16 
C*r. Grobstein suqqested a more detailed discussion of the time-line for scheduling 
meetings miqht be held at the next working qroup meeting in light of clincians' 
experience with clinical trials. 
C*r. Gottesman said the working qroup miqht at some meeting address the issue 
of what constitutes a minor modification of a protocol. 
Dr. Motulsky suggested the working group also discuss how confidential information 
should be handled; he could imagine cases where confidential information disclosed 
in one proposal miqht affect review of other proposals. 
Ms. Areen suggested the working qroup might consider how the group would proceed 
on receipt of a report of a harmful effect. Would the working group be called 
into session to address the issue, the impact of the harmful effect on the 
protocol, and the impact on other protocols? 
Dr. Walters asked the working qroup whether they would approve of the formation 
of a subgroup to develop a document describing in lay terminology the purpose 
of the points to consider document and the working qroup. The second issue 
which could be evaluated is whether the points to consider have reached the 
appropriate audience. 
Ms. Witherby said she would like to see a "lay" statement describing the working 
group's aqenda. She agreed to attempt to write a first draft for such a statement. 
Dr. Walters ad ioumed the meeting of the Working Group on Human Gene Therapy 
at 3:35 p.m. on December 16, 1985. 
Respectfully submitted 
Elizabeth A. Milewski, Ph.D. 
Rapporteur 
I hereby certify that, to the best of 
my knowledge, the foregoing Minutes and 
Attachments are accurate and complete. 
Chair 
[582] 
