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Animal Use Protocol Submission And Review Process - Teaching and Research Protocols

In January 2019, the University implemented the Huron Research Suite IACUC module. The software, branded by FSU as the Research Administration Management Portal or RAMP, includes electronic Animal Use Protocol (AUP) development and routing. The ACUC currently manages AUPs in dual formats. Amendments to AUPs submitted on or prior to February 28, 2019 are managed through the former ACUC process using electronic word processing documents until such time as a triennial rewrite is required. AUPs submitted after February 28, 2019 are managed electronically through RAMP.

Description of the process for review and approval for Animal Use Protocols

Submission

AUPs are submitted electronically to the ACUC through RAMP.

Pre-Review

Administrative review
The ACUC Coordinator accepts the AUP and performs a basic review to verify completion of all relevant sections and to ensure OHP enrollment and training completion for each participant. If required, the coordinator contacts the PI (Principal Investigator) to request additional information.

Veterinary Review
LAR veterinarians, including the AV/LARD, perform review of each AUP to ensure appropriateness of described procedures, husbandry methods, drug selection and dose, pain and distress monitoring, and endpoint determination. LAR veterinarians assign each AUP an initial pain/distress category based on ACUC guidelines and USDA guidance. LAR veterinarians are provided three business days from receipt of the AUP to complete veterinary review.

Environmental Health and Safety Review
EHS reviews each AUP to identify associated hazards. When hazards are identified, EHS performs risk assessment and determines risk mitigation practices.

ACUC Review

All AUPs must be approved by the ACUC regardless of funding source. In instances where proposals do not involve a formal grant application, the ACUC may perform merit review. The ACUC uses both full committee review (FCR) and designated member review (DMR) for AUP review. Proposals assigned a pain/distress category of B, C, or D, excluding those involving major survival operative procedures or post procedural outcomes resulting in pain/distress, may be reviewed through DMR. Proposals assigned a pain/distress category D that involve major survival operative procedures or post procedural outcomes resulting in pain/distress and category E proposals are reviewed by FCR, unless DMR is specifically requested by the PI and approved by the ACUC Chair.

The AUP form prompts investigators to describe the project’s relevance to human or animal health, the advancement of knowledge, and/or the good of society, which allows the ACUC to weigh potential harm against benefit. Investigators must explain the rationale for using live animals and provide scientific and/or statistical justification for how animal numbers are derived. For all studies involving potential pain/distress, the ACUC requires an alternative search regardless of species. Additionally, all protocols must identify how pain and distress will be assessed and define humane endpoints.

Full Committee Review
FCR occurs only at a convened meeting of a quorum of the ACUC. An ACUC member, hereafter referred to as the primary reviewer, appointed by the chair presents the AUP to the full committee. Approve, require modifications to secure approval, or approval withheld are allowed protocol dispositions for FCR. Protocol disposition is determined by simple majority vote of the members present. If modifications are required, the ACUC may decide by unanimous vote of members present if revisions can be approved by an individual ACUC member. All ACUC members have agreed, in writing, to this provision. Any member of the ACUC may, at any time, request to see the revised AUP and/or request FCR prior to approval.

Designated Member Review
AUPs assigned a pain/distress category B, C, or D, excluding those involving major survival operative procedures or post procedural outcomes resulting in pain/distress, may be reviewed through DMR. In extenuating circumstances, proposals assigned a pain/distress category D that involve major survival operative procedures or post procedural outcomes resulting in pain/distress and category E proposals may be reviewed through DMR if specifically requested by the PI and approved by the ACUC Chair. Proposals for DMR are available to all ACUC members. ACUC members are provided 5 business days to call the AUP to FCR. If FCR is not requested, the ACUC Chair appoints a single member to review the AUP. Approve, require modifications to secure approval, or call to FCR are the only allowed protocol dispositions for DMR.


Description of the process for review and approval of amendments to currently approved protocols

Submission

Amendments to AUPs submitted on or prior to February 28, 2019, are submitted electronically using standardized word processing forms. Amendments to AUPs submitted after February 28, 2019, are submitted electronically through RAMP. Amendment forms are provided in Appendix 9.

Pre-Review

Administrative review
The ACUC Coordinator accepts the AUP and performs a basic review to verify completion of all relevant sections and to ensure OHP enrollment and training completion for each participant. If required, the coordinator contacts the PI to request additional information. The ACUC Coordinator has been given full authority, by the ACUC to approve amendments requesting change in personnel, other than the PI or addition of personnel to the venomous snake protocol

Veterinary Review
LAR veterinarians, including the AV/LARD, perform review of each amendment, except as described above, to ensure appropriateness of described procedures, husbandry methods, drug selection and dose, pain and distress monitoring, and endpoint determination. LAR veterinarians are provided three days from receipt of the modification to complete veterinary review.

Environmental Health and Safety Review
EHS reviews each modification, except as described above, to identify associated hazards. When hazards are identified, EHS performs risk assessment and determines risk mitigation practices.

ACUC Review

Modifications are reviewed and approved through the following mechanisms.

Following an opportunity for all voting members to call the amendment to FCR, the ACUC Chair will serve as the DMR and has been given full authority by the ACUC to review and approve amendments requesting:

  1. Changes in animal numbers up to and including 10% or addition of a single animal, whichever is greater
  2. Change in source of animals
  3. Addition of noninvasive procedures
  4. Addition of a procedural area (laboratory) for noninvasive procedures
  5. Changes which result in a decrease of invasive procedures
  6. Changes which have been approved by the AV or his/her designee as necessary to promote animal welfare or to relieve animal suffering

Amendments requesting any of the following will be reviewed and approved through DMR unless called to FCR:

  1. Increase of animal number greater than 10% of the number originally approved
  2. A species change
  3. Changes that require Environmental Health and Safety review
  4. Requests for special housing or husbandry related to the research protocol
  5. Change of principal investigator
  6. Addition of procedures that change the current AUP pain/distress category from B to C or D, excluding amendments involving major survival operative procedures or procedures that may result in pain, discomfort, or distress
  7. Any amendment the chair may deem necessary for DMR

Amendments requesting any of the following will be reviewed and approved through FCR unless DMR is specifically requested by the PI and approved by the ACUC chair:

  1. Addition of procedures that change the current AUP pain/distress category from B or C to D, specifically amendments involving major survival operative procedures or procedures that may result in pain, discomfort, or distress, or category E
  2. Addition of invasive or major operative procedures
  3. Addition of a surgery area
  4. Changes in housing, husbandry, or enrichment that do not comply with the Guide
  5. Any amendment distributed for DMR and called to FCR by an ACUC member

Full Committee Review
FCR occurs only at a convened meeting of a quorum of the ACUC. An ACUC member, hereafter referred to as the primary reviewer, appointed by the chair presents the amendment to the full committee. Approve, require modifications to secure approval, or approval withheld are allowed dispositions for FCR. Amendment disposition is determined by simple majority vote of the members present. If modifications are required, the ACUC may decide by unanimous vote of members present if revisions can be approved by an individual ACUC member. All ACUC members have agreed, in writing, to this provision. Any member of the ACUC may, at any time, request to see the revised amendment and/or request FCR prior to approval.

Designated Member Review
Modifications for DMR are electronically distributed to all ACUC members. ACUC members are provided five business days to call the modification to FCR. If FCR is not requested, the ACUC Chair appoints a single member to review the modification. Approve, require modifications to secure approval, or call to FCR are the only allowed dispositions for DMR.