the institution,
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and the potential funding Institute or Center within the NIH.
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D. FURTHER INFORMATION
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Questions regarding this process should be directed to
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<a href="/cdn-cgi/l/email-protection#384b4c5d555b5d5454785559515416565150165f574e"><span class="__cf_email__" data-cfemail="a7d4d3c2cac4c2cbcbe7cac6cecb89c9cecf89c0c8d1">[email protected]</span></a> or call the Office of Science Policy at (301) 594-
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7741.
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II. HUMAN PLURIPOTENT STEM CELLS DERIVED FROM FETAL TISSUE
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A. MATERIALS TO BE SUBMITTED TO THE OFFICE OF SCIENCE POLICY
|
|
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1. Cover Page with the following information (See sample below)
|
|
|
|
a. Name of the Principal Investigator (PI).
|
|
|
|
b. Title of the grant or cooperative agreement application (See NIH
|
|
GUIDELINES, Section II.B.1.f). If part of a multicomponent
|
|
submission (for example a Program Project), include the name of
|
|
the PI, the title of the overall application, and the title(s) of
|
|
the project(s) involving human pluripotent stem cells. If a
|
|
competing continuation, revised application, administrative
|
|
supplement, or existing award without a request for additional
|
|
funds, also include the grant number (for example, R01 CA12345).
|
|
|
|
c. Anticipated date of submission of the competing grant/cooperative
|
|
agreement application.
|
|
|
|
d. Name, title, telephone number, fax number, and e-mail address of
|
|
the institutional official submitting the information.
|
|
|
|
e. Signature of the institutional official.
|
|
|
|
SAMPLE COVER PAGE
|
|
|
|
Principal Investigator: Roberta Dilan, M.D.
|
|
|
|
Title of Project: Use of Human Pluripotent Stem Cells to Treat
|
|
XYZ Disease,
|
|
Project 4 of Renewal of Program Project,
|
|
Diagnosis and Therapy of XYZ Disease,
|
|
Renewal of P01 ZZ123456
|
|
(P01 Principal Investigator: James Blue, M.D., Ph.D.)
|
|
|
|
Anticipated Submission Date of Grant Application: February 1, 2001
|
|
|
|
Submitted by: University of Lakeview
|
|
|
|
Institutional Official: Eileen Smith, Ph.D.
|
|
Associate Provost for Research
|
|
University of Lakeview
|
|
555-555-1212 (voice)
|
|
555-555-2121 (fax)
|
|
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="4f3c22263b272a0f232e242a39262a38612a2b3a">[email protected]</a>
|
|
|
|
2. Documentation of compliance with the NIH GUIDELINES specific to
|
|
research using human pluripotent stem cells derived from FETAL
|
|
TISSUE.
|
|
|
|
a. An assurance signed by the responsible institutional official that
|
|
the pluripotent stem cells were derived from human fetal tissue in
|
|
accordance with the conditions set forth in Section II.B.2 of the
|
|
NIH GUIDELINES and that the institution will maintain
|
|
documentation in support of this assurance. The official’s
|
|
signature will attest that the institution has documentation (or
|
|
an assurance) from the person(s) who derived the human pluripotent
|
|
stem cells stating that the derivation process was conducted in
|
|
accordance with the NIH GUIDELINES (See NIH GUIDELINES Section
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|
II.B.1.a). The assurance should also include statements that the
|
|
research complies with all of the requirements of
|
|
42 U.S.C. 289g-1, 42 U.S.C. 289g-2(a) and (b) and
|
|
45 C.F.R. 46.210; that the required informed consents were
|
|
obtained; and that IRB approval was obtained.
|
|
|
|
b. A sample of the informed consent document that was used for the
|
|
donation of the human fetal tissue for the purpose of deriving the
|
|
human pluripotent stem cells (with patient identifying information
|
|
removed) (See NIH GUIDELINES, Section II.B.1.b). A description of
|
|
the required elements in the informed consent process is given at
|
|
Section II.B.2.b of the NIH GUIDELINES.
|
|
|
|
c. An abstract of the scientific protocol that was used to derive the
|
|
human pluripotent stem cells obtained from the person(s) who
|
|
derived the human pluripotent stem cells, describing the methods
|
|
and materials used (See NIH GUIDELINES Section II.B.1.c). Note:
|
|
This is not the abstract of the grant application.
|
|
|
|
3. Other Documentation
|
|
|
|
a. Documentation of IRB approval of the derivation protocol (See NIH
|
|
GUIDELINES, Section II.B.1.d).
|
|
|
|
b. An assurance signed by the responsible institutional official that
|
|
the human pluripotent stem cells to be used were, or will be,
|
|
obtained through donation or through payment that does not exceed
|
|
the reasonable costs associated with the transportation,
|
|
processing, preservation, quality control, and storage of the stem
|
|
cells (See NIH GUIDELINES, Section II.B.1.e).
|
|
|
|
c. An assurance signed by the responsible institutional official that
|
|
the proposed use of human pluripotent stem cells is not a class of
|
|
research that is ineligible for NIH funding, as set forth in
|
|
Section III of the NIH GUIDELINES (See NIH GUIDELINES, Section
|
|
II.B.1.g).
|
|
|
|
d. The Principal Investigator’s written consent to the disclosure of
|
|
all material submitted as part of this compliance documentation,
|
|
as necessary to carry out the public review and other oversight
|
|
procedures set forth in the NIH GUIDELINES (See NIH GUIDELINES,
|
|
Section II.B.1.h).
|
|
|
|
B. MATERIALS TO BE SUBMITTED TO THE CENTER FOR SCIENTIFIC REVIEW (CSR)
|
|
|
|
A cover letter should accompany the submission of a competing grant
|
|
application to the Division of Receipt and Referral, CSR (see
|
|
instructions in the application form for complete address and
|
|
application information), indicating that the documentation of
|
|
compliance with the NIH GUIDELINES has been, or will be, provided to the
|
|
NIH Office of Science Policy.
|
|
|
|
C. DECISIONS
|
|
|
|
HPSCRG may ask the institution to provide additional materials to
|
|
clarify the documentation of compliance with the NIH GUIDELINES. This
|
|
could delay the completion of the HPSCRG review. Following the meeting
|
|
of the CSRAC, the NIH Office of Science Policy will convey the results
|
|
of the compliance review to the principal investigator, the institution,
|
|
and the potential funding Institute or Center within the NIH.
|
|
|
|
D. FURTHER INFORMATION
|
|
|
|
Questions regarding this process should be directed to
|
|
<a href="/cdn-cgi/l/email-protection#e29196878f81878e8ea28f838b8ecc8c8b8acc858d94"><span class="__cf_email__" data-cfemail="0b787f6e66686e67674b666a626725656263256c647d">[email protected]</span></a> or call the Office of Science Policy at
|
|
(301) 594-7741.
|
|
|
|
|
|
</pre>
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|
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<P><HR><P>
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