NIH Guidelines for iPS Cell Research

HHS Regulations that Govern Derivation and Use of Human iPS Cells

All derivation and use of human iPS cell lines is subject to the following HHS regulations:

• Research that is conducted within the NIH IRP involving the derivation of pluripotent cell lines from non-embryonic sources may be subject to the HHS regulations for the protection of human subjects who are the donors of the tissue or cells (45 CFR part 46).
• Submit a Request for Review to the Office of Human Subjects Research (301-402-3444) before deriving iPS cell lines from categories (1) and (2).
  • (Category 1) When using stored tissue or cells that retain no links to the identity of the individual from whom the tissue or cells were originally obtained, the derivation of the cell line is not considered human subjects research. In addition, the derivation of the cell line may not constitute human subjects research if the stored tissues or cells are coded and certain other conditions are met. See the HHS Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008.
  • (Category 2) When using stored tissue or cells from a deceased donor, the derivation of the cell line would not be considered human subjects research (45 CFR 46.102(f)). However, state or local laws may apply (e.g., if material is obtained from autopsy).
• Contact your IRB Office prior to deriving cells from categories (3) and (4):
  • (Category 3) When using stored tissue or cells that can be linked by the investigators to the identity of the individual from whom the tissue was obtained, the derivation of the cell line constitutes human subjects research. IRB review and approval and informed consent would be required from the subject, unless the IRB determines that the criteria for a waiver of informed consent have been met (45 CFR 46.1 02(£)(2).
  • (Category 4) When tissues or cells for cell line derivation are obtained specifically for the proposed derivation of pluripotent cell lines through an interaction or intervention with a living individual (45 CFR 46.102(£)(1), IRB review is required and informed consent must be obtained, unless the IRB waives the requirement for obtaining informed consent .in accordance with the requirements of the HHS regulations at 45 CFR 46.116(d).
• If the derivation of the pluripotent cell line involves recombinant DNA, the investigator should consult the NIH Guidelines for Research Involving Recombinant DNA Molecules to determine whether they apply. The Guidelines are available for download at http://oba.od.nih.gov/rdna/nih guidelines oba.html.
• Users of iPS cells should be aware of the restrictions on chimeras and breeding noted in Section IV of the National Institutes of Health Guidelines on Human Stem Cell Research at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx.