APPROVAL PROCESS FOR THE USE OF HUMAN PLURIPOTENT STEM CELLS IN NIH-SUPPORTED RESEARCH Release Date: August 23, 2000 NOTICE: OD-00-050 (See Notice OD-02-007 dated November 7, 2001) National Institutes of Health The purpose of this Notice is to outline procedures that the NIH is adopting for the approval of the use of human pluripotent stem cells in NIH-supported research. The NIH published the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (the Guidelines) in the Federal Register on August 25, 2000 (see http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp and http://stemcells.nih.gov/news/newsArchives/fr21no00-104.asp). The Guidelines establish procedures for investigators/institutions requesting NIH funds for research using human pluripotent stem cells is conducted in an ethical and legal manner. NIH will fund research using human pluripotent stem cell lines derived from embryos or fetal tissue only if that research is conducted in compliance with the Guidelines. This Notice outlines the procedures NIH will use to implement oversight of this process. Further details about this process will be published within weeks in the NIH Guide for Grants and Contracts. The Guidelines outline the documentation that must be submitted by intramural investigators and by institutions on behalf of extramural investigators requesting the use of NIH funds to conduct research using human pluripotent stem cells derived from human embryos or human fetal tissue. This applies to investigators who want to use existing funds and who are requesting an administrative or competing supplement, and to those who are applying for new NIH funding. This documentation will be reviewed for compliance with the Guidelines by a working group of the NIH Center for Scientific Review Advisory Committee (CSRAC), called the Human Pluripotent Stem Cell Review Group (HPSCRG). Recommendations of the members of HPSCRG will be reviewed by CSRAC, and, if appropriate, approved in its public meetings. Details on the documentation required for HPSCRG review can be found in Section II.A.1 of the Guidelines for the utilization of human pluripotent stem cells derived from human embryos and in Section II.B.1 for the utilization of human pluripotent stem cells derived from fetal tissue. For existing awards and administrative supplements, the applicant institution should reference the grant number under which the proposed research using human pluripotent stem cells derived from human embryos or human fetal tissue is to be conducted. If the proposed research constitutes a change in scope of the funded project, the principal investigator must obtain prior approval for the change in scope from NIH (see NIH Grants Policy Statement). In the case of intramural projects, investigators should send documentation materials to their Scientific Director, who should forward the materials to the Office of Science Policy (with a copy to the Deputy Director of Intramural Research). Only after these materials have been reviewed by the HPSCRG and approved by the CSRAC will the research be allowed to proceed. These submissions will be considered on the same schedule as outlined below for extramural requests. The NIH Office of Science Policy will forward the CSRAC’s decision to the funding Institute or Center. The originals and two copies of materials documenting compliance as described in the Guidelines, should be submitted (separate from any grant application) to the NIH Office of Science Policy at: NIH Office of Science Policy Attn: HPSCRG Bldg. 1, Rm. 103 1 Center Drive Bethesda, MD 20892 Applicants need to consider the meeting schedules of both the HPSCRG and the CSRAC in planning for potential start dates. The HPSCRG process does not change the receipt date, peer review date, or any other deadlines related to grant applications. In no event will the NIH provide funds or allow existing funds to be used for research utilizing human pluripotent stem cells derived from human embryos or human fetal tissue until the documentation has been received and reviewed by the HPSCRG and approved by the CSRAC. The NIH Office of Science Policy will forward the CSRAC decision to the funding Institute or Center. Materials should be submitted according to the following schedule: Materials received: For review by HPSCRG in: For consideration by CSRAC in: March 15 April May July 15 August September November 15 December January Investigators/institutions may be asked to provide additional supporting materials prior to determination of compliance. This could delay final approval. At this time, the NIH is establishing these procedures for grant and cooperative agreement applications and intramural projects only. More information about this process will be available in the forthcoming NIH Guide notice mentioned above. Procedures for contract awards are being developed and will be published in the future. In the meantime, questions and inquiries may be forwarded to: stemcell@mail.nih.gov.

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