Human Gene Therapy Subcommittee - 11/21-22/91 
HGTS should offer suggestions to the investigators on how to improve their consent 
forms. However, researchers could not be expected to make all of the suggested changes 
since that is not within their authority. 
Mr. Capron remarked that the HGTS was one of the few public forums in which patient 
consent forms could be reviewed. This review gives insight as to the operation of IRBs 
around the country on a scale that is unprecedented. However, the HGTS should only 
focus on areas of the consent form that concern gene transfer or gene therapy. 
Dr. Zallen asked the investigators to address the process that is involved in obtaining 
informed consent from these patients. What avenues of information transfer are 
available to the potential subject? What kinds of time frames are involved? 
Ms. Meyers maintained that the HGTS's role was vital in addressing public concern 
about gene therapy. In-depth review of patient consent forms is one process by which 
the rights and welfare of the patient can be protected. 
Dr. Epstein said that the purpose of the experiment was not readily apparent. There is a 
question if the goal is to test the various lymphocyte populations for therapeutic purposes 
or if this was merely a trafficking study to differentiate homing of PBL versus TIL. The 
degree of purification of CD4( + ) and CD8( + ) cells isolated from the bulk populations is 
unsatisfactory. If the separation technique employed allows for contamination of the 
separate populations, the resulting data will be uninterpretable. The problem of 
contamination could be amplified further since there is often clonal selection in these 
tumors. The investigators need to address the degree of separation achieved by the 
Cellector*. 
Dr. Parkman asked the investigators to provide information concerning what control 
would be used to distinguish between lymphocytes present in the tumor as a result of 
circulation as opposed to those which specifically home to tumor targets. Will biopsies 
of tissues other than tumor be performed? 
Dr. Walters asked for clarification concerning a change in the revised consent form 
concerning the establishment of cell lines from patient's blood and/or tumor specimens. 
In the original consent document, the patient had the option to grant permission to use 
his/her specimen to establish a commercial cell line. In the revised document, the 
patient's option statement has been removed. The new version states that cells obtained 
from the patient may be used to establish cell lines that may be shared with other 
researchers and may be of commercial value. 
Presentation-Dr. Economou 
Recombinant DNA Research, Volume 15 
[231] 
