Animal Activities Exempt From IACUC Review Under the PHS Policy
One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research as part of the 21st Century Cures Act is for OLAW to clarify animal activities that are exempt from the PHS Policy requirements for IACUC review.
Request for Information
The NIH Office of Laboratory Animal Welfare (OLAW) proposed guidance clarifying animal activities that are exempt from the PHS Policy requirements for IACUC review. Comments were accepted through a Request for Information (RFI) between April 25 and July 31, 2023.
The proposed guidance can be found here: NOT-OD-23-119
The comment period is now closed.
The final guidance will be published along with a new webpage once comments have been considered.
Policies and Laws
PHS Policy III.A. Definition of Animal: Any live, vertebrate animal used or intended for use in research, research training, experimentation, or for related purposes.
PHS Policy IV.B. As an agent of the institution, the IACUC shall with respect to the PHS-conducted or supported activities:
- Review and approve, require modification in (to secure approval), or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals as specified in IV.C. of this Policy
- Review and approve, require modification in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities
For activities that are required to be reviewed by the IACUC, the review must be conducted according to PHS Policy Section IV.C.
FAQ A.1 Should institutions apply the PHS Policy to all animal activities regardless of the source of funding?
It is permissible for institutions to delineate animal areas that are programmatically and functionally separate and that do not support PHS animal activities such as a herd of beef cattle used for food production or a stable of riding horses. The Assurance should explicitly reflect the exclusion of any specific area or activity. [A1, A4]
FAQ A.2 Does the PHS Policy apply to the production of custom antibodies or to the purchase of surgically modified animals?
The generation of custom antibodies is an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for an awardee must have or obtain an Assurance, or be included as a component of the awardee’s Assurance. In addition, the awardee must provide verification of project-specific IACUC approval for the production of the antibodies.
FAQ A.3 Does the PHS Policy apply to use of animal tissue or materials obtained from dead animals?
FAQ A.4 Does the PHS Policy apply to live embryonated eggs?
FAQ A.5 Does the PHS Policy apply to larval forms of amphibians and fish?
Yes, larval forms of fish and amphibians have vertebrae and are covered by the PHS Policy. As noted in FAQ A4, the PHS Policy applies to the offspring of egg-laying vertebrates only after hatching. Zebrafish larvae, for example, typically hatch 3 days post-fertilization. [A21]
FAQ A.6 Does the PHS Policy apply to animal research that is conducted in the field?
The IACUC is responsible for oversight of vertebrate animal activities supported by the PHS and those supported by NASA, NSF, and VA, in accord with PHS Policy. To conduct such activities in the field, the investigator must provide the IACUC with the following information:
- where the activity will be conducted;
- what procedures will be involved;
- a brief overview of how those procedures are likely to affect the biology and behavior of the individual study animals and their ecology (e.g., surroundings and social setting), the interrelationship of those animals with their habitat and with other species, including the nature and duration of potential effects; and
- assurance that permit requirements of applicable local, state, national, and international wildlife regulations will be obtained before work begins.
If the IACUC determines that the proposed activity is likely to alter or influence the biology, behavior or ecology of the study animals or other species, then protocol review and approval is required. However, if the IACUC determines that the proposed activity is purely observational and will not alter or influence the biology, behavior or ecology of the study animals or other species, IACUC review and approval is not required. Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies (Guide page 32, Appendix A). Studies with the potential to impact the health or safety of personnel (Guide page 18) or the animal’s biology, behavior, ecology or other species may need IACUC oversight, even if described as purely observational. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, IACUC review and approval is required, and the IACUC must ensure that proposed studies are in accord with the PHS Policy and Guide (page 32). A study of free-living wild Animal Welfare Act-regulated species that involves invasive procedures, harms, or otherwise materially alters the biology, behavior, or ecology of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval.
See also FAQ E4: Is the IACUC required to inspect field study sites?
FAQ A.7 Does the IACUC need to approve research studies that use privately owned animals, such as pets?
FAQ A.8 How can the IACUC determine if activities involving privately owned animals constitute veterinary clinical care or research activities?
Veterinary research activities are typically supported by a grant or contract. The data are collected for the advancement of animal and/or human health. If the study is PHS funded, the institution must have an OLAW-approved Animal Welfare Assurance covering all performance sites and IACUC approval for the research activity. If the study is being conducted in collaboration with a private clinical veterinary practice, the operational components of the practice associated with the research activity should be a covered component of an Assured institution.
When doing research on a pet, the institution is responsible for obtaining informed consent for the research activity. If the research activity is being conducted in collaboration with a private veterinary practice, the institution should consider the use of a memorandum of understanding agreement. The institutional legal counsel may be involved in the development of the document.
The veterinary clinical care of a privately owned animal is not a research activity and does not require IACUC approval. Veterinary clinical care is typically offered as a fee-for-service activity and is regulated by state veterinary licensing boards.
FAQ D.13 If an animal activity will be performed outside of the US (either by a foreign awardee or by a foreign institution as a subproject for a domestic awardee), is the awardee’s IACUC required to review and approve that activity?
When the awardee is a domestic institution (i.e., domestic award with a foreign component), the IACUC approval requirement applies. Accordingly, the awardee remains responsible for animal activity conducted at a foreign site and must provide verification of IACUC approval. That approval certifies that the activity, as conducted at the foreign performance site, is acceptable to the awardee. The awardee IACUC may accept, as its own, the approval of a foreign entity's oversight body however, the awardee IACUC remains responsible for the review. Additionally, the foreign institution must complete the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance) available from OLAW. This document certifies that the institution will comply with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and that the institution will be guided by the International Guiding Principles for Biomedical Research Involving Animals. OLAW encourages foreign institutions to use the standards in the Guide for the Care and Use of Laboratory Animals. If the prime awardee is a foreign institution, IACUC approval is not required.
FAQ D.14 May standard operating procedures (SOPs) or blanket protocols that cover a number of procedures be utilized in lieu of repeating descriptions of identical procedures in multiple protocols?
FAQ D.15 Is IACUC approval required for the collection of samples in foreign countries from captive wild animals or research colonies?
Collection of biological samples from any live vertebrate animal for the purpose of a PHS-supported activity is covered by the PHS Policy. If the awardee is a domestic institution, the IACUC should consider the species involved, nature of the specimens, invasiveness of the procedure, risks to personnel, and qualifications of the individual(s) taking the sample(s). (For further information concerning foreign performance sites see FAQ D13.)
Awardee institutions should also consult with other agencies of the federal government as appropriate, e.g., US Fish and Wildlife Service, USDA-APHIS-Veterinary Services, and the CDC for specimen importation requirements. [A7]
FAQ D.16 Is IACUC approval required for the use of animals in breeding programs, as blood donors, as sentinels in disease surveillance programs, or for other non-research purposes?