Presentation on IaCUC Compliance and Research Misconduct May 13, 2011

1. Presentation on IaCUC Compliance andResearch MisconductMay 13, 2011 Tulane University IACUC and Research Compliance

2. Instructors • Brian Weimer Tulane University Research Compliance Officer bweimer1@tulane.edu 504.988.1147 http://tulane.edu/asvpr/research-compliance.cfm • Sheila Garrison Tulane University IACUC Director sgarriso@tulane.edu 504.988.6868 http://tulane.edu/asvpr/iacuc/index.cfm

3. Outline of Presentation • Oversight of use of animals in research • Non-Compliance • Writing and submitting an animal use protocol • Research Misconduct policy (if time permits) Please ask questions at any time if you have them.

4. IACUC • Institutional Animal Care and Use Committee • The IACUC existence and functions are mandated by the PHS’s Office of Laboratory Animal Welfare (OLAW) and the USDA to ensure the humane care and use of animals used in research and compliance with guidelines and regulations

5. Animal Research has Oversight provided by: • The IACUC, which must review and approve all animal research before the research begins • Vice President for Research (Laura Levy, PhD) • Principal Investigators • Department of Comparative Medicine (DCM), which administers the Tulane’s vivariums and has the charge of being directly responsible for the care and well-being of animals • Research Compliance Officer

6. IACUC SOPs, Guidelines and Policies • The IACUC SOPs Guidelines, & Policies are located online at http://tulane.edu/asvpr/iacuc/index.cfm • The SOPs and Policies are campus-specific. • The SOPs and Policies are based on laws, regulations, and policies from federal agencies and other accrediting organizations

7. Laws, Regulations, and Policies that Impact Care and Use of Animals • USDA’s Animal Welfare Act (Animal Welfare Regulations and Animal Care Policies) • Guide for the Care and Use of Laboratory Animals (“The Guide”) • Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals • Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) requirements

8. Federal Animal Welfare Act • First version passed in 1966 • Administered by USDA-APHIS • Provisions for “covered species” include: • Handling, housing, feeding, watering, sanitation, ventilation, shelter, and adequate veterinary care • Use of tranquilizers, anesthetics, and analgesics to minimize pain or distress • Periodic, unannounced visits • IACUC • Personnel training • Detailed records • Annual reports to USDA • Penalties for violation – fines or revocation of funding

9. Animal Welfare Act (continued) • Excluded Species: • Laboratory mice and rats • Cold-blooded vertebrates (such as fish or frogs) • Invertebrates (such as fruit flies or worms) • Although certain species are not covered by the Animal Welfare Act, Tulane IACUC SOP’s are applicable to all species, unless noted otherwise in the SOP.

10. Guide for the Care and Use of Laboratory Animals (“The Guide”) • PHS-funded institutions are required to follow • Forms the basis for AAALAC Accreditation • Covers all aspects of animal care programs and facilities • Focuses on: • Institutional Policies • Animal Environment, Housing, and Management • Veterinary Medical Care • Physical Plant • Available online at http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf

11. PHS Policy on Humane Care and Use of Laboratory Animals • Applies to any institution that receives PHS funds for vertebrate animal research (broader than the Animal Welfare Act) • Institutions with an “Assurance” must: • Establish an appropriate line-of-authority • Use the “Guide” as a basis for operating their animal care program • Maintain an IACUC • Maintain records • Report annually to OLAW (Office of Laboratory Animal Welfare) • Report serious and/or continuing non-compliance to OLAW • Submit to on-site visits

12. US Government Principles for the Utilization & Care of Vertebrate Animals Used in Testing, Research & Training • A set of 9 general principles adhered to by institutions receiving federal funds for animal research • Reinforced by the PHS Policy on Humane Care and Use of Laboratory Animals

13. Reporting Non-Compliance • Section IV.F.3 of the PHS Policy on Humane Care and Use of Laboratory Animals requires that the institution promptly report a full explanation of the circumstances and actions taken with respect to: • any “serious or continuing” noncompliance with the Policy • any serious deviation from the provisions of the “Guide” • any suspension of an activity by the IACUC.

14. Examples of Serious Non-Compliance • Conditions that jeopardize the health or well being of animals, including natural disasters, accidents, and mechanical failures, that results in actual harm or death to the animals. • Conducting animal-related activities without appropriate IACUC review and approval • Failing to adhere to IACUC-approved protocols • Implementing any significant change to IACUC-approved protocols without prior IACUC approval as required by section IV.B.7 of the PHS Policy • Conducting animal-related activities beyond the expiration date established by the IACUC (a complete IACUC review is required by section IV.C at least once every three years)

15. Examples of Serious Non-Compliance • Participating in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained by section IV.C.1.f of the PHS Policy. • Failing to monitor animals post-procedure as necessary to ensure well being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures) • Failing to maintain appropriate animal-related records (e.g., identification, medical, husbandry)

16. Examples of Serious Non-Compliance • Failing to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO 2) • Failing to carry out veterinary orders (e.g., treatments) • Any activity that results in the IACUC or institution suspending an activity due to noncompliance with the PHS Policy, Animal Welfare Act, the “Guide,” or the institution’s Animal Welfare Assurance

17. Examples of Serious Non-Compliance • Conducting official IACUC business requiring a quorum (full Committee review of an activity or suspension of an activity) in the absence of a quorum • Conducting official IACUC business during a time that the Committee is improperly constituted • Failing to correct deficiencies identified during the semiannual evaluation • Chronic failure to provide space for animals in accordance with the Guide, unless the IACUC approves a protocol-specific deviation from the Guide based on written scientific justification

18. Penalties for Non-Compliance • USDA Animal Welfare Act • Institutional fine • Cease and desist order • Request to federal funding agencies to suspend or revoke funding • PHS Policy • Revocation of assurance and loss of funding for entire institution

19. What is OLAW looking for when the IACUC reports Non-Compliance? • What happened? • How was the non-compliance discovered? • Was the health, welfare, and safety of the animals jeopardized? • What will the PI do to prevent the non-compliance from occurring in the future? • Was training for non-compliant individuals provided?

20. Accreditation by AAALAC International • Association for the Assessment and Accreditation of Laboratory Animal Care organizations. • A non-profit corporation directed by its member organizations • Voluntary program for accreditation of laboratory animal use facilities • Organizational goals: • High standards for care and use of animals • Control of variables that may adversely affect research • Protection of the health of animal research workers • Conducts site visits every three years

21. Tulane Research Misconduct Policy • Required by federal government since Tulane is a recipient of federal research funding • Located in Faculty Handbook, Sec. III(H)(3) • Defines Research Misconduct as: • Falsification of data: ranging from fabrication to deceptive, selective reporting, including the purposeful omission of conflicting data with the intent to falsify results; • Plagiarism:representation of another's work as one's own; or • Violation of Federal Regulations: material failure to comply with federal requirements that uniquely relate to the conduct of research. • If the activity is not falsification of data, plagiarism, or violation of federal regulations, the activity is not research misconduct.

22. Tulane Research Misconduct Policy – the Process • Complainant files written allegation with respondent’s Dean or Chief Administrator of the division in which the respondent resides: • Complainant: person making the accusation of research misconduct • Respondent: person accused of research misconduct • Complaint can also be filed with Research Compliance Officer, (“RCO”) who will report allegation to Dean. • RCO has duty to consult confidentially with persons uncertain about whether to submit a research misconduct allegation • RCO has an open-door policy

23. Tulane Research Misconduct Policy – the Process (continued) • Complainant can request to remain anonymous. • University must protect complainant who has made an allegation in good faith, even if the allegation is not sustained. • Respondent (person accused of misconduct) has due process rights, and the identification of respondent must be kept confidential throughout process.

24. Tulane Research Misconduct Policy – the Process (continued) 4 Stages of the process: • Inquiry • Investigation • Formal Finding • Appropriate Disposition.

25. Examples of Disciplinary Actions by the University for Research Misconduct • Letter of reprimand; • Removal from the particular project; • Special monitoring of future work • Suspension or expulsion of students • Termination of employment of staff • Dismissal of faculty member • Notification of co-authors, co-investigators, collaborators, editors of journals, professional societies, and licensing boards

26. Tulane Research Misconduct Policy – Disposition • The University must notify federal sponsoring agencies if there is a finding of research misconduct. • Sponsoring agencies can accept the University’s findings or can conduct a further investigation and/or impose additional disciplinary measures • For NSF and PHS sponsored research, the University shall make all reasonable and practical efforts to protect or restore the reputation of a respondent when no finding of research misconduct is made

27. Federal Research Misconduct Policy – Disciplinary Actions by Sponsors • Letter of reprimand • Restrict expenditures under award • Suspension or termination of award • Require correction of research record • Prohibition of individual as federal agency reviewer, advisor, or consultant • Prohibition of individual and/or institution from receiving federal funds (debarment)

28. Examples of Research Misconduct: • Selective “omitting” of data • Representing animal data as if it were from humans • Falsifying images in presentations and published reports • Falsifying data in grant applications • Misrepresentation of others’ works to create independent support for claims • Citation to other works as independent verification for claims when works were ghost-written • Failure to report research misconduct • Obstructing investigations or retaliation against complainant

29. Lessons Learned from Past Research Misconduct Cases • Any person involved in research may be responsible for misconduct, regardless of rank or duties on the project • The majority of respondents have held technical positions and were not doctoral degree holders • Common excuse for research misconduct: excessive work loads and/or time pressure. • Scientific “divorces” are often bitter and irrational; however, the accusations usually do not constitute research misconduct.