Submitting an IACUC Protocol, Amendment, or Annual Continuation
All Animal Use Protocols, amendments, administrative changes and annual continuations must be submitted in InfoEd for IACUC review.
Additional requirements for Department of Defense sponsored protocols
What happens when I submit a new protocol?
Common reasons for delays in review
Pre-Review by the Animal Research Protection Program
Building flexibility into your protocol
What happens when I submit a De Novo (three-year) renewal protocol?
What happens when I submit an Annual continuation?
What happens when I submit an Amendment?
Examples of Significant Changes
Examples of Administrative Changes
Protocols using hazardous agents or human embryonic stem cells in animals
Types of Review
Full Committee Review
Designated Member Review
Any IACUC protocol funded in whole or in part by the Department of Defense (DoD) must undergo secondary review by the DoD following review and approval by the Brown IACUC. The DoD has its own animal use forms that must be completed by the laboratory in addition to the protocol forms required by Brown. For details regarding the additional requirements and the process established to facilitate duplicate review, please see our SOP.
A New protocol covers newly proposed projects, whether they are to be funded externally (e.g., by NIH or NSF) or internally (e.g., using start-up funds, seed funds, via Brown award-granting programs). When a protocol is funded internally and has not undergone external peer review, the IACUC may rely on a review by the investigator’s departmental chair to verify the scientific justification or educational merit for the proposed use of animals. New protocols are approved for a maximum of 3 years, at which point a De Novo Renewal protocol must be submitted.
New protocols that involve USDA-covered species, Department of Defense (DoD) funding, other sponsor requirements for annual review, or a determination by the IACUC that the protocol requires more frequent monitoring, will be reviewed no less than annually via the PI’s submission of an Annual Continuation.
New protocols that are reviewed by Full Committee Review are typically reviewed and approved within 3-4 weeks. New protocols that are reviewed by Designated Member Review are typically reviewed and approved within 2-3 weeks. Please keep in mind that these are average review times, and depend significantly upon the quality and completeness of the protocol when it is submitted and the investigator’s response time to IACUC reviewer comments. Please see Common Reasons for Review delays and How to build flexibility into your protocol, outlined below.
Failure to obtain a required Veterinary consultation for protocols involving Category D/Category E/potentially painful or distressful procedures prior to submitting the protocol.
Failure to conduct searches for alternatives for each Category D/Category E/potentially painful or distressful procedure, in accordance with Brown’s Guidelines for Literature Searches for Alternatives. Click here for additional resources to help with your alternative searches.
Failure to provide adequate scientific justification for exceptions to requirements in the Guide for the Care and Use of Laboratory Animals and/or Brown policy
Insufficient justification for animal numbers and/or calculations of animal numbers that don’t add up correctly or conflict with other parts of the protocol
Failure to respond to pre-review comments (from the IACUC Manager/Specialist) or IACUC reviewer comments in a timely manner
Veterinary pre-review is required for all new protocols, de novo (3-year) protocol submissions, as well as significant amendments that involve Category D or E procedures and/or potential for pain or distress. Please note that veterinary pre-review is now conducted in the InfoEd system. You must complete your full protocol in InfoEd and it will route to a veterinarian upon submission if veterinary review is required.
A veterinarian will review the protocol to ensure that any and all veterinary matters are addressed and will provide you with guidance on animal welfare, animal care, along with design and implementation of study proposals (e.g., correct analgesic and anesthetic dosages, appropriate animal housing, enrichment and exercise plans, etc.). Exchanges between the investigator and the veterinarian before submission to the IACUC may address many of the Committee's concerns and could help expedite the process.
Please note that new protocols and de novo protocol submissions that meet Full Committee Review criteria must meet the veterinarian pre-review deadlines to be reviewed at the next meeting. If your amendment to an existing protocol involves Category D or E procedures / procedures that involve pain or distress, a veterinarian pre-consultation is still required, even if the amendment qualifies for review via DMR.
When your protocol is submitted via InfoEd, the IACUC Manager and/or the IACUC Specialist will conduct an initial pre-review to ensure that it is complete, does not contain contradictory information, adheres to regulatory requirements, and is generally in good form to submit to the IACUC reviewers. You may receive requested revisions to your protocol based on the ARPP staff’s pre-review; these comments are always aimed at improving your protocol so that it can be efficiently reviewed by the IACUC and will be clearly marked as pre-review comments. The ARPP knows the IACUC reviewers’ expectations and pain points, and is always available to work with you to ensure your protocol is in the best possible state for review. Please do not hesitate to contact us for assistance with protocol development and submission.
In general, the IACUC encourages PIs to build an appropriate degree of flexibility into their protocols to enable the research team to maintain compliance and reduce administrative burden by reducing the need for amendments. For example:
for blood collection, provide a range of acceptable amounts, frequencies and intervals (e.g., 0.05-0.10 ul of blood will be drawn from either the tail vein or the facial vein every 1 to 3 days for up to 14 days).
for needle gauges or catheters, provide an appropriate range of sizes
for study endpoints, give justifiable maximum times or markers (e.g., animals will be euthanized no later than three weeks after administration of the test article, or earlier if the animal’s condition or study progress warrants it).
for behavioral tests or radiographic exams, give a range of time and frequency (e.g., x-rays will be taken 3-5 times during the 2-3 weeks following the procedure).
When employing flexible options, please ensure that they are consistent with Brown’s policies and appropriate in the context of the study design.
All protocols are set to expire three years after their original IACUC approval date, at which time the project must be reviewed de novo. De Novo protocols undergo the same level of review as a new protocol. You should be aware that regulatory requirements and IACUC policies/guidelines may have changed since your protocol was last reviewed, which could result in required revisions. Like new protocols, De Novo Renewal protocols can be reviewed by either Full Committee Review or Designated Member Review, and are typically reviewed within 3-4 weeks.
Annual Continuations are required for all protocols that use USDA-covered species and for DoD-sponsored projects. They must be submitted in advance of the 12-month protocol expiration date in order to be reviewed and approved before the date of expiration. For those protocols that do not require an annual continuation (per relevant regulations and sponsor requirements), the ARPP staff will contact you around the protocol’s one-year approval ‘anniversary’ to affirm that a subset of information you provided in your original protocol is still accurate. This process was implemented to reduce administrative burden for investigators, and we hope that you will take the time to affirm that the basic information we provide to you remains accurate as it greatly improves our ability to perform efficient inspections, verify procedures, and close out protocols that are no longer active. Please note that the IACUC can, at any time, request that any protocol be subject to the annual continuation requirement; the IACUC can also call Annual Continuations for Full Committee Review. Annual Continuations that require IACUC review and approval (and are reviewed by Designated Member Review) are typically approved within five days of submission.
An Amendment is required when a PI would like to make a change to an approved protocol. Amendments should be submitted via InfoEd. All changes must be approved prior to implementation; approval time varies depending on the complexity of the amendment, but typically approval time is 1-3 weeks.
There are two categories of amendments: significant change(s) and administrative change(s). The following are examples for each category:
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
Examples include but are not limited to:
Addition of new personnel participating in animal procedures
Change in animal housing location
Addition of new funding sources
Any protocol that proposes the use of hazardous agents in animals must receive approval by Brown’s Institutional Biosafety Committee (IBC) and/or the Radiation Safety Committee (RSC). The IACUC may not issue approval of a submitted IACUC protocol that requires IBC/RSC review and approval until after such approval is granted. Brown has established an ad hoc Embryonic Stem Cell Regulatory Oversight (ESCRO) committee. Given this is an ad hoc committee and not a standing committee that meets routinely, it is imperative that any investigator proposing to use hESCs in animal research contact Brown’s Office of Research Integrity well in advance of requiring approval to begin such work to allow time for a committee meeting to be called. For an ESCRO committee application, please contact Holly Clifford in the Office of Research Integrity at Holly_Clifford@Brown.edu.
Protocols involving the use of Category E procedures and/or Non-Human Primates are typically reviewed via FCR. In addition, protocols involving a principal investigator (or student mentee) who has not previously submitted a protocol to the Brown IACUC should anticipate FCR of his/her first submitted protocol. Any member of the IACUC may also request FCR of any protocol. Deadlines for protocols to be reviewed at the Full Committee meeting are two weeks prior to the meeting date.
The possible outcomes of FCR are as follows: The IACUC may approve, require modifications (to secure approval), defer or table review, or withhold approval of activities related to the care and use of animals. Approval must be granted through the vote of a majority of the quorum present. If the outcome of FCR is anything other than approval, then the PI will receive comments from the Committee that must be addressed in order to secure approval. Comments will be sent to the PI in writing by the ARPP; the ARPP staff is very willing to assist you with addressing the Committee’s comments at your request. Please note that delays in responding to reviewer comments will result in approval delays. Comments that are not addressed within 45 days will likely result in withdrawal of the protocol and require re-review by the Committee.
New protocols, De Novo Renewals, Annual Continuations and Amendments typically are reviewed via DMR unless they meet the criteria outlined under FCR.
DMR is conducted by 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 possible outcomes of DMR review are as follows: approval, require modifications (to secure approval), or referral of the protocol for Full Committee Review. Protocols reviewed via DMR are typically reviewed and approved within 2-4 weeks. If the outcome of DMR is anything other than approval, then the PI will receive comments from the Committee that must be addressed in order to secure approval. Comments will be sent to the PI via InfoEd; the ARPP staff is very willing to assist you with addressing the Committee’s comments at your request. Please note that delays in responding to reviewer comments will result in approval delays. Comments that are not addressed within 45 days will likely result in withdrawal of the protocol and require re-review by the Committee.
Contact the IACUC office at 401-863-2356 or IACUC@brown.edu.