Department of Defense Instruction (DoD) 3216.01 clarifies several animal use requirements that are applicable to marine mammal studies.
The Navy Bureau of Surgery and Medicine Requirements
For the time being, if you are conducting research with marine mammals that could be considered a field study (see below for the definition) and going out on, or putting anything in, the water, then you are required to fill out a Navy Bureau of Surgery and Medicine (BUMED) Animal Use Appendix.
If you are conducting field research (see below for the definition), you must complete the appropriate BUMED Animal Use Appendix. If you, in consultation with your IACUC, decide that your project should be classified as a field study instead of field research you can make your case directly to the DoD veterinarian.
Which Appendix to Use
If your Institutional Animal Care and Use Committee (IACUC)-approved protocol includes ONLY those activities described in your Office of Naval Research (ONR) proposal, then the abbreviated BUMED Appendix can be used. However, if your IACUC-approved protocol includes activities beyond the scope of the ONR proposal, or includes activities funded by other agencies or groups, then the full version of the BUMED Appendix is required.
BUMED approval must be received before any DoD/ONR funding can be obligated and before any DoD/ONR-funded work may begin (see the instructions below for the requirements). The primary documents for review by BUMED for projects will be:
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Your institute’s approved IACUC protocol
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The appropriate BUMED Appendix
When filling out the BUMED Appendix you can reference the IACUC-approved protocol (page #/paragraph #).
Example: BUMED Appendix: i. Describe methods or strategies planned for chemical restraint (i.e., if a procedure would not otherwise cause more than slight or momentary pain or distress, but the anesthetic is used to facilitate administration by holding the animal still): Please see IACUC section A page 2, paragraphs 1-5.
DoD Veterinarian Site Visits
See page 14 of DoD Animal Use Instructions for official language:
‘If you are conducting research with marine mammals in the field, in the lab, or in captivity, then you could be requested to allow the DoD veterinarian to inspect your field site, laboratory or facility to make sure the program meets the standards in References (d), (e) and (j). This applies to projects taking place in, or outside of, the United States.’
ONR-Required Documentation for Animal Use
For field study projects:
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Copies of your entire National Oceanic and Atmospheric Administration (NOAA) Fisheries scientific research permit (not just the cover letter) or other applicable permits (i.e., country permit if working in another country’s national waters) – if applicable
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Documentation from the IACUC that they agree the proposed project is a field study or if there is no IACUC supporting the institution, a DoD veterinarian shall determine if the activity is a field study
For field research projects:
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Copies of your entire NOAA Fisheries scientific research permit (not just the cover letter) or other applicable permits (i.e., country permit if working in another country’s national waters) – if applicable
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Documentation of approval from IACUC, i.e., IACUC approval letter
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Copy of the institutional protocol approved by the IACUC
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Completed and signed BUMED Animal Use Appendix (see above for documents detailing the template)
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Documentation that the facilities are AAALAC-approved and/ or have an National Institutes of Health Animal Welfare Assurance for captive animal work – if applicable
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Copy of most recent U.S. Department of Agriculture inspection report for captive animal work – if applicable
These documents must be submitted to Ms. Suzanne May when the research proposal is submitted. For assistance with these requirements, please contact Ms. May at suzanne.b.may.civ@us.navy.mil.
Definitions
Field study: An observational study conducted on free-living wild animals in their natural habitat (i.e., passive acoustic monitoring, photo-id, line transect survey, etc.) A field study excludes any investigation that involves an invasive procedure, harms the animal or materially alters the behavior of the animal under study. A field study is neither governed by Animal Welfare Act regulations nor DoD Instruction 3216.01. A field study is distinct from field research.
Field research: An investigation conducted on free-living wild animals in their natural habitat that DOES involve an invasive procedure, harms the animal, or materially alters the behavior of the animal under study (i.e., suction cup tagging, biopsy darting, controlled acoustic experiments, etc.). Field research is governed by Animal Welfare Act Regulations and DoD Instruction 3216.01.
Harm: Any procedure that either causes lasting detrimental physical, behavioral or psychological damage, or exposes an animal to potentially perilous situations (e.g., releasing an anesthetized animal before it is fully recovered from anesthesia or releasing a nocturnal animal during daylight hours).