8/5/2014. The source document for DoD use of animals. DOD Policy (dated Sept 2010)

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1 The source document for DoD use of animals. DOD Policy (dated Sept 2010) The Care & Use of Laboratory Animals in DoD Programs AFMAN (1) SECNAVINST C DARPAINST 18 USUHSINST 3203 The implementation document for the DoD Instruction. Dated: March 2005 Under revision! (Expected publication date 2014?) 1

2 All NIH research MUST be covered by a PHS Assurance. May subordinate under an affiliate s Assurance or have stand alone. Re do every 4 years; annual report No different than academia DOD requires all research comply with the AWA USDA VMOs do not inspect DoD activities Annual USDA reports are required Congress also requires DoD Annual Work summary Report Colonel (Dept Chief/Director: ~ Prof.) Lieutenant Colonel (Dept Assist Chief: ~ Assoc Prof / Prof) Major (Division Head: ~ Assoc Prof / Assist Prof) Captain (Clinic Manager: ~ Assist Prof / Instructor) First Lieutenant (Section Manager: ~ Instructor) Second Lieutenant (Lab Manager) Provides oversight of medical centers ACUPs. Now integrated with the U.S. Army Animal Care and Use Review Office (ACURO) 2

3 Provides audit, higher HQs approval for NHP, dogs, cats, mms Proponent of regulatory changes for DoD activities, including DTRA, DARPA, and ARO. Provides audit, higher order taxonomy approval, and process development for Navy activities. Provides audit, higher order taxonomy approval, and process development for Air Force activities. Service & DoD agency representatives who recommend and revise/update policy. Meet monthly quarterly attempting to harmonize guidance & discuss emergent issues. Reported to Armed Services Biomedical Research Evaluation and Management (ASBREM) Discontinued as JTWG in 2012 but continues to function under the direction of senior veterinarian at DOD Veterinary Services Activity DoD term used to refer to the animal committee most now called IACUC Receive initial training that consists of at least 4 hours of training in regulatory responsibilities and proper techniques of the animal protocol review process; and Receive at least 4 additional hours of training on humane care and ethical issues dealing with animal use. Non affiliated individuals receive 8 hours of training. NOTE: The requirements are system wide; training is generally through the AALAS Learning Library. *Time requirement (hours required) removed from updated AR

4 The DoD requires a specific checklist be used. Checklist revised/updated in new AR Requires a specific protocol template be used. Search the web for DoD Protocol Template Prolonged restraint Food and fluid restriction Multiple major survival procedures Enrichment of primates Exercise of dogs 4

5 Scientific Review: Coordination: (Research Unit Chief/Directors Signature) Attending/Consulting Veterinarian: (Attending/Consulting Veterinarian) Statistical Review: (Biostatistician/Person knowledgeable in statistics) Literature Search: Must be performed to prevent unnecessary duplication of previous experiments Biomedical Research Database (BRD) required, and Either: Federal Research in Progress (FEDRIP), or Computer Retrieval of Information on Scientific Projects (CRISP) Protocols are FOIABLE Must have Military Relevance Uses the 4 R s, not the 3 R s Must be easily understood with high school education Non technical Synopsis and the Objective are included in DoD annual report (called Work Unit Summary) Literature Search requires minimum of 2 databases, one of which covers federally funded projects (FEDRIP, CRISP, BRD must include) Any living or dead vertebrate animal, including birds, coldblooded animals, rats of the genus Rattus and mice of the genus Mus. With respect to avian and other egg laying vertebrate species, their offspring are considered animals only after hatching. With respect to fish and amphibians, their larval offspring are considered animals. For the purposes of this definition, dead is defined as animals killed for the direct purpose of conducting RDT&E <experimentation> or training. However, it does not include dead animals or parts of dead animals purchased at grocery stores or slaughterhouses 5

6 Animals used strictly for ceremonial and/or recreational purposes and working animals, such as military working dogs (unless subjects of a research project), caisson horses Farm animals such as but not limited to livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use improving animal nutrition, breeding, management, or production efficiency; or for improving the quality of food or fiber Animals used in disease surveillance, unless the disease screening procedure harms the animal Animals involved in field studies. (delineation between field research and field study) DoD requires suppliers licensed by the U.S. Department of Agriculture (USDA) in accordance with reference unless specifically exempted from the licensing requirements stated in reference. Exemptions must come from ACURO. (actual exemption from USDA but coordinated by ACURO or other service agency) Must have a non scientific and non affiliated member. Must have a primary and alternate nonaffiliated member AV and non aff MUST be present at FC meeting for quorum (may request waiver for nonaff attendance) Intramural (DoD owned facilities) use of NHP, dog, cat and marine mammals require a headquarters level (ACURO) review ACURO or the appropriate service oversight office Second level review emphasizes importance of meeting regulatory compliance This results in local plus system wide review / consistency of review 6

7 Extramural animal use (all species) require a headquarters level review (ACURO or appropriate oversight office) A site visit to the extramural sites that conduct NHP, dog, cat or marine mammal is generally required (any where in the world can be exempted) The most recent USDA inspection reports are reviewed prior to initiating the project Annually, the USDA inspections reports are reviewed for the duration of the award DoD intramural facilities must apply for AAALAC accreditation AR 40 33: Will attain and maintain AAALAC accreditation Activities sponsored by DoD funds and conducted in other countries are conducted in accordance with US and the host country regulations and standards. If exist between the US and host country standards, unless prohibited by the host country, the more stringent standard applies (generally thought of as the US standards) but not always (UK deviation may result in imprisonment of PI) Research for development of biological, chemical or nuclear weapons Any kind of weapon development (Offensive or Defensive) or research in these areas (EXCEPT defensive countermeasures) Inflicting wounds for medical or surgical training Advanced trauma life support (ATLS) medical training 7

8 Since the DoD IACUCs perform a Government function in an approval process and do not serve merely as an advisory body, the non affiliated and the non scientific member(s) to DoD IACUCs shall either be a Federal employee, with demonstrated commitment to the community or a contractor/consultant consistent with the requirements established by reference. Personnel with complaints of violation shall report such violations to the IACUC chairperson, the attending veterinarian, the facility Commander, or the Inspector General. Protects the identity of the individual At a minimum, the DOD component headquarters oversight office must conduct an administrative review and approval all DOD supported RDT&E and training. must be conducted to ensure conformance with all applicable regulations and policies. conducted by a DOD veterinarian trained or experienced in laboratory animal science and medicine 8

9 (LTC Sarah Bro; Nina Cisar ; nina.cisar@us.army.mil Oversight for Army conducted or supported animal research Provides oversight of work funded by DARPA and DTRA Provides oversight of the Congressionally Directed Medical Research Program and the Armed Forces Institute of Regenerative Medicine (LTC Dave Bentzel; ; david.bentzel@pentagon.af.mil) Air Force s oversight office (BUMED LTC Joe Harre; ) Navy s oversight office COL Brian Ketzenberger Director, ACURO Dr. Sue Goodwin Deputy Director (10/3) LTC Krinon Moccia Air Force Vet Program Manager Ms. Nina Cisar Manager LTC Larry Shelton Navy Vet Program Manager LTC Sarah Bro (9/25) Clinical Invest Regulatory Office Review Staff Mr. Joe Kallhoff Ms. Blair Warfield Ms. Sheron Westbrook

Extramural facilities using nonhuman primates, dogs, cats, marine mammals or as deemed to warrant review If an institution is AAALAC accredited, waiver of site visit is permissible Site visit is

10 Extramural facilities using nonhuman primates, dogs, cats, marine mammals or as deemed to warrant review If an institution is AAALAC accredited, waiver of site visit is permissible Site visit is conducted by a DOD veterinarian in the early stages of the study Site visit process will be similar to an IACUC semiannual facility inspection and program review but more limited in scope Every three years prior to AAALAC site visit 10

11 For use when the PI s protocol includes only work funded by the DOD grant Only includes information generally not found in non DOD protocol formats For use when the PI s protocol includes animal studies not funded by the DOD grant Must include a complete description of only the funded animal work Covers all aspects of a DOD animal protocol 11

12 New Protocols or Triennial Renewals (Rewrites) Proposal is approved for funding and forwarded to ACURO from Contracting Agent or Program Managers; submissions must be sent electronically to the central ACURO account at unless required to send to funding agency first, like DTRA and CBMS. If so, the regulatory offices at those agencies will send submission to ACURO. Proposal is logged into IMS database by ACURO administrative staff Upon receipt of complete packet, the file goes into the reviewers queue. A reviewer picks up protocols on a first come, first served basis. The wait is less than 10 days. If submission is incomplete, the administrative staff contacts the investigator to provide any missing documents. A reviewer pulls the next protocol in the queue, evaluates it, and sends comments as needed to the PI. The PI replies to questions and reviewer assesses responses within about 3 days. If questions remain, the PI is contacted again for further clarifications until all issues are resolved. When all issues are resolved, the reviewer completes a detailed review checklist and puts the file into the veterinarians review queue. The average time for vet review is 3 days. If the veterinarian has no questions, the proposal is approved. If the veterinarian has questions, further information will be requested from the PI. Once all questions have been answered, the proposal is approved. Once the vet signs off on the submission, ACURO administrative staff generates the formal approval letter which is sent to the award PI, protocol PI, Contract Specialist, Grants Manager, IACUC and Research office points of contact identified by the PI. Amendments/Modifications Submissions must be sent electronically to the central ACURO account at acuro@amedd.army.mil unless required to send to funding agency first, like DTRA and CBMS. If so, the regulatory offices at those agencies will send submission to ACURO. Amendment/modification is logged into IMS database by ACURO administrative staff Upon receipt of complete packet, the file goes back to the original reviewer and is evaluated by the reviewer within the day. If submission is incomplete, the administrative staff contacts the investigator to provide any missing documents. The reviewer evaluates the amendment and sends comments as needed to the PI. If the amendment is minor, the reviewer acknowledges receipt to PI and no approval is necessary. The PI replies to questions and reviewer assesses responses within a day. If questions remain, the PI is contacted again for further clarifications until all issues are resolved. When all issues are resolved, the reviewer completes a short memorandum and puts the file at the front of the veterinarians review queue. Amendments are usually reviewed by the vet in the same day. If the veterinarian has no questions, the amendment is approved. If the veterinarian has questions, further information will be requested from the PI. Once the vet signs off on the submission, ACURO administrative staff generates the formal approval letter which is sent to the award PI, protocol PI, Contract Specialist, Grants Manager, IACUC and Research office points of contact identified by the PI. 12

Formal approval letter acts as a contract modification Copies sent to contracting personnel, funding component, awardee PI and protocol PI Outlines protocol maintenance requirements Remember,

13 Formal approval letter acts as a contract modification Copies sent to contracting personnel, funding component, awardee PI and protocol PI Outlines protocol maintenance requirements Remember, subsequent protocol modifications must be submitted prior to implementation After approval, collect animal usage information by fiscal year Animal usage information required for every award administered by ACURO Information collected by award NOT protocol Members of ACURO staff notify each awardee of submission deadlines for the data call All species used must be reported, including rats and mice Information is used to populate the Biomedical Research Database 13

The Care and Use of Laboratory Animals in DOD Programs

Army Regulation 40 33 SECNAVINST 3900.38C AFMAN 40 401(I) DARPAINST 18 USUHSINST 3203 Medical Services The Care and Use of Laboratory Animals in DOD Programs Departments of the Army, Navy, Air Force, Defense