Review and Approval of Materials Submitted (IACUC)

Purpose

Boston University (BU) is committed to observing Federal policies and regulations and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards for the humane care and use of animals. This policy describes the review process and the essential elements of IACUC review.

Covered Parties

This policy is applicable to all persons responsible for conducting animal research, teaching, training, breeding, and related activities, hereinafter referred to collectively as “activities” involving live vertebrate animals and conducted at or under the auspices of Boston University.

Policy

The following are the specific responsibilities of the IACUC relative to the review and approval of animal related activities:

• Review and approve, require modifications to secure approval or withhold approval of those components of proposed activities related to the care and use of animals;
• Review and approve, require modifications to secure approval or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and
• Conduct continuing reviews (at least annually) of protocols as required by the funding agency or IACUC. Effective December 27, 2021, the USDA no longer requires annual continuing reviews of protocols that include USDA-covered species.  The scientific justification for exemption of an NHP from some or all of the enrichment plan must still be reviewed by the IACUC not less than annually. The IACUC has the authority to review applications involving the use of animals on an ongoing basis.

The following activities involving vertebrate animals are subject to review by the IACUC prior to initiation:

• Activities conducted by faculty, staff, or students affiliated with BU, as part of their BU responsibilities;
• Activities performed on the premises of the University;
• Activities performed with or involving the use of BU funds, facilities or equipment;
• Activities satisfying a requirement imposed by the University for a degree program or completion of a course of study; and
• Activities conducted on an award for which BU is the awardee.

Examples of Activities that Require IACUC Review include but are not limited to:

• Research: The use of live animals in research, including medical, biological, behavioral, and research with free-ranging wildlife;
• Teaching, demonstrations, exhibitions: The use of live animals in educational settings, such as: workshops using animals to teach techniques; animal husbandry; medical or veterinary procedures; or other demonstrations;
• Testing: The use of live animals for any testing, such as clinical tests, vaccine trials or tests, screening or diagnostic assays; and
• Projects conducted in collaboration with other institutions in the U.S. or in foreign countries. All projects involving animals purchased with BU funds or conducted by BU personnel, are subject to IACUC This includes, but is not limited to: projects conducted in foreign countries or at other institutions; the use of animals at foreign research institutions; and fieldwork involving domestic or wild animals. All animal work and procedures are subject to IACUC review.

Examples of Activities that are Exempt from IACUC Review include but are not limited to:

• Use of tissues, organs or other parts of dead animals if the animals were not euthanized for the collection of these tissues;
• Observation of wild animals in their natural habitat without any capture or handling of the animals nor any manipulation of their habitat.

Types of Applications for IACUC Review

• New protocols;
• 3-year renewals: A full de novo review is required for all protocols at least once every 3 years. The IACUC does not have the authority to extend the three year approval period;
• Amendments are required when any changes to an approved protocol are proposed. Proposed changes  may not be implemented prior to receiving written approval;
• Transfer of ownership of a protocol is considered a significant change and must be approved by the IACUC; and
• Continuing reviews

Application Review Criteria

The IACUC shall review all applications to determine that the proposed projects are in accordance with the provisions of the Guide for the Care and Use of Laboratory Animals (“The Guide”), Public Health Service (“PHS”) Policy, Animal Welfare Regulations (“AWRs”), AAALAC and the US Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training. In all cases, the investigator must justify and explain the proposed animal use to the satisfaction of the IACUC before the application may be approved. If the IACUC does not have the scientific and technical expertise to evaluate all aspects of an application, it may bring in external expert consultants to assist with fact-finding and/or deliberations. Such consultants must not have a conflict of interest with the research activity or researchers proposing it.

The procedural review requirements of the PHS Policy and AWRs are followed in all IACUC review procedures. PHS Policy and AWRs recognize two methods of application review: Full Committee Review (“FCR”) and Designated Member Review (“DMR”). The IACUC may conduct application reviews using the DMR method or a FCR, provided such reviews are done in accordance with PHS policy.

Types of Applications and Allowable Methods of Application Review

* FCR: Full Committee Review
**DMR: Designated Member Review
***VVC:  Veterinary Verification and Consultation

Full Committee Review (“FCR”)

• Applications that require FCR are reviewed at a convened meeting of a quorum of the IACUC The Committee has the authority to approve, require modifications to secure approval, withhold approval, or defer any proposed activity to a future meeting. Applications must receive a majority vote of the quorum present, to be approved.
• In many cases, the Committee requires modifications to secure approval and votes to allow the modified application to be reviewed and approved, using the Designated Member Review (“DMR”) process as described

Designated Member Review (“DMR”)

• When using the DMR method, all IACUC members receive a list of proposed animal use applications and access to the necessary information on the applications to be Any member may request to send the application to FCR. If no member calls for FCR (within the polling period of 3 business days), at least one member of the IACUC, designated by the Chairperson, and qualified to conduct the review, shall review the application and have the authority to approve, require modifications to secure approval, or request full committee review of the application. DMR reviewers do not have the authority to withhold approval; in such cases the application is submitted for FCR.  DMR approval has equal validity to full-committee review approval, and does not require subsequent re-approval or notification at a convened meeting.

Types of DMR

• DMR for Amendments: Significant changes that may increase pain or distress to animals or increase the risk to personnel are submitted as amendments and normally reviewed by the DMR using at least one IACUC member and the Attending Veterinarian or his/her designee.

Examples of such changes include, but are not limited to:

• Change resulting in greater pain, distress, or degree of invasiveness
• Change from non-survival to survival surgery;
• Change in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
• Addition of new species;
• Change in study objectives or addition of new experiment;
• Change in Principal Investigator (PI);
• Changes that impact personnel
• DMR approvals subsequent to FCR for any application: a quorum of members present at a convened meeting may decide by unanimous vote to use the DMR process to secure approval for applications requiring
• DMR with approval from the IACUC Chair: New protocols or 3 year renewals may be sent for DMR with the approval of the IACUCInstitutional Animal Care and Use Committee IACUC oversee...

Veterinary Verification and Consultation (VVC)

Specific significant changes may be handled administratively in consultation with a veterinarian authorized by the IACUC. The veterinarian is not conducting DMR but is serving as a subject matter expert to verify that compliance with the IACUC-reviewed and -approved policy is appropriate for the animal activity in this circumstance. This includes changes in:

1. Anesthesia, analgesia, sedation, or experimental substances;
2. Euthanasia to any method considered acceptable or acceptable with conditions (provided conditions are met) in the AVMA Guidelines for the Euthanasia of Animals
3. Duration, frequency, type, or number of procedures performed on an animal.

Other changes that may be handled by VVC include:

• Increase in animal numbers up to 10% of original approved number for protocol not regulated by USDAUnited States Department of Agriculture
• Addition of strains with no adverse phenotype for species not regulated by USDA
• Minor change of standard diet or treat consistent with original protocol goals and from a commercially approved vendor to one of the following diets:
  • Breeder Diet
  • Doxycycline Diets: 45-625 mg/kg
  • High Fat or High Fat high sucrose
  • Low Fat Diet

See BU IACUC policy Veterinary Verification and Consultation (VVC) for additional information.

Administrative Changes

• Amendments proposing “Administrative Changes” that are not considered significant by the IACUC can be approved once the conditions set for approval are met.

Examples of Administrative Amendments requiring only IACUC Administrative Staff Approval include, but are not limited to:

• Modification of personnel, other than the PI, provided personnel are qualified, adequately trained and meet other criteria as required by the IACUC;
• Contact information updates;
• Removal or addition of animal housing or procedure rooms, provided such rooms are approved by the IACUC and the facility manager concurs with the use of the space for the purposes of the protocol;
• Removal or addition of funding sources
• Correction of grammar, typographical errors, or non-substantive errors in the software

Automatic Routing of Submissions for Review

Submissions automatically routed to FCR:

• New protocol or triennial renewal containing procedures that involve unrelieved pain or distress (Category E)
• Amendment that adds a Category E procedure
• Amendment that adds additional animals to a previously approved Category E procedure

Submissions automatically routed to VVC:

• Amendments to characterize experimental substances once they have been identified

Responsible Parties

Principal Investigators are responsible for: preparing and submitting applications; making modifications in applications in order secure IACUC approval; ensuring adherence to approved protocols; ensuring that all personnel have completed required training; and reporting any adverse events to the IACUC.

The IACUC Administrative Staff are responsible for providing the following administrative support to the IACUC: performing an administrative pre-review of all applications for completeness and consistency of information; verifying personnel training and suitability of rooms and facilities selected for housing and procedures; determining if the application is eligible for processing as an administrative change and if so, completing the processing and approval; determining if the submission is eligible for VVC and if so, routing it to a veterinarian for review; managing the processes that support application review and approval (including the appropriate notifications to PIs and reviewers at each stage of the process): routing the application to the reviewers; ensuring all applications are available to IACUC members for review as required by the AWR, PHS Policy, and Institutional policies; for applications reviewed at IACUC Committee meetings, documenting review comments in the meeting minutes; throughout the review process, communicating with the PI and reviewers as needed to facilitate the review and approval process; and conducting a final administrative review to ensure that all concerns and queries from the IACUC and the requirements of the BU policy and regulatory requirements are met before processing the final approval.

Veterinarians are responsible for: performing a complete review of the application, with particular attention to animal health and welfare considerations raised by the animal use described in the application. This review includes, but is not limited to, the appropriateness of: the species and the number of animals proposed; the drugs and dosages used; procedures such as restraints, acclimatization, enrichment, and quarantine; pre-op, surgery, and post-op procedures and monitoring plan; any non-surgical procedures or experiments performed on the animals; monitoring and management of discomfort, distress, or pain to animals; euthanasia methods; exemptions from standards of care, if requested; confirming that proposed changes are eligible for authorization by VVC, fall within current IACUC-approved policy or guidance, and are appropriate for the animals in the particular circumstance.

IACUC Reviewers are responsible for performing a complete review of the application, including the sections pre-reviewed by the IACUC Administrative staff and Veterinarians, with particular attention to: scientific design and the relevance of the species used; the justification for the use of animals and the number of animal numbers used to meet the purpose of the scientific design; appropriateness of the proposed procedures used to achieve the scientific goal of the project, while appropriately managing issues related to animal welfare; suitability of the alternatives suggested, when Pain Category D and E procedures are proposed.

The Primary IACUC Reviewer is responsible for: presenting the application at convened IACUC meetings; and leading the review discussion.

Definitions

Institutional Animal Care and Use Committee (IACUC): means the committee that is responsible for oversight and evaluation of the entire Animal Care and Use Program and its components as described in other sections of The Guide for the Care and Use of Laboratory Animals. Its oversight functions include review and approval of proposed animal use (protocol review) and of proposed significant changes to animal use; regular inspection of facilities and animal use areas; regular review of the Program; ongoing assessment of animal care and use; and establishment of a mechanism for receipt and review of concerns involving the care and use of animals at the institution.

References

PHS Policy on Humane Care and Use of Laboratory animals

US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

Health Research Extension Act of 1985, Public Law 99-158 November 20, 1985, “Animals in Research”

Possible methods of IACUC Approval

Guidance on Significant Changes to Animal Activities

Veterinary Verification and Consultation (VVC)

Review History

Effective Date: 11/07/2023
Next Review Date: 11/06/2026
First Approved: 06/07/2016
Revised: 11/07/2023