NOTICE OF EXTENDED RECEIPT DATE AND SUPPLEMENTAL INFORMATION GUIDANCE FOR
APPLICATIONS REQUESTING FUNDING THAT PROPOSES RESEARCH WITH HUMAN EMBRYONIC
STEM CELLS
Release Date: November 7, 2001
NOTICE: NOT-OD-02-006
Office of the Director, NIH
The NIH is preparing to accept requests for funding of research using
human embryonic stem cells. Federal funding is available only for
research using those lines included on the NIH Human Embryonic Stem
Cell Registry http://escr.nih.gov (hereafter referred to as the
Registry ) which confirms that the stem cell lines are in compliance
with the President’s criteria as stated on August 9, 2001
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Principal investigators and their applicant institutions are urged to
read this guidance carefully and follow the steps outlined for the
specific types of funding requests that follow.
The NIH is operating in accordance with the President’s guidance. The
NIH Guidelines for the Use of Human Pluripotent Stem Cells
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html no
longer apply for research on human embryonic stem cells
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-007.html.
Applicants who wish to submit for the Oct. 1 receipt date for new,
competing applications or Nov. 1 for competing renewals and competing
supplements may do so. The Registry will be posted in the immediate
future. Applicants should either indicate the specific cell line they
plan to use and include this information in the DESCRIPTION section of
the grant application or note that they cannot specify the line, but
will use one from the Registry, once the Registry is posted. In the
latter case, they will have to provide the specific information in a
letter prior to the initial scientific review. Bearing in mind the
timing of this Notice, applications for the use of human embryonic
stem cells will be considered as late as November 27, 2001 for this one
round only.
Grantees who wish to submit requests for administrative supplements to
their funding Institute or Center may do so. The request should include
information about which cell lines in the Registry will be used.
Grantees who plan to request administrative supplements should be in
contact with their project officers for further information. These
requests should follow the usual procedures for the specific Institute
or Center in regard to administrative supplements. Final action on
such a request and authorization to spend federal funds cannot occur
until 30 days after the publication of this Notice.
Grantees who wish to rebudget existing funds may do so, but the cell
line to be used must be one that is presently on the NIH Registry.
Even when funds already exist in the grant, they may not be expended
until 30 days after the publication of this Notice.
All stem cell lines that are listed on the Registry were obtained with
informed consent of the donors. Such research is subject to the Common
Rule (45 CFR 46) if it involves individually identifiable private
information such that the identity of the donors is or may readily be
ascertained by the investigator or associated with the information.
Further clarification of the application of the Common Rule can be
obtained from the Office of Human Research Protections (OHRP)
http://www.hhs.gov/ohrp/references/HESCGuidance.pdf.
The NIH anticipates issuing several RFAs and PAs over the next few
months that would encompass research using human embryonic stem cells.
In all cases, applicants must use cell line(s) from the Registry and
include the information about which cell line is proposed for use in
the description portion of their application.
Questions about the implementation of these guidelines should be
directed to the Deputy Director for Extramural Research [email protected].
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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