Full Review vs. Designated Review
Protocols and amendments submitted to the IACUC for review can be reviewed via two methods, a Designated Member Review and a Full Committee Review. The method used for the review is determined by the timing of protocol submission and consensus of the committee. The two methods for protocol review are described below.
Protocol Review via Designated Member Review (DMR)
Proposed activities involving animals are reviewed as efficiently as possible to facilitate the research or teaching effort and funding agency needs. Some Animal Study Protocols undergo full committee review (FCR) at a convened meeting of the IACUC; however, an alternate manner of review and approval for protocols and amendments may be conducted via designated member review (DMR). DMR may provide a shorter response time for the investigators and decreased time investment by all members of the IACUC while still providing a robust review process.
DMR is conducted by a subset of the IACUC members and occurs outside a convened meeting. The DMR process can be used to review and approve new protocols and amendments. The amendment or protocol will be sent out to all IACUC members by the IACUC Administrator for review. The IACUC members have 5 business days to respond to request FCR or state that they agree that the submission can be reviewed via DMR. Any IACUC member may, at any time, call the protocol or amendment for FCR that has been sent to DMR. If no member calls the submission for Full Committee Review (FCR), the IACUC Chairman will appoint one or more qualified reviewer(s) for DMR.
The appointed reviewer(s) can make the following determinations:
- Approve the submission as submitted
- Request modifications to secure approval: If modifications are requested to secure approval, the original designated reviewers will review the modified protocol/amendment.
This is the most common determination. This process may require more than one round of modification requests from the appointed reviewer(s) before final approval of the protocol.
- Request FCR of the protocol: The protocol/amendment would be reviewed at the next convened meeting.
In addition, with a unanimous vote of the quorum present at a convened meeting, the Committee can vote to have a DMR review and approve protocols/amendments for final protocol approval after modifications requested in the FCR have been addressed in the revised protocol/amendment. In this case, one or more designated reviewers will review the modified protocol/ amendment following the convened meeting once the revised protocol has been resubmitted.
A large number of protocols at the University of Maine are reviewed via DMR. Please note that protocols that are submitted for review within two weeks of a scheduled Committee meeting generally will not be reviewed by DMR and will instead be reviewed in the upcoming Committee meeting.
Protocol Review via Full Committee Review (FCR)
Protocols and amendments may be reviewed at a Full Committee Meeting. In general if the submission is submitted to the IACUC Office two weeks or less before the scheduled meeting, the protocol will automatically be reviewed at an IACUC meeting and not by DMR. In addition, members of the IACUC may request that protocols and amendments be reviewed via FCR instead of DMR at any time.
Prior to the monthly meeting, at least two reviewers are assigned as primary and secondary reviewers for each of the submissions for that meeting. All committee members are expected to review all protocol submissions, however, the primary and secondary reviewers are responsible for presenting the protocol to the Committee for discussion at the meeting.
After the protocol is discussed at the meeting, the following determinations are possible:
- Recommended for approval: The Committee approves the submission as it was submitted.
- Modifications required to secure approval: Minor questions and/or clarifications must be resolved by the protocol’s PI to secure final protocol approval. The committee members present at the meeting must decide by unanimous vote to use DMR to review the submission after it has been modified and resubmitted. This process may require more than one round of modification requests from the appointed reviewer before final approval of the protocol.
This is the most common determination.
- Tabled: The submission is written in such a way that the Committee cannot complete the review because there are significant omissions and questions that must be resolved to secure approval. A Tabled ruling requires that the revised protocol be resubmitted as a new protocol for FCR at a convened meeting.
- Withhold Approval: If the PI and the IACUC cannot agree on fundamental aspects of the protocol, such as protocol design and animal welfare issues, the Committee may withhold approval. The PI would receive a letter from the IACUC explaining why approval is being withheld.
Protocols/amendments that involve complicated, invasive, or novel procedures and protocols that involve significant pain and distress often will be reviewed at a full committee meeting and not in a DMR. The decision to hold a submitted protocol for FCR is the Committee’s prerogative. In addition, protocols involving a principal investigator who has not previously submitted a protocol to the UMaine IACUC should anticipate FCR of his/her first submitted protocol.
Time required for FCR and DMR
The PI should anticipate that a submitted protocol may require a month to several months to complete the protocol review and approval process. Please plan accordingly.
Protocols are reviewed by the Committee with the expectation that the PI will address the requested revisions/modifications and resubmit the protocol promptly. Protocols requiring modifications that are not resubmitted within 60 days of receipt of the Committee’s comments from the initial review will be archived. An archived protocol that is resubmitted after 60 days will be handled as a new submission.