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Results for “Recombinant DNA Advisory Committee”

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PubMed1991

Development of guidelines for small scale genetic manipulation work.

The Genetic Manipulation Advisory Committee (GMAC) is the national body which reviews research and development work in Australia using genetic manipulation technologies. It supersedes and continues the work of the Recombinant DNA Monitoring Committee (RDMC). GMAC has recently drafted new guidelines for small scale laboratory work. The difference between these guidelines and the ones they have replaced is the broadening of the scope of work to be monitored, from recombinant DNA work to other genetic technologies which may also produce new combinations of inheritable genetic material. Experience from assessing proposals over the life of the RDMC and a previous Academy of Science committee enabled the GMAC Scientific Sub-committee to be more specific about the experiments it wanted to assess before they can begin, and those which could be safely exempted from the guidelines.

Animals↗
PubMed1982

Institutional biosafety committees and public participation: assessing an experiment.

The most innovative aspect of institutional biosafety committees, responsible in the United States for local oversight of recombinant DNA research is mandatory participation from outside the institution. A survey of Californian committees and selected national data reveals wide variability in committee structure and procedures. Public participation, although constrained in various ways, has been generally constructive.

Advisory Committees↗
PubMed1987

Update on hepatitis B prevention. Recommendations of the Immunization Practices Advisory Committee. Centers for Disease Control, Department of Health and Human Services.

Since plasma-derived hepatitis B vaccine was licensed for use in the United States in 1982, use of the vaccine in high-risk health care professions has been modest, despite widespread participation in the establishment of vaccination programs among these institutions. The incidence of hepatitis B virus infection has continued to increase in the past 5 years, presumably because vaccination programs have failed to reach the major risk groups of homosexual men, parenteral drug abusers, and heterosexually active persons with multiple sexual partners. Increased efforts toward the development of programs to vaccinate persons in all high-risk groups are recommended. The immunogenicity, safety, efficacy, and precautions involved in the use of a new recombinant DNA vaccine (licensed in 1986) are also discussed, and the need for booster doses of plasma-derived vaccine are evaluated.

Adult↗
PubMed1994

Gene therapy for cystic fibrosis in humans by liposome-mediated DNA transfer: the production of resources and the regulatory process.

The number of clinical trials using gene transfer technology, either active or under discussion, is increasing rapidly. However, little information is available describing the regulatory procedures or safety specifications that must be considered before initiation of such trials in Europe. We describe the procedure used by our group to produce resources for the first stage of a phase I trial of liposome-mediated gene therapy for cystic fibrosis. The current lack of written and co-ordinated guidance from the numerous interested regulatory agencies within the UK and Europe makes determination of the appropriate safety specifications and procedures for these novel trials difficult, as does the fact that some new agencies (such as the Genetic Therapy Advisory Committee in the UK) and some which are unfamiliar with clinical trials (such as the Department of the Environment) are involved as well as the Medicines Control Agency. In addition, we estimate that the realistic cost of these trials, which in many cases will have to be covered from research budgets provided by government agencies or medical charities, could lead to delays in the clinical application of this important new therapeutic strategy.

Base Sequence↗