PRESENTATION ON IACUC COMPLIANCE ANDRESEARCH MISCONDUCTMAY 13, 2011 Tulane University IACUC and Research Compliance

Instructors Brian Weimer

Tulane University Research Compliance Officerbweimer1@tulane.edu504.988.1147http://tulane.edu/asvpr/research-compliance.cfm

Sheila GarrisonTulane University IACUC Directorsgarriso@tulane.edu504.988.6868http://tulane.edu/asvpr/iacuc/index.cfm

Outline of PresentationI. Oversight of use of animals in researchII. Non-ComplianceIII. Writing and submitting an animal use

protocolIV. Research Misconduct policy (if time

permits)

Please ask questions at any time if you have them.

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

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

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

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

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

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.

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

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

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

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.

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)

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)

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

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

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

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?

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

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:

1. Falsification of data: ranging from fabrication to deceptive, selective reporting, including the purposeful omission of conflicting data with the intent to falsify results;

2. Plagiarism: representation of another's work as one's own; or3. 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.

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

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.

Tulane Research Misconduct Policy – the Process (continued)

4 Stages of the process:1. Inquiry2. Investigation3. Formal Finding4. Appropriate Disposition.

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

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

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)

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

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.