Local Accountability: Critical Roles in the Animal Care and Use Program

1. Local Accountability:Critical Roles in the Animal Care and Use Program Mike Fallon, DVM, PhD, DACLAM; CVMO, ORD michael.fallon@va.gov "Always do right. This will gratify some people and astonish the rest." Mark Twain (1835 - 1910)

2. Animal Care and Use Program- Critical Roles • CEO/Institutional Official • IACUC and Attending Veterinarian • IACUC Coordinator • Research Administrators • Animal Facility Supervisor • Animal Care Staff

3. CEO IO

4. Two Important Officials To meet its regulatory mandates, the IACUC must interact effectively with two administrators given specific responsibilities by the Animal Welfare Act Regulations and PHS Policy: • The CEO (Chief Executive Officer) • The IO(Institutional Official)

5. What Do They Do? • CEO; as the highest operating official of the institution (such as the president of a university). The CEO is required to appoint members qualified to serve on the IACUC. • IO; the person in the organization having the administrative and operational authority to commit institutional resources to ensure that the animal care and use program complies with requirements of the Animal Welfare Act Regulations, PHS Policy, and VA Policy.

6. The Director is the CEO and Must be the IO Many VA Research Chiefs held the position of IO in years past, but their lack of influence over other hospital services such as Facilities Management /Engineering proved to be problematic. Thus VA Policy requires the Director to retain both roles. (1200.7, items 3g and 3k)

7. Duties of the IO • The IACUC must notify the IO whenever significant deficiencies are found in the animal care and use program. • When progress toward correcting significant deficiencies falls short of the plan and schedule for these corrections, the IACUC must inform the IO. • When the IACUC suspends a protocol previously approved by the IACUC, the IO, in consultation with the IACUC, must review the reasons for the suspension and take appropriate corrective action, and report the incident to ORD/ORO, OLAW, USDA/APHIS, and other affected federal funding agencies.

8. Duties of the IO • The IO must receive recommendations from the IACUC about any aspect of the animal care and use program, facilities, or personnel training. • The IO must sign the PHS Assurance document which must be submitted and approved by OLAW prior to use of PHS funds for animal research. (each VA must be covered by the affiliate’s or their own PHS Assurance; item 4b(4)(a)) • The IO must sign the USDA/APHIS Annual Report, which must be submitted annually to the USDA (online submission using the USDA website is now required).

9. OLAW Best Practices for the IO • The institutional or attending veterinarian and the IACUC should report directly to the IO. • IO should clearly define and assign responsibilities and reporting channels for other essential program elements such as training, occupational health, and facility maintenance. OLAW Staff. Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals. ILAR News 35(3-4):47-49, Summer/Fall, 1993 (Institutional Responsibilities, Question 4)

10. Approving Animal Procedures The USDA Animal Welfare Act Regulations and PHS Policy provide only the IACUC with authority to approve animal studies on behalf of the institution, and no official has the authority to approve an animal study in the absence of IACUC approval. However, the IO or any other administrator may suspend any animal study for any reason without IACUC concurrence. (Tab C, AWAR Section 2.31(d)(8)) -Animal Welfare Act Regulations, 9 CFR Part 2 (Regulations), Subpart C (Research Facilities), Section 2.31 (Institutional Animal Care and Use Committee, IACUC), paragraphs (c)(6), (c)(8), and (d)(2)(viii) -Public Health Service Policy on Humane Care And Use of Laboratory Animals, IV. Implementation by Institutions, paragraphs B.6., B.8, and C.8

11. Director: Specific VA Policies • Approve tours of the animal research facility by internal/external groups. (1200.7, item 7j(1)) • Assure adequate administrative support for the IACUC (to include timely preparation of minutes and timely preparation of investigator correspondence and other documents). (1200.7, item 8)

12. Director: Specific VA Policies • Officially appoint members to the IACUC in writing, and include the term length. (1200.7, item 8a) • Chair: 1 year term, may be renewed (1200.7,item 8a(6)(a)) • Other members: term up to 3 years, may be renewed (1200.7item 8a(6)(b)) • Arrange time to meet in person with IACUC to discuss semi-annual self-review within 60 days of the review. (1200.7 Appendix E, item 7e) • Personally sign the semi-annual report form; no other official may sign for the Director. (1200.7 Appendix E, item 7e)

13. Director: Specific VA Policies • Review and forward written IACUC reports of investigations of internal/external adverse allegations about the animal care and use program to ORD/ORO and other entities as needed. (1200.7, item 8i) • Review and forward copies of any regulatory correspondence to and from other agencies and groups to ORD/ORO within 15 business days of receipt or submission. (1200.7, items 8g(5)(a)-(g))

14. An Effective Director • Understands program obligations. • Commits enough intellectual capital to understand problems in the animal care and use program. • Brings adequate resources to bear on problems identified by the IACUC so that timely corrections are made. • Holds all stakeholders and support personnel accountable- across hospital services. • Is a strong advocate for the research program within the VISN- makes the best possible case for VISN support of compliance and committee support positions

15. An Effective Director • Communicates a strong interest in the research staff taking their committee responsibilities seriously, and expresses appreciation for time and effort committed. • Has an open door policy and ensures that concerns are heard and addressed fairly. People respect a well reasoned “no” answer much better than no answer. • Gets out of the office and walks around unannounced to see how research labs and the animal facility look without prior notice.

16. The “Mother” Test of Appearances If I showed this animal (housing/surgery/laboratory) area to my mother and told her that procedures on animals are being performed, what would she think?

17. The Director Holds Primary Responsibility for Compliance with Animal Research Regulations and Policies Section 9 of the Animal Welfare Act: When construing or enforcing the provisions of this Act, the act, omission, or failure of any person acting for or employed by a research facility…shall be deemed the act, omission, or failure of such research facility… as well of such person.

18. IACUC

19. IACUC- Guts of the Program • Without a functioning and committed IACUC, a program is doomed to failure. • Composed mostly of scientists who use animals in their work; another form of a peer review group. • In the Animal Welfare Act, Congress purposely gave the IACUC broad powers and responsibilities as a self-regulatory agenton behalf of the institution. • This contrasts to European philosophies in which the government dictates the conduct of animal research to a much greater degree.

20. Brief Summary of IACUC Functions 1. Review and approve proposed activities involving animals in research, testing, or teaching, and significant changes to previously approved activities. 2. Evaluate the animal care and use program and the animal facility itself at least every six months. 3. Review any concerns about the care and use of animals at the institution and institute appropriate action. 4. Suspend animal work if its conduct is not in compliance with regulations or consistent with conditions of approval. 5. Make recommendations to a designated “Institutional Official” to make sure the institution is aware of issues affecting the animal research program.

21. An IACUC Must be Constituted • To perform any official business, an IACUC must have the following members appointed in writing per PHS Policy (1200.7, item 8a(1)) • Chair • Attending Veterinarian (ex officio***) • Scientist using animals in research, teaching, or testing • Non-affiliated member (“NAM”) • Non-scientist (“NSM” or “lay” member) *** ”by virtue of the office”; commonly misconstrued to denote a non-voting position, or to apply to non-voting members

22. An IACUC Must be Constituted • If an appointed member who fills a specified position leaves the committee such that the position is no longer filled, the IACUC is not properly constituted and may not conduct official business(1200.7, item 8a(1)) • Consequently, it is a best practice to have at least two NAM and two lay members because replacing one on short notice can be difficult. One person can fill both a NAM and a NSM (lay) position if they meet the criteria for both. (PHS Guidance, IACUC Composition, Functions and Authority, Q1)

23. Chair • Should not be concurrently filling another required position. (PHS Guidance, IACUC Composition, Functions and Authority, Q1;) • Can not simultaneously chair another committee such as R&D or SRS. (1200.7, item 8a(2)) • Should be a more senior scientist with animal research experience and good committee management skills. (1200.7, item 8a(2)) • VA programs are encouraged to rotate chairs often to develop a cadre of experience IACUC members. (1200.7, item 8a(6)(a))

24. Chair- Desirable Characteristics 1. Experience or familiarity with animal research and animal research regulations. 2. A working knowledge of parliamentary process to conduct IACUC business fairly and efficiently. 3. Enough maturity to keep deliberations focused, to make sure all IACUC members can participate, and to prevent attempts to silence dissenting opinions. 4. Adequate institutional seniority and authority in order to perform duties without concern that IACUC actions may jeopardize position or career.

25. Attending (or Institutional) Veterinarian 1. They must have graduated from a veterinary school accredited by the AVMA Council on Education, or have an ECFG certificate. (Tab B AWAR; Tab G item A.3.b.(1)) 2. They must be certified by the American College of Laboratory Animal Medicine (ACLAM) or have received training and/or have experience in laboratory animal medicine and in the care and management of the species at the institution. ( AWAR; PHS Policyitem A.3.b.(1); see also VA Handbook 5005, Staffing, Part II, Appendix F32.) 3. They must have direct or delegated authority (and accordingly, responsibility) for activities involving animals at the institution. ( AWAR; PHS Policyitem A.3.b.(1))

26. Attending Veterinarian- Specific Authority 1. Must approve specific details of proposals involving surgery, including pre- through post-procedural care and relief of pain and distress, and to change postoperative care as necessary to ensure the comfort of animals. (USDA Policies, #3) 2. Must make recommendations regarding activity level or restrictions of animals in health records. (Tab E, USDA Policies, #3) 3. Must decide when necropsies (autopsies) of animals should be performed to investigate health problems in the institution. (USDA Policies, #22) 4. Must provide consultations during the planning stages of proposed animal activities, prior to IACUC review. (1200.7, item 8d(2)(b)) 5. Must determine the frequency, method, and duration of dog exercise in consultation with and approval by the IACUC. (AWAR, Section 3.8 pars (a) and (b)) 6. Must direct the required environmental enrichment plan for primates. (AWAR, Section 3.81, preamble)

27. Attending Veterinarian- No Regulatory Authority Given to… • Suspend any animal procedure unilaterally unless that privilege is given to them by the institution • Veto IACUC decisions regarding protocol reviews or other matters before the committee • Set animal care policies without IACUC review and approval. However…whomever makes the decision takes the responsibility…

28. Attending Veterinarian- Interaction with IACUC • Each of the preceding responsibilities of the attending veterinarian is carried out as part of the overall veterinary care program with the support and approval of the IACUC. It is important, therefore, for the attending veterinarian and IACUC to work together closely and well.

29. Veterinarian’s Oath • Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of livestock resources, the promotion of public health and the advancement of medical knowledge. • I will practice my profession conscientiously, with dignity and in keeping with the principles of veterinary medical ethics. • I accept as a lifelong obligation the continual improvement of my professional knowledge and competence.

30. Attending Veterinarian and IACUC- Ethical Tensions • The IACUC and veterinarian are responsible for advancing the interests of two entities- the animals, and the public health (researchers, and by extension, our VA patients).  • These interests conflict, and the mark of a good IACUC-veterinarian partnership is the ability to find ways to compromise and maximize benefits to both entities. • Typically an IACUC that does so will foster a program that is both compliant and service-oriented to investigators. 

31. Attending Veterinarian and IACUC- Ethical Tensions • The animal care and use program exists because investigators are successful in convincing their peers and others that their work is worthy of funding.  Accordingly, a critical role of the veterinarian in the program is to assist the investigators in completing their work so that they can receive the money they need to do their work, and thus benefit humanity. 

32. Attending Veterinarian and IACUC- Ethical Tensions • For the veterinarian to be in an effective partnership, a trust relationship must be in place- the investigators can be trusted to do their best to treat animals humanely and according to what the IACUC has approved, and the veterinarian can be trusted to help the investigators do their work.  • This trust relationship allows the veterinarian and IACUC to face the tension caused by the joint obligation to protect the interests of animals while accepting the credo that animal research is an ethical imperative because human life is more precious than animal life.

33. Human vs. Animal Interests • Principle #3 of the Nuremberg Code of 1947.The (human) experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment. • Title 45 CFR part 46, Subpart B (the Common Rule; research protections for pregnancy/fetuses). No activity to which this subpart is applicable may be undertaken unless appropriate studies on animals and non-pregnant individuals have been completed; except when the purpose of the activity is to meet the health needs of the mother or the particular fetus…

34. Human vs. Animal Interests • Animal Welfare Act, Section 1: “The Congress further finds that-- (1) the use of animals is instrumental in certain research and education for advancing knowledge of cures and treatment for diseases and injuries which afflict both humans and animals;” • U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training: “The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species.”

35. Human vs. Animal Interests 1200.7, item 2. … Most research and testing involving human patients continue to be based on the results of animal experimentation. To provide hope for veterans suffering from diseases that currently lack cures or effective treatments, VA actively supports the use of animals in research, teaching, and testing.

36. Attending Veterinarian and IACUC- Hallmarks of a Healthy Relationship • Support for Investigators.If an investigator's request for support does not involve a practice that is illegal, immoral, or unethical, then the animal care staff should try very hard to say "yes."  • Service-Oriented Philosophy. The animal care staff should understand that investigators are customers and that helping them is a priority. 

37. Attending Veterinarian and IACUC- Hallmarks of a Healthy Relationship • Reciprocity of Respect and Accountability. Investigators commit to a good faith effort to follow regulations and interact with animal care staff to protect well-being of animals, and the vet and animal care staff know that if they have concerns about something they see, the IACUC will take their concerns seriously, and treat them as legitimate.  

38. Attending Veterinarian- Typical Duties • Manage animal care program professionally and with financial responsibility. • Monitor supervisor and animal are staff. • Work with supervisor to develop SOPs to standardize practices and maintain consistency of care. • Interact with veterinary colleagues to find solutions and help investigators. • Keep IACUC and IO informed of problems • Serve as regulatory and veterinary medical consultant • Full list of duties found in 1200.7 (item 6b(5))

39. Scientist • Must have experience in research involving animals.(PHS Policy, IV. Implementation by Institutions, paragraph A.3.b.(1)-(2)) • Further guidance is not given, but it is always helpful to have a scientist on the IACUC with expertise and knowledge that overlaps with the research being proposed to the IACUC. • The majority of IACUC members are typically scientists with animal research experience.

40. Non-Scientific (NSM or Lay) Member • Must be an individual whose primary concerns are in a nonscientific area (for example, an ethicist, lawyer, or member of the clergy). (PHS Policy, IV. Implementation by Institutions, para A.3.b.(3) • It is common sense for the Chair and other IACUC members to help this member gain an adequate understanding of issues before the IACUC. Jargon should be minimized, and questions raised by any member during the meeting should be addressed to the satisfaction of the NSM (as well as the NAM).

41. Non-Affiliated (NAM) Member • Must not be affiliated with the institution in any way other than as a member of the IACUC, and cannot be a member of the immediate family of a person who is affiliated with the institution." (PHS Policy, IV. Implementation by Institutions, para A.3.b.(5) • Cannot be a laboratory animal user at any research facility. (USDA Policy Manual, #15; Guide, Institutional Animal Care and Use Committee, page 9) • A veterinarian can fulfill this role as long as the veterinarian is not the Attending Veterinarian (and meets other criteria). (USDA Policy Manual, #15)

42. Non-Affiliated (NAM) Member • Members of the clergy, lawyers, and teachers often sought to fill this position. • Both PHS and USDA allow financial compensation to the non-affiliated member for expenses such as travel, parking, meals, and even participation, as long as such compensation: • Is not so substantial as to be considered an important source of income. • Does not influence the member's voting on the IACUC, and • Does not qualify the member as an employee of the institution. (PHS Guidance, IACUC Composition, Functions and Authority Q11; USDA Policy Manual, #15)

43. Veterans Serving on the IACUC- 1200.7 • 8a(3)(a) A veteran who volunteers at the medical center is considered to have an affiliation with the institution and is disqualified from serving as the non-affiliated IACUC member; however, appointment of such veterans to the IACUC in another capacity, such as lay member is strongly encouraged. • 8a(3)(b) Veterans who do not use a VA medical center for medical care may serve as the non-affiliated member on that medical center’s IACUC, as long as they have no other affiliation with the medical center and are not in the immediate family of a medical center employee.

44. IACUC Coordinator

45. IACUC Coordinator- Requires Complex Skills • IACUC appointment letters are current for all required positions. • Minutes, packets, and agendas go out on schedule before meetings. • Dates of semi-annual reviews are planned so that no more than 6 months elapse between them. • Written correspondence to investigators is initiated promptly to allow timely responses and reduce delays in approvals.

46. IACUC Coordinator • Complete IACUC files maintained: • Final version of ACORP approved by IACUC • Documentation of IACUC reviews and investigator responses • Approval letters • Amendments and proof of approvals • Proof of training is maintained either in individual files, or in a master folder

47. IACUC Coordinator • Other documentation: • Records of previous semi-annual reports and other regulatory reports are maintained. • A clear paper trail for self-reported deficiencies is available. • AALAC Program Descriptions and correspondence are maintained.

48. Keeping Records- How Long? • All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. (AWAR Section 2.35, item (f); PHS Policy, IV.E.2)

49. IACUC Coordinator- Other Duties • Interface with investigators to help them arrange veterinary consults and facilitate document submission. • Make sure letters requesting annual and triennial documents go out in advance to prevent lapses in protocol approval. • Maintain a list of animal procedure areas outside the animal facility so the IACUC can visit them as part of the semi-annual review.

50. 1200.7, items 8f(1) and 8d(1)(d)3a(6) • Preparation of IACUC Minutes. IACUC minutes must be written and published within 3 weeks of the meeting date. VA medical centers with their own IACUCs must format their minutes to comply with following subparagraphs 8f(1)(a) through 8f(1)(j). For VA projects under consideration, the minutes of joint or affiliate IACUCs need to contain the same information somewhere in the document. • Inadequate IACUC administrative support is a serious, reportable deficiency.