HEPATOCELLULAR TRANSPLANTATION AND TARGETING GENETIC MARKERS TO HEPATIC CELLS 
quarters of those patients who sign informed consent forms may be aware that they are 
participating in research (Bergler et al , 1980). Among the factors which correlate with 
the subjects' ability to assimilate medical information are their stress level, 
encouragement to ask questions, understanding of the material presented, and their 
preconceived ideas about research (Nealon et al, 1985). 
The nature of informed consent for somatic gene therapy is further complicated by 
the relatively limited knowledge about genetics among the general public (as well as 
among physicians) , the novelty of paradigms involving genetic manipulation, the 
controversial nature of this research, the anticipated public interest in these studies, 
the extensive discussions that have taken place concerning theoretical risks of gene 
transfer, and the unproven benefits of clinical trials. As part of the aforementioned 
study of psychosocial issues related to somatic gene therapy, we will study a large 
series of families who could be asked to participate in somatic gene therapy trials in 
the future. These families will be asked a series of questions about their knowledge 
of somatic gene therapy, sources of information of exposure to somatic gene therapy, and 
their interest in somatic gene therapy and will be studied with quantitative instruments 
to assess the subject's beliefs, sources of information, networks of support, and 
patterns of control. These data will be analyzed in the context of established models 
for reasoned action (Fishbein, 1980) or health beliefs (Mikhail, 1981; Becker and 
Maiman, 1975). We will also evaluate the informed consent form which will be used in 
the current protocol for effectiveness by testing patient's knowledge of somatic gene 
therapy before, and after, having the opportunity to review this form. (Ledley, 
Mikhail, and Schwartz, Psychosocial Issues in the Clinical Application of Somatic Gene 
Therapy) . 
iv) Concern has been expressed about the "novel" and "irreversible" nature of 
somatic gene therapy and how it will affect patients or their families. The "Points To 
Consider..." asks specific questions about how these issues will be communicated to 
families (see below). Moreover, opponents of somatic gene therapy have suggested that 
genetic meddling is de -humanizing and may have adverse effects on individual personality 
development and self image. These issues are not new to clinical research. We will 
assess the psychosocial consequences of somatic gene therapy using quantitative , 
measurements of self esteem, well being, behavior, and psychosocial development in order 
to generate data concerning the psychosocial consequences of somatic gene therapy. J 
We believe that attention to psychosocial dynamics may be important in evaluatingj | tj 
the success of the present experiments. Psychosocial dynamics contribute substantially r i is 
to all medical therapeutics, and even the most deterministic medical interventions can _ 
be complicated by the appearance of "non-disease" (Bergman and Stamm, 1967) or placebo! 
effects (Haegerstam et al, 1982). I 
v) Extensive safety testing has been performed with the LNL6 virus in conjunction 
with animal experiments and clinical protocols at the NIH, and it has been concluded 
that there is no risk of horizontal transmission of vectors from transplantation 
transduced cells . On an ongoing basis we are continuing to assess any potential risk ^ ij 
to laboratory personnel from exposure to recombinant retroviruses by collecting bloody 
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Recombinant DNA Research, Volume 14 
