Whether it is blastocyst donation or the donation of gametes and somatic cells, even where the federal regulations require informed consent, IRBs are permitted to waive the requirement if certain conditions are met (45 CFR 46. 116(8)(d)), that is, if the research is of minimal risk, waiver of consent would not adversely affect rights and welfare of subjects, and obtaining consent is impracticable. In the case of gamete or somatic cell donation, in which the donors must be present at the time of donation, not all those conditions apply, and waiver of consent cannot be granted. In the case of blastocyst donation, the committee finds that informed consent should be required in all cases (see Chapter 5): a waiver should not be granted even when the specified conditions can be met.

Although OHRP requires IRB review of the procurement process for blastocyst donors only under certain conditions, this committee finds that the best way to ensure that protections are in place for all potential donors is to require IRB review at all times for the process by which somatic cells, gametes, and blastocysts are obtained to ensure that risks are minimized and voluntary and informed consent is provided. (Consent issues are addressed in greater detail in Chapter 5.) In contrast, as noted below in the discussion of privacy protections, when research is to be conducted on hES cell lines that have already been derived through a procurement process approved by an IRB, the committee does not find that there is need for additional IRB review of work with coded or anonymous cell lines.

Recommendation 8:

Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from in vitro fertilization clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines derived through nuclear transfer.

Recommendation 9:

Institutional Review Boards may not waive the requirement for obtaining informed consent from any person whose somatic cells, gametes, or blastocysts are used in hES research.

Requiring informed consent before donation of gametes, somatic cells, or blastocysts and requiring oversight by such a body as an IRB would bring U.S. practices into conformity with the practices in Australia, Canada, Israel, Singapore, the United Kingdom, and other major centers of hES cell research. That, in turn, will not only ensure the ethical conduct of procurement practices in the United States but also facilitate collaboration with investigators subject to regulations in the other countries.

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