Frequently Asked Questions
- Protocol Submission Process
- Grant-Protocol Congruency Review Process
- Semi-Annual IACUC Inspection
- InfoEd Matching
Q. How do I create and submit a protocol?
- If you are a new PI at Northwestern University, you must:
Q. 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.
Q. 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 submit an eIACUC Training & Assistance Request Form.
Q. 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 approval is in process.
Q. If I have a question regarding the status of my protocol, who do I contact?
- Call the IACUC mainline at 312-503-9339 or email firstname.lastname@example.org and we will provide you with an update.
Q. What happens when I have not made any requested modifications within my protocol after 60 days?
- Although at least one reminder will be sent before any action is taken, when protocol submissions, including amendments, have been inactive because the PI or PI Proxy have not taken action (i.e. in the “Returned for Modifications” or “Changes Required by Coordinator” state) for 60 days, that protocol or amendment is subject to administrative withdrawal. In the case of amendments, the entire protocol will not be inactivated or withdrawn, only that particular amendment.
Q. Who do I contact if I am having trouble making revisions within my protocol?
- Please make sure that your name appears in the “PI Proxy” section on the “Study Personnel” page within your protocol. This field allows permission to edit and submit protocols. If you are not listed as a PI Proxy on the “Study Personnel” page of the protocol you are attempting to edit, the PI or listed PI Proxy will then be required to submit a personnel amendment to allow access to make protocol edits. If you have any further questions or if the previous PI Proxy has already left the lab, please ssubmit an eIACUC Training & Assistance Request Form for further assistance.
Q. Will I be able to view my protocol once it has been inactivated or withdrawn?
- Yes, the entire protocol (and associated procedures and substances) will still remain within your PI Library, but you will be unable to make edits or reactivate the protocol after inactivation/withdrawal.
Q. What is grant-protocol congruency, and why does it have to be confirmed by the IACUC?
- According to the NIH Grants Policy Statement (18.104.22.168 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 22.214.171.124) 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. What agencies require congruency review?
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 Members 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. Congruency review is conducted simultaneously with the IACUC Coordinator administrative pre-review. This approach ensures protocols are complete and facilitates efficiencies during Committee review, while improving protocol quality and satisfying the institutional requirement for congruency review.
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. If you wait for the JIT notice, it is imperative that you submit the protocol immediately to ensure IACUC approval is obtained in the allotted 90 days. 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.
- Although not subject to congruency review, non-federally funded projects must have their grant/research proposal attached to the protocol, but do not necessarily have the same specific sections as listed in previous bullet. However, it is expected that the full grant application/research proposal will be attached for all externally funded projects, though any budgetary or salary-related information can be omitted.
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?
- 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. What if I am sub-awarding to a PI at another institution?
- 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 collaborating institutions, and that the NU IACUC 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 at Northwestern?
- Yes, a grant may have one or more collaborators performing live animal work at the same institution. As detailed above, all protocols would require congruency review.
Q. Is it permissible to fund a protocol with two or more grants?
- A 1:1 grant-to-protocol ratio is required at Northwestern. However, fellowship/salary awards are an exception. This means that a protocol with sponsored funding can also add one or more fellowship/salary awards that are within scope of the main funding source. Please note that protocol amendments adding fellowship/salary awards involving federal funding (either with the main funding source and/or the fellowship/salary awards themselves) are required to undergo a grant-protocol congruency review. However, if a fellowship has its own budget for animal work, a separate protocol may be required. Please contact the IACUC Office for additional guidance.
Q. If I am receiving a federal grant, what can I do to accelerate the protocol review process?
- Submitting the protocol with the full grant application attached to the protocol attachments section once you receive a fundable score is the best way to meet JIT deadlines.
- If the award has received a JIT notice while the protocol is under review, please forward the JIT notice to the IACUC Office at email@example.com. The IACUC Office will relay any specific deadlines to the reviewers.
If the protocol has not been submitted when the JIT notice has been received, please notify the IACUC Office as stated above and submit the protocol with both the full grant and JIT notice attached to the protocol attachments section. The IACUC Office will relay and specific deadlines to the reviewers.
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?
- Even 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 firstname.lastname@example.org with any questions related to this process.
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 for which immediate solutions generally are not necessary to protect life or prevent distress. 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. If the same recommendation/reminder is noted on 3 consecutive inspections, the finding may be elevated to a minor deficiency.
- Safety Item: Highly encouraged reminder/recommendation findings based on best practice measures related to Research Safety. If the same recommendation/reminder is noted on 3 consecutive inspections, the finding may be elevated to a minor deficiency.
Q. What should a laboratory confirm prior to an IACUC Semi-Annual Inspection?
- Please follow the link to our IACUC Inspection Checklist to review common aspects that help prepare for IACUC semi-annual inspections.
Identifying Protocol Funding Sources via InfoEd Matching
What is new?
- The updated funding page in eIACUC will require selection of the appropriate InfoEd record corresponding to the grant or contract that is funding the IACUC study. InfoEd record numbers usually look like “SP00XXXXX,” but can also lead with “CNV” or “PROJ.”
What if I don’t know the InfoEd number (SP#, CNV# or PROJ#)?
- Talk to your department. This is usually managed by the research administrator or financial administrator that helps to make sure the contracts are in place.
What if my project is sponsored, but did not go through Northwestern University (e.g., SRALab or Lurie Children’s is managing the grant)?
- If your project is sponsored, but did not go through Northwestern University (e.g., SRALab or Lurie Children’s is managing the grant), please select “No” to the question, “Is this funded by a sponsored project awarded to Northwestern University?” and then proceed to enter your funding information as you normally would have prior to this update.
What if we don’t have the InfoEd number yet when we are submitting the study?
- Please request that your department’s finance team and/or research administrator create an InfoEd record that will correspond to the project and provide you with the corresponding InfoEd number. This is the strongly recommended process by OSR, in order to allow contract negotiations to happen in parallel with IACUC review of a study, and minimize any delays.
Will I always be matching to an SP # or are the PROJ # or CNV# also possibilities?
- The match will almost always be made to an SP #.
The exception would be if the funding source is a large center grant with multiple cores where each core is funding a different study. Then, it would be best to link to the specific PROJ # under the parent SP #. If you know that the study is part of a large center grant, and you know that a specific PROJ # has the chart string that will be used for any charges for this study, you can match to the PROJ #. The “parent SP #” column is displayed in the InfoEd matching table to help with these cases.
There are still some very old contracts and/or master agreements that lead with “CNV” in the InfoEd system which may be the correct funding source for a study.
There may be multiple InfoEd records that have the same title. How do I know which InfoEd record is the right one if I’m relying on title match?
- We recommend talking to your finance and/or research administration team to make sure you have the correct InfoEd number. This is most common for grants that were submitted, but not funded in the first round, revised, and then re-submitted.
There are also some clues in the record, for example the “Proposal Status” column. “Submitted” means that the project was submitted, but it may not have been funded. If there are multiple SP # records with the same title, but one has a status of “Award QA Check Complete” or “Prespending”, those statuses indicate that the grant is awarded and/or the contract is moving forward.
My PI has hundreds of projects, how do I easily find the correct funding source?
- Use the different fields to add additional filters. For example, if this study is sponsored by AbbVie, you can add “Abb” to the originating sponsor field as a filter to narrow it down – this would display any AbbVie and Abbott sponsored projects. Note that “Originating Sponsor” is often the pharma company or the federal agency, and the “Sponsor” field is often a CRO (e.g., Parexel) or university that the funding is flowing through. If you know that this is an NIH project, but the lead site is University of South Carolina, you can put “South” in the “Sponsor” field as an additional filter.
How will the match I make be used?
- This match will be used as an attestation by the PI that the IACUC approval is for the sponsored research project in the linked InfoEd record. Many sponsors of research, including the federal government, require confirmation from the university that a project has IACUC approval. This match will serve as evidence of compliance with those regulatory requirements.