Through this Request for Information (RFI), the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) seeks input on proposed clarifications of animal activities that are exempt from the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) requirements for Institutional Animal Care and Use Committee (IACUC) review.
The 21st Century Cures Act, Section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In response to the 21st Century Cures Act, one of the action items identified in the report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, included reviewing existing guidance, clarifying activities that are exempt from IACUC review, and seeking public comment on the updated guidance.
OLAW oversees animal activities at Assured institutions by the authority of the Health Research Extension Act of 1985 (HREA), the PHS Policy, and memoranda of understanding with other funding components, which at the time of publication include the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and Department of Veterans Affairs (VA).
The PHS Policy, III.A., defines an animal as “any live, vertebrate animal used or intended for use in research, training, experimentation, or biological testing or for related purposes.”
IACUCs are required by PHS Policy IV.B.6.-7. to review funded or supported animal activities and proposed significant changes in ongoing activities related to the care and use of animals with a decision to approve, require modifications in (to secure approval) or withhold approval.
Examples of funded or supported animal activities that are covered by the PHS Policy and subject to IACUC review in accordance with Section IV.C. of the Policy include:
- Animals used as sentinels, breeding stock, blood and blood product donors
- Animals used for training and holding protocols/standard operating procedures (SOPs)
- Activities with the larval forms of fish and amphibians
- Activities with avian or other egg-laying vertebrate species after hatching
- Activities conducted in the field, if the activity alters or influences the biology, behavior or ecology of the study animals or other species (e.g., capture and release, banding)
- When a privately owned animal participates in a study or veterinary clinical trial and the activity includes collection or generation of data for research purposes
- Project-specific manipulation of animals prior to euthanasia to obtain tissues or other biological products
- In response to a specific request from the investigator, using animals for:
- Custom antibody production
- Custom surgical procedures
- When the award recipient is a domestic institution and performance sites are foreign (i.e., domestic award with a foreign component)
OLAW is not requesting comments on the background information. This information is provided for context and provides the framework upon which the described clarifications can be implemented. OLAW will only consider comments regarding the information under the Information Requested section of the RFI.
The NIH OLAW is seeking input on proposed clarifications of animal activities that are exempt from the PHS Policy requirements for IACUC review.
Clarification of Activities Exempt from the PHS Policy Requirements for IACUC Review
When considering whether a funded or supported animal activity may be exempt from IACUC review and approval as it applies specifically to the PHS Policy, the information provided is intended to help guide an IACUC’s decision to ensure compliance with the PHS Policy. Other funding sources or oversight authorities may require IACUC review for these activities (e.g., AAALAC International). IACUCs have the discretion to be more restrictive and require review based on factors determined to be appropriate, including societal expectations and best practices.
Researchers and institutions should be aware that regardless of funding source, animal activities conducted with the intent to publish results in refereed journals may require adherence to editorial or professional society animal welfare policies, including confirmation that the activity received IACUC approval.
Animal activities that may be exempt from IACUC review and approval, as they apply to the PHS Policy, include:
- Animal activities conducted by institutions that do not receive funding from any of the federal entities that OLAW oversees (e.g., NIH, Centers for Disease Control and Prevention, Food and Drug Administration, Biomedical Advanced Research and Development Authority, NASA, NSF, VA).
- Animal activities conducted in areas that are programmatically and functionally separate, with no funded or supported animal activities (e.g., beef cattle used for food production, horses used for riding, school mascots). Any standards for these areas/activities that might not be consistent with the PHS Policy must not affect or pose risks to funded or supported activities. The scope of the Assurance should be clearly described in Section I, Applicability of Assurance, including any areas to be excluded.
- Animal activities involving invertebrates, unless IACUC review is specifically required by the funding agency (e.g., NASA requires IACUC review of cephalopod activities).
- Activities with avian or other egg-laying vertebrate species (e.g., fish, amphibians, reptiles) prior to hatching. Although avian and other egg-laying vertebrates develop backbones prior to hatching, OLAW interprets the PHS Policy as applicable to their offspring only after hatching. IACUCs should consider the potential for pain and distress of manipulation on pre-hatched vertebrates during later stages of development. IACUC oversight is required for offspring that hatch unexpectedly.
- Purely observational field studies that the IACUC determines are unlikely to alter or influence the biology, behavior or ecology of the study animals or other species. As recommended by the Guide for the Care and Use of Laboratory Animals (Guide), studies with the potential to impact the health or safety of personnel or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral.
- Veterinary clinical care of a privately owned animal exclusively for the health and well-being of the animal that does not include collection or generation of data for research purposes (e.g., routine vaccinations, surgery, medical treatment).
- Purchase of commercially available, surgically modified animals (e.g., surgically modified animals generally available to order from a vendor). However, if the animal modification requires a custom request from the vendor for a funded or supported activity, it then requires IACUC review and approval. Additionally, the subsequent use of the surgically modified animal constitutes an activity that requires IACUC review.
- Purchase of standard off-the-shelf animal-based reagents or antibodies from a commercial supplier that are for general sale (e.g., through a catalogue). These reagents and antibodies are not customized and not produced specifically at the request of a principal investigator for funded or supported activities.
- The use of dead animals, body parts, or tissues not specifically killed for funded or supported activities.
- Sharing of dead animals, animal parts, or animal-derived reagents produced for other purposes that may otherwise be discarded. Examples include excess carcasses, formalin-preserved, or frozen tissues and cell lines.
- Dual review of a protocol by more than one IACUC involving partnerships between collaborating institutions or relationships between institutional animal care programs. Collaborating Assured institutions may exercise discretion in determining which IACUC reviews protocols for animal activities performed on an award. It is recommended that if an IACUC defers protocol review to another IACUC, then documentation of the review should be maintained by both committees.
- Animal activities conducted at a foreign institution when the prime awardee is a foreign institution. However, the foreign institution where the animal work is performed must complete the Animal Welfare Assurance for Foreign Institutions which certifies that the institution will comply with the applicable laws, regulations, and policies of the jurisdiction in which the activities will be conducted, and that the institution will be guided by the International Guiding Principles for Biomedical Research Involving Animals. OLAW encourages, but does not require, foreign institutions to use the standards in the Guide.
How to Submit a Response
All responses to this RFI must be submitted electronically on the RFI webpage by July 31, 2023 at 11:59 ET. The comments may be made available on the OLAW website.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.