PRESENTATION ON IACUC
COMPLIANCE AND
RESEARCH MISCONDUCT
MAY 13, 2011
Tulane University IACUC and Research Compliance
Instructors
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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
Outline of Presentation
I.
II.
III.
IV.
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.
IACUC
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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:
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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
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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
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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
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First version passed in 1966
Administered by USDA-APHIS
Provisions for “covered species” include:
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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)
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Excluded Species:
 Laboratory
mice and rats
 Cold-blooded vertebrates (such as fish or frogs)
 Invertebrates (such as fruit flies or worms)
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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”)
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PHS-funded institutions are required to follow
Forms the basis for AAALAC Accreditation
Covers all aspects of animal care programs and facilities
Focuses on:
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Institutional Policies
Animal Environment, Housing, and Management
Veterinary Medical Care
Physical Plant
Available online at
http://grants.nih.gov/grants/olaw/Guide-for-the-Careand-use-of-laboratory-animals.pdf
PHS Policy on Humane Care and Use
of Laboratory Animals
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Applies to any institution that receives PHS funds for
vertebrate animal research (broader than the Animal
Welfare Act)
Institutions with an “Assurance” must:
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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
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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
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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
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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
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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
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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
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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
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USDA Animal Welfare Act
 Institutional
fine
 Cease and desist order
 Request to federal funding agencies to suspend or
revoke funding
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PHS Policy
 Revocation
institution
of assurance and loss of funding for entire
What is OLAW looking for when the
IACUC reports Non-Compliance?
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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
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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
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Conducts site visits every three years
Tulane Research Misconduct Policy
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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:
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3.
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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.
Tulane Research Misconduct Policy –
the Process
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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
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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
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Tulane Research Misconduct Policy –
the Process (continued)
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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.
2.
3.
4.
Inquiry
Investigation
Formal Finding
Appropriate Disposition.
Examples of Disciplinary Actions by the
University for Research Misconduct
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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
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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
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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:
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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
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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.