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Public Sector Oversight

While efforts by the private sector to provide for ethical review of controversial research are to be applauded, for all of the above reasons a clear federal role in funding and oversight would be far superior to a research endeavor left solely to private institutions. The use of federal funds to support all forms of stem cell research will assure that, where needed, proper oversight mechanisms and guidelines will evolve in order to promote the advancement of promising medical research, balanced with a healthy respect for the American public’s expectations for research conducted according to the highest ethical standards.

Federal funding would automatically trigger a set of oversight mechanisms now in place to ensure that the conduct of biomedical research is consistent with broad social values and legal requirements. While basic laboratory research with personally non-identifiable stem cells does not pose any special ethical or over-sight challenges, an elaborate system of review is in place for research involving human subjects. The Federal Common RuleTitle 45, Code of Federal Regulations, Section 46.governing human subjects research provides for local and federal agency review of research proposals in such circumstances, weighing risks against benefits and requiring informed and voluntary consent. The Food and Drug Administration (FDA) has the authority under the Public Health Service Act and the Food, Drug, and Cosmetic Act to regulate the development and use of human stem cells that will be used as biological products, drugs, or medical devices to diagnose, treat, or cure a disease or underlying condition.Brady, R.P., Newberry, M.S., and Gerard, V.W., "FDA Regulatory Controls Over Human Stem Cells." Professional Ethics Report XII: 5-6 (1999). Additionally, the FDA has proposed developing product standards for hematopoietic stem/progenitor cell products intended for allogenic use in recipients unrelated to the donor.Department of Health and Human Services, Food and Drug Administration., "Request for Proposed Standards for Unrelated Allogeneic Peripheral and Placenta/Umbilical Cord Blood Hematopoietic Stem/Progenitor... This proposal is intended to “streamline regulatory requirements...while providing adequate protection to the public health,”Ibid., p. 2985. where cellular products posing increased risk to health or safety would be required to undergo clinical trials as investigational drugs, biologics, or devices, and to secure FDA approval prior to marketing. This approach, which relies on existing regulatory authority, is consistent with the one recommended in this report. The federal government’s Model Program for the Certification of Embryo Laboratories should be generally endorsed and its adoption by the states strongly encouraged. The program is a useful first step toward achieving greater quality control in private fertility clinics that obtain, store, and implant human embryos.

Complementing these regulatory mechanisms are two national advisory bodies. The National Bioethics Advisory Commission (NBAC), which has issued its own recommendations for stem cell research,The executive summary is available online: http://bioethics.gov/stemcell_exec_intro.htm. For information about the full report, see: http://bioethics.gov/pubs.html.has demonstrated its legitimate claim to respect for its efforts as a national body to promote public input into social policy related to advances in biomedical research. The Recombinant DNA Advisory Committee (RAC) currently has a mandate to review ethical and policy issues associated with human gene therapy and could be authorized to change its mission to broaden its purview. Almost two decades of experience with RAC suggest that it could be an effective institutional focal point within the federal government to facilitate the type of public dialogue on stem cell research proposed here, and to coordinate efforts to develop new guidelines, where needed. The RAC has a proven track record of providing an open forum for sorting out complex ethical issues and of defusing conflict. Furthermore, it has acquired a degree of legitimacy among scientists in both the public and private sectors, with its Points to ConsiderSometimes referred to as "Appendix M," the "Points to Consider" is found in the document Guidelines for Research Involving Recombinant DNA Molecules (last update May 1999). See: http://www.nih.gov/od/orda/toc.htm...in the design and conduct of gene therapy research widely accepted. This experience of functioning as a sort of national research ethics committee for gene therapy research protocols from 1984-1994,For an overview of the history of gene therapy, including the role of RAC, see Coutts, M.C., "Human Gene Therapy." Scope Note 24 (1994). National Reference Center for Bioethics Literature, Georgetown...indicates that federal oversight can be effective in fostering rigorous scientific and ethical review and in encouraging public participation in the process.

These federal bodies should work with interested stakeholders in the conduct of stem cell research - professional organizations, patient disease groups, religious communities, the Congress, funding agencies and private foundations, industry, and others - so that the public can be assured that appropriate safeguards are in place as this research evolves. Furthermore, there are some ethical and policy issues that, while not unique to stem cell research (e.g., intellectual property claims, creation of new life forms, commercial sale of tissue), should be part of any broader discussion among those stakeholders.

There are advantages to using this approach. The most obvious one is that it avoids the need to create a new administrative and costly structure when existing mechanisms are in place that could be readily adapted to achieve the objectives of oversight without impeding promising research. This approach balances the promise of scientific innovation with serious consideration of public concerns about a novel technology that manipulates human tissue. It encourages public involvement in national discussions and in deliberations on policy. It permits flexibility through incremental adjustments in guidelines and/or policy in anticipation of or in response to changes in knowledge or technology. It also relies on a system with which researchers in both the private and public sectors and their institutions are accustomed. Therefore, both the ethical and legal requirements governing research will be familiar to them as they plan and conduct their studies. And it acknowledges the scientific contributions made by the private sector and supports public-private partnerships by encouraging the private sector to contribute to the development of ethical guidelines and professional standards for the conduct of stem cell research.

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