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Opinion 2.13 - Genetic Engineering

The Federal Recombinant DNA Advisors Committee and the Food and Drug Administration oversee and regulate gene splicing, recombinant DNA research, chemical synthesis of DNA molecules, and other genetic engineering research. However, for genetic engineering technologies that represent a significant departure from familiar practices there should be independent input from the scientific community, organized medicine, industry, the public, and others, in addition to the federal government, to prevent abuse from any sector of society, private or public. Such departures include the use of novel vectors, gene transfer in utero, potential germ line modification, and gene transfer to normal volunteers. If and when gene replacement with normal DNA becomes a practical reality for the treatment of human disorders, the following factors should be considered:

(1) If procedures are performed in a research setting, reference should be made to the Council’s guidelines on clinical investigation.

(2) If procedures are performed in a non-research setting, adherence to usual and customary standards of medical practice and professional responsibility would be required.

(3) Full discussion of the proposed procedure with the patient would be required. The consent of the patient or the patient’s legal representative should be informed, voluntary and written.

(4) There must be no hazardous or other unwanted virus on the viral DNA containing the replacement or corrective gene.

(5) The inserted DNA must function under normal control within the recipient cell to prevent metabolic damage that could damage tissue and the patient.

(6) The effectiveness of the gene therapy should be evaluated as well as possible. This will include determination of the natural history of the disease and follow-up examination of subsequent generations.

(7) Such procedures should be undertaken in the future only after careful evaluation of the availability and effectiveness of other possible therapy. If simpler and safer treatment is available, it should be pursued.

(8) These considerations should be reviewed, as appropriate, as procedures and scientific information are developed in the future. (I, V, VII)

Issued March 1980; Updated June 1996.