Summary

The animal research projects are reviewed by the IACUC through one of the two following mechanisms:

1. Designated Member Review (DMR)
   1. After the Office of Research Compliance notifies the IACUC that all necessary documentation are complete, the protocol will be reviewed by a single IACUC member as appointed by the Chair
   2. The activities proposed in the protocol must be “tolerable”
   3. Most teaching projects and field studies with minimal disruptions to the animals can be eligible
   4. Certain minor changes to previously approved protocols may qualify
2. Full Committee Review (FCR)
   1. After the necessary documentation are complete, the protocol will be reviewed by the entire IACUC
   2. The activities may not be conserved as “tolerable”
   3. Continuing review and most amendments for all previously approved protocols, even those approved by DMR

Designated Member Review (DMR)

1. Prescreen: When this mechanism is chosen by the researcher, the Office of Research Compliance (ORC) initially determine if the documents supporting this proposal is appropriate forDMR.
   1. If the application is complete, a protocol ID will be generated if this is a new application
   2. Once ORC determines that the application is complete, the IACUC will be notified for subsequent action
2. DMR Validation – The application’s DMR eligibility will be determined using the following work flow:
   1. The application documents will be circulated to the entire IACUC and the members will be informed to review the protocol
   2. Adequate time will be given to the members to complete their DMR validation vote – the MTSU IACUC allows a minimum of 5 business days
   3. During DMR validation period, the members are:
      1. ALLOWED to ask for additional information to make up their mind
      2. DISALLOWED from approving or deferring a protocol
      3. DISALLOWED to request changes to the protocol
      4. ALLOWED to call for FCR and request changes at the convened meeting 
3. Review initiation – Once there is “no call” for FCR, the IACUC Chair will appoint one or two member(s) to conduct the review
   1. The OCR will contact the designated reviewer(s) (DR)
   2. The DR will be supplied with additional review report documents
4. DMR – DR(s) will complete the protocol review and can notify the ORC or the Chair after making one of the following decisions:
   1. Approve the protocol outright
   2. Refer to the full committee
   3. Refer to the full committee with alterations
5. But the DR(s) is/are NOT allowed to:
   1. request modifications to the protocol – all changes to the application must be reviewed by the full committee
   2. defer a protocol 
   3. vote in a convened meeting if he/she recommends FCR
   4. If two DRs are appointed in a protocol, consensus is required for approval – the protocol will be moved to FCR or else
6. Approval – Once the ORC receives the DMR report with approval, the following actions will be taken:
   1. The Chair will be requested to make a form ruling
   2. The ORC will confirm if health screening has been completed
   3. Once all other formalities have been completed, a formal approval notice detailing the conditions and terms will be emailed to the investigative team
7. Important Considerations – The following factors must be considered:
   1. once a protocol has been approved by DMR, the full committee cannot bring it back for a review until the protocol is ready for its annual continuing review
   2. all protocols previously approved by DMR will have to be reviewed by the full committee for a continuing review 
   3. The protocols approved by DMR will be presented to the IACUC in the following convened meeting.  It is important to note that the Committee can strike down DR’s determination and hold the protocol for further review. 

Full Committee Review (FCR)

1. Prescreen and Review Initiation:  the OC will initially conduct the following pre-review steps steps:
   1. If the application is complete, a protocol ID will be generated if this is a new application
   2. Once OC determines that the application is complete, the IACUC will be notified for subsequent action
   3. The OC will subsequently send the documents for IACUC review
   4. The researchers have to submit all of the necessary documents, including all permission letters and training documents, at least 10 business days prior to the upcoming IACUC meeting.  Click here for the IACUC calendar. 
2. Review Period – The OC will facilitate the review process as below: The OC will contact the designated reviewer (DR)
   1. Entire IACUC will receive all of the documents pertaining to the study
   2. The members of IACUC, both voting and non-voting, can request for additional documents or raise their concerns to the researchers through the Compliance Officer
   3. After there are no objects from the IACUC, the OC will add the protocol the agenda of the upcoming IACUC meeting
   4. The members can request additional information from the researchers
   5. The IACUC can also invite the researcher team to the IACUC meeting
3. Convened Meeting –
   1. DISCUSSION
      1. Quorum requirement has to be met in order for any IACUC action to be valid – A simple majority of the IACUC’s voting members has to be present at the meeting (NOTE – except the Chair and the Compliance Officer, no mandatory requirements exist at MTSU IACUC)
      2. The Chair will open the initial conversation to voting as well as non-voting members to consider any ethical consideration
      3. No member who may shares conflict of interest with the study must be present when the protocol is discussed/voted
   2. VOTE
      1. Once sufficient time has been spent on the initial discussion, the Chair will entertain a motion
      2. After a motion has been entered and seconded by a different member, the Chair can call for additional discussion on the motion
      3. The motion will be called for a vote (NOTE: if the protocol was reviewed originally through DMR and referred to FCR, then the DR(s) are ineligible from voting)
      4. The simple majority vote by the remaining voting members will carry 
      5. If the motion does not carry, then members can make subsequent motion(s) until an IACUC action has been made
      6. The administrative members of the IACUC can voice concerns but cannot influence the voting members to approve
      7. IMPORTANTIACUC VOTING RULES:
         1. Absentee members cannot give proxy votes
         2. Quorum is required
         3. Real-time electronics can be used to include an off-site member – CURRENTLY UNAVAILABLE AT MTSU
         4. Administrative and ex-officio members, including the Institutional Official (IO) are ineligible to vote
   3. ADDITIONAL MOTIONS: The IACUC can also vote on how the protocol can be dealt with when it is up for continuing review and how the amendments can be handled in the future.  If the IACUC does not vote on these, future continuing reviews and amendments will be conducted through FCR by default.
4. IACUC Actions –
   1. Approve the protocol outright
   2. Approve the protocol with modifications  –
      1. the IACUC may assign the inspection of the modification through DMR
      2. If no such assignment is made, then the protocol has to go back to FCR for a vote
   3. Table the protocol for the subsequent meeting (this will happen if the members determine that the research has a few major concerns that need to be addressed but the study does not a warrant deferral)
   4. Defer the protocol outright
   5. IMPORTANT – regardless of the IACUC’s determination, the minority view points will be noted for future reference
5. Appeal IACUC’s decision – :
   1. Presently, the MTSU researchers may not appeal the IACUC decision of their protocol received a deferral notice 
   2. However, the researcher may request to appeal the decision my sending a written request to the Chair
   3. If the researcher has proof that the IACUC’s ruling is based on prejudice, then they can request for a mediation through the IO.  Since the IO cannot approve the protocol, the IO may request for an independent review. 

Decision Guide – DMR vs FCR? 

The following table is expected to provide the highlights of the major differences between DMR and FCR:

Designated Member Review – DMR	Full Committee Review – FCR
Activities appropriate for DMR	Activities require FCR
Non-survival surgery Tissue collection Antibody production Telemetry Animal behavior (observational)	Major survival surgery Radiation-related studies Tumor inducement Toxicology studies Infectious diseases
Procedures appropriate for DMR	Procedures require FCR
Minor Amendments Certain continuing reviews	Major Amendments Most continuing reviews (unless specified) All continuing reviews for DMR-approved protocols All unspecified IACUC actions All adverse event notifications
Work Flow	Work Flow
Pre-review >> DMR Validation >> DMR >> Action It will take at least 10 business days for a review cycle AFTER ALL CRITERIA HAVE BEEN MET	Pre-review >> Review >> FCR >> Action ALL APPLICATION CRITERIA HAVE TO BE MET 10 business days before the IACUC meeting