The Top 13 Questions on NSF IACUC Documentation


Many people in the DEB community work with vertebrate animals, and therefore require approval from their Institutional Animal Care and Use Committees (IACUCs) to conduct their research.

Since NSF does not oversee or regulate animal research, it is important for investigators to know that a project’s IACUC approval must be adequately documented before program officers can recommend an award for funding. In this blog post we offer answers to common questions regarding the NSF documenting procedures for IACUC protocols[1].

  1. Where can I find information on NSF guidelines regarding IACUCs?

The place to find information is the NSF Proposal & Award Policies & Procedures Guide (PAPPG). The PAPPG contains an entire section on IACUC approval and how to document it in your proposal (Part I, Chapter II Proposal Preparation Instructions, D. Special Guidelines, 4. Proposals Involving Vertebrate Animals). The PAPPG is the official policy; this post provides tips intended to help you to efficiently identify and comply with the existing policy.

 

  1. Where in the proposal is IACUC approval documented?

On the proposal cover page there is a box that should be checked if the proposal includes use of vertebrate animals. Immediately following there is a space to provide the IACUC protocol approval date as well as the Public Health Service (PHS) Animal Welfare Assurance number. The PHS number has to do with your institution’s authorization for vertebrate research and is separate from a particular IACUC approval date or protocol number. Each institution usually has a single, unique PHS number and each protocol/proposal usually has a single, unique IACUC approval number.

 

  1. What if I have a current IACUC protocol that encompasses the type of work that I am proposing to do in the NSF proposal that I am submitting?

Most proposals submitted to do work with vertebrate animals include preliminary data in the proposal. Presumably, this means that the PI has an approved IACUC protocol to work with vertebrates. If that is the case, we strongly urge investigators to indicate both the IACUC protocol approval date as well as the PHS assurance number for the institution if they need to check the vertebrate box for the proposed work.

If the box for vertebrate animals is checked, and an IACUC approval date and PHS Assurance number are provided on the proposal cover page then no additional IACUC documentation is required for the proposal to be recommended or an award processed (although the program officer may still ask you to email a pdf of the IACUC approval). When the officer from your institution’s Sponsored Research Office (SRO) signs off on the proposal, they are affirming that the approved protocol exists and is congruent with the work outlined in the NSF proposal. It is important to note that this IACUC protocol must still be current at the time of the proposal submission and an approved protocol for the project must be maintained for the duration of the award[2] (most IACUC protocols expire after 3 years).

 

  1. What if I do not have an approved IACUC protocol for the proposal I am submitting?

If your IACUC protocol is not yet approved, you can indicate that the IACUC approval is “pending” on the cover page. If you fall in this category, here are a few things to keep in mind:

  • IACUC committees at large, research-oriented institutions tend to meet regularly and be efficient, whereas those at smaller institutions may take months to consider a protocol. Some don’t meet at all during the summer – which is exactly the time when DEB is under the most pressure to get awards processed. If you have not yet started the IACUC approval process, please be aware of the timelines and recognize that proposals cannot be recommended for funding and awards cannot be processed without this approval.
  • Once granted, NSF must receive a signed letter from your institution indicating this IACUC approval. Since this document affirms that the protocol is consistent with the work outlined in the proposal, the letter must include your institution’s PHS Assurance number, the IACUC approval date, and it must specifically reference the NSF proposal title and number.

 

  1. What if the research I am proposing to do will take place outside of the United States?

Even if the planned work will take place outside of the U.S., IACUC approval from your home (U.S.) institution is still required since the award is being made to that institution. Often local approval from an international institution will also be necessary. Note that IACUCs vary widely in the extent to which they attempt to regulate research on animals in foreign countries. The bottom line is that you should ask the IACUC at your institution about how they handle international projects that use animals.

 

  1. If the NSF proposal is for a fellowship or for an individual (e.g. postdoc), how is the documentation for the IACUC different?

For fellowships and proposals to individuals[3], even if there is an IACUC approval date and PHS Assurance number documented on the proposal cover page at the time of submission, a signed letter from the institution must still be submitted to NSF. The letter must include the IACUC approval date, the institution’s PHS Assurance number, and it must specifically reference the NSF proposal title and jacket number. This letter is needed because the award is going to an individual and not an institution.

 

  1. What if I am applying for a fellowship or award to an individual and I plan to conduct this work outside of the United States?

If the proposal is to fund an individual (not an institution) and the proposed work is to take place outside of the U.S., then a signed letter from the appropriate official at the foreign institution must be submitted to NSF that confirms that the work will comply with applicable laws in that foreign country and that it will adhere to the International Guiding Principles for Biomedical Research Involving Animals.

 

  1. If I am applying for an REU (or any other award supplement) will I need to resubmit IACUC documentation?

Supplements to existing awards generally do not require a separate IACUC approval letter. However, if the IACUC approval on the parent award is more than three years old or if the scope of the project has changed substantially, then a new IACUC approval letter is required.

  • If the scope of the work has changed, in lieu of resubmitting an entirely new IACUC protocol (which would add work for you and your institution’s IACUC committee) an amendment to your existing IACUC protocol may suffice. An amendment is typically much easier to prepare and be reviewed than a new protocol. Check your institution’s IACUC policies to see what types of revisions they recognize as appropriate for a protocol amendment.

 

  1. If I am submitting a collaborative proposal with multiple institutions will each institution need a separate approved IACUC protocol?

If research with vertebrates will occur at an institution, then that institution must have their own current and approved IACUC documentation – this includes work conducted by a non-lead collaborative institution and work conducted under a subaward. In rare and special circumstances a lead institution may oversee animal work conducted by affiliates of a collaborating institution. However, if you think this case applies to you, we recommend contacting the NSF animal welfare Officer (see contact information below).

 

  1. My proposed research entails using multiple species and type of vertebrates. Will one IACUC protocol be sufficient?

Depending on the nature of the work, one IACUC may not be sufficient to cover the entire scope of your work. Please confirm with your institution’s IACUC that all of the work is being covered.

 

  1. I am submitting a proposal to NSF, but I am not sure if the vertebrate animal work in the proposal actually requires IACUC approval (e.g., the research involves only observations of vertebrates in the field).

Ask your institution’s IACUC whether the proposed work warrants IACUC approval. If the IACUC does not think one is needed, we recommend that you procure an email from the chair of the IACUC committee (using their institution email) stating that IACUC approval is not necessary for the scope of the proposed work. It is always safer to have the committee make this decision rather than making the decision on your own.

 

  1. What about preserved specimens — will I need an IACUC to work with non-living vertebrate animals from a natural history collection?

IACUC approvals are only necessary for living vertebrate animals.

 

  1. My proposal doesn’t include vertebrate animals in a research capacity, but my broader impacts outreach activities do involve vertebrate animals. Will I still need IACUC approval?

Most likely IACUC approval is still necessary in this circumstance. Please contact the NSF animal welfare officer for additional information.

 


Additional resources for model species can be found here:

The Guide for the Care and Use of Laboratory Animals (the Guide)

And resources for taxon specific wild/non-model species can be found here:

Guidelines to the Use of Wild Birds in Research

Guidelines to the American Society of Mammalogists for the Use of Wild Mammals in Research

Guidelines for the Use of Fishes in Research

Guidelines for the use of Live Amphibians and Reptiles in Field and Laboratory Research

 

The NSF Animal Welfare Officer is Dr. Edda Thiels. Specific questions that are not outlined in this blog post or in the PAPPG can be addressed to ethiels@nsf.gov and (703) 292-8421.


 

[1] Most of what is written in this blog post about IACUC preparation also can be applied to Institutional Review Board (IRB) protocols, which are required for research involving data collection on human subjects.

[2] Remember that it is the investigator’s responsibility to provide updated IACUC approval documentation on any existing NSF award before the protocol on file expires.

[3] DEB rarely handles these types of proposals, but such opportunities relevant to DEB researchers are found elsewhere in NSF so we decided to address it here.

One thought on “The Top 13 Questions on NSF IACUC Documentation

  1. Pingback: The Top 13 Questions on NSF IACUC Documentation – BIO BUZZ

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