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Guidelines for Gene Therapy Authorizations Offered

January 27, 1985

WASHINGTON (AP) _ The National Institutes of Health, moving toward approval of human gene therapy, has issued preliminary guidelines setting forth information scientists must submit to get authorization to attempt the therapy.

The ″submission guidelines,″ published last week in the Federal Register, are a ″necessary first step″ toward eventual NIH sanction of gene therapy to be done by institutions receiving federal aid, Dr. Bernard Talbot, director of the National Institute of Allegeries and Infective Diseases, said Sunday.

The public has 30 days to comment on the proposal, which is subject to change at a meeting next May of the NIH Recombinant DNA Advisory Committee, Talbot said.

The guidelines are aimed at setting policy for gene therapy, which scientists say will likely involve removing defective cells from a patient’s body and replacing with them manufactured copies of good genes.

Genes are pieces of DNA, or deoxyribonucleic acid, the basic substance of heredity. The 100,000 genes that humans are thought to possess switch on and off to produce chemicals that control every function of the body.

Talbot said the guidelines basically set forth the questions that will be asked of institutions seeking to perform therapy on genes that are not tied to human reproduction and would not affect the gene structure of a patient’s offspring.

One such question is whether research with primates is planned before tests begin involving humans. Another asks about the types of human cells that would be treated and about the efficiency of the transplant.

The guidelines, called ″Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols,″ also stress making information about gene therapy available to the public.

It asks prospective researchers what steps they will take to ensure that ″accurate information is made available to the public with respect to such public concerns as may arise from the proposed study.″

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