Docket Management
Docket: 01N-0322 - Institutional Review Boards
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Ms. Staci Abramsky Date/Time 2002-05-31 10:27:19
Organization St. Luke's-Roosevelt Hospital Center
Category Other

Comments for FDA General
Questions
1. General Comments As the Project Manager for a large, multi-center international trial I have concerns over the proposed requirement. We have more than two hundred participating centers and many more which are considering participation or have considered participation. It would be extremely difficult to provide current and accurate information on every site's IRB decision making to every other site that is participating in the trial or is considering participation in the trial. With a large number of centers, the logistics of providing accurate and complete information would be overwhelming. In addition, I agree with the stated concern that informing IRB X of IRB Y's negative decision does not provide enough information to impact on the decision making of IRB X in a meaningful way. In my experience sometimes the decision has nothing to do with the merits of the protocol, but rather with specific problems or circumstances within the institution or the IRB. I realize from the proposal that the purpose is to prevent sites from IRB shopping; however I believe the problems I've described above would be a by-product of the requirement. Staci Abramsky




EC -5