Research

IACUC Protocol Review Policy


I. General

  • All vertebrate animal use at Brown University, including for research, instruction or testing, must be approved by the Brown University Institutional Animal Care and Use Committee (IACUC). 
  • The IACUC review will be conducted in accordance with the USDA Animal Welfare Regulations (AWR), the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), and the Guide for the Care and Use of Laboratory Animals (The Guide)
  • The IACUC review and proposed animal use must also be consistent with the USDA Animal Welfare Regulations (AWR), the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), and the Guide for the Care and Use of Laboratory Animals (The Guide) unless acceptable justification for departure has been provided and approved.

II. Types of Submissions

The principle investigator (PI) is responsible for preparing a protocol describing animal care and use and for obtaining IACUC approval prior to using animals.  The following are types of submissions:

  • New Protocol covers newly proposed projects, whether they are to be funded externally (e.g., NIH or NSF) or internally (e.g., start-up funds or GIP accounts).  Protocols are approved for a maximum of 3 years, with a required annual renewal every 12 months.
  • Three Year Renewal - for projects continuing more than 3 years after the original approval (e.g., for 4- or 5-year grants), the project must be reviewed de novo by submission of a new protocol.
  • Annual Renewal – submitted at least every 12 months, or as determined by the IACUC, and must be reviewed and approved prior to the expiration date.
  • Amendment is any change to the ongoing approved project. All changes must be approved prior to implementation. See our Amendment Guidance webpage for more information.

These submission types are summarized in the following table:

Submission Type

Project Proposed

Required Forms

New Protocol

New research project

Protocol with required Appendices

Three Year Renewal

Continuation of approved project beyond 3rd year

Protocol with required Appendices

Annual Renewal

Progress report every 12 months, or as determined by the IACUC

Annual Protocol Renewal Form

Amendment

Significant or Minor Change to existing project

A memo describing the change(s) and appropriate appendices

III. Receipt of Protocol

The formal review process is initiated with the acceptance of the complete protocol, including all required parts, by the IACUC Coordinator. Before accepting the protocol, the IACUC Coordinator may request that the PI correct simple technical errors or omissions.

The full protocol is forwarded to each IACUC member via email and the following information is communicated in the body of the email:

  • Protocol number
  • Principal Investigator
  • Protocol Title
  • Funding Source
  • Species and pain/stress category

After receipt of the protocol via email members are requested to notify the Coordinator if they want Full Committee Review (FCR), otherwise the Designated Member Review (DMR) process is initiated. The notification must be done within 5 business days for new protocols and three year renewals (and within 3 business days for amendments). A request by a single member of the IACUC is sufficient to trigger FCR at a convened IACUC meeting. Under unusual circumstances committee members may be asked to provide notification of their preference for FCR within a shorter time frame.

IV. Review Types

Designated Member Review (DMR) 

DMR of New Protocols and Three Year Renewals:

  • The DMR subcommittee for the above listed protocol types consists of one or more IACUC member(s) designated by the Chair of the IACUC. Additionally, non-voting consultants may be recruited to review aspects of protocols requiring expertise not adequately represented on the DMR subcommittee. The following are outcomes of the DMR subcommittee:
    • Approval – requires acceptance of all members reviewing the protocol.
    • Modifications requested to secure approval.
    • Refer to Full Committee Review – any designated reviewer can refer the project to FCR.

     

DMR of Amendments:

All amendments to a protocol will be reviewed by a veterinarian member of the IACUC for the determination of whether the change is minor or significant. See our Amendment Guidance webpage for more information.

  • Significant changes will be reviewed by a DMR subcommittee, consisting of one or more IACUC member(s) designated by the Chair of the IACUC.
  • Minor changes will be reviewed and approved administratively by the Research Protections Office (RPO).

DMR of Annual Renewals:

· All annual renewals will be reviewed by a DMR subcommittee, consisting of one or more IACUC member(s) designated by the IACUC Chair.

Full Committee Review (FCR)

  • A meeting of the IACUC is convened, and the protocol is reviewed and discussed. In order to convene a meeting a quorum of the members must be present.  At the discretion of the Chair, the PI may be invited to the IACUC meeting to address questions the committee may have. The PI will be excused from the room before the deliberations and vote. The following are outcomes of a FCR:
    • Approval - requires a majority affirmative vote.
    • Modifications requested to secure approval.
    • Defer or table review – the IACUC can table the review of a protocol if, e.g., clarifications are required, if outside consultation is needed, or loss of quorum.
    • Withhold approval - the IACUC determines that a protocol has not adequately addressed all requirements necessary and withholds approval.

NOTE: IACUC members participating in any proposed project or who have a real or potential conflict of interest must recuse themselves from DMR or FCR process deliberations and vote. 

V. Notification of IACUC Determination

  • Notification of approval will be sent to the PI via email including a copy of the approved protocol, annual renewal protocol, or amendment.
  • Notification of the need for additional information will be sent to the PI. A revised protocol addressing the IACUC questions is required.
  • When IACUC is unable to approve a protocol, the reasons for withholding approval are detailed and emailed to the PI. The PI has an opportunity to address the concerns of the committee through a new protocol.

References

-Institute of Laboratory Animal Resources, National Research Council. Guide for the Care and Use of Laboratory Animals 8 (National Academy Press, Washington, DC, 1996).

- Public Health Service Policy on Humane Care and Use of Laboratory Animals

- USDA Animal Welfare Act Regulations, CFR, Title 9, Chapter 1, Subchapter A, Parts 1 - 3.

- ARENA/OLAW. Institutional Animal Care and Use Committee Guidebook, 2nd edn (2002).