14 
Ms. Areen pointed out that item 1 in the section Privacy and Confidentiality 
(Attachment II) could be phrased as a question rather than a statanent. 
Hr. Miller argued that IRBs should be able to close their meetings to the 
public, and the working group document should include such a statanent. He 
felt the points to consider document should contain language stressing that 
this might be necessary to protect the privacy rights of patients. 
Mr. Capron said IRBs should be advised to protect patient identities if 
open meetings are held. He said proposals sent to the RAC for ra/iew should 
only include information on the institution and the investigators. Nonetheless, 
the working group aa reed to delete item 2 in this section which advises review 
bodies to conduct review in a way that minimized the possibility of inadvertent 
disclosure of a patient's identity. 
Dr. Walters called the attention of the working group to the section on General 
Social Issues Not Covered by the DHHS Regulations for Research Involving Human 
Subjects (Attachment II) . Mr. Capron thought item A which discusses the 
possible effect of somatic cell therapy on reproductive cells is a clinical 
question. Dr. Mahoney questioned whether the investigator could provide 
information on this question in a social context. He argued that this question 
should not be included in Part II of the document as it is already considered 
in Section 2-(3)-[4], Research Methods , of part I of the document. 
Dr. Miller said this information request is a rod herring and not a social 
issue. The working group agreed the issues raised in item A of Part II should 
be emphasized in Part I of the document. 
The working group agreed to delete the phrase "if it were successful" from 
item B which addresses the impact of the proposed study on patient welfare, 
public health, clinical research, or practice of medicine. Dr. Rich offered 
to redraft item B during the comment period. 
Ms. Areen questioned whether item C in Part II differs frcxn itan B. Dr. Gorovitz 
said the concern in item C is whether gene therapy may be used to modify charac- 
teristics for cosmetic purposes. Dr. Miller said item C adds nothing substantive 
to the document; the objectives and rationale section would indicated whether 
the protocol addresses cosmetic effects. 
Ms. Areen said she die not see how the investigator could respond to itan D. 
.She did not think it reasonable to pose a question on whether the work is 
likely to raise or exacerbate public fears. 
Ms. Areen said itan E, dealing with provisions to ensure that accurate informa- 
tion is available to the public, appears reasonable. Dr. Grobstein said itan F 
is a part of itan E; human gene therapy presents no special concerns with 
regard to these points. He then proposed that itans E, F, and G be conbined 
into a single itan. The working group voted with 6 in favor, 1 opposed, and no 
abstentions to delete itan F and modify itan G. 
