|
Protocol Review and Protocol Categories
Protocols designated as "A" (no pain or distress beyond that
involved in a simple injection) or “B” (Pain/distress is
relieved by either physical or chemical means):
Definition of Designated Review: In this method, prior to review,
all IACUC members are provided with the necessary information
concerning
the proposed research projects. All members are then given the opportunity
to request full committee review. Polling is an acceptable mechanism
for providing all IACUC members with the prior opportunity to call
for full review. It should be noted that the polling of IACUC
members in
this instance is not an approval vote on the proposed research. Records
of such polling, however, are useful to document that the opportunity
for members to call for full committee review has been provided. Should
the protocol not have to be reviewed by the Full Board it can then
be reviewed by one IACUC member (designated reviewer).
- Protocols designated as "A" and/or “B” can
be reviewed by a designated reviewer. The reviewer is encouraged
to ask another IACUC member for advice on areas they are not comfortable
reviewing
alone.
- Seeking advice outside of IACUC members is also permitted
as long as the PI’s identity is kept confidential.
- The reviewer
is permitted to contact the PI if they wish; however, under no circumstances
should the reviewer indicate to the PI that
the protocol is approved. There may be additional administrative issues of which
the reviewer is unaware.
- The designated reviewer has the authority to approve,
require modifications in (to secure approval), or request full committee
review of
assigned protocols.
Protocols designated as Category "C" (corresponding
to USDA reporting requirements "E" in which Pain/Distress
can not be relieved by either physical or chemical means):
- Protocols designated as "C" require full
review by the IACUC.
- Each protocol will have a primary and secondary
reviewer. The primary reviewer will give the Committee a short synopsis
of the protocol,
and
outline deficiencies in the protocol. The secondary reviewer will also
comment on the protocol, followed by discussion of the whole committee.
- The reviewer has the opportunity to request input from other Committee
members and give other committee members the opportunity to comment on
the protocol.
The primary reviewer will recommend one of the four protocol designations:
1) Full approval
2) Withheld approval pending modifications
3) Table
4) Dissaprove
- A vote shall be taken and the minutes shall reflect the number
voting for and against the primary reviewer’s recommendation.
The Minutes shall also reflect the discussion of the major issues
presented by the reviewer and committee members.
- No protocol can be disapproved without consideration by the
full IACUC.
|