Protocol Submission and Review
When will IACUC protocols transition to InfoEd?
Will multiple species still be allowed on a single protocol? What about USDA and non-USDA covered species on the same protocol?
- Will I finally be able to submit an administrative amendment at the same time as a substantive amendment?
Inspections and Site Visits
You can request access by completing the CAP Access Form on the Coeus website.
Add personnel in Coeus under the 'Investigators/Study Personnel' tab. Click 'Add Investigator/Study Personnel Information' at the top of the screen and then select 'Employee Search'. You can search for the person using their first or last name (just be sure to use * around the name.. e.g., *Jones*). When you find the person, select his/her name as well as their protocol role and affiliation. Click 'Save' to complete.
If you are adding non-Brown personnel, the first step is to contact the ARPP with the non-Brown personnel's name, email, and affiliated organization. We will add them to the 'Rolodex' in Coeus. Once we do so, you can add them using the same process outlined above except use the 'Non Employee Search.'
If I have external funding that is not through Brown, how do I add this to my protocol?
Any funding that supports the research, regardless of source, should be listed on your protocol. On the 'Funding Source' tab, there are two options for 'Type' - Sponsor and Institute Proposal. If you are adding funding that is not through Brown, you only need to add a Sponsor (e.g., NIH, NSF). This can be done by selecting 'Sponsor' as the type and then clicking 'Search'. Search using 'Sponsor Name' and be sure to use * around the name (e.g., *National Institute of Health*). Select the sponsor and click 'Save'.
I am submitting an amendment, but Coeus won't let me modify any information or upload documents. How do I fix this?
The problem is likely that you have not selected the appropriate checkbox on the 'Summary' tab. Any box that is checked on this page will allow you to edit the corresponding section in Coeus. For example, if you check 'Add/Modify Attachments', Coeus will allow you to upload documents (note: this box should always be checked).
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 Coeus. If the answer to both questions is “no,” you do not need to submit an annual continuation - you will be contacted by ARPP to affirm all protocol information is still accurate.
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 you will still need to engage a veterinaryian for 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.
IACUC protocols funded in whole or in part by the Department of Defense (DoD) must undergo secondary review and approval by the DoD following receipt of IACUC approval at Brown. No animal use activities may be implemented at Brown until DoD approval is received. To facilitate this duplicate review process, the ARPP has established the following procedures:
New IACUC protocols: A new IACUC protocol that is funded in whole or in part by the DoD must first be completed by the laboratory and submitted to the ARPP via Coeus / using Brown IACUC forms. The ARPP does permit investigators to include DoD and non-DoD funded animal activities on a single IACUC protocol. The ARPP recommends that the laboratory work on completing the requisite DoD Animal Appendix while the protocol is under review by Brown's IACUC. Please note that the U.S Army Medical Research and Material Command (USAMRMC - ACURO) Animal Appendix differs from the Animal Appendix required by the Department of Navy Bureau of Medicine and Surgery (ONR - BUMED). In addition, please be sure to complete the correct version of the relevant Animal Appendix -- the Abbreviated Version may be used when the animal activities on the Brown-approved IACUC protocol are ALL funded by the DoD, whereas the Full Version must be used if the Brown-approved IACUC protocol includes animal activities funded by DoD and another funding source(s).
Once Brown IACUC approval is issued for the new protocol, the ARPP will contact the laboratory for the completed DoD Animal Appendix unless the laboratory has already furnished it to the ARPP. The ARPP will then submit to the DoD (1) the Brown IACUC approved protocol and approval letter, (2) the DoD Animal Appendix completed by the laboratory, and (3) a copy of Brown's most recent USDA inspection report. If Brown is the prime recipient of DoD funding and has a subcontractor performing animal work, the ARPP will coordinate directly with the subcontractor institution to obtain its most recent USDA inspection report and will include this report as required in the submission to the DoD. When DoD approval is received, the ARPP will inform the laboratory and provide all approval documents to the PI for the lab's records.
Amendments/administrative changes to an approved protocol: The DoD requires that all changes to an approved protocol be subsequently reviewed and approved by the DoD prior to implementation. For amendments and administrative changes, the DoD does NOT require submission of a DoD-specific form. As such, the laboratory should submit any requested modifications via the appropriate process: the amendment form for substantive modifications and VVC, or via email for requests to remove personnel or a funding source. For protocols that are supported by more than just DoD funding, the laboratory must indicate in the modification request whether the change is for the DoD component of the protocol. If this is not clearly indicated in the modification request, the ARPP will confirm with the laboratory that the modification pertains to the DoD work before sending the modification to the DoD for secondary approval.
Once Brown IACUC approval is received for the requested modification, the ARPP will send the modification request and the Brown IACUC approval letter to the DoD for secondary approval, marking the communication as an "amendment." In instances when a change is truly urgent, please alert the ARPP and we will mark the email to the DoD accordingly (as the DoD has instructed us to do). When secondary approval is received from the DoD, the ARPP will inform the laboratory and provide all approval documents to the PI for the lab's records.
Annual Continuations: The DoD does not require copies of annual continuation documents; as such, the laboratory should submit the annual continuation form to the ARPP for the IACUC's review by the deadlines set forth in communications to the PI from the ARPP.
Noncompliance incident reports: Consistent with its practice for all IACUC protocols (DoD funded or otherwise), reports of noncompliance are reviewed by the IACUC. The IACUC determines whether the incident meets sponsor or other regulatory reporting criteria. If so, draft copies of correspondence to the sponsor / regulatory agencies will be provided to the PI to review for factual accuracy; any recommended revisions by the PI will be considered. The final reports will be submitted to the sponsor / regulatory agencies by the ARPP.
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. The veterinary pre-review requirement must be satisfied before you submit to the ARPP office and you must indicate in your submission which of the three Brown veterinarians pre-reviewed your protocol.
The veterinary pre-review requirement is not satisfied if you only have a verbal discussion with a Brown veterinarian. Instead, a pre-review consists of:
Electronically distributing in Word format to one of Brown's veterinarians the full draft protocol and all applicable appendices;
Receiving edits/comments made by the veterinarian electronically and integrating those edits/comments into your draft protocol;
Following this, engaging in a face-to-face meeting (or telephone meeting, depending on the number and complexity of the comments) to ensure that the protocol is in the shape needed to be reviewed by the IACUC.
Not following this procedure will result in delayed review and approval of your submission. 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.
Protocol review and approval times are greatly impacted by the quality of the submission and whether the investigator has engaged in veterinary pre-review, either because veterinary pre-review was required or to adhere to best practices. Below is turnaround time data reflecting the time-to-approval for protocols in which veterinary pre-review was properly performed as compared to times when investigators circumvented the pre-review process:
De novo protocol involving rodents, Category E procedures: Veterinary pre-review conducted on February 19th, review completed on March 6th. 16 days from pre-review to IACUC approval.
New protocol involving rodents, Category D procedures: Submitted with veterinary pre-review conducted on September 8th, approved on October 7th. 30 days from submission to IACUC approval.
New protocol involving snakes, Category D procedures: Submitted with veterinary pre-review conducted on February 16, approved on March 8th. 21 days from submission to IACUC approval.
De novo protocol involving rodents, Category E procedures: Submitted on January 20th, no veterinary pre-review conducted before submission to ARPP (despite being required). Approved on March 1st. 41 days from submission to IACUC approval.
De novo protocol involving rodents, Category E procedures: Submitted on December 20th, no veterinary pre-review conducted before submission to ARPP (despite being required). Approved on February 13th. 55 days from submission to IACUC approval.
New protocol involving NHPs, Category D procedures: Submitted on November 21st, no veterinary pre-review conducted before submission to ARPP (despite being required). Approved on February 27th. 98 days from submission to IACUC approval.
Please see the IACUC protocol submission page for more information regarding the IACUC review process and expected turnaround times.
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.
When are IACUC meetings held?
The new Lab Animal module in InfoEd is scheduled to go live in early 2018 to allow for system upgrades that will greatly improve system functionality. Staff will be working behind the scenes to transfer as much information from your active protocol(s) as possible into the new system to minimize your work during the transition period. In other words, we will be building a 'shell protocol' for you in the new system , pre-populating as much information for you as we can. There will be some instances where the system-to-system transfer of information does not have a direct one-to-one match, and in those instances we may rely on you/your lab to assist. You will also have the opportunity to verify that all information entered on your behalf is complete and accurate.
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.
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.