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.

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]

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.

To learn more, see the OLAW Online Seminars on Wildlife Research Permits and Oversight of Research Involving Wildlife.

See also FAQ E4: Is the IACUC required to inspect field study sites?

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.

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]