Notice Number: NOT-OD-09-123

Key Dates
Release Date: July 15, 2009

Other Relevant Notices

• September 10, 2010 See NOT-OD-10-136 Amended Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration
• August 30, 2010 - See NOT-OD-10-126 Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration.
• February 19, 2010 - See Notice NOT-OD-10-063 Status of Certain Human Embryonic Stem Cell Lines.
• February 19, 2010 - See Notice NOT-OD-10-056 Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research.
• December 14, 2009 - See Notice NOT-OD-10-029 Clarification of Terms and Conditions of Awards using Human Embryonic Stem Cells.
• December 2, 2009 - See Notice NOT-OD-10-020 First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research.
• April 17, 2009 - See NOT-OD-09-085 Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
• April 24, 2009 - See NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009
• July 6, 2009 NIH Guidelines for Human Stem Cell Research

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The final NIH Guidelines for Human Stem Cell Research became effective on July 7, 2009, implementing President Barack H. Obama’s Executive Order 13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The NIH Guidelines establish policy and procedures under which the NIH will fund human embryonic stem cell (hESC) research. The final NIH Guidelines are available at: http://stemcells.nih.gov/policy/pages/2009guidelines.aspx.

The NIH Guidelines establish a new NIH Registry of hESCs eligible for use in NIH funding, and centralize the processes and procedures for NIH review of hESCs for inclusion on the Registry. NIH is working to develop the process for submission of hESCs for NIH administrative review or review by a Working Group of the Advisory Committee to the Director in accordance with the Guidelines. As soon as information about that process becomes available NIH will provide it. We anticipate that a number of hESC lines will be submitted to NIH as soon as possible, and NIH is committed to reviewing them for inclusion on the Registry in an expeditious manner. The Registry will be posted at: http://grants.nih.gov/stem_cells/registry/current.htm.

This Notice provides information about new applications proposing to use hESCs, ongoing NIH research using previously approved hESC lines, and the status of applications previously submitted to NIH proposing to use hESCs, including those that received initial peer review prior to April 17, 2009 when NIH announced that applications that had not already been reviewed would be held pending issuance of the final Guidelines.

New Applications Proposing to Use hESCs

NIH is continuing to accept new and competing applications and R&D contract proposals proposing to use hESCs. Until hESC lines are listed on the new NIH Registry, applicants and offerors should not identify a specific hESC line, but should include a statement that one from the new Registry will be used.

• For grant applications using the SF424(R&R) electronic application packages, a checkbox labeled Specific stem cell line cannot be referenced at this time. One from the registry will be used is found in section 4 of the PHS398 Cover Page Supplement component. Checking this box is sufficient.
• For grant applications using the SF424(R&R) Individual Fellowship electronic application packages, a checkbox labeled Specific stem cell line cannot be referenced at this time. One from the registry will be used is found in section C of the PHS Fellowship Supplemental Form component. Checking this box is sufficient.
• For grant applications using the PHS 398 paper application form, the statement Specific stem cell line cannot be referenced at this time. One from the registry will be used should be inserted in the Human Embryonic Stem Cells section on page 3. Adding this statement is sufficient.

Ongoing Awards

Ongoing NIH-supported research involving hESC lines approved before April 17, 2009 may continue through the remainder of the currently approved competitive segment of the award. No new uses of hESCs may be initiated in ongoing funded studies unless hESCs have been approved through the new NIH process and are on the new Registry, and the grantee notifies NIH which stem cell line from the Registry will be used. Consistent with the new policy, when these projects are competitively renewed or submitted for any competing revision, they must use only approved cell lines listed in the new Registry.

Status of Pending Applications, Including Applications for ARRA Funding

Meritorious hESC applications that were peer reviewed before April 17, 2009, but were held pending issuance of the final NIH Guidelines, as well as administrative supplements, may now be paid. These awards will be restricted from using funds for hESC research until the grantee identifies an eligible hESC line that has been approved through the new NIH process and appears on the new NIH Registry. Grantees will be asked, prior to award (just-in-time), to provide a statement to this effect and a description of the impact, if any, using a new line will have on the science proposed.

Review of all hESC Challenge/RC1 applications will be delayed until the Fall of 2009, for consideration for funding in the January/February 2010 Council rounds. Since these applications are for ARRA funding but awards will be delayed until FY2010, they will be multiyear-funded for 24 months. This applies only to hESC Challenge/RC1 grants.
Review of all Grand Opportunity (GO/RC2) applications and competitive revision applications that were submitted for the April 21, 2009 due date and ARRA funding, and propose the use of hESC, will be completed by late August 2009.

Review of all other non-ARRA hESC applications (except those submitted in response to Requests for Applications (RFAs) for FY2009 funding) that were submitted for FY2009 non-ARRA funding will occur in late September or early October 2009, for consideration for funding in January/February 2010 Councils. These applications will be referred to Scientific Review Groups following standard procedures. Applicants will be notified by email of a change in the review of their application, and new review assignment information will be accessible in the eRA Commons. Applications submitted in response to certain RFAs for non-ARRA FY2009 funding will be reviewed for consideration for funding in September/October 2009 Councils.

In order to maintain consistency in review, additional information will not be accepted for the initial peer review of hESC applications during this time. Reviewers will be informed that only restricted awards will be issued until eligible hESC lines are approved. Also, reviewers will be instructed that the choice of hESC line in the research plan should not affect the individual criterion scores, assessments of overall merit, or overall impact/priority scores.

Applicants may consider the option of withdrawing a pending application and submitting a more current application for a future due date (http://grants.nih.gov/grants/funding/submissionschedule.htm). Subsequent applications that change activity code or were submitted previously in response to a Request for Applications will be considered new applications. Finally, withdrawal and submission of a subsequent application due to the issuance of the NIH Guidelines for Human Stem Cell Research will not be viewed as an acceptable justification for a late application.

Applications using hESCs submitted for ARRA funding, except hESC Challenge/RC1applications, if awarded, will be awarded by September 30, 2009. All awards will be restricted as described above until an eligible line is available and designated.

Human Subjects Research Considerations

According to OHRP guidance (http://www.hhs.gov/ohrp/references/HESCGuidance.pdf), HHS-supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research according to regulations at 45 CFR 46. Therefore, in vitro research or research in animals using previously derived and established human cell lines, from which the identity of the donor cannot be readily ascertained by the investigator, is not considered human subjects research and does not require IRB review and approval. If the identity of the donor is known to the investigators, such research is generally considered to involve human subjects and to require IRB review and approval.

Clinical research that involves interactions with living individuals, including the transplantation of human cells or test articles, such as differentiated cells derived from human embryos or human fetal tissue, into human recipients is considered human subjects research and requires IRB review and approval. Note that other regulations, including relevant state or local laws and FDA regulations governing IND’s or INE s, may also apply to research involving the transplantation of cells or test articles derived from human fetal tissue into human recipients.

Inquiries

Inquiries should be directed to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Email: [email protected]