18 
Dr. Walters said four issues should be addressed in this section of the document. 
These are: (1) the reversibility of the procedure; (2) conveying to the patient 
that at certain points in the protocol it is not advisable to withdraw from the 
study; (3) prevision for long-term follow-up; and (4) autopsy. 
Dr. Anderson thought human gene therapy would become irreversible when the 
transformed bone marrow cells are introduced into the patient. 
Dr. Walters suggested the title of Section II might be modified to "Special 
Issues." Ms. Witherby questioned the rationale for this title change. 
Dr. Grobstein felt the proposed title modification would change the emphasis. 
Dr. Rich said the word "social" should be retained in the title of this section. 
Mr. Capron agreed; he felt social issues do exist in the application of human 
gene therapy. The working group agreed to retain the title of "Social Issuss." 
Mr. Capron suggested the sentence indicating why the working group wishes to 
evaluate these issues should be deleted from the introductory paragraph in 
Section II. The working group agreed. 
Dr. Walters called the attention of the working group to Section III of the 
document. Ms. Witherby suggested the working group request an abstract in lay 
terms. Dr. Temin agreed with this suggestion. Dr. Gottesman suggested the 
following language be added to Section III to read: "A one page description of 
the proposed experiment in nontechnical Language." 
Dr. waiters called the attention of the working group to Section IV of the 
document. Mr. Capron suggested the last sentence of Section IV-B dealing with 
autopsy should be modified. He suggested the word "when" be substituted for 
the word "if," since no patient will be immortalized by the procedure. Dr. Rich 
suggested the sentence should read: "In the event of a patient's death, the 
autopsy report should be submitted to the IRB and CRD A. " 
The working group agreed to this proposed language. 
Dr. Grobstein sugqested the telephone numbers be deleted frem Sections IV-A 
and IV-B since he did not see the logic of including these numbers in these 
sections. Section IV-A requests that serious adverse effects be reported 
immediately; .Section IV-B requests reports on the general progress of the 
patient. Ms. Witherby thought the document should request written reports 
be submitted to the Office of Recombinant DIN& Activities (OR DA) as well as to 
the local Institutional Review Board (IRB) and the Office of Protection from 
Research Risks (OPRR). The working group agreed to these proposals. 
Dr. Whlters then called the attention of the working group to the language 
(Attachment VII) the subworking group had composed over lunch. He said this 
alternative language would be substituted for the third paragraph in the intro- 
duction. 
Dr. Anderson suggested the first sentence should indicate a distinction "should 
be made" between genetic modifications in somatic cells and in germ line cells. 
[ 103 ] 
