IACUC FAQs

Protocol Submission and Review

InfoEd

Inspections and Site Visits

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Protocol submission and Review

Do I need to submit an annual continuation?

Do you have a USDA-covered species listed on your protocol (e.g., pigs, sheep, bats)? Do you have Department of Defense funding (e.g., DARPA, Air Force, ONR)? If the answer to at least one of these questions is “yes,” then you do need to submit an annual continuation via InfoEd. If the answer to both questions is “no,” you do not need to submit an annual continuation. 

Do I need to assign animals to pain categories if my protocol does not involve USDA-covered species and/or DoD funding?

No, you do not need to assign animals to pain categories if your protocol does not involve USDA-covered species or have Department of Defense funding.

However, if your protocol involves potentially painful or distressful procedures, your protocol will still require veterinary pre-review. You will also need to describe in your protocol how you will alleviate and monitor for pain and/or distress or, in the case of unrelieved pain or distress, provide a scientific justification for withholding anesthesia/analgesia.

What constitutes veterinary pre-review for protocols and amendments involving Category D/Category E/potentially painful or distressful procedures?

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/potentially painful or distressful procedures.  Veterinary pre-review is now conducted in the InfoEd system. You must complete your full protocol / amendment submission in InfoEd and the system will determine whether it requires veterinary pre-review. If it does, the system will route your submission to a veterinarian and you will communicate in the system with the vet until you've satisfied any vet pre-review comments. Once comments are satisfied, your protocol will be routed by the vet to the ARPP for its pre-review.

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 adds a new Category D/Category E/potentially painful or distressful procedure, a veterinarian pre-consultation is still required, even if the amendment qualifies for review via DMR.

What do reviewers look at when they review my submitted protocol?

IACUC reviewers are reviewing your protocol to ensure that the use of animals in your research is justified, the procedures to be done to each animal are clear, and that your protocol complies with all governing regulations and institutional policies that are in place to assure the humane and ethical use of animals in teaching and research.  Brown's IACUC has developed a reviewer checklist that reviewers may use to help guide their review.  Investigators are encouraged to use this checklist to conduct a self-review prior to submitting a protocol to the IACUC.

What is required when Brown is the prime recipient of a sponsored award and a subcontract site(s) is performing vertebrate animal work?

Regulatory requirements set forth the expectation that institutions will have a formal written understanding (e.g., a Memorandum of Understanding [MOU]) that addresses responsibilities for animal care and use, animal ownership, and IACUC review and oversight when more than one institution is engaged in animal research. PHS Policy requires that all awardees and sites at which animal work will be performed hold an approved Animal Welfare Assurance.

When Brown is the prime recipient of an award and a subcontract site is performing vertebrate animal work, the Animal Research Protection Program (ARPP) will work with the collaborating site to execute Brown’s MOU. Brown is responsible for assuring congruency between the IACUC approved work at the collaborating site and at Brown. As such, we will request a copy of the IACUC protocol and approval letter from the collaborating site and the grant proposal from the Brown PI to review for congruency.

Once grant congruency is verified, and the collaborating site has completed its section of the MOU, Brown’s Animal Research Protection Program (ARPP) team will upload the approved IACUC approved protocol and approval documents from the subcontract site to InfoEd and will request and document subsequent approval letters from the collaborating site throughout the lifetime of the award.

What is a congruency review and when is it conducted?

It is the institution’s responsibility to ensure that the IACUC has approved the proposed use of animals described in a grant application or contract proposal. This is required to comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals as stated in Section V.B.

In addition to the NIH, the NSF and the Department of Veteran Affairs require a congruency review when they are funding animal research. While the Department of Defense does not specifically require a congruency review, Brown conducts a review as recommended by OLAW as a best practice.

What does Brown's Animal Research Protection Program (ARPP) look at in its review?

  • To meet the congruency review requirement, the ARPP compares the vertebrate section of the grant application identified by the PI as funding the IACUC-approved protocol. The IACUC-approved protocol must be consistent with the aims, species, procedures/surgeries, anesthesia, and method(s) of euthanasia described in the grant application. 

  • In the case where the period of performance for the grant is more than 3 years, the ARPP must ensure that the first 3 years of animal work described in the grant application are also described in sufficient detail in the IACUC protocol. It is the expectation of the sponsor (and of the IACUC) that any work to be conducted in later years of the award (i.e., years 4 and 5 of a 5-year grant) will be briefly described without experimental details in the IACUC protocol, with detail regarding these later-year studies to be included in the protocol's de novo 3-year renewal.

  • When Brown is the prime awardee, the ARPP must ensure that the research described in the grant application is congruent with any corresponding protocols approved by the IACUC of any subawardee. Brown accomplishes this via the Memorandum of Understanding (MOU) process

What is the PI's responsibility?

The PI or delegated lab member is responsible for either: 

  • Submitting a new IACUC protocol for review and approval in anticipation of forthcoming funding, as soon as you know you have a potentially fundable score. With your new IACUC protocol, please submit the vertebrate section of your pending award or provide the Institute Proposal number (from Coeus) to the ARPP. This will enable the ARPP to complete its congruency review while the protocol is under review by the IACUC.

  • If you intend to rely on an existing IACUC-approved protocol for a pending award (i.e., you intend to add the new funding source to your IACUC-approved protocol), please submit an administrative change via InfoEd to add the new funding source and provide the vertebrate section of your pending award or provide the Institute Proposal number (from Coeus) to the ARPP. *Please note that if you intend to rely on an existing IACUC approval for submission of requested documentation at Just-in-Time, the NIH will not accept an IACUC approval that expires within a few weeks.*

Once the ARPP has the required information in-hand from the PI, we are able to conduct a congruency review in approximately 2 business days.

What happens if my grant is not consistent with my IACUC approved protocol?

If the new grant includes additional or different aims, species, procedures/surgeries, anesthesia, and method(s) of euthanasia, please include those changes in the protocol amendment to add the new funding source. This will enable the ARPP to assure protocol-grant congruency once the new modifications have been reviewed and approved by the IACUC.

It is the institution’s responsibility to ensure that the IACUC has approved the proposed use of animals described in a grant application or contract proposal. This is required to comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals as stated in Section V.B.

In addition to the NIH, the NSF and the Department of Veteran Affairs require a congruency review when they are funding animal research. While the Department of Defense does not specifically require a congruency review, Brown conducts a review as recommended by OLAW as a best practice.

What does Brown's Animal Research Protection Program (ARPP) look at in its review?

  • To meet the congruency review requirement, the ARPP compares the vertebrate section of the grant application identified by the PI as funding the IACUC-approved protocol. The IACUC-approved protocol must be consistent with the aims, species, procedures/surgeries, anesthesia, and method(s) of euthanasia described in the grant application. 

  • In the case where the period of performance for the grant is more than 3 years, the ARPP must ensure that the first 3 years of animal work described in the grant application are also described in sufficient detail in the IACUC protocol. It is the expectation of the sponsor (and of the IACUC) that any work to be conducted in later years of the award (i.e., years 4 and 5 of a 5-year grant) will be briefly described without experimental details in the IACUC protocol, with detail regarding these later-year studies to be included in the protocol's de novo 3-year renewal.

  • When Brown is the prime awardee, the ARPP must ensure that the research described in the grant application is congruent with any corresponding protocols approved by the IACUC of any subawardee. Brown accomplishes this via the Memorandum of Understanding (MOU) process

What is the PI's responsibility?

The PI or delegated lab member is responsible for either: 

  • Submitting a new IACUC protocol for review and approval in anticipation of forthcoming funding, as soon as you know you have a potentially fundable score. With your new IACUC protocol, please submit the vertebrate section of your pending award or provide the Institute Proposal number (from Coeus) to the ARPP. This will enable the ARPP to complete its congruency review while the protocol is under review by the IACUC.

  • If you intend to rely on an existing IACUC-approved protocol for a pending award (i.e., you intend to add the new funding source to your IACUC-approved protocol), please submit an amendment via Coeus to add the new funding source and provide the vertebrate section of your pending award or provide the Institute Proposal number (from Coeus) to the ARPP. *Please note that if you intend to rely on an existing IACUC approval for submission of requested documentation at Just-in-Time, the NIH will not accept an IACUC approval that expires within a few weeks.*

Once the ARPP has the required information in-hand from the PI, we are able to conduct a congruency review in approximately 2 business days.

When are IACUC meetings held?

IACUC meetings are held on the first Friday of each month between 12:30pm and 3:00pm, unless otherwise noted.

InfoEd

When will IACUC protocols transition to InfoEd?

The new Lab Animal module in InfoEd is scheduled to go live on June 15, 2018 for a soft launch to enable transition of active protocols into the new system. 

  • June 15-July 13:  Migration of Active Protocols

    • Active protocols will be migrated from Coeus to InfoEd

      • Principal Investigator, Delegate, and Lab Manager(s) will be notified when protocol record(s) is migrated

      • After the protocol record is migrated, all future protocol actions (administrative changes, amendments, or continuations) must be done in InfoEd

    • All new protocols initiated during this time period must be created in InfoEd

  • Starting July 15: InfoEd Lab Animals Module will be Live

    • All protocol activity will be processed in InfoEd. 

Will multiple species still be allowed on a single protocol? What about USDA and non-USDA covered species on the same protocol?

Yes, multiple species may still be included on a single IACUC protocol. USDA and non-USDA covered species may not be included on a single protocol. We have worked hard to eliminate protocol questions and requirements for non-USDA animal users (e.g., eliminating annual continuations) and the non-USDA protocol form in InfoEd has been programmed to reflect this.

Will I finally be able to submit an administrative amendment at the same time as a substantive amendment?

Yes! In InfoEd, you will be able to submit administrative change requests contemporaneous with substantive amendments and they will be approved separately. This will enable you to make quick, administrative changes without having to wait for a substantive amendment to be approved.

Inspections and Site Visits

How do I prepare for an AAALAC accreditation site visit?

Site visitors may direct their questions to any research personnel in the lab. Therefore, it is important that all personnel be familiar with approved protocol(s) on which they are listed, know what is approved (and what is not), be prepared to speak about their training, and demonstrate an understanding of institutional policies and procedures.  Brown has created a Self-Assessment checklist  to help laboratories prepare for AAALAC accreditation visits, and encourages laboratories to complete the checklist a few weeks prior to the planned site visit.

Who do I contact about issues or questions related to animal husbandry (caging, space availability, etc.)?

The Animal Care Facility (ACF) team at Brown University is dedicated to provide a healthy, well cared for environment and living space for animals which are essential to meaningful research.  The veterinarians are directly responsible for the care and use of all animals at all Brown University facilities.  As the veterinary IACUC members, they review all animal care and use protocols.  Their contact information can be found here.

I can’t find the answer to my question. Who can I talk to?

Contact the ARPP for more assistance on protocol submission or animal research related questions, policies, or procedures.