The WSMA affirms that whatever form of regulation of gene splicing, recombinant DNA research, chemical synthesis of DNA molecules, or other genetic engineering research is eventually developed, there should be independent input from the scientific community, organized medicine, industry, and others, in addition to the federal government, to prevent abuse from any sector of society, private or public.
If gene replacement with normal DNA becomes a practical reality for the treatment of human disorders, the WSMA has developed the following guidelines for treatment procedures:
- If procedures are performed in a research setting, reference should be made to the Judicial Council's guidelines on clinical investigation.
- If procedures are performed in a non-research setting, adherence to usual and customary standards of medical practice and professional responsibility would be required.
- Full discussion of the proposed procedure with the patient would be required. The consent of the patient or his/her legal representative should be informed, voluntary and written.
- There must be no hazardous or other unwanted virus on the viral DNA containing the replacement or corrective gene.
- The inserted DNA must function under normal control within the recipient cell to prevent metabolic damage that could damage tissue and the patient.
- The effectiveness of the gene therapy should be evaluated as best as possible. This will include determination of the natural history of the disease and follow-up examination of subsequent generations.
- 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.
- These considerations should be reviewed, as appropriate, as procedures and scientific information are developed in the future.
(JC 2.11-87) (Reaffirmed A-17)
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Abbreviations for House of Delegates report origination:
EC – Executive Committee; BT – Board of Trustees; CPA – Council on Professional Affairs; JC – Judicial Council; CHS – Community and Health Services