PROCEDURES FOR SUBMISSION OF COMPLIANCE DOCUMENTS TO THE HUMAN PLURIPOTENT STEM CELL REVIEW GROUP FOR THE RESEARCH USE OF HUMAN EMBRYONIC GERM CELLS Release Date: May 3, 2002 NOTICE: NOT-OD-02-049 National Institutes of Health Research use of human embryonic germ cells derived from fetal tissue with Federal funds requires review of compliance with the NIH Guidelines for Research Using Human Pluripotent Stem Cells http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp. Embryonic germ cells are pluripotent stem cells derived from fetal tissue and are distinct from human embryonic stem cells that are derived from human embryos. This notice does not pertain to human embryonic stem cells. The Guidelines require that certain documents be submitted to and reviewed by the Human Pluripotent Stem Cell Review Group (HPSCRG). In accordance with the NIH Guidelines, the HPSCRG review will be conducted in a public meeting. This notice describes the documents investigators are required to submit and the submission process for HPSCRG review. Investigators who intend to use existing funds, request an administrative supplement, or apply for new Department of Health and Human Services (DHHS) funds for research using human embryonic germ cells derived from fetal tissue are required to submit the following for HPSCRG review: 1. An assurance signed by the responsible institutional official that the embryonic germ 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 the assurance, 2. A sample informed consent document (with patient identifier information removed) and a description of the informed consent process that meet the criteria for informed consent set forth in Section II.B.2.b of the NIH Guidelines, 3. An abstract of the scientific protocol used to derive human embryonic germ cells from fetal tissue, 4. Documentation of institutional review board approval of the derivation protocol, 5. An assurance that the stem cells to be used in the research were or will be obtained through a donation or through a payment that does not exceed the reasonable costs associated with the transportation, processing, preservation, quality control and storage of the stem cells, 6. The title of the research proposal or specific subproject that proposes the use of human embryonic germ cells, 7. An assurance that the proposed research using human embryonic germ cells is not a class of research that is ineligible for NIH funding as set forth in the NIH Guidelines (Section III) and, 8. The Principal Investigator"s written consent to the disclosure of all material submitted as necessary to carry out the public review and other oversight procedures set forth in the NIH Guidelines. DHHS funds may be used to support research to derive human embryonic germ cells from fetal tissue, as well as for research utilizing such cells. Such research is governed by Federal statutory restrictions regarding fetal tissue research at 42 U.S.C. § 289g-2(a) and the Federal regulations at 45 CFR § 46.210. All DHHS-funded research involving the derivation or utilization of embryonic germ cells from human fetal tissue must comply with the fetal tissue transplantation research statute at 42 U.S.C. § 289g-1 and with 42 U.S.C. § 289g-2(b). Applicants to the HPSCRG review process are advised to review issues pertaining to informed consent processes described in Section II.B.2.b. of the NIH Guidelines. Applicants should also review the Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell Derived Test Articles issued on March 19, 2002 by the Office of Human Research Protections, DHHS. http://www.hhs.gov/ohrp/references/HESCGuidance.pdf Applications for HPSCRG review may be submitted prior to, at the time of, or after the scientific review of a research proposal. Federal funds may not be used or awarded prior to the approval by HPSCRG. All documents described above should be accompanied with a cover letter describing the grant application or research grant under which the proposed research will be conducted. These materials should be submitted by mail to: Dr. Della Hann Office of Extramural Research Office of the Director, NIH, Bldg 1, Rm 144 One Center Drive, Bethesda, MD 20892. Inquires about the HPSCRG review process can be made to DDER@nih.gov or by phone (301) 496-1096.
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