Protocol Submission Procedures
- 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.
- DeNovo (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. (Investigators should remember to incorporate all previously approved amendments in the new 3 year renewal submission.)
- Annual Renewal - submitted at least every 12, or as determined by the IACUC, months and must be reviewed and approved prior to the expiration date. The Research Protections Office (RPO) will remind PIs approximately 2 months prior to the 1 year and 2 year anniversary date of the project. If you do not receive the form please contact RPO.
- Amendment is any change to the ongoing approved protocol. Amendments should be submitted by memo, with appropriate appendices as necessary. All changes must be approved prior to implementation. See our Amendment Guidance webpage.
There are two categories for amendments: significant change and minor change. The following are examples for each category:
Significant changes directly impact animals or the research.
Examples include but are not limited to:
- Change in PI
- Altered objective of study
- New or modified procedure
- Modification of survival surgery
- Change from non-surgery to surgery, from minor to major surgery, from non-survival to survival, or from single to multiple survival surgery.
- Increased invasiveness or potential discomfort/distress to animals caused by a procedure
- Changes in species or increase the number (except for less than 10% in rats and mice bred for research) of animals approved
- Modified choice of anesthetic or analgesic agent(s), or in the route of administration or dosage of these agents
- Altered method of euthanasia
- Change in duration, frequency or number of procedures performed on an animal
Minor changes do not directly impact the animal or the research.
Examples include but are not limited to:
- Addition of new personnel participating in animal procedures
- Change in animal housing location
- A less than 10% increase in the number of rats and mice bred for research. approved for use
- Additional rodent genetic strain
These submission types are summarized in the following table:
New research project
Protocol with required Appendices
DeNovo (Three Year) Renewal
Continuation of approved project beyond 3rd year
Protocol with required Appendices
Progress report every 12 months, or as determined by the IACUC
Annual Protocol Renewal Form
Significant or Minor Change to existing project
A memo describing the change(s) and appropriate appendices
III. Preparation of Protocol
- Current forms for new protocols and DeNovo (three year) renewals, can be obtained from the Coeus IACUC Protocol Submission page,
or by contacting RPO at 863-6303 or via IACUC@brown.edu. To request approval for significant or minor changes to an ongoing project, an optional form is available on our webpages which outlines the necessary information the IACUC requires. The amendment submission should be sent to the IACUC requesting the changes and providing the rationale for them. Depending on the nature of the change, appropriate appendices may be required. See the RPO webpages for information on when appendices are needed.
- Consultation with a campus veterinarian is required for all research projects that have the potential for producing pain or distress (i.e., USDA pain categories D or E). After consultation the veterinarians are available to provide a "pre-review" of the draft protocol, if requested.
- PHS policy requires the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. Protocols that are externally funded should be accompanied by the proposal/grant research plan, animal use section, and face page (cover page).
- All projects that will be funded entirely or partially by internal funds require Scientific or Educational Merit Review by Department Chair.
- All protocols proposing the use of hazardous agents in animals must receive Biohazard and/or Radiation Safety Committee. Biohazard and/or Radiation Safety Committee approval is required before IACUC approval will be granted.
- The PI should generally allow 3 weeks for protocol review. Under unusual circumstances review time may be extended.
IV. Submission of Protocol
- Submit the completed protocol or amendment by email to the IACUC Coordinator (IACUC@brown.edu). In addition, send a signed hardcopy of the 'Certification of IACUC Approval' page to RPO (Hemisphere Building, Lower Level, Box 1986).
- New or DeNovo (three year) renewal protocols should include the following required components:
- Signed 'Certificate of IACUC Approval' page
- Completed protocol (all sections completed), in addition to appendices that might apply
- Research plan, animal use section, and face page of proposal/grant, if project is externally funded
- Scientific or Educational Merit Review by Department Chair, if project is internally funded
- Annual protocol renewals should include the following components:
- Completed and signed protocol addressing all questions.
- Amendments should include the following components:
- Brief summary of the approved protocol (1-2 paragraphs).
- Outline of the proposed changes.
- Scientific justification for the proposed changes.
Note: Incomplete submissions will be returned to the investigator.
V. Review of Protocol
The following are outcomes of IACUC review (see Protocol Review Policy for details):
- 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.
VI. 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.
- 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).