Institutional Oversight: The Role of the Attending Veterinarian ACLAM Forum-2013

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Clarence Morris
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1 Institutional Oversight: The Role of the Attending Veterinarian ACLAM Forum-2013 John Bradfield, DVM PhD DACLAM Joe Thulin, DVM MS DACLAM

2 Trends in Institutional Compliance? Review Survey Data Demographics Highlight opinions of respondents Summarize models of compliance Focus on the AV responsibility

3 Survey 233 Respondents (ACLAM Diplomates) 96 questions - Institutional compliance - Social Housing - Drug Management Institutional demographics/practices - AV responces Opinions - All respondents

4 Institution Type Which of the following best describes the institution that is your primary place of employment? 11.5% Academic institution, e.g., university or college 12.3% Animal producer 54.0% For profit research organization, e.g., pharmaceutical company or contract research organization Government agency/organization 1.7% Non-profit research organization

5 Non-Academic Which of the following best describes the institution that is your primary place of employment? 3.7% Animal producer 25.2% 43.9% For profit research organization, e.g., pharmaceutical company or contract research organization Government agency/organization 27.1% Non-profit research organization

6 What is your Primary Role? 7.5% 8.0% 33.3% 59.2% Attending Veterinarian / Program Director Clinical Veterinarian** Veterinarian IACUC support** 72.0% Attending Veterinarian / Program Director Clinical Veterinarian** Veterinarian IACUC support**

7 Laboratory rodents Rabbits Dogs and cats Nonhuman primates Ag/farm species (pigs, domestic ruminants, Fish/ aquatics Wild animals Laboratory rodents Rabbits Dogs and cats Nonhuman primates Ag/farm species (pigs, domestic ruminants, Fish/ aquatics Wild animals Species Housed?

8 Total Square Feet?

9 Number of Protocols? 3.8% 75 or less 12.9% 75 or less 18.8% % % % 37.1% More than % More than 500

10 Number of FTE s devoted to the IACUC? 8.9% 7.1% 22.8% 44.3% 24.1% More than % 44.3% More than 4

11 AV not a Director in which department do they reside? vet services + animal husbandry 4.5% 13.6% vet services + animal husbandry 36.4% 9.1% 54.5% vet services, not animal husbandry program oversight + vet services program oversight only 81.8% vet services, not animal husbandry program oversight + vet services program oversight only

12 Does the AV report directly to the IO? 21.3% Yes No 36.8% Yes No 78.8% 63.2%

13 Which unit provides support for the IACUC? 10.1% 30.4% 23.1% 46.2% 59.5% The animal resource unit An IACUC office Instiutional compliance office 30.8% The animal resource unit An IACUC office Insitutional compliance office

14 Does IACUC staff report to the AV (directly or indirectly)? 16.5% Yes No 5 Yes No 83.5% 5

15 What is the AV s (or AV staff s) role in the semiannual process? 5.1% 13.9% The AV or the AV s staff organizes the semiannual process (i.e., has a leadership role) 1.4% The AV or the AV s staff organizes the semiannual process (i.e., has a leadership role) The AV or AV s staff participates in the semiannual process (i.e., a role equal to that of other committee members) 42.0% The AV or AV s staff participates in the semiannual process (i.e., a role equal to that of other committee members) 81.0% The AV or AV s staff is excluded from participation in any portions of the semiannual inspections or program review 56.5% The AV or AV s staff is excluded from participation in any portions of the semiannual inspections or program review

16 Compare to another survey To avoid potential conflicts of interest, does your IACUC attempt to assure that during semiannual inspections the attending veterinarian or other member(s) of the IACUC who are responsible for the daily operations of your central animal facility(s) do not inspect the central animal facility(s)? 0% 4% 10% N/A Yes 31% No Don't know N=294 55% Other From: The IACUC Handbook, 3 rd edition, ed. Silverman and Suckow (In press).

17 Does the AV lead/organize other compliance activities? 25.3% 42.0% Yes No 58.0% Yes No 74.7%

18 Does the AV have a responsibility to ensure institutional compliance? 0.9% 7.4% 9.3% 1=strongly disagree 40.2% 1.1% 5.4% 14.1% 1=strongly disagree 5.6% 2=disagree 3=neutral 4.3% 2=disagree 3=neutral 24.1% 4=agree 34.8% 4=agree 5= strongly agree 5= strongly agree 52.8% 6= I don t know or not applicable 6= I don t know or not applicable 23-25% believe the AV does not have a responsibility to ensure compliance

19 The roles of the AV & IACUC are separate and distinct? 30.6% 0.9% 3.7% 14.8% 1=strongly disagree 14.1% 1.1% 6.5% 1=strongly disagree 2=disagree 31.5% 2=disagree 13.0% 3=neutral 3=neutral 4=agree 39.1% 4=agree 37.0% 5= strongly agree 7.6% 5= strongly agree 6= I don t know or not applicable 6= I don t know or not applicable

20 The Authority of the IACUC supersedes that of the AV? 4.6% 3.7% 21.3% 1=strongly disagree 2=disagree 8.8% 1.1% 12.1% 1=strongly disagree 2=disagree 20.4% 3=neutral 30.8% 3=neutral 4=agree 4=agree 20.4% 5= strongly agree 16.5% 30.8% 5= strongly agree 29.6% 6= I don t know or not applicable 6= I don t know or not applicable - 51% disagree, Non-academia 43% disagree

21 The authority of the AV and IACUC are equivalent? (with separate areas of responsibility) 16.7% 6.5% 14.8% 1=strongly disagree 16.3% 2.2% 1.1% 31.5% 1=strongly disagree 2=disagree 2=disagree 12.0% 3=neutral 3=neutral 5 4=agree 40.2% 8.7% 4=agree 5= strongly agree 5= strongly agree 6= I don t know or not applicable 6= I don t know or not applicable 67% agree, Non-academia 57% agree

22 Topics on which and are similar Is AV a Director of a department/unit? Yes (71-90%) What kind of department/unit? Vet services + husbandry (80-94%) Is the AV an IACUC member? Yes (99%) Apart from the semiannual process, does the AV participate in other compliance activities? Yes (~ 73%) The IACUC and AV share some responsibilities? Yes (95%)

23 Topics on which and are similar It is inappropriate for the AV to engage in (or be a part of) compliance activities? Disagree (~85%) The AV has direct or delegated responsibility & authority for animal activities? Yes (91-95%) The AV should be the institution s subject matter expert on regulatory compliance? Yes (62-70%)

24 Organizational Models of Program Oversight AV manages both the animal resource and IACUC/oversight activities AV manages the IACUC/oversight activities not the animal resource AV manages the animal resource only. Separate IACUC/compliance office.

25 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure is most effective? =strongly disagree 2=disagree 3=neutral 4=agree 5= strongly agree =strongly disagree 2=disagree 3=neutral 4=agree 5= strongly agree 31% agree (50% disagree), 43% agree (31% disagree )

26 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure places too much authority on the AV? % agree (29% disagree), 33% agree (41% disagree )

27 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure places too much responsibility on the AV? % agree (25% disagree), - 41% agree (42% disagree)

28 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure creates a potential conflict of interest for the AV? % agree (26% disagree), 52% agree (35% disagree)

29 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure is the most logical because the AV is the most qualified to manage these aspects of the program? % agree (47% disagree ), 41% agree (30% disagree)

30 AV manages/supports both the animal resource and IACUC oversight activities. This organizational structure is the most logical because it is most closely aligned with the regulations and guidelines? % agree (50% disagree), - 43% agree (33% disagree)

31 AV manages/supports both the animal resource and IACUC oversight activities Selected Comments The structure described removes the checks-and-balances of the tripartite program; IO, AV, and IACUC. I think there has been a separation between the roles of the AV and IACUC in recent years. They should overlap and it is a mistake to clearly separate the roles of then AV and IACUC; they should work together in a seamless manner to make the system as efficient as possible. Too much authority placed in a single individual. Would breed mistrust among researchers who might feel they had little to no recourse in the event of a disagreement with the AV. There is no good reason that the IACUC administrative support cannot be provided out of the animal resource, whether or not it is directed by the AV.

32 AV manages/supports both the animal resource and IACUC oversight activities. Summary There was no clear consensus opinion about the appropriateness of this model In general, veterinarians in non-academic setting were somewhat more supportive of this model of institutional oversight

33 AV manages the IACUC/oversight activities not the animal resource This organizational structure is most effective? % agree (73% disagree), Non-academia 9% agree (70% disagree)

34 AV manages the IACUC/oversight activities not the animal resource This organizational structure places too much authority on the AV? % agree (38% disagree), 28% agree (49% disagree)

35 AV manages the IACUC/oversight activities not the animal resource This organizational structure places too much responsibility on the AV? % agree (33% disagree), 29% agree (48% disagree)

36 AV manages the IACUC/oversight activities not the animal resource This organizational structure creates a conflict of interest for the AV? % agree (40% disagree), 26% agree (51% disagree)

37 AV manages the IACUC/oversight activities not the animal resource This organizational structure is the most logical because the AV is most qualified to manage these aspects of the program? % agree (60% disagree), 12% agree (65% disagree)

38 AV manages the IACUC/oversight activities not the animal resource This organizational structure is the most logical because it is most closely aligned with the regulations and guidelines? % agree (69% disagree), 9% agree (66% disagree)

39 AV manages the IACUC/oversight activities not the animal resource Selected Comments A trained lab animal vet is likely the best IACUC office manager, but in my opinion, that vet should not be the AV This organizational structure tends to undermine the role of the veterinary support staff because they are not seen as being involved with program oversight If the AV is not directly providing and/or supervising veterinary medical care and related activities, e.g., husbandry, the AV is not fulfilling the responsibilities specified by the AWAR, PHS Policy, and Guide There is absolutely no reason a program cannot be set up to run this way

40 AV manages the IACUC/oversight activities not the animal resource Summary For those AV s who are currently operating with this organizational structure. The majority of your colleagues think this doesn t make sense!

41 AV manages the animal resource only. Separate IACUC office. This organizational structure is the most effective? % agree (14% disagree), 38% agree (31% disagree)

42 AV manages the animal resource only. Separate IACUC office. This organizational structure places too much authority on the AV? % agree (85% disagree), 8% agree (81% disagree)

43 AV manages the animal resource only. Separate IACUC office. This organizational structure places too much responsibility on the AV? % agree (82% disagree), 5% agree (89% disagree)

44 AV manages the animal resource only. Separate IACUC office. This organizational structure creates a conflict of interest for the AV? % agree (85% disagree), 9% agree (83% disagree)

45 AV manages the animal resource only. Separate IACUC office. This organizational structure is the most logical because the AV is most qualified to manage these aspects of the program? % agree (18% disagree), 43% agree (36% disagree)

46 AV manages the animal resource only. Separate IACUC office. This organizational structure is the most logical because it is most closely aligned with the regulations and guidelines? % agree (18% disagree), 42% agree (34% disagree)

47 AV manages the animal resource only. Separate IACUC office. Selected Comments This organizational structure can result in the IACUC administration dictating to the AV on veterinary care matters..a potential conflict exists but only if the AV and IACUC Director are not compatible. This model would help keep the AV neutral, but the veterinary staff is often the ones who first learn about potential noncompliances first, and are the ones in the best position to work with research staff the most closely to solve them. Taking them out of the picture completely doesn't seem the right thing to do, either. This system could work very well depending upon the people in place and their working relationship. It can also be confrontational and impede the program. I have seen both, each at a separate academic institution I have worked at.

48 AV manages the animal resource only. Separate IACUC office. Selected Comments This structure may be preferred for large, complex programs over the AV over all type structure. This organizational structure can create conflict between the AV and the IACUC, detrimental to the program as a whole. This one makes the most sense to me. The AV is focused on the clinical and husbandry care of the animals, but acts as a member of the IACUC, forcing the rest of the IACUC to assist in the oversight of the program. More effective at spreading the responsibility.

49 AV manages the animal resource only. Separate IACUC office. Summary This model may be somewhat more favored by those in academic settings or large programs Interestingly, most believed this model was most closely aligned with the regulations and guidelines This model can work well, but it can also create a disconnect between the IACUC (office) and AV.

50 Overall Summary AV manages both the animal resource and IACUC/oversight activities AV manages the animal resource only. Separate IACUC/compliance office AV manages the IACUC/oversight activities not the animal resource Model #1 (AV manages the animal resource and supports the IACUC favored by those in non-academic settings Model #3 (AV manages animal resource. Separate IACUC office) favored by those in academic settings Model #2 (AV manages the IACUC but not the animal resource) favored by very few

51 Overall Summary AV manages both the animal resource and IACUC/oversight activities AV manages the animal resource only. Separate IACUC/compliance office AV manages the IACUC/oversight activities not the animal resource There is no one-size-fits-all model There are pro s and con s to each Keep in mind the recommendations of the Guide that animal program management and oversight is a collaborative effort among the AV, IACUC & IO Any model that unnecessarily separates the roles of these key entities is unwise The AV is a key leader of the Program and it is difficult to separate the AV from oversight, and still have a sound Program

NIH Adopts 8 th Edition of the Guide: A Discussion

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