July 21, 2001
Hopkins Statement Re Review of Research Protocols
Johns Hopkins officials wish to make clear that, contrary to statements by the
Office of Human Research Protection (OHRP), all proposed research protocols at
Johns Hopkins undergo extensive review by members of our Institutional Review
Boards (IRBs). Reviews of each protocol always include members of the
IRB who have particular expertise in the subject matter involved. In
fact, the process involves a "triple review.":
First, the protocol is circulated to all IRB members for comment.
Second, the protocol is re-reviewed by an executive subcommittee.
Third, the protocol is recirculated to all IRB members, with all related
correspondence, before final approval at a convened meeting.
The impression that we only review groups of these protocols together, with no
real analysis, is absolutely incorrect.
We continue to work with OHRP to achieve speedy reversal of its suspension of
our research, a suspension that we believe was unnecessary in order to
accomplish the goal we all have of protecting the health and safety of those
participating in research studies.
