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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.
 
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