Submitting a New Protocol
Only Weill Cornell Medicine (WCM) employees with a faulty appointment or higher can serve as principal investigators on WCM Institutional Animal Care and Use (IACUC) protocols. Approval must be acquired for animal research funded through WCM regardless of where the research is actually performed or if activities are conducted by WCM employees. Additionally, most granting agencies (federal and private) require that projects involving the use of animals are approved by the IACUC prior to or shortly after submission. Due to the nature of the review process, timely submission of the application for animal use is essential. Please visit Submission Deadlines and Meeting Dates to view the IACUC meeting schedule and submission deadlines.
Procedure: Complete the application in EnCCoMPass Protocol Management System. The application should be submitted before the deadline for the meeting at which you would like your proposal considered. Proposals are assigned to two or three Committee members who will provide a preliminary review. Typically, clarifications and revisions to the protocol that are requested by the assigned members must be addressed expeditiously in order for the proposal to be reviewed at the next scheduled meeting. Committee's decision on the proposal will be sent to the Principal Investigator (PI). Protocols reviewed and approved by the IACUC are assigned a protocol number which is required to order animals and house animals in the Research Animal Resource Center (RARC). You may not initiate studies utilizing animals until you are notified of their approval and receive a protocol number. Animal Care and Use Protocols may also be requested and reviewed by Federal and State Inspectors who conduct unannounced site visits at WCM.
Procedures:
Protocols approved within the EnCCoMPass:
Thirty days prior to its review date, the EnCCoMPass will send an email notification to the PI which provides instructions on the steps that need to be taken to have the protocol reviewed. It will entail that the PI login into the system and provide responses to questions that pertain to the progress of his/her project.
Three-Year Renewals:
After three years, renewal proposals must receive the same critical review as the initial submission. This entails submitting a new project proposal must include a summary of the results obtained while the project was active.
Procedure: One hundred and twenty (120) days prior to its three-year anniversary date, the PI will obtain an email notification from the EnCCoMPass providing instructions on the steps that need to be taken to have the protocol reviewed. The application should be submitted before the deadline for the meeting at which you would like your proposal considered. Proposals are assigned to two or three Committee members who will provide a preliminary review. Typically, clarifications and revisions to the protocol that are requested by the assigned members must be addressed expeditiously in order for the proposal to be reviewed at the next scheduled meeting. Committee's decision on the proposal will be emailed to the PI. Renewed protocols retain the same protocol number. If the proposal being renewed has expired/ terminated, you may not initiate studies utilizing animals until you are notified of their approval. In the interim if there are any animals within the facility under the expired/ terminated protocol will be transferred to the RARC holding protocol. Please note that investigators will not have access to the animals as their care and maintenance will be the responsibility of the RARC veterinary staff.
Submitting an Amendment
All changes to the project affecting the number or use of animals, or the personnel involved must be approved as an addendum (amendment), prior to initiation of the change. Addenda, in general, may be approved within two weeks of submission, unless the changes are considered significant requiring review by the full Committee. There are no deadlines for amendment submissions; requests may be submitted at any time.
Procedures:
Protocols approved through EnCCoMPass:
Protocols submitted and approved through EnCCoMPass should be amended through the system.
Using EnCCoMPass
Please refer to the EnCCoMPass Protocol Module User Instruction Guide for step by step process for submitting any of the above requests to the IACUC.
PRE-APPROVED TECHNIQUES (PATs):
PATs are WCM and MSKCC agreed upon standardized surgical and technical procedures. Use of these PATs will help investigators spend less time writing animal use protocols and responding to committee comments, reduce the length of time for protocol approval and reduce regulatory burden.
Currently, there are ~270 pre-approved techniques available for use in EnCCoMPass under the following categories:
- Anesthesia
- Blood Collection
- Device Implantation
- Euthanasia
- Genetically Engineered/Mutant Animal Model
- Imaging
- Surgery/Technical Procedures &
- Tissue/Fluid (non-blood) Harvest
Recent enhancements to EnCCoMPass allow for better management of these PATs to ensure they are periodically reviewed and updated to verify continued validity with evolving and expanding research, as well as continued compliance with regulatory requirements and guidelines. New techniques are added on a regular basis and a new keyword search feature to better assist PIs when looking for a particular PAT.
A PAT cannot be altered; it must be used as described. If an investigator’s research requires variations of a PAT in any way, then they must not use the PAT but rather provide full details of their technique(s) to be used. The system allows investigators to search and preview techniques prior to selection so that they can evaluate whether the PAT is appropriate for their use. An investigator may choose to use multiple PATs within their animal use protocol; there are no limitations. Detailed instructions for adding PATs is described in the EnCCoMPass Protocol Module User Instruction Guide.
The Protocol Labyrinth: Interview with the IACUC
Every research facility is required to have an Institutional Animal Care and Use Committee (IACUC) but how much do you really understand about the IACUC? Join us for a conversation with an IACUC chair to dispel some of the mystery behind the committee, help you through the protocol process, and learn a little about why we have regulations in the first place. For more information watch, "Interview with the IACUC Webinar" below:
Click Here to View the Recording
ARRIVE guidelines
The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of recommendations to improve the reporting of research involving animals – maximizing the quality and reliability of published research, and enabling others to better scrutinise, evaluate and reproduce it.
Animal Health Emergencies: https://research.weill.cornell.edu/integrity-compliance/animal-research/research-animal-resource-center-rarc/animal-health-emergency
Animal Facility Emergencies: https://research.weill.cornell.edu/integrity-compliance/animal-research/research-animal-resource-center-rarc/facility-emergencies
Veterinary Services (VS) can aid investigators with a variety of technical procedures. Please review the VS Experimental Service Brochure for more details.
IACUC Protocol Support: https://library.weill.cornell.edu/research-support/iacuc-protocol-support