15 
Dr. Walters said the working group feels local ccsrmittees should review 
arrf approve proposals prior to NIH review. He loped the points to consider 
document would provide guidance to IRBs and IBCs. 
Dr. Gottesman said the working group realizes a heavy burden will be placed 
on local c emit tees by prior review requirements, but the working group 
feels IRB evaluation of protocols with respect to protecting the individual 
patient's interests is important. The IRB could request NIH consideration 
of specific aspects of protocols. 
Dr. McGarrity asked if an IRB might abstain from voting on a protocol; 
would there be another mechanism to send the proposal to NIH review or 
would it sinply die at the local level if they did not wish to vote on that 
particular proposal. 
Dr. Gottesman felt that while the IRB would at some point have to approve 
the proposal, the working group and RAC could probably accept tentative IRB 
and IBC recommendations . RAC could review the proposal and subsequently 
return it to the local carmittees for final action. 
Dr. Rapp felt local committees should have the opportunity to evaluate 
proposals prior to NIH review, although they should have the option of 
asking NIH for input. 
Dr. Landy asked what would happen if RAC determined that one hospital or 
one clinician is qualified to perform an experiment but another institution 
submitting an identical proposal is not. 
Dr. Rapp asked whether review will be on a "case-by-case" basis or an 
"institution-by-institution" basis. 
Dr. Walters replied the working group believes review should tie on a case- 
by-case basis. Empirical data and normative judgements form the basis of 
review, but the working group will attempt to make the process as objective 
and neutral as possible. Dr. Walters said the Working Group on Human Gene 
Therapy does not intend to function as a peer review body. The working 
group will simply determine whether the investigator and the facilities 
meet a minimum threshold of competence. 
Dr. McKinney asked whether mechanisms were in place to deal with privacy 
and confidentiality issues. 
Dr. Walters said Dr. McKinney's question raises two concerns: (1) the 
privacy of the patient; and (2) the protection of proprietary information. 
Dr. Walters said the working group and RAC will attempt to protect the 
privacy of the patients. Protocols could be reviewed without reference to 
the names of patients. Dr. Walters said the working group has not yet 
addressed proprietary issues other than that the points to consider docu- 
ment will ask the investigator's intentions regarding patents or trade 
secrets. The working group anticipates that patent questions and trade 
secrecy will not be a major issue in human gene therapy. 
[147] 
