Recombinant DNA Advisory Committee - 09/14-15/92 
several thousand HIV patients who have an identical twin. The registry referred to those 
patients with a twin who have contacted the investigators regarding their interest to 
participate in select experimental protocols. Twenty-four actually represents a fraction of 
the total eligible population. 
Dr. Secundy asked for clarification regarding the extent to which sections of the 
informed consent document are deliberated that are not directly related to gene marking. 
Dr. D. Miller stated that the RAC should only discuss issues that pertain to the use of 
recombinant DNA in a patient. In the case of the current protocol, the RAC should 
probably not consider the donor twin consent issues since the donor will not be 
undergoing any recombinant DNA procedure. Mr. Capron said that since the RAC is 
advisory to the NIH Director, it is obligated to discuss any problems that manifest during 
the review process, whether they are recombinant DNA issues or not. Dr. Wivel noted 
that the final control over informed consent documents resides with the local 
Institutional Review Board (IRB) irrespective of RAC recommendations. However, the 
RAC should not be discouraged from discussions it views as relevant. 
Dr. Walters suggested that since this protocol actually consists of two separate protocols, 
the adoptive transfer of syngeneic lymphocytes that has the potential for therapeutic 
effect and gene marking of CD4( + ) and CD8( + ) fractionated T cells, perhaps the 
informed consent document should be divided into two distinct sections. The gene 
marking of fractionated cells is not a Phase I or Phase II study, only a method for 
monitoring their survival after they have been transferred for therapeutic purposes. The 
informed consent might be clarified for the recipient if it was presented as a gene 
marking form and a therapeutic form. Dr. Leventhal agreed with Dr. Walters 
suggestion. 
Committee Motion 
A motion was made by Dr. Post and seconded by Dr. Parkman to approve the protocol 
with the following stipulations: (1) the investigators may use the vector supernatants 
currently in storage; however, any future vector preparations will be tested by long-term 
culturing of the packaging line following vector supernatant harvest, (2) that the 
informed consent document should be divided into two separate documents, one for gene 
marking and the other the therapeutic aspects, and (3) the section of the donor informed 
consent document describing the lymphopheresis procedure should be moved before the 
section describing the required travel schedule. 
Mr. Capron suggested an additional stipulation to include a sentence in the recipient 
informed consent document stating that there will be no waiver of liability for negligent 
injury. Obviously, the consent form will have to be approved by the IRB. Dr. Lane 
stated that inclusion of such a statement would create potential problems with the NIH 
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