FAQ: Research Involving Vertebrate Animals
Table of Contents
Questions
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What is NIH/OLAW?
The Office of Laboratory Animal Welfare (OLAW), housed in the Director's Office of the National Institutes of Health (NIH), provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the policy by assured institutions.
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What does this MOU cover?
NIH/OLAW will now conduct PHS assurance and oversight of awardees' use of vertebrate animals in NSF-funded projects. This MOU allows NSF-funded projects using vertebrate animals to come under the purview of NIH/OLAW oversight, provides improved sharing of information between the agencies, and includes partnerships on animal welfare related outreach and educational activities.
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Why is this MOU necessary?
Most academic and research institutions that receive NSF funds also receive NIH funds. As a result, the vast majority of NSF awardees are already PHS-assured as a requirement of receiving NIH funds. However, if an NSF awardee never had NIH funding, it is likely the awardee is not PHS-assured. As a result, prior to this MOU, NSF would work with the institution and issue a one-time, project-associated assurance. This situation created a burden for the awardee, delayed the award process, and resulted in inconsistency in requirements from awardee to awardee.
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When does this MOU take effect?
The MOU took effect October 1, 2015.
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What is PHS assurance? Is this different from IACUC approval? Do we still require both?
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires that institutions have an OLAW-approved Animal Welfare Assurance before carrying out any activities involving live vertebrate animals. Part of this assurance is the requirement that the institution has an appropriate Institutional Animal Care and Use Committee (IACUC) with associated policies and procedures in place. Every NSF award that includes work with vertebrate animals requires an animal use protocol covering the proposed work to be approved by the awardee's IACUC prior to funds being expended. Both are still required for any NSF award that includes vertebrate animals.
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Is PHS assurance required for projects involving the study of wildlife in the field?
Yes, if the project is NSF-supported, involves vertebrate animals, and alters or influences the normal activities of the animals. For an institution with field-based animal research to obtain OLAW-approved PHS Assurance, the research must be reviewed and approved by the institution's IACUC. The IACUC must insure that the studies are in accord with the Guide for the Care and Use of Laboratory Animals. Taxon-specific guidelines1 may be used as supplemental references. Departures from the Guide must be approved by the IACUC and based on scientific, veterinary medical, or animal welfare issues (for more information, see OLAW-Departures from the Guide).
1. Guidelines to the Use of Wild Birds in Research; Guidelines of the American Society of Mammalogists for the Use of Wild Mammals in Research; Guidelines for the Use of Fishes in Research; Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research.
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How do I know if an institution already has PHS assurance?
Institutions proposing to use vertebrate animals in an NSF-funded project are required to list their PHS assurance number on the NSF proposal cover sheet. If there is no PHS assurance number listed, check the NIH/OLAW website for the current list of PHS assured institutions.
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Should an institution contact NIH/OLAW directly to get PHS assurance prior to submitting a proposal or receiving an award?
No. NIH/OLAW will only begin the PHS assurance process once NSF intends to make an award to that institution. PHS assurance is not required for the NSF review process, only for awarding funds. NIH/OLAW will not begin the PHS assurance process without a direct request from NSF.
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How does this change affect active NSF awards to institutions that currently have NSF issued assurances?
NIH/OLAW will begin the PHS assurance process for all institutions that are currently assured through a one-time project-based NSF-issued assurance and have at least one year remaining on an active award.
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Will this change NSF's PHS assurance-related reporting requirements?
Yes. Prior to this MOU, awardees were not required to include NSF-funded projects in their reporting to NIH/OLAW. Now that the MOU is in effect, NSF-funded projects must be included in an awardee’s reporting to NIH/OLAW.
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Where can I find more information?
More information can be found on NIH/OLAW's website.
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Who can I contact for more information?
Please feel free to contact the NSF Animal Welfare Officer, Dr. Edda (Floh) Thiels, with any questions or to schedule an informational meeting with your group.