Purpose
In order to comply with government regulations and
simplify the approval process, the ACC has established a policy on the ability
to utilize the Designated Member Review (DMR) for approval of new protocols.
Action
IF THE ORIGINAL FULL COMMITTEE REVIEW RESULT IS "MINOR MODIFICATIONS
REQUIRED", THEN:
- The changes requested to the protocol are forwarded by
the program coordinator to the Principal Investigator (PI) of the protocol.
- When the PI has responded to the request for changes,
the critique, the PI's changes, and the revised protocol are placed into the
shared folder in the month of the original review and are also sent to the
reviewers (primary, veterinarian, research safety) of the protocol via email.
- When all three (3) reviewers have indicated in writing
their approval of the change(s) to the program coordinator, the coordinator
will complete the paperwork required to approve the protocol.
IF THE ORIGINAL REVIEW RESULT IS "DEFERRED", THEN:
- in exceptional circumstances, a vote may be taken at
the ACC meeting that the subsequent, secondary review will be by the DMR
process.
- The changes requested to the protocol are forwarded by
the program coordinator to the PI of the protocol.
- When the PI has responded to the request for
changes, the critique, the PI's changes, and the revised protocol are placed
into the shared folder in the month of the original review and are also sent
to the reviewers (primary, veterinarian, research safety) of the protocol via
email.
- When all three (3) reviewers have indicated in writing
their approval of the change(s) to the program coordinator, the coordinator
will complete the paperwork required to approve the protocol.
- The designated reviewers may not subsequently
disapprove the protocol If the changes are not satisfactory to the
designated reviewers, the protocol must be brought to a full committee for
discussion.
- At any time in this process, any designated reviewer
may request full committee review.
Effective Dates: September 27, 2007 through
September 26, 2010
This policy has been approved by a majority vote of the Animal Care Committee
Members
Joseph Lorenzo, M.D., Chair, Animal Care Committee