The United States lacks federal oversight of stem cell research, and instead relies on a patchwork of regulations and guidelines from states, funders, and nonprofit organizations. Most influential have been the National Academies' Guidelines for Human Embryonic Stem Cell Research, which were just revised for the second time since their debut in 2005. Although the guidelines are nonbinding, they have served as the model for others, particularly California's $3 billion program, and will likely do so for policy under the new presidential administration.
The press release from the National Academies highlights changes in two key areas, one encouraging, and one less so. First, the committee revisited the question of payments to women who provide eggs for cloning-based stem cell research, and maintained their position that these women should not be compensated. The amendments, though, clarify the types of reimbursements that are allowed. Taking a cue from California's regulations, they aim to make the egg donor neither better nor worse off.
Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for NT [nuclear transfer, or cloning-based stem cell research]) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. Direct expenses may include costs associated with travel, housing, child care, medical care, health insurance, and actual lost wages. No payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes or of somatic cells for use in NT.
Second, the committee now recommends that the institutionally-affiliated boards that approve the stem cell research projects, ESCROs, undergo audits whose results are publicly available. We've long maintained that leaving this oversight to boards that are essentially part-and-parcel of the research institutions themselves is tantamount to letting the fox guard the henhouse. However, the National Academies is an independent nonprofit organization, and cannot impose mandates or real regulation. While this change is certainly an improvement, let's hope that any legislation under a new administration does not merely mimic the Academies' Guidelines, but instead recognizes that they were drafted by an agency with limitations.
An institution that maintains its own ESCRO committee should conduct periodic audits of the committee to verify that it is carrying out its responsibilities appropriately. Auditable records include documentation of decisions regarding the acceptability of research proposals and verification that cell lines in use at the institution were acceptably derived (see Section 1.6). Institutions should make the results of the audits available to the public.
An institution that uses an external ESCRO committee should nevertheless ensure that the registry and educational functions of an internal ESCRO committee are carried out by the external ESCRO committee on its behalf or internally by other administrative units. Those institutions that use external ESCRO committees are also responsible for ensuring that these committees are likewise carrying out their responsibilities appropriately.
Previously on Biopolitical Times: