21 
Working Group on Human Gene Therapy would form a panel of retrovirology experts 
to review protocols. 
Dr. Walters said it is possible the Working Group on Human Gene Therapy would 
form such a panel of experts. Both the RAC and the working group should be 
educated in the science of retroviral vectors. 
Dr. Simpson said the requirement that IBCs and IRBs must review the protocols 
before the proposal is submitted to RAC for review puts pressure on IBCs and 
IRBs since they cannot send a "shoddy" review to RAC. He thought IRBs and 
IBCs would probably wish to have more guidance. 
Dr. Walters said the Working Group on Human Gene Therapy has prepared points 
to consider for evaluating human gene therapy protocols. These points to 
consider will be sent to IBCs. He hoped his working group will be able to 
supply more detailed information for evaluating the vector constructs and safety 
cons i de rat ions . 
Dr. Gottesman said the Working Group on Human Gene Therapy is willing to assist 
IRBs and IBCs in protocol review. 
Dr. Anderson said another issue should be addressed by the Working Group on 
Human Gene Therapy; protocols must be submitted to IRBs and IBCs before submis- 
sion to the RAC. This process will require a certain amount of time. If the 
protocols were submitted to NIH before IRB review is complete, could IRBs 
accept the amount of publicity associated with the NIH review process? 
Dr. Gottesman adjourned the meeting of the Working Group on Viruses at 3:20 p.m. 
on November 12, 1985. 
[Rapporteur's Note: Primary reference sources used for expanding upon certain 
portions of the discussion are cited in Attachment III]. 
[460] 
