Engineering
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 their 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-23)
Return to the WSMA Policy Compendium index
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