GENE THERAPY INFORMED CONSENT REVISED POINTS-TO-CONSIDER PROPOSAL

Executive Summary

GENE THERAPY INFORMED CONSENT REVISED POINTS-TO-CONSIDER PROPOSAL submitted to members of the Recombinant DNA Advisory Committee April 27 specifies that a separate informed consent document must be submitted for the "gene transfer portion" of a project when gene transfer is used as an adjunct, when the gene is a "marker" or when it is used to "enhance the power of immunotherapy for cancer." The proposal, from Doris Zallen, PhD, Virginia Polytechnic Institute, attempts to answer some of the concerns relating to patients being fully informed of the potential risks and outcomes of human gene therapy that were originally raised by the National Institutes of Health RAC at its Dec. 2-3, 1993 meeting ("The Pink Sheet" Dec. 6, 1993, p. 3).