As the the race to control the human
gene continues, an imperative question is raised, who will control the
uses of gene therapy? 
Two
different areas of study include gene therapy researched in both the public
and private sectors. At present the regulation concerning private institutions
are overseen by the US Food and Drug Administration
(FDA) and the National Insitute of Health
(NIH). Their approval is needed to pursue all forms of gene therapy
protocol. Oversight of government-funded experiments involving gene
therapy for human patients occur at both the national and local level.
Public Sector
Government regulation at the national level, is overseen by the Director of the NIH, who must approve each human gene therapy proposal. Decisions made by the director are aided by advice arising from members of the Recombinant DNA Advisory Committee (RAC). The RAC is a subcommittee of the NIH that reviews gene therapy protocols. Actions performed by the RAC are guided by a set of regulations that can be found in the Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human Subjects. The RAC is comprised of 25 professionals in the fields of science, medicine and law.
At this time, gene therapy experiments
performed at the local level are required to have two committees to oversee
all proposals. 
First,
hospitals and universities involved in experiments with human subjects
are required to have Institutional Review Boards (IRB) that ensures research
complies with Department of Health and Human Services (DHHS) regulations
for protection of human subjects. Second, experiments that involve
gene insertion must be approved in advance by an Institutional Biosafety
Committee (IBC). These review boards are performed at the local level
and allow an opportunity for the general public to become involved in the
decisions made about research involving gene therapy for human patients.
The DHHS regulations require that at least one nonscientist serve as a
member of each IRB. The NIH Guidelines for Recombinant DNA Molecules
require that 30 days notice must be given to the Federal Register prior
to any NIH Recombinant DNA Advisory Committee (RAC) meetings. Federal
regulations require all meetings involving gene therapy must be given 15
days advance notice in the Federal Register. To ensure participation
from the general public, the NIH Guidelines for Research Involving Recombinant
DNA Molecules encourages research facilities to open their IBC meetings
to the public.
Private Sector
In the private sector the NIH has authority only over certain federally funded research. However, many private companies that do not receive federal funding or support voluntarily submit proposals to NIH for review. In addition, the Food and Drug Administration (FDA), which has jurisdiction over drug and biological products intended for use in human patients, must also review and approve experiments involving gene therapy for human patients, whether the research is federally funded or not.
History of Government Regulation
Since the 1970's, general interest in human gene therapy has increased both at home and at the international level, along with awareness of the need for oversight and regulation. In 1974, the Secretary, Department of Health, Education, and Welfare (now the DHHS), chartered the Recombinant DNA Advisory Committee (RAC) to develop recommendations for the regulation of recombinant DNA research. The Guidelines for Research Involving Recombinant DNA Molecules were published in 1976. In 1978, the Guidelines were revised, relaxing many of the requirements for recombinant DNA experiments.
At the behest of three major
religious groups in this country, the President requested that the President's
Commission for the Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research examine the topic of human genetic engineering
in 1980. In November of 1982, one of the Commission's eleven reports,
Splicing Life; The Social and Ethical Issues of Genetic Engineering with
Human Beings, was submitted to the President and Congress. 
A
subcommittee of the United States House of Representatives held three days
of hearings on the report. Congressional interest also resulted in
a 1984 background paper entitled, Human Gene Therapy, produced by the Office
of Technology Assessment. In response to one recommendation of the
President's Commission, the NIH Recombinant DNA Advisory Committee formed
a working group in 1984, to specialize in human gene therapy. This
is now the Human Gene Therapy Subcommittee. In 1985, the White House
Office of Science and Technology Policy created the Biotechnology Science
Coordinating Committee (BSCC). The Committee includes federal officials
representing the National Institutes of Health, the Environmental Protection
Agency, the U.S. Department of Agriculture, the Food and Drug Administration,
and the National Science Foundation. The BSCC provides a forum for
discussion of biotechnology issues and an opportunity to make recommendations
on the federal regulation of biotechnology.
Legislative interest continues to be expressed through activities of the Subcommittee on Science, Research and Technology of the House Committee on Science and Technology and the Office of Technology Assessment. In 1986, a Congressional Biomedical Ethics Board was formed to oversee research and developments in genetic engineering. This Board is composed of six Senators and six Representatives.
Government Regulation Abroad
International interest in human gene therapy has resulted in a number of reports and recommendations submitted by foreign government committees. For example, in 1982, the Parliamentary Assembly of the Council of Europe issued a statement including proposals for oversight and recommendations for certain restrictions on human genetic engineering.
Conclusion
Overall, gene thearpy research is closely
monitored at the local, national, and even international levels.
The magnitude of this issue has ensured that great care has been taken
to make certain that not only scientists are involved in the decision making
process. With members of the general public represented and encouraged
to participate, the prospects of gene therapy as a means of an improved
humanity should be encouraged and not feared.
