Promoting Integrity in Your Animal Research Program Paul Braunschweiger Ph.D Professor Radiation...

Promoting Integrity in Your Promoting Integrity in Your Animal Research ProgramAnimal Research Program

Paul Braunschweiger Ph.DPaul Braunschweiger Ph.DProfessor Radiation OncologyProfessor Radiation Oncology

Chair, University of Miami IACUCChair, University of Miami IACUCDirector, Office of the IACUCDirector, Office of the IACUCCo-Founder, CITI Program.Co-Founder, CITI Program.

www.citiprogram.org www.citiprogram.org

Talking PointsTalking Points

• Why does integrity in the Research Enterprise matter?Why does integrity in the Research Enterprise matter?• The Responsible Conduct of Research and the Public The Responsible Conduct of Research and the Public

TrustTrust– Consequences of violating the Public Trust.Consequences of violating the Public Trust.

• Understanding and managing the conflicts of interestUnderstanding and managing the conflicts of interest• Promoting Integrity and ethical behavior in your animal Promoting Integrity and ethical behavior in your animal

research program.research program.– Post approval monitoringPost approval monitoring

– Foundation of ethical behavior is education.Foundation of ethical behavior is education.

““A personal and steadfast A personal and steadfast commitment to a set of moral or commitment to a set of moral or ethical standards defined by ethical standards defined by your religion, community or your religion, community or professional discipline.”professional discipline.”

Miriam Webster Dictionary www.Miriam-Webster.com Miriam Webster Dictionary www.Miriam-Webster.com

"Integrity" by Canneto, Columbus, OH "Integrity" by Canneto, Columbus, OH

IntegrityIntegrity

Integrity & Responsible Conduct of Integrity & Responsible Conduct of Research Research

• Accepted practices for the RCR can vary from Accepted practices for the RCR can vary from discipline to discipline and even from discipline to discipline and even from laboratory to laboratory. laboratory to laboratory.

• Shared values for the RCR that bind all Shared values for the RCR that bind all researchers together: researchers together: – Honesty - conveying information truthfully and Honesty - conveying information truthfully and

honoring commitments. honoring commitments. – Accuracy- reporting findings precisely and Accuracy- reporting findings precisely and

taking care to avoid errors. taking care to avoid errors. – Efficiency -using resources wisely and avoiding Efficiency -using resources wisely and avoiding

waste. waste. – Objectivity - letting the facts speak for Objectivity - letting the facts speak for

themselves and avoiding improper bias. themselves and avoiding improper bias. – Compliance with regulatory requirements to Compliance with regulatory requirements to

document ethical behavior. document ethical behavior. • Integrity in the ResearchIntegrity in the Research

““IntegrityIntegrity” Fredric Terral 2007” Fredric Terral 2007

Why Does Integrity Matter in Why Does Integrity Matter in Research?Research?

• Puts subjects at risk.Puts subjects at risk.• Injures careersInjures careers• Wastes ResourcesWastes Resources• Wastes TimeWastes Time• Delays acceptance of other research Delays acceptance of other research • Delays development of affective therapies Delays development of affective therapies

or advanced technologies.or advanced technologies.• Undermines the Public Trust.Undermines the Public Trust.

The Public TrustThe Public Trust• The “The “PublicPublic” supports most of the research in the US. ” supports most of the research in the US. • Sponsored research is a privilege and not an entitlement. Sponsored research is a privilege and not an entitlement. • Society Society TrustsTrusts investigators to conduct research ethically investigators to conduct research ethically

and responsibly.and responsibly.• Violation of the public’s trust, brings Violation of the public’s trust, brings RegulationRegulation..• To preserve the Public’s Trust there must be:To preserve the Public’s Trust there must be:

– Accountability.Accountability.– Documentation of ethical conduct.Documentation of ethical conduct.

• Federal Regulations (AWA and PHS Policies) specifically require Federal Regulations (AWA and PHS Policies) specifically require documentation of ethical behavior. documentation of ethical behavior.

• Regulatory requirements to document are designed to:Regulatory requirements to document are designed to: Help investigators conduct research responsibly Help investigators conduct research responsibly

Preserve the Public Trust in research.Preserve the Public Trust in research.

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Consequences of betrayal of the Consequences of betrayal of the Public TrustPublic Trust

• Puts subjects at riskPuts subjects at risk• Federal inquiry / interventionFederal inquiry / intervention• Institutional embarrassmentInstitutional embarrassment• FinesFines• Wasted resources Wasted resources • Personal embarrassmentPersonal embarrassment• Loss of funding, Loss of livelihood Loss of funding, Loss of livelihood • JailJail• Justification and / or vindication for Justification and / or vindication for

groups with anti-research agenda.groups with anti-research agenda.

A.L.F.

Ethical Basis for Responsible Conduct of Ethical Basis for Responsible Conduct of Animal ResearchAnimal Research

• Ethical basis for the RegulationsEthical basis for the Regulations

– 569 - 475 BC569 - 475 BC Pythagoras of SamosPythagoras of Samos

– Greek philosopher - mathematics, astronomy, and Greek philosopher - mathematics, astronomy, and the theory of music. the theory of music.

– Believed in ReincarnationBelieved in Reincarnation– Should not be cruel to animals or eat them. Should not be cruel to animals or eat them. – VegetarianVegetarian

The Athens School by RaphaelThe Athens School by Raphael


• AristotleAristotle– Student of Plato, Teacher to Alexander the Great.Student of Plato, Teacher to Alexander the Great. – Research - Empirical observation and experience.Research - Empirical observation and experience.– Scientific method.Scientific method.– Animals: Animals:

• Sensation, Passion, memory, understand Sensation, Passion, memory, understand relationships. relationships.

• NOT Capable of Thought or reasoningNOT Capable of Thought or reasoning

– Aristotle believed that creatures were arranged in a Aristotle believed that creatures were arranged in a graded scale of perfection.graded scale of perfection.

– Man at a higher state of perfection because Man at a higher state of perfection because Man can reason and reflect.Man can reason and reflect.

– Animals and plants exist for man’s use, but Animals and plants exist for man’s use, but not abuse.not abuse.

Plato and Aristotle – Plato and Aristotle –

““The Athens School” by RaphaelThe Athens School” by Raphael


• Ethical basis for the RegulationsEthical basis for the Regulations– 22ndnd Century Galen "father of vivisection” Century Galen "father of vivisection” – 1313thth Century St T. Aquinas. Charity to animals. Century St T. Aquinas. Charity to animals.– 1717thth Century - R. Descartes Century - R. Descartes

• Animals are complex automata.Animals are complex automata.

• Unconscious beings that can see, hear, touch, anger, fear Unconscious beings that can see, hear, touch, anger, fear

• Do not think or feel pain.Do not think or feel pain.

– 1717thth Century J. Rousseau. Century J. Rousseau.• Animals are sensitive beings, devoid of intellect and Animals are sensitive beings, devoid of intellect and

freedomfreedom

• Man has a duty towards animals to not uselessly mistreat Man has a duty towards animals to not uselessly mistreat them. them.

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• Ethical basis for the RegulationsEthical basis for the Regulations– 1818thth Century - Jeremy Bentham 1748 - 1832 Century - Jeremy Bentham 1748 - 1832

• UtilitarianismUtilitarianism

• The moral status of animals The moral status of animals

• Animals had moral status and rights to be treated Animals had moral status and rights to be treated humanely. humanely.

• ““Cruelty towards animals is an incentive to cruelty towards Cruelty towards animals is an incentive to cruelty towards men.”men.”

• In response to Descartes:In response to Descartes:

““The question is not, Can they reason? nor, The question is not, Can they reason? nor,

Can they talk? but, Can they suffer?Can they talk? but, Can they suffer?””

Before his timeBefore his time

In 1831, he outlined five principles to govern animal experimentation. In 1831, he outlined five principles to govern animal experimentation. Of the Principles of Investigation in PhysiologyOf the Principles of Investigation in Physiology . Lancet 1 (1856), pp. 393–394.. Lancet 1 (1856), pp. 393–394.

• Marshall Hall (1790–1857), a physician and noted Marshall Hall (1790–1857), a physician and noted physiologist, supported animal research but stated physiologist, supported animal research but stated

• ‘‘Unhappily… the subjects of animal physiology are Unhappily… the subjects of animal physiology are sentient, and every experiment is attended by pain sentient, and every experiment is attended by pain and suffering.’and suffering.’

• Hall set out five guiding principles of animal Hall set out five guiding principles of animal research to stimulate debate in the scientific research to stimulate debate in the scientific community:community:– i) the lack of an alternativei) the lack of an alternative– ii) a clear objectiveii) a clear objective– iii) the avoidance of repetition of workiii) the avoidance of repetition of work– iv) the need to minimize sufferingiv) the need to minimize suffering– v) full and detailed publication of the results.v) full and detailed publication of the results.

Marshall HallMarshall Hallby J Holl 1939by J Holl 1939


• Ethical basis for the RegulationsEthical basis for the Regulations– 2020thth Century – Organizations, Codes and Century – Organizations, Codes and

LegislationLegislation• Nuremberg Code. Nuremberg Code.

– Point 3. The experiment should be so designed Point 3. The experiment should be so designed and based on the results of animal and based on the results of animal experimentation and a knowledge of the natural experimentation and a knowledge of the natural history of the disease or other problem under history of the disease or other problem under study that the anticipated results will justify the study that the anticipated results will justify the performance of the experiment.performance of the experiment.

• NIH, NIH, Russell WMS and Burch RL (1959);Russell WMS and Burch RL (1959); – Reduction, Replacement and Refinement Reduction, Replacement and Refinement

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• Ethical basis for the RegulationsEthical basis for the Regulations– 2020thth Century – Organizations, Codes and Legislation Century – Organizations, Codes and Legislation

• The Guide 1963, 1996The Guide 1963, 1996

• AWA, 1966, amended 1970, 1976, AWA, 1966, amended 1970, 1976, 19851985, 1989, 1991, , 1989, 1991, 19931993

• HREA HREA 1985 -- IACUC1985 -- IACUC

– 2121stst Century – Century – • Shift away from animal based models “Alternatives”Shift away from animal based models “Alternatives”

• Animal welfare vs. animal rights.Animal welfare vs. animal rights.

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Integrity in Your Animal Research ProgramIntegrity in Your Animal Research Program

• Starts with Institutional CommitmentStarts with Institutional Commitment• Promoted and nurtured by the IACUCPromoted and nurtured by the IACUC• Embraced by the investigators, staff and students as Embraced by the investigators, staff and students as

““The right thing to do”The right thing to do”

"Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903 "Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903

Promoting Integrity and Ethical BehavioralPromoting Integrity and Ethical BehavioralShared ResponsibilityShared Responsibility

• VeterinariansVeterinarians• Husbandry TechniciansHusbandry Technicians• Vet TechniciansVet Technicians• StudentsStudents• Lab technicians.Lab technicians.• Grad studentsGrad students• Post docs Post docs • CollaboratorsCollaborators• Principle InvestigatorPrinciple Investigator• Institutional officialInstitutional official

Animal Research Enterprise is a Animal Research Enterprise is a Partnership?Partnership?

• The Public The Public • Investigators Investigators • VeterinariansVeterinarians• IACUCIACUC• Institutional officialInstitutional official• Institutions Institutions • Animal subjectsAnimal subjects

Relationships with some common goals and Relationships with some common goals and Interest among stakeholders, but, alsoInterest among stakeholders, but, also

• Many Conflicting InterestsMany Conflicting Interests

Conflicts of Interest in the Animal Use Conflicts of Interest in the Animal Use Program.Program.

• A conflict of interest is a situation in which financial or other personal A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias considerations have the potential to compromise or bias professional judgment and objectivity.professional judgment and objectivity.

– The The appearanceappearance of a conflict of interest is one in which a reasonable of a conflict of interest is one in which a reasonable person would think that the professional's judgment is likely to be person would think that the professional's judgment is likely to be compromised. compromised.

– AA potential potential conflict of interest involves a situation that may develop into conflict of interest involves a situation that may develop into an an actualactual conflict of interest. conflict of interest.

Conflicts of Interest and CommitmentConflicts of Interest and Commitment

• A A conflict of interestconflict of interest exists whether or notexists whether or not decisions are affected by a personal interest. decisions are affected by a personal interest.

• A A conflict of interestconflict of interest implies only the potential for implies only the potential for bias, not a likelihood. bias, not a likelihood.

• A A conflict of interestconflict of interest is is notnot considered research considered research misconduct. misconduct.

• A A conflicts of interestconflicts of interest could lead to misconduct, could lead to misconduct, questionable research practices and/or questionable research practices and/or noncompliance.noncompliance.

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Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

• Tangible CoITangible CoI– An institution's researcher holds an executive position with a company An institution's researcher holds an executive position with a company

that stands to benefit from the animal research he is conducted at the that stands to benefit from the animal research he is conducted at the institution.institution.

– An institutional official is faced with the suspension of a well funded PI’s An institutional official is faced with the suspension of a well funded PI’s protocol for non-compliance.protocol for non-compliance.

– High profile, big $$ investigator expects preferential treatment from the High profile, big $$ investigator expects preferential treatment from the institution. institution.

• Intangible CoIIntangible CoI– Intellectual Bias.Intellectual Bias.

• Peer reviewPeer review– Academic conflict of interest.Academic conflict of interest.

• IACUC reviewsIACUC reviews• Conflicts of conscienceConflicts of conscience

– Religious or Social beliefs might prevent an objective review of a Religious or Social beliefs might prevent an objective review of a protocol or project (e.g., animal research; embryonic stem cell researchprotocol or project (e.g., animal research; embryonic stem cell research

Conflicts of CommitmentConflicts of Commitment

• A researcher is overcommitted.A researcher is overcommitted.– Clinical dutiesClinical duties– Academic committeesAcademic committees– Lab animal researchLab animal research– Clinical researchClinical research– Consulting activitiesConsulting activities– Graduate students and fellowsGraduate students and fellows– FamilyFamily

• Leads to taking short cutsLeads to taking short cuts

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Promoting Integrity and Ethical BehavioralPromoting Integrity and Ethical BehavioralUnderstanding and Understanding and Managing the Conflict of InterestManaging the Conflict of Interest

• The ConflictThe Conflict

– Valuable medical advances with animals as test subjects. Valuable medical advances with animals as test subjects. – Society understands that animals:Society understands that animals:

• Can not understand the research. Can not understand the research. • Can not consent to participate in what may cause them harm, pain or death.Can not consent to participate in what may cause them harm, pain or death.

– Society demands that research animals only be used in ethically Society demands that research animals only be used in ethically designed and conducted projects. designed and conducted projects.

– Investigators must get the data, publish the papers, get the grants Investigators must get the data, publish the papers, get the grants

support their labs and get promoted. support their labs and get promoted. – Institutions want the grants, patents and indirect costs.Institutions want the grants, patents and indirect costs.– A conflict of interest with respect to institutional welfare, the investigators A conflict of interest with respect to institutional welfare, the investigators

welfare, the welfare of their animal subjects and the Public Trustwelfare, the welfare of their animal subjects and the Public Trust

Conflict ResolutionConflict Resolution

• Mismanagement of the conflict can lead to Mismanagement of the conflict can lead to noncompliance, questionable research practices, noncompliance, questionable research practices, sloppy science, and perhaps misconduct. sloppy science, and perhaps misconduct.

• The IACUC specifically empowered by the The IACUC specifically empowered by the federal regulations to manage the conflicts of federal regulations to manage the conflicts of interest between:interest between:– InvestigatorsInvestigators– Welfare of Animal Subjects Welfare of Animal Subjects – Institutions Institutions – SocietySociety

Promoting Integrity and Ethical BehavioralPromoting Integrity and Ethical BehavioralManaging the conflict of interestManaging the conflict of interest

• Vast majority of investigators understand the conflicts and the Vast majority of investigators understand the conflicts and the IACUC’s role in managing them.IACUC’s role in managing them.

Others require special help:Others require special help:– Case 1. Ends justify the means; Case 1. Ends justify the means;

• Busy investigator, juggling lab and clinical researchBusy investigator, juggling lab and clinical research• Several big grants, $$$$$ to the institutionSeveral big grants, $$$$$ to the institution• Must get the data,Must get the data,

– Patients are waiting for new treatmentsPatients are waiting for new treatments– The editor is waiting.The editor is waiting.

• Lip service to animal welfare.Lip service to animal welfare.• Follows most of the rules when convenient, butFollows most of the rules when convenient, but• May take risks because: May take risks because:

– Doesn’t have time to submit the amendment.Doesn’t have time to submit the amendment.– Chances of getting caught are slim and Chances of getting caught are slim and – Consequences are minor or nonexistent Consequences are minor or nonexistent

• Ultimately gets in trouble with the IACUC.Ultimately gets in trouble with the IACUC.• Work is suspendedWork is suspended• Report to sponsor and regulatorsReport to sponsor and regulators


• Others require special help:Others require special help:– Case 2. Pushing the envelope Case 2. Pushing the envelope

• Senior investigatorSenior investigator• ““I have been doing it this way for 20 years”I have been doing it this way for 20 years”• Wants to “do the right thing”. Wants to “do the right thing”. • ““Knows the right” thing to do. But abhors any oversight, Knows the right” thing to do. But abhors any oversight, • Sees the IACUC as an impediment to academic freedom.Sees the IACUC as an impediment to academic freedom.• Pushes the administration for less oversight.Pushes the administration for less oversight.• Reluctantly compliant, but doesn’t buy into the process.Reluctantly compliant, but doesn’t buy into the process.• Provides poor example to trainees lab staff.Provides poor example to trainees lab staff.• Ultimately he or the trainee / staff member gets in trouble Ultimately he or the trainee / staff member gets in trouble

with the IACUC.with the IACUC.• Work may be suspendedWork may be suspended• Report to sponsors and the regulatorsReport to sponsors and the regulators


• Others require special help:Others require special help:– Case 3. Ignorance is blissCase 3. Ignorance is bliss

• Big $$ program, Big $$ program, • Corporate and Public fundingCorporate and Public funding• Thousands of animals.Thousands of animals.• Really wants to do the right thing, but:Really wants to do the right thing, but:

– Poorly organized lab.Poorly organized lab.– Personnel OverwhelmedPersonnel Overwhelmed– Understaffed, Poorly trained staffUnderstaffed, Poorly trained staff– Under funded orUnder funded or– Too cheap to invest in lab manager.Too cheap to invest in lab manager.

• Inevitably will have problems with the Inevitably will have problems with the IACUC.IACUC.

• Work will ultimately be suspended.Work will ultimately be suspended.• Report to sponsors and the regulatorsReport to sponsors and the regulators


• Common elements are:Common elements are:– Inevitably will have problems with the IACUC.Inevitably will have problems with the IACUC.– Work will ultimately be suspended.Work will ultimately be suspended.– Report to sponsors and the regulatorsReport to sponsors and the regulators

• Investigators are busy, high achievers Investigators are busy, high achievers who are under considerable who are under considerable professional pressures to:professional pressures to:– Get the data.Get the data.– Get the data in print.Get the data in print.– Get the next grant funded.Get the next grant funded.– Keep staff employedKeep staff employed– Start the companyStart the company– Get promoted.Get promoted.– Get the raiseGet the raise


• How can the institution help all it’s investigators How can the institution help all it’s investigators conduct their work to the highest ethical conduct their work to the highest ethical standards?standards?

Promoting Integrity.Promoting Integrity.Institutional levelInstitutional level

• Institutional OfficialInstitutional Official– Clear understanding of the IO’s role and responsibility Clear understanding of the IO’s role and responsibility

• Ethics Education and training Ethics Education and training • Reporting to the RegulatorsReporting to the Regulators

– Infrastructure & Resources for veterinary staff. Infrastructure & Resources for veterinary staff. – Infrastructure & Resources for the IACUCInfrastructure & Resources for the IACUC

• StaffingStaffing• TrainingTraining• Oversight ProgramsOversight Programs

– Conflicts of InterestConflicts of Interest• Institution vs. IACUC vs. FacultyInstitution vs. IACUC vs. Faculty

– Commitment to AAALAC accreditationCommitment to AAALAC accreditation

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Promoting IntegrityPromoting IntegrityThe IACUCThe IACUC

Active and rigorous promotion of the “3R”Active and rigorous promotion of the “3R”

• Reduction.Reduction.– Science Review for experimental designScience Review for experimental design

• ControlsControls• Sample size determination.Sample size determination.• Pilot studiesPilot studies

• ReplacementReplacement– Literature review for models with less ethical cost.Literature review for models with less ethical cost.

• RefinementRefinement– New approaches to mitigate against pain and distress.New approaches to mitigate against pain and distress.

• Analgesia strategies Analgesia strategies • EnrichmentEnrichment• Better documentation for waivers of analgesia.Better documentation for waivers of analgesia.

– Technical refinement to reduce model failure.Technical refinement to reduce model failure.

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Promoting IntegrityPromoting IntegrityThe IACUC MembershipThe IACUC Membership

• IACUC membershipIACUC membership– Member education and training.Member education and training.

• New member training.New member training.• Continuing education, refresher courses.Continuing education, refresher courses.• IACUC Members need to understand the expectations of the IACUC Members need to understand the expectations of the

regulators.regulators.• Include educational sessions at meetings.Include educational sessions at meetings.• Participation in national meeting and OLAW, USDA Participation in national meeting and OLAW, USDA

sponsored events.sponsored events.– Enhance the role of the Community MemberEnhance the role of the Community Member

• Insure Community Member understands the process and Insure Community Member understands the process and his/her role.his/her role.

• Encourage questions.Encourage questions.• Multiple Community Members.Multiple Community Members.

– Non Science members Non Science members • StatisticianStatistician• LibrarianLibrarian

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Promoting IntegrityPromoting IntegrityThe IACUC MembershipThe IACUC Membership

• IACUC membershipIACUC membership– Science membersScience members

• Anesthesiologist or pain researcherAnesthesiologist or pain researcher

– Evaluate your IACUC member performance.Evaluate your IACUC member performance.• AttendanceAttendance

• Protocol ReviewProtocol Review

• Participation in Subcommittee ActivitiesParticipation in Subcommittee Activities

– Excuse non-participatory members.Excuse non-participatory members.– Retain responsible members.Retain responsible members.

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Promoting IntegrityPromoting IntegrityIACUC Procedures and ProcessIACUC Procedures and Process

• Protocol ReviewProtocol Review– Designated Review vs. Full Committee ReviewDesignated Review vs. Full Committee Review

• Clear written policies.Clear written policies.• Choice of ReviewersChoice of Reviewers

– Science ReviewScience Review

– Literature Search ReviewLiterature Search Review

– Statistical ReviewStatistical Review

– Analgesia reviewAnalgesia review

• Efficient communication between the “3 I’s” Efficient communication between the “3 I’s” – IACUC, IBC, and IRB.IACUC, IBC, and IRB.

• ConfidentialityConfidentiality• Manage conflicts of interest.Manage conflicts of interest.

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Promoting IntegrityPromoting IntegrityThe IACUC The IACUC

Issues of non-complianceIssues of non-compliance

• Dealing with non-compliance.Dealing with non-compliance.– Provide a easy way for the reporting of concerns.Provide a easy way for the reporting of concerns.

– Clear policies and SOPs for reviewing allegations of non-Clear policies and SOPs for reviewing allegations of non-compliance.compliance.

• Communicate those polices to investigators.Communicate those polices to investigators.• Follow the policies.Follow the policies.

– Get the IO involved early.Get the IO involved early.

– Confidentiality.Confidentiality.

– Protection of whistleblowers.Protection of whistleblowers.

– Reporting promptly to the regulators, AAALAC, sponsors.Reporting promptly to the regulators, AAALAC, sponsors.

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Promoting IntegrityPromoting IntegrityInvestigatorsInvestigators

• Education and Communication.Education and Communication.– Simple and effective means of communication between Simple and effective means of communication between

the IACUC and investigators.the IACUC and investigators.• When policies change alert the investigators. When policies change alert the investigators. • Have a mechanism in place.Have a mechanism in place.

– Training and educationTraining and education• Basic Animal Welfare InstructionBasic Animal Welfare Instruction• Refresher or continuing education.Refresher or continuing education.• Wet labs.Wet labs.

– Documentation of training.Documentation of training.

– Enforcement of the training mandates.Enforcement of the training mandates.

• Monitor Adherence to the protocolsMonitor Adherence to the protocols

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Promoting Integrity in Your Animal Promoting Integrity in Your Animal Research Program.Research Program.

The Post Approval Monitor (PAM)The Post Approval Monitor (PAM)

Integrity in the research program requires oversight.Integrity in the research program requires oversight.

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Post Approval Monitor (PAM)Post Approval Monitor (PAM) ““We are the IACUC and we are here to help you.”We are the IACUC and we are here to help you.”

• PAM - lab science training and customer service PAM - lab science training and customer service demeanor. demeanor. – Arranges meeting with PI & the research team. (annually)Arranges meeting with PI & the research team. (annually)

– Reviews all active protocols.Reviews all active protocols.• Unreported changes to the protocol. Unreported changes to the protocol. • New personnel, training issues.New personnel, training issues.• Record keeping procedures. Record keeping procedures. • Provides Information.Provides Information.

– Training opportunities, Training opportunities,

– Reporting concernsReporting concerns

– Amendments Amendments

• We are the IACUC and we are here to help you.We are the IACUC and we are here to help you.

– Report at the monthly IACUC meeting.Report at the monthly IACUC meeting.

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Promoting Integrity in Your Animal Promoting Integrity in Your Animal Research Program.Research Program.

Investigator TrainingInvestigator Training

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Promoting IntegrityPromoting IntegrityInvestigator TrainingInvestigator Training

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• PHS Policy and USDA RegulationPHS Policy and USDA Regulation– Basic Training Lab Animal WelfareBasic Training Lab Animal Welfare– Continuing EducationContinuing Education

• Investigators, staff, studentsInvestigators, staff, students• IACUC membersIACUC members

– Procedure or model specific trainingProcedure or model specific training• Training vehiclesTraining vehicles

• 1 on 1 instruction1 on 1 instruction• Classroom sessionsClassroom sessions• Web based instructionWeb based instruction

– ““Home Built”Home Built”– AALAS Learning Library, IACUC.orgAALAS Learning Library, IACUC.org– CITI Program. CITI Program.

• Combination of approaches.Combination of approaches.• Evaluation of the training programEvaluation of the training program

CITI Program CITI Program Lab Animal Welfare Educational ProgramLab Animal Welfare Educational Program

opened opened 5-15-07 5-15-07

Anonymous Voluntary User Satisfaction Survey DataAnonymous Voluntary User Satisfaction Survey Data 8-27-07 to 4-2-088-27-07 to 4-2-08

Training Program EvaluationTraining Program Evaluation

• Age, gender, course completed, years conducting L.A. Age, gender, course completed, years conducting L.A. Research Research

• About how many hrs did it take you to complete your Lab About how many hrs did it take you to complete your Lab Animal Welfare Course requirements? Animal Welfare Course requirements?

• The quiz questions addressed the relevant issues in the The quiz questions addressed the relevant issues in the modules? modules?

• I think that the Internet is an appropriate tool to deliver basic I think that the Internet is an appropriate tool to deliver basic instruction in the ethical conduct of research with animal instruction in the ethical conduct of research with animal subjects.subjects.

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Training Program EvaluationTraining Program Evaluation

• After completing this instruction, I now have a better After completing this instruction, I now have a better understanding of how to apply the "3Rs" to insure that my lab understanding of how to apply the "3Rs" to insure that my lab animal studies are conducted to the highest ethical standards?animal studies are conducted to the highest ethical standards?

• Now that I have completed the course, I am more confident in Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on how to apply the my ability to advise a student or a colleague on how to apply the "3Rs" to insure that their lab animal studies are conducted to "3Rs" to insure that their lab animal studies are conducted to the highest ethical standards?the highest ethical standards?

• Now that I have completed this course on the ethical conduct of Now that I have completed this course on the ethical conduct of studies with laboratory animals, I intend to take a more active studies with laboratory animals, I intend to take a more active role in assuring that lab animal research at my institution is role in assuring that lab animal research at my institution is conducted to the highest ethical standards by pursuing conducted to the highest ethical standards by pursuing professional certification, an ethics committee or by joining an professional certification, an ethics committee or by joining an Institutional Animal Care and Use Committee (IACUC)Institutional Animal Care and Use Committee (IACUC)

• How do you rate the Course?How do you rate the Course?

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9% 69%

I intend to take a more active role in assuring that lab animal research at my I intend to take a more active role in assuring that lab animal research at my institution is conducted to the highest ethical standards by pursuing professional institution is conducted to the highest ethical standards by pursuing professional

certification, or by joining an ethics committee or Institutional Animal Care and Use certification, or by joining an ethics committee or Institutional Animal Care and Use Committee (IACUC).Committee (IACUC).

0%0%

5%5%

10%10%

15%15%

20%20%

25%25%

30%30%

% R

es

po

nd

ers

(n

=1

29

7)

% R

es

po

nd

ers

(n

=1

29

7)

11 22 33 44 55 66 77 88 99

Strongly disagree Strongly agreeStrongly disagree Strongly agree

14% 14% 58% 58%

SummarySummary

• The active promotion of integrity in the research The active promotion of integrity in the research enterprise is essential to maintain the enterprise is essential to maintain the Public Public TrustTrust. . – Without the Public Trust there can be now Without the Public Trust there can be now

researchresearch

• Institutional Support provides the backbone for Institutional Support provides the backbone for the Animal Research Program.the Animal Research Program.– Educate the IOEducate the IO– AAALAC accreditationAAALAC accreditation

• Management of conflicts of interest between Management of conflicts of interest between – Investigators, the institution and the animal Investigators, the institution and the animal

subjects is crucial to well run animal care program.subjects is crucial to well run animal care program.

““Integrity” by Joris Plu 2005Integrity” by Joris Plu 2005

SummarySummary• Institution and the IACUC should make it easy for Institution and the IACUC should make it easy for

investigators to be compliant. investigators to be compliant. – Take a look at your process. Reduce the time between Take a look at your process. Reduce the time between

submission and approval.submission and approval.– Institute Post Approval Protocol Monitor systemInstitute Post Approval Protocol Monitor system

• ““We are the IACUC, yes we are the cops, but we are here to help We are the IACUC, yes we are the cops, but we are here to help you.”you.”

• Marked reduction in non-compliance. Marked reduction in non-compliance.

– The foundation of research integrity is educationThe foundation of research integrity is education• Early, often, multiple formatsEarly, often, multiple formats• Evaluate your Animal use training program. Is it working Evaluate your Animal use training program. Is it working

for you?for you?• Listen to the feedback from your learners.Listen to the feedback from your learners.

• Promoting Integrity is everyone’s responsibility.Promoting Integrity is everyone’s responsibility.– Leads to good animal careLeads to good animal care– Leads to good science.Leads to good science.– Compliance Compliance

• The Responsible Conduct of Research is beyond simply The Responsible Conduct of Research is beyond simply being compliant with Federal regulationsbeing compliant with Federal regulations..

It is just The “right thing to do”.It is just The “right thing to do”.

““New Integrity” by Artibella Avanti New Integrity” by Artibella Avanti

Joseph Wright (September 3, 1734 - August 29, 1797),

““An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797)An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797)British National Gallery- London British National Gallery- London

Promoting Integrity in Your Promoting Integrity in Your Animal Research ProgramAnimal Research Program

Paul Braunschweiger Ph.DPaul Braunschweiger Ph.DProfessor Radiation OncologyProfessor Radiation Oncology

Chair, University of Miami IACUCChair, University of Miami IACUCDirector, Office of the IACUCDirector, Office of the IACUCCo-Founder, CITI Program.Co-Founder, CITI Program.

Promoting Integrity in Your Animal Research Program Paul Braunschweiger Ph.D Professor Radiation...

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