An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.
Originally published in 2005, the amended guidelines, contained in a report released May 26, were developed "to avoid complications, contradictions, and confusion," wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, who were led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.
The updated version "recognizes the new and increased influence" of the National Institutes of Health Guidelines on Human Stem Cell Research released in 2009, and "incorporates references to the NIH guidelines as appropriate."
Where there is complete overlap, the report continues, "the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines."
The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. "Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines," the report states.
The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, "only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding," the report states.
A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.
The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' Guidelines were issued, the Ethics Committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.
"Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes," the report notes. "Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines" and recognizes "that states and other entities may choose to set their own policies, as New York has done."
The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. "Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies."
The committee, which chose to disband after completion of the current guidelines, called for an "ongoing neutral forum" in which stem cell issues can be discussed.
"Perhaps most needed is a forum that could bring together key stakeholders--including federal, state, academic, patient, and industry organizations and institutions--for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities," they wrote.
The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known under the umbrella name the National Academies.
Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.