Frequently Asked Questions
Protocol Submission Process
How do I create and submit a protocol?
- If you are a new PI at Northwestern University, you must:
Will my protocol require Full Committee Review (FCR) at the monthly IACUC meeting?
- Protocols describing work with primates, food and/or water restriction of any species, and other special review items (as defined in the Policy on IACUC Review of Animal Study Protocols [ASPs], Addenda Requests, and Annual Certifications) are automatically sent for FCR. To ensure FCR at a particular meeting, protocols must be submitted 10 business days before a scheduled meeting. Protocols that do not meet the criteria for FCR will be reviewed via Designated Member Review (DMR). For more information, please visit the Review Process page of our website.
How do I amend my protocol?
- Guides for each type of amendment are available on the Protocol Entry Guides page of our website. If you would like to schedule a one-on-one training session for an amendment submission, please contact the IACUC Office.
What is an under review letter? How do I obtain one?
Once a protocol is submitted, the IACUC Office can provide a letter stating that the protocol is under review with an anticipated approval date. This letter is available upon request and can demonstrate to your funding agency that the protocol is in process.
Grant-Protocol Congruency Review Process
Q. What is grant-protocol congruency, and why does it have to be confirmed by the IACUC?
According to the NIH Grants Policy Statement (22.214.171.124 Verification of IACUC Approval): “NIH will delay an award for research involving live vertebrate animals until the grantee organization and all performance sites are operating in accordance with approved Animal Welfare Assurances and the grantee has provided verification of IACUC approval of those sections of the application that involve use of vertebrate animals… It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.”
“PHS Policy and the NIH Grants Policy Statement (NIH GPS, chapter 126.96.36.199) require 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… institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with what is in the application/proposal.”
To meet this requirement, the Northwestern IACUC Office conducts a congruency review to compare a federal grant to the animal study protocol it is funding, in order to confirm that they are congruent. This means that the scope of the animal study protocol should match the federal grant, and that significant differences (change in scope, species, animal numbers, etc.) should not exist, without approval from the federal funding agency.
Q. Is the grant-protocol congruency review a separate step in the protocol review process?
- Yes. This review is usually conducted by members of the IACUC Office, before members of the IACUC Committee are assigned to review the animal study protocol. For more information on the protocol review process, please visit that page of the IACUC website.
Q. How does this affect the time required for protocol approval?
- The IACUC Office is primarily responsible for grant-protocol congruency reviews, thereby alleviating some of the burden on Committee reviewers. This approach allows for a decrease in the overall review period, while improving protocol quality and satisfying the institutional requirement.
Q. What if I have received a good score or Just-in-Time (JIT) notification?
- Once you receive a fundable score, it is advantageous to start your protocol submission. If you have received the automatic notification that you might receive funding, it is recommended to begin work on your animal study protocol and reach out to IACUC Office personnel with questions. While investigators may wish to wait for confirmation that they will in fact receive JIT funding, the final notification by NIH personnel can leave very little time for the protocol drafting, submission, and review process, and may jeopardize the funding opportunity. Even if funding is not secured in this attempt, having an animal study protocol prepared will save time, should you receive funding after resubmitting your grant application.
Q. What grant information do I need to attach to my protocol?
- The full grant application, though any budgetary or salary-related information can be omitted. At a minimum, the provided grant information must include the cover page, performance sites, specific aims, research strategy, and vertebrate animals sections.
Q. Is it helpful to provide the necessary grant information as one large PDF, or multiple smaller attachments?
- Please provide the full grant application as a single PDF. Breaking the information into multiple PDF files is extra work for the laboratory, and impedes the congruency review process.
Q. Is a congruency review necessary if I am receiving a sub-award from another PI’s federal grant?
- Yes, though the institution that received the grant is responsible for the congruency review.
Q. What if I am sub-awarding federal funds to another PI at Northwestern? What if I am sub-awarding to a PI at another institution?
- If you have sub-awarded federal funds to a PI at NU, their protocol would also be assessed for grant-protocol congruency, with their protocol being compared to your grant. If you are sub-awarding to a PI at another institution and live animal work is involved, the IACUC Office will ensure that the necessary IACUC agreement is in place between our institutions, and that our IACUC Committee has a chance to review their protocol (including a congruency review). For more information about sub-awards and offsite collaborations involving animal work, please visit our Collaborations page.
Q. Is it permissible to fund two or more protocols with the same federal grant?
- NIH umbrella (U) and project (P) grants are allowed to fund more than one animal study protocol, as these grants typically require collaboration to address all grant study objectives. In all other circumstances NU requires a 1:1, grant-to-protocol ratio.
Q. Is it permissible to fund a protocol with two or more federal grants?
- As detailed in the Q&A above, a 1:1 grant-to-protocol ratio is required. In this case, federal fellowship awards are the only exception. This means that a protocol with federal funding can also add one or more fellowship awards. Please note that protocol amendments adding federal fellowship awards are required to undergo a grant-protocol congruency review.
Q. If I am receiving a federal grant, what can I do to accelerate the protocol review process?
- If the award is JIT, please attach the NIH JIT letter to the protocol, and inform the IACUC Office of the protocol’s JIT status via email at firstname.lastname@example.org. In addition, please attach the required grant information as a single PDF; both of these files should be attached in the protocol’s Protocol Attachments section.
Q. If my laboratory is responsible for one part or project described in a grant, is it acceptable to attach the documentation specific to that project, instead of the entire grant application?
- If your protocol focuses on a specific project in a multi-project federal grant (e.g., a P50 grant), the full grant application needs to be provided. It is understood that these grant applications can be particularly lengthy, but it is nonetheless important for the grant to be provided in its entirety.
Q. If I have other questions on the grant-protocol congruency review process, is there someone that I can contact?
- Certainly. Please contact the IACUC Office at email@example.com with any questions related to this process.
Semi-Annual IACUC Inspection
Q. What are the classifications of Semi-Annual IACUC Inspection findings?
- Significant Deficiency: Any unapproved departure from the provisions of the Guide, PHS Policy, or AWAR that could cause injury, death, or severe stress to animals or people. No consecutive allowance permitted for significant deficiencies. The finding will automatically be reviewed by the IACUC committee to determine if it is reportable to Institutional Officer (IO) and the funding agency.
- Minor Deficiency: Any unapproved departure from the provisions of the Guide, PHS Policy, or AWAR that does not directly impact the health of research animals or pose a direct threat to their safety. If 3rd consecutive finding, the matter will be reviewed by the IACUC committee and may be elevated to a significant deficiency
- Suggestion for Improvement: Preventative finding to avoid a potential deficiency in the future. If the same suggestion is noted on 2 consecutive inspections, the finding may be elevated to a minor deficiency.
- Best Practice: Highly encouraged reminder/recommendation findings based on best practice measures.