Recombinant DNA Advisory Committee - 09/14-15/92 
the HIV status of the infected recipient prior to obtaining the informed consent. Dr. 
Lane responded that in previous HIV twin studies, the infected twin always places the 
initial telephone call to the investigator performing the research. At that time, the 
investigator asks the patient for permission to discuss their HIV status with the healthy 
identical twin. The researcher then meets with the twins together and separately, 
providing each the opportunity to ask questions privately. Therefore, the informed 
consent issue raised by Dr. Zallen has never been a concern in previous protocols. 
Dr. Lane also addressed the issue of liability. The NIH has standard language for 
informed consent documents. If the RAC is concerned about particular wording in these 
documents, perhaps the RAC should present this issue before the General Counsel and 
the NIH Director. Mr. Capron suggested that the RAC should advise the NIH Director 
that the language that addresses physical injury is misleading, and that there is no 
liability for such injury. The language should state that there will be no liability from 
injury that is not caused by negligence. Mr. Capron added that such a statement will not 
encourage litigation, only clarify the patient's rights. 
Mr. Capron inquired as to the process by which patients will become informed about the 
availability of this protocol. Will information be disseminated in the medical 
community? Will there be a press release by the lay media? Are there special 
publications distributed only to patients who are HIV infected? He inquired about the 
process of determining the HIV status of the donor twin. If the proposed donor is tested 
and found to be HIV( + ), how will this issue be dealt with? Dr. Walker replied that the 
NIH donor consent form addresses HIV testing policies. The prospective donor is 
informed that there is a remote chance that they will have an HIV( + ) test, and this 
section is followed by an explanation of the implications of a positive test. Dr. Walker 
explained that the donor and recipient are counselled extensively prior to signing the 
informed consent document. In fact, both parties will have read and discussed the 
protocol with their primary physician prior to coming to NIH for screening. 
Dr. Walker stated that there has been an HIV infected identical twin registry in 
existence since the early 1980s, and this database serves as the primary source from 
which patients are recruited. In addition, there is an extensive mailing list of 
practitioners in the U.S. that receive HIV announcements of protocols. Occasionally, 
researchers advertise in local and national publications. Dr. Dronamraju inquired as to 
the number of identical twin pairs that are currently on the registry. Dr. Walker stated 
that there are currently 24 pairs of twins on the registry. Dr. Dronamraju asked about a 
similar registry for nonidentical twins. Dr. Walker answered that this population has 
never been a research interest. Dr. Dronamraju asked the investigators to expand on 
their statement that approximately one-half to two-thirds of these patients have 
expressed interest in participating in this protocol. Dr. Walker said that this statement is 
based on telephone conversations with these patients lasting an average of 30 minutes. 
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