The protocol principal investigator (PI) is responsible for satisfying the elements of a protocol.
Other offices at UC Santa Cruz may be involved in developing parts of the protocol. Most commonly these are:
- EH&S (Environmental Health and Safety)
- OSP (Office of Sponsored Projects)
- OES (Office of Emergency Services)
Protocols cannot be approved until both CITI training and risk assessments (OHSS enrollment) have been completed.
Elements of a protocol
- Training, regulatory and animal
- Online CITI Training
- In-lab training, which refers to a description of the experience of the research staff included in the protocol with the species and techniques described. It is acceptable to write that a senior experienced lab member will train and supervise others.
- Note: Personnel who are not affiliated with UC Santa Cruz may be exempted by confirmation by the PI of animal care and use training at the individual’s home institution.
- Safety for personnel
- Occupational Health Surveillance System (OHSS) assessment/clearance
- Completion of the BUA (Biological Use Authorization) with approval by the IBC (Institutional Biosafety Committee), as needed
- A field work safety plan, which EH&S manages, as needed
- Note: Personnel who are not affiliated with UC Santa Cruz may be exempted by confirmation by the PI of occupational health and safety assessment training at the individual’s home institution.
- Engagement with the veterinarian
- When surgery is part of the protocol.
- When selecting animal housing area(s) not previously approved.
- Establishing the planned location of the animal work. Consult with:
- The animal resources manager for Biomed vivarium studies.
- Department heads for PI-managed spaces.
- Local authorities for wildlife research work/permit requirements.
Choosing the correct protocol form
New projects/protocols or protocols approaching expiration dates: expand to see the four IACUC application form types.
Because invertebrate animals are not included by regulations, the term “vertebrate animal” is used in the descriptions below. A PI wanting an invertebrate study to be reviewed by the IACUC may use any of the forms as appropriate.
Full Use Biomedical Protocol Application Form(.docx) or FUB
- Completed for: typically traditional biomedical research that involves
- any contact with any living vertebrate animal by any personnel, or
- any alteration of animal environment(s) during observational work.
- Species include: generally mice, rats, zebrafish, and small birds (e.g., canaries, zebra finches).
- Locations include: the Biomed vivarium and PI-managed lab spaces.
Full Use Non-Biomedical Protocol Application Form(.docx) or FUNB
- Completed for: typically for non-biomedical research that involves
- any contact with any living vertebrate animal by any personnel, or
- any alteration of animal environment(s) while engaged in non-biomedical research.
- Species include: generally marine mammals, marine fishes, and reptiles.
- Locations include: work in the field (aquatic, terrestrial, and aerial), Coastal Science Campus, and in other PI-managed lab spaces.
Vertebrate Sample Use Protocol Application Form(.docx) or VSU
- Completed for: research with animal samples (tissues, scat, blood derivatives) involving no contact with any living vertebrates.
- Species include: everything from mice to non-human primates to marine mammals.
- Locations include: work in field settings.
Observational Protocol Application Form(.docx) or OBS
- Completed for: research that only involves the observation of animal subjects with no contact.
- If the research involves the observation of vertebrates with “material alteration” of their environment or behavior, then the research is no longer considered “no contact” and a “full use” protocol is necessary.
- This form may also be used for observational studies that involve sample collection (e.g., discarded feathers, scat) which does not disturb animals.
- Species include: typically everything from wild birds to non-human primates to marine mammals.
- Locations include: work in field environments and zoos.
Protocol amendments
See Modify/amend a protocol for details.
Tips for completing the protocol form
The IACUC understands no two protocols are the same, so respond to the protocol application questions as best you can. Request assistance from the IACUC office or members of the IACUC.
- Include all personnel who will be working directly or have oversight with the animals. Advisors, consultants, statisticians, and the like are not considered to be protocol personnel.
- The PI has the ultimate responsibility for the content of the protocol and for submitting it to the IACUC for review and approval. The IACUC office will communicate primarily with the PI. The PI may designate a co-respondent to be included in such communications. Learn more about who can be listed as a PI.
- Enter “N/A” where a question/item is not applicable.
- Be consistent with the information in your grant or contract application. Learn more about grant congruency.
- Use language that could be understood by a layperson in the justification section (a faculty member in a non-scientific discipline).
- Learn more about animal numbers.
- Learn more about food and fluid restriction.
- Learn more about major survival surgery and multiple survival surgery.
- Learn more about pain and distress classifications.
- If you are proposing Class E procedures, submit a completed Class E Justification Form (in addition to the current form).
- Learn more about alternatives searches.
- Learn more about IACUC collaborative processes.
- When complete, save the protocol application in Word doc format and email it to iacuc@ucsc.edu.
Do not begin activities until you have received final IACUC approval for your proposed protocol or amendment.