Docket Management
Docket: 01N-0322 - Institutional Review Boards
Comment Number: EC -14

Accepted - Volume 2

Comment Record
Commentor Mr. Jeff Carey Date/Time 2002-06-04 18:02:43
Organization GenVec Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Dear Sir or Madam: I am responding to Docket No. 01N-03322 on behalf of GenVec, Inc., Gaithersburg MD. We are opposed to the proposed requirement for notification of IRBs regarding prior IRB decisions. As many of our clinical studies and those of other companies involve multiple institutions, a requirement such as this would represent a significant logistical problem. Each IRB review would have to be cross-submitted to all the other institutions. This would be time-consuming and likely would slow the review process significantly. In addition, the first completed reviews might actually bias the ongoing reviews at the other sites. This seems to defeat the purpose of local review. Last, we would question whether the issue of IRB Shopping has been adequately demonstrated to exist and to be a significant problem that requires such a sweeping response. We would propose that FDA concentrate efforts and resources on improving the quality of each IRB review at every institution. Sincerely, Jeff Carey Senior Director of Regulatory Affairs GenVec, Inc. 65 West Watkins Mill Road Gaithersburg, MD 20878




EC -14