Exempt Research Guidelines

Purpose

The purpose of these guidelines is to provide guidance regarding which studies involving animals are subject to full IACUC oversight and approval and which studies require IACUC notification and limited oversight.

Scope

These guidelines apply to all University of Oregon students, staff, and faculty conducting studies with live, vertebrate animals.

Guidelines

To comply with federal regulations and guidelines, UO requires that the IACUC, or a subset thereof, review all studies, research, testing, or teaching activities involving live vertebrate animals. This includes field, zoological studies, and general observation studies as defined by activities involving live vertebrate animals not performed in a laboratory.

Exempt Research Activities

Exempt as used in these guidelines refers to research activities that may require limited or no IACUC review or oversight. These activities are conducted outside of the laboratory, in field, zoo, animal rescue, or private settings and may be non-invasive or involve limited manipulation, which, depending on animal ownership, funding source, and regulatory applicability, can lead to exemption. The following activities, identified as exempt, only apply to activities that are conducted in areas that are programmatically and functionally separate, with no funded or supported animal activities, that do not affect or pose risks to funded or supported activities. Any new areas to be excluded must be submitted for approval and incorporated into the University’s PHS Assurance. Exempt activities include:

  1. Observational studies involving animals residing in zoos or animal rescues, that are unlikely to influence the biology, behavior or ecology of the animals, that have no potential to impact the health or safety of personnel or the animal’s environment, are exempt.
    • An observational study is a study that involves the observation of animals or passive collection of samples (e.g. collection of fecal droppings) outside of a laboratory setting. These animals are not purchased or acquired for research purposes. These animals are not the property of the university, nor are they maintained as part of an institutionally managed research colony or teaching herd.
    • Passive collection of samples is allowed provided it is non-invasive and does not impact animal behavior or nutrition. Samples may be collected during routine husbandry or veterinary procedures by trained professionals and provided to the researcher(s), however active participation of University faculty, staff or students in the collection of these samples may require additional oversight. Contact the UO IACUC with further questions.
    • Zoo is an establishment which maintains a collection of wild animals, typically in a park or gardens, for study, conservation, or display to the public.
    • Animal rescue entities are defined as any individual or organization—including but not limited to an animal control agency, humane society, animal shelter, animal sanctuary, or boarding kennel not subject to ORS 167.374 , but excluding a veterinary facility—that keeps, houses, and maintains in the individual’s or organization’s legal custody, 10 or more animals at any given time and that solicits or accepts donations in any form.
  2. Studies that are conducted on free-living wild animals in their natural habitat or captive-animals living in a zoological environment or animal rescue and which do not involve an invasive procedure, handling, any potential harm to the animal, or any material alteration of the behavior of an animal under study are exempt from full committee review.
    • Any studies involving the capture or handling (e.g., trapping or netting) of wild or domestic animals must be reviewed by the IACUC; unobtrusive observational studies (e.g., passive video and audio recording) are exempt.
    • Field research is a research project conducted on wild animals free-living in their natural environment. Field research that includes trapping, tagging, handling, or invasive procedures requires IACUC review and approval unless otherwise exempted under federal regulations. Principal Investigators must design studies to minimize disturbance, including avoiding repeated encroachment on nests, dens, roosts, breeding sites, or other sensitive habitats during critical life stages, unless scientifically justified and approved.
  3. Studies involving privately-owned animals may qualify as exempt research activities with limited IACUC oversight, even when animal manipulation or invasive procedures are proposed, provided all of the following conditions are met:
    • Funding source (must not be funded by government agencies such as NIH, NSF, NASA, USDA, FDA)
    • Consistency with PHS Policy standards and absence of risk to PHS-supported animal activities at UO
    • The procedures are consistent with accepted veterinary or animal care practices for the species
    • The animals are not owned, housed, bred, maintained, acquired, or transported by UO
    • Procedures involving privately owned animals may include handling, restraint, administration of substances, collection of biological samples, imaging, or other invasive procedures, provided that:
      • Procedures are performed or directly supervised by qualified personnel (e.g., licensed veterinarian or appropriately trained professional)
      • Informed owner consent is obtained and documented if required by UO
      • The activity does not meet the definition of a regulated animal activity under the AWA or PHS Policy
  4. Dead animals: The use of dead animals, body parts, or tissues not specifically collected for funded or supported activities does not require IACUC review or oversight. These studies must be reviewed for safe handling and proper personnel protection by the Institutional Biosafety Committee (IBC).

Principal Investigators must assure the IACUC that the principal investigator(s) will have all applicable local, regional, and national permits or other authorizations required for the observation, data collection or other proposed activity prior to the start of the study and for the appropriate duration. Occupational health and safety (OHS) issues, including zoonoses, are to be covered by the institution’s OHS program with assurances to the IACUC that the non-invasive field or observational study does not compromise the health and safety of persons in the field.

Background and Regulatory Guidance

The use of animals for research, teaching, and testing at UO is regulated by and conducted in accordance with the Animal Welfare Act (AWA) of 1966 as amended, the United States Department of Agriculture (USDA) AWA regulations, the U.S. Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy), and the Rules of Accreditation of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International). 

Federal guidance recognizes that not all activities involving animals require full IACUC review. The USDA Animal Welfare Regulations exempt certain field studies from IACUC review, specifically studies conducted on free-living wild animals in their natural habitat that do not involve invasive procedures, cause harm, or materially alter the behavior of the animals under study. Consistent with this framework, the Guide for the Care and Use of Laboratory Animals acknowledges that field investigations may involve observation of undomesticated vertebrate species in natural conditions, while affirming that the basic principles of humane care and use apply regardless of setting.

Oversight expectations also vary based on the nature of the activity and the setting in which it occurs. Guidance in The IACUC Handbook notes that zoological institutions are generally required to register as research facilities only when conducting invasive procedures for research purposes, whereas typical behavioral and observational studies do not involve invasive procedures and therefore do not require such registration. Best practices for wildlife research further emphasize minimizing disturbance and avoiding unnecessary encroachment on sensitive life stages, such as breeding or rearing periods, as outlined in The Wildlife Techniques Manual.

Additional clarification is provided by the National Institutes of Health through NOT-OD-23-119, which identifies categories of animal activities that may be exempt from full committee IACUC review under the PHS Policy. These include activities conducted in areas that are programmatically and functionally separate from PHS-supported animal programs and that do not affect or pose risks to funded or supported activities. The guidance also recognizes that purely observational field studies may be exempt when the IACUC determines they are unlikely to influence the biology, behavior, or ecology of the animals, while noting that activities with potential impacts on animal welfare, personnel safety, or the environment may still require oversight.

NIH guidance further identifies activities that do not constitute research use of animals under the PHS Policy, including veterinary clinical care of privately owned animals provided solely for the health and well-being of the animal without collection or generation of research data and the use of dead animals, tissues, or body parts not specifically killed for research. These distinctions support a risk-based approach to IACUC oversight that ensures animal welfare and institutional compliance while recognizing activities that fall outside full regulatory review requirements.

Process

The Principal Investiragor (PI) should submit a Research Exemption Form to the IACUC office.

Research Exemption Forms are reviewed by the IACUC Chair, the Attending Veterinarian, and the Director of Animal Welfare Services or their designees. Any of these individuals may call for full committee review of the proposed project.

If research is federally funded, an IACUC protocol may be a requirement of funding. Check with your funding source prior to submission of an exemption form.

After the IACUC leadership review, the PI will receive an exemption letter detailing any specific requirements; a final copy will be maintained in IACUC files.

References

2016 Guidelines of the American Society of Mammalogists for the Use of Wild Mammals in Research. Journal of Mammalogy, 97(3):663-688, 2016.
 
Guidelines to the Use of Wild Birds in Research (3rd Edition – 2010, The Ornithological Council). With Clarifications and Exceptions as outlined by AAALAC International.
 
Guidelines of the American Society of Ichthyologists and Herpetologists for the use of amphibians, reptiles, and fishes in research.

The IACUC Handbook, 3rd edition, 2025, Taylor and Francis.

The Wildlife Techniques Manual (8th Edition – 2020, The Wildlife Society). Edited by Nova J. Silvy, Johns Hopkins University Press.

Approvals

Effective date: February 10, 2026