The Recombinant DNA Advisory Committee (RAC) was
established on October 7, 1974, in response to public concerns regarding the safety of
manipulation of genetic material through the use of recombinant DNA techniques. As
described in its charter, the RAC is advisory to the Director, NIH. At that time, it was
thought that, "The use of this technology has various possible hazards because new
types of organisms, some potentially pathogenic, can be introduced into the environment if
there are no effective controls."
The RAC developed a set of Guidelines that were
first published in 1976 and have been revised periodically since then. These
Guidelines include a comprehensive description of facilities and practices intended to
prevent unintended release or inadvertent exposure to either genetically modified
organisms or recombinant DNA. Compliance with the Guidelines is mandatory for
investigators at institutions receiving NIH funds for research involving recombinant DNA.
The RAC is a technical committee whose goal is to
consider the current state of knowledge and technology regarding recombinant DNA.
This includes review of human gene transfer trials, and an assessment of the ability of
DNA recombinants to survive in nature and the potential for transfer of genetic material
to other organisms. It also considers hypothetical hazards and methods for
monitoring and minimizing risks. Approximately one-third of the 15 members do not have
scientific expertise but represent public interests and attitudes. This balance is
intended to provide a forum for open public debate of social and scientific issues
attendant to recombinant DNA research. The RAC has been overwhelmingly successful in
achieving this goal.
As described above, a major role for the 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. Factors that may contribute to
public discussion of a protocol by the RAC include: (i) new vectors/new gene
delivery systems, (ii) new diseases, (iii) unique applications of gene transfer, and (iv)
other issues considered to require further public discussion. Compliance with the
NIH Guidelines is ensured at the local level by Institutional Biosafety Committees (IBCs),
which are registered with the Office of Biotechnology Activities. Many experiments
are thus reviewed and approved by the IBCs without any input from the RAC. In
addition, the 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 summary, the RAC serves a critical role in the
oversight of Federally funded research involving recombinant DNA. While its workload has
varied over the years as the regulatory agencies have begun to review products developed
for commercial purposes, the RAC continues to provide invaluable advice concerning
advances in recombinant technology, new organisms under investigation, and public
attitudes associated with research in molecular biology
http://www4.od.nih.gov/oba/rac/aboutrdagt.htm
