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AAMC Comment Letter on NIH Proposed Stem Cell Guidelines

January 19, 2000

To whom it may concern:

I am writing on behalf of medical schools, teaching hospitals, and academic, scientific and professional societies to applaud the NIH on the development of its "Guidelines for Research Involving Human Pluripotent Stem Cells" [64 Federal Register 67576]. This Association firmly believes in the scientific and health promise of research using stem cells and fully appreciates the ethical complexities and public concerns associated with this area of activity. These factors amplify the importance of having thoughtful guidelines to direct future research efforts in the most responsible manner possible. Ethical research is also fruitful research, and so it is clearly in the interest of both the research community and the public to have such guidelines in place.

We recognize that these guidelines have been developed in an environment in which federal monies may not legally be used for the creation of embryos for research purposes. That said, we concur with HHS legal opinion that the funding of stem cell research is distinguishable from the creation of embryos. Thus federal support should not only be viewed as permissible, but also as highly desirable, given the beneficial oversight that accompanies government funding, the tremendous promise of this type of research, and the fact that the results of federally funded research will flow into the public domain and not be sequestered in propriety databases. In the absence of this proposal, stem cell work would undoubtedly occur, but in a very limited private context without the benefit of public scrutiny and ethical oversight that this proposal affords.

Overall, we feel the December 2 proposal is quite reasonable and handles some very difficult issues in sensible and sensitive ways. For example, we agree with the NIH's decision to limit permissible sources of embryos to those derived from fertility treatments. This is an ethically sound approach that is responsive to public sensibilities and enables a positive outcome for human cells that should be treated with respect. Instead of simply being discarded, these cells will serve a positive, humanitarian purpose by enabling therapies and cures for some of the most vexing illnesses and disabilities facing society today.

Most of the proposed protections associated with the collection of stem cells are sound as well. Seeking the informed consent of donors is in keeping with well established rules of ethically conducted medicine and research. Creating mechanisms to separate the decision to undergo fertility treatment and the donation of excess embryos wards off concerns about freedom of choice and inappropriate inducements. Prohibiting recompense for donations similarly avoids the ethical problems associated with pecuniary incentives for producing embryos. Requiring that embryos used for stem cell derivation be "only frozen early embryos" allows additional time for the more thoughtful provision of consent for their research use. In short, these characteristics of the proposal are thoughtful, well reasoned, and to be supported.

Those positive comments notwithstanding, we do offer some important suggestions and raise a few items in need of clarification.

Research vs. practitioner roles - The AAMC appreciates the intent behind the proposal's prohibition against allowing the researcher who utilizes excess embryos also to be the attending physician conducting fertility treatments. On its face, this is certainly an appealing way to avoid the conflicts that one might perceive between an individual's clinical and research roles. In reality, however, the situation is more complex than such an absolute stance can accommodate. Research and practice are highly intertwined in academic medical centers, and this proposal has the potential to inhibit the academic responsibilities of faculty unfairly. For example, a faculty member engaged clinically in in vitro fertilization may also be the director of a research laboratory investigating stem cells. Also, from the perspective of those who are most skeptical of possible conflicts, the prohibition fails to address scenarios whereby the stricture could be circumvented by relying on a close collaborator as the embryo source. Ultimately the ethics of this area of activity will depend intensely on the integrity of the researcher, as is the case in so many professional arenas.

That said, a better way to deal with concerns about conflicts of interest between research and practice roles is to have an independent physician uninvolved with the professional activities of the individual in question provide oversight to ensure that such conflicts do not occur. This kind of oversight is relatively easy to accomplish in the setting of the academic medical center. For example, when one faculty member is the principal investigator (PI) on a clinical trial of a product developed by a company in which the PI has a significant interest, some medical schools and teaching hospitals require that a colleague uninvolved in the research or the company in question oversee the investigative activity and review its results.

Role of the Human Pluripotent Stem Cell Review Group (HPSCRG) - The AAMC, in general, has supported this kind of oversight in the past for promising, yet controversial, areas of research, and also does so in this arena. Nonetheless, a number of aspects of the HPSCRG's functioning are unclear as articulated in the draft and could benefit from elaboration. For example, will it review each and every application? When in the course of grant application review and approval would HPSCRG review occur? What will be the scope of its authority? How will it relate to other federal review bodies?

Oversight - This proposal would require researchers to document that stem cells were derived in accordance with the conditions that the guidelines set forth. This, too, is appealing on its face, but presents some practical problems. Federally-funded researchers often will be obtaining these embryos from the private sector and can only rely on the attestations of the suppliers concerning the circumstances under which the embryos were obtained. Thus, at best, an investigator could have the supplier sign an assurance form, but this could not reasonably be accompanied by any verification process, which would be beyond the resources and authority of individual researchers. Also, a given assurance concerning the ethical origins of a novel cell line should apply to all the progeny of that cell line, without requiring investigators to seek additional assurance as to the conditions under which the cells were obtained. Similarly, existing cell lines already in research use should be grandfathered in without retrospective review of their origins (which would be largely impossible to obtain).

In summary, we once again commend the NIH for this seminal guidance and for taking a critical first step towards enabling federally supported discovery in this vital area of research. We would add that, should the current federal funding restrictions against embryo research be lifted, the guidelines should be modified to permit federal grant monies to support cell line derivation from this source, as well, in keeping with the parameters outlined in the NIH proposal, and as recommended by the NBAC. In that instance, the guidelines should also permit the derivation of stem cell lines using somatic cell nuclear transfer, a very important and promising line of research that would be prohibited by these guidelines.

Sincerely,

Jordan J. Cohen, M.D.