controversial research involving recombinant DNA (see Box). Other means for regulating research exist, such as the passage of federal and state laws, but the public funding mechanism is the major means by which NIH influences the type of research performed and the way it is conducted. Public funding would guarantee regulatory oversight for stem cell research, allowing, for example, a careful informed consent procedure for obtaining ESCs that is subject to public scrutiny.

Peer review, as noted above, helps to ensure the quality of research proposals. As part of peer review, the importance of the research questions addressed and the methods used to answer them are considered by leading scientists with appropriate expertise. In some fields, review committees also use the input of experts in ethics and representatives of the public who are stakeholders in the research, ensuring greater public

The Recombinant DNA Advisory Committee

The Recombinant DNA Advisory Committee, or RAC, was established by the director of NIH in 1975. Its creation was the result of concern among scientists and the public about the safety of laboratory studies aimed at introducing new DNA into organisms. The committee, after addressing laboratory safety and commercial development of recombinant DNA techniques and release of altered organisms into the environment, established benchmarks for review and approval of protocols for applying the techniques of gene transfer to humans. Both technical and ethical issues were considered. RAC advises the NIH director as to whether specific research proposals should be approved and gives guidance on recombinant-DNA research and relevant ethical issues.

Scientists and physicians make up the majority of RAC’s membership with lawyers, social scientists, ethicists, and stakeholders from the public. Because it was a federal advisory committee, its meetings were announced in the Federal Register and were open to the public. When important new scientific projects came before the committee for review, mass-media attention would often be intense, giving the group’s recommendations extensive coverage.

Although RAC officially was limited to providing advice to the NIH director on whether studies should be approved, its power extended beyond NIH-sponsored research. In a recent rechartering of RAC, nonvoting representatives from various other federal agencies were included. The Food and Drug Administration and Environmental Protection Agency indicated that any products developed using recombinant DNA must comply with RAC guidance.

Source: Institute of Medicine, Society’s Choices: Social and Ethical Decision Making in Biomedicine. 1995.

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