Whether it involves receiving donated blastocysts that would otherwise be discarded after infertility treatment or procuring gametes and somatic cells to make blastocysts specifically for research purposes, the procurement process often requires oversight by an Institutional Review Board (IRB), whose membership and functions are described in Department of Health and Human Service (DHHS) regulations at 45 CFR 46.107-115 and in FDA regulations at 21 CFR 56.107-115.2 IRB
2DHHS has codified its human subjects protection regulations at 45 CFR 46, Subparts A through D. Other federal research agencies have signed onto Subpart A, which is referred to as the Common Rule. In this report, the DHHS regulations are cited in discussing the protection of human subjects of research because they are more inclusive than the Common Rule alone. The DHHS regulations extend additional protections to vulnerable populations, such as pregnant women, viable fetuses, prisoners, and children. FDA also has codified Subpart A of the regulations at 21 CFR 50 and 56, although with slightly different interpretations. In some cases, FDA regulations and HHS regulations might apply to research.
review is the primary means of implementing the research protections found in the federal regulations, which generally require that human research be undertaken with the informed and voluntary consent of the subjects, that the risks to subjects be minimized, and that the research be approved and monitored by an IRB. The federal regulations generally are triggered when research is funded by the federal government, when privately funded research is aimed at developing data for a product to be approved by FDA, or when privately funded research takes place at institutions that have agreed to adopt the protections more broadly than required by law. In addition, some states, such as California and New Jersey, have adopted legislation requiring IRB review and many of the substantive protections of the federal regulations with regard to hES cell research conducted in those states.3
Research involving hES cells will require access to human oocytes and blasto-cysts, which in turn will necessitate some interaction between donors of oocytes and blastocysts and the people or institutions seeking to procure these materials for use in hES cell research. The federal regulations governing human subjects research define human subjects research as involving either
(1) obtaining data from a living individual through intervention or interaction with the individual; or
(2) obtaining private (i.e., individually identifiable) information about a living individual (45 CFR 46.102(f)).
The DHHS Office for Human Research Protections (OHRP) has made it clear that hES cell research "that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research [and therefore] IRB review is not required for such research."4 According to OHRP, merely asking couples whether they wish to donate their surplus blastocysts for research does not render them "human subjects of research" if no data on them are being gathered and there is no substantive interaction with them other than gaining their consent.5
On the other hand, where physical interaction is needed to obtain biological materials, such as in the case of donors whose sperm, oocytes, or somatic cells are used to make blastocysts for research, the interaction brings them under the purview of the human subjects protections system and IRB review is required, even though the donors are not themselves the subjects of scientific study. Thus, their fully informed and voluntary consent is required before such research use.
4Guidance for Investigators and Institutional Review Boards Regarding Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles, OHRP/DHHS, Mar. 19, 2002, at 3.
5OHRP staff briefing to the committee, January 8, 2005, interpreting 45 CFR 46.102(f).
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.
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.
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 blas-tocysts 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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