Recombinant DNA Advisory Committee - 03/1-2/93 
protocol using the MFGS vector. Approval of this protocol is contingent on the 
submission of relevant safety studies with the MFGS vector. The motion was approved 
by a vote of 15 in favor, 0 opposed, and 3 abstentions (Leventhal, Carmen, Meyers). 
IX. ADDITION TO THE POINTS TO CONSIDER OF THE NIH GUIDELINES 
REGARDING SEPARATION OF THE GENE MARKING INFORMED CONSENT 
DOCUMENT FROM THE THERAPEUTIC INFORMED CONSENT 
DOCUMENTS/DR. POST 
Presentation-Dr. Post 
Dr. Walters called on Dr. Post to present the proposed amendment to the Points to 
Consider. Dr. Post explained that the proposed amendment is intended to clarify the 
informed consent process for patients considering participation in a human gene transfer 
protocol. When one informed consent document is used for two independent procedures 
the patient may be given the impression that participation in one form of therapy is 
contingent on participation in the gene transfer protocol. Therefore, a new sentence will 
be added to Section I-D-Informed Consent of the Points to Consider. 
"When gene transfer is a procedure separate from the therapeutic protocol, 
informed consent documents should be submitted for both the gene marking and 
therapeutic procedures." 
Committee Motion 
A motion was made by Dr. Post and seconded by Dr. Krogstad to approve the proposed 
amendment to the Points to Consider. Dr. Leventhal objected to the use of the word 
"marking" and suggested that "transfer" is a more appropriate term because the word 
"transfer" encompasses marking as well as therapeutic procedures. Also, Dr. Leventhal 
recommended that the phrase "therapeutic procedures" be replaced with "other clinical 
protocols." Drs. Post and Krogstad accepted Dr. Leventhal's recommendations as a 
friendly amendment to the motion. 
Dr. Walter stated that the revised language of the proposed amendment will read as 
follows: 
"When gene transfer is a procedure separate from the clinical protocol, informed 
consent documents should be submitted for both the gene transfer and the clinical 
protocol." 
The motion to approve the revised amendment was approved by a vote of 17 in favor, 0 
opposed, and no abstentions. 
[ 100 ] 
Recombinant DNA Research, Volume 1 "t 
