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Guidelines for Human Embryonic Stem Cell Research
conduct of such research at the local level, and oversight is managed through an Institutional Biosafety Committee (IBC), a review body registered with NIH and appointed by an institution to review and approve potentially biohazardous lines of research.10
The need for IBCs grew out of the Asilomar Conference, when scientists agreed to self-regulate recombinant DNA research to avoid any potential threats to human health or the environment. Much of that research was initially reviewed case-by-case, not only by IBCs but also by a federal-level committee, the Recombinant DNA Advisory Committee (RAC). Over time RAC’s role has evolved, first toward a focus on human gene transfer therapy study approvals and more recently toward human gene transfer therapy policy development, with authority to approve gene transfer therapy studies lodged solely in FDA’s jurisdiction. To the extent possible, review of individual recombinant DNA research proposals has been delegated to local IBCs, and they remain as the guardians of public safety with regard to all recombinant DNA research and other potentially biohazardous research. They focus their review on safety, not on compliance with human subjects protections or other aspects of state and federal law governing the ethical conduct of scientific research. Many experiments are reviewed and approved by IBCs without any input from RAC.
At present, RAC is an advisory committee whose goal is to consider the current state of knowledge and technology regarding recombinant DNA. This includes review but not approval of human gene transfer trials, and assessment of the ability of DNA recombinants to survive in nature and the potential for transfer of genetic material to other organisms. A major role for RAC is to examine clinical trials that involve the transfer of recombinant DNA to humans. Currently, all human gene transfer trials in which NIH funding is involved (either directly or indirectly) are registered with the RAC. Protocols that contain unique and/or novel issues are discussed in a public forum. In addition, RAC advises the NIH director and his/her staff in a number of activities, including the preparation of materials required in legal actions, international coordination of biotechnology regulations, and the review of regulations proposed by other federal agencies.
In contrast to RAC’s role, FDA’s role is to determine whether a sponsor may begin studying a gene transfer product and, ultimately, whether it is safe and effective for human use. FDA regulates the products evaluated in human gene transfer clinical trials that are intended for eventual sale in the United States and is responsible for reviewing serious adverse events that occur in a gene transfer study.
Animal Care and Use
Increasingly, hES cell research might also involve the manipulation of hES cells in a nonhuman animal, such as a mouse. Laboratory work with nonhuman animals