14 
C*r. Motulsky said FCA oversight is required at the development and commercial- 
ization stages. He questioned, however, whether FCA oversight was necessary 
for early experimental stages of a protocol. He argued that FDPk oversight 
would not be necessary for this stage if the NIH and the RAC working groups 
were providing oversight. 
Ms. Areen said FCA is constrained by law to regulate certain procedures and 
must adhere to these statutes. Mr. Capron said FCA may be able to proceed 
with greater rapidity than NIH in reviewing human gene therapy protocols. 
Or . Gorovitz thought the proposals submitted to FCA and to NIH far review 
could employ an identical format, but the substantive evaluation of the proposals 
would be different in the agencies. Dr. Ackerman said although the issues may 
be the same, the emphasis will not be the same; and the reviews would not be 
well served by use of an identical format. 
Or. Anderson said the Working Group on Human Gene Therapy attempted in its 
Points to Consider document to take account of the points addressed in an 
FCA review; the concepts included in the working group document correspond to 
the concepts in an IND. 
Or. Gar tl and asked if FCA either approves or disapproves of an IND. Or. Ackerman 
replied that INDs are either active or inactive; the IND is related to the 
product not to the particular study. 
Dr. Gar tl and asked what type of action FCA could take if an investigator proceeds 
in the absence of FCA approval. Or. Ackerman said FCA could inactivate the 
IND and disqualify the investigator from participation in clinical protocols. 
FCA might also take legal action. Ms. Areen added that subjects participating 
in a protocol with an inactive IND could sue the investigator. 
Other Issues 
Dr. Walters informed the working group that President Reagan's veto of the NIH 
appropriations bill had been overridden by the Senate. This bill contains 
language for the establishment of a "Biomedical Ethics Board." One of the 
first studies of this board will be human applications of genetic technologies. 
Cr . Walters also announced the procedure the NIH and the Working Group on 
Hunan Gene Therapy would follow in dealing with consent forms. He said the 
NIH does not generally review consent forms since the Office of Protection 
Against Research Risks (OPRR) is too small to review all the forms associated 
with NIH funded protocols. Nonetheless, OPRR does review approximately 200 
forms a year. The NIH would not prevent the working group from requesting 
consent forms for the earliest gene therapy protocols, and the working group 
will request and review these forms. 
[580] 
