the responsible conduct of research

The Responsible Conduct of Research The Responsible Conduct of Research

Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.Professor of Radiation OncologyProfessor of Radiation OncologyChair, University of Miami IACUCChair, University of Miami IACUC

Talking pointsTalking points

• What is RCRWhat is RCR and why is it importantand why is it important• New Guidelines, NSF, NIH.New Guidelines, NSF, NIH.• Intersection of RCR and Lab animal Intersection of RCR and Lab animal

welfare.welfare.• Resources for teaching the RCRResources for teaching the RCR

NSF Mandate for RCR EducationNSF Mandate for RCR Education

• August 20, 2009 NSF implementation of Section 7009 of the August 20, 2009 NSF implementation of Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C. in Technology, Education, and Science (COMPETES) Act (42 U.S.C. 1862o–1).1862o–1). http://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf

• Requires that …..‘‘each institution that applies for financial assistance Requires that …..‘‘each institution that applies for financial assistance from the Foundation for science and engineering research or from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research postdoctoral researchers participating in the proposed research project.’’project.’’

http://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf


• January 4, 2010, NSFJanuary 4, 2010, NSF will require that, at the time of will require that, at the time of proposal submission to NSF, a proposing institution’s proposal submission to NSF, a proposing institution’s Authorized Organizational RepresentativeAuthorized Organizational Representative certify that certify that the institution has a plan to provide appropriate the institution has a plan to provide appropriate training and oversight in the responsible and ethical training and oversight in the responsible and ethical conduct of research to undergraduates, graduate conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be students, and postdoctoral researchers who will be supported by NSF to conduct research. supported by NSF to conduct research.


• ContentContent– No specific recommendation. No specific recommendation. – ““Therefore, it is the responsibility of each institution to determine both the Therefore, it is the responsibility of each institution to determine both the

content and the delivery method for the training that will meet the institution’s content and the delivery method for the training that will meet the institution’s particular needs for RCR training in all areas at that institution for which NSF particular needs for RCR training in all areas at that institution for which NSF provides support.”provides support.”

• Delivery methodDelivery method– No specific recommendationsNo specific recommendations– ““It will be up to each institution to determine how best to ensure It will be up to each institution to determine how best to ensure

effective and appropriate education in responsible research practices.”effective and appropriate education in responsible research practices.”

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NIH MandateNIH Mandate

• PolicyPolicy– NIH requires that all trainees, fellows, participants, and scholars receiving support through any

NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. This policy will take effect with all new and renewal applications submitted on or after January 25, January 25, 20102010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011January 1, 2011..

• National Institutes of Health (NIH), NOT-OD-10-019, issued November National Institutes of Health (NIH), NOT-OD-10-019, issued November 24, 2009.24, 2009.

NIH MandateNIH Mandate

• National Institutes of Health (NIH), NOT-OD-10-019, National Institutes of Health (NIH), NOT-OD-10-019, November 24, 2009.November 24, 2009.1.1. Develops principles on providing instruction in responsible conduct of research.Develops principles on providing instruction in responsible conduct of research.2.2. Specific about who should participate, how often instruction should occur, and the Specific about who should participate, how often instruction should occur, and the

form that instruction should take; form that instruction should take; 3.3. Addresses issues that have arisen as the practice of biomedical, behavioral and Addresses issues that have arisen as the practice of biomedical, behavioral and

clinical science has evolvedclinical science has evolved4.4. Provides guidance to applicants, peer reviewers and NIH staff in determining how Provides guidance to applicants, peer reviewers and NIH staff in determining how

well specific plans for instruction in responsible conduct of research compare with well specific plans for instruction in responsible conduct of research compare with the best practices.the best practices.

NOT-OD-10-019, issued November 24, 2009.NOT-OD-10-019, issued November 24, 2009.RCR 12-29-07

ApplicabilityApplicability

• This Notice applies to:This Notice applies to:– All NIH Institutional Research Training Grants, All NIH Institutional Research Training Grants, – Individual Fellowship Awards, Individual Fellowship Awards, – Career Development Awards (Institutional and Individual),Career Development Awards (Institutional and Individual),– Research Education Grants, Research Education Grants, – Dissertation Research Grants, Dissertation Research Grants, – Other grant programs with a training component that requires Other grant programs with a training component that requires

instruction in responsible conduct of research as noted in the instruction in responsible conduct of research as noted in the Funding Opportunity Announcement.Funding Opportunity Announcement.


Principles for the RCRPrinciples for the RCR1.1. Responsible conduct of research is an essential component of research training. Instruction in RCR is an Responsible conduct of research is an essential component of research training. Instruction in RCR is an

integral part of all research training programs. integral part of all research training programs. Its evaluation will impact funding decisions.Its evaluation will impact funding decisions.

2.2. Active involvement in the issues of responsible conduct of research should occur throughout a scientist’s Active involvement in the issues of responsible conduct of research should occur throughout a scientist’s career. career. – Instruction in responsible conduct of research should therefore be appropriate to the career stage of the Instruction in responsible conduct of research should therefore be appropriate to the career stage of the

individuals receiving training.individuals receiving training.

3.3. Individuals supported by individual funding opportunities such as fellowships and career development Individuals supported by individual funding opportunities such as fellowships and career development awards awards are encouraged to assume individual and personal responsibilityare encouraged to assume individual and personal responsibility for their instruction in for their instruction in responsible conduct of research.responsible conduct of research.


Principles for the RCRPrinciples for the RCR4.4. Research faculty Research faculty of the institution should participate in instruction in of the institution should participate in instruction in

RCR in ways that allow them to RCR in ways that allow them to serve as effective role models serve as effective role models for for their trainees, fellows, and scholars. their trainees, fellows, and scholars.

5.5. Instruction should include face-to-face discussions Instruction should include face-to-face discussions by course by course participants and faculty; i.e., participants and faculty; i.e., on-line instruction may be a component on-line instruction may be a component of instruction of instruction in responsible conduct of research in responsible conduct of research but is not sufficient to but is not sufficient to meet the NIH requirement meet the NIH requirement for such instruction, except in special or for such instruction, except in special or unusual circumstances. unusual circumstances.

6.6. Instruction in responsible conduct of research must be Instruction in responsible conduct of research must be carefully carefully evaluated in all NIH grant applications for which it is a required evaluated in all NIH grant applications for which it is a required component. component.

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5 Instructional Components5 Instructional Components

1.1. FormatFormat– Face-to-face discussionsFace-to-face discussions among the participating among the participating

trainees/fellows/scholars/participant. trainees/fellows/scholars/participant. – While While on-line courses can be a valuable supplementon-line courses can be a valuable supplement to to

instruction in responsible conduct of research, online instruction instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. is not considered adequate as the sole means of instruction.


Instructional ComponentsInstructional Components2. Subject Matter 2. Subject Matter • While there are no specific curricular requirements for instruction While there are no specific curricular requirements for instruction

in responsible conduct of research, the following topics have been in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction: incorporated into most acceptable plans for such instruction: – Conflict of interest Conflict of interest – personal, professional, and financial– personal, professional, and financial– Human and non-human subjects Human and non-human subjects welfare, and welfare, and safe laboratory practicessafe laboratory practices– Mentor/mentee responsibilities Mentor/mentee responsibilities and relationships and relationships – Collaborative research Collaborative research including collaborations with industry including collaborations with industry – Peer review. Peer review. – Data acquisition Data acquisition and management.and management.– Research misconduct Research misconduct and reporting misconduct .and reporting misconduct .– Responsible authorship Responsible authorship and publication.and publication.– The scientist as a responsible member of societyThe scientist as a responsible member of society, contemporary ethical , contemporary ethical

issues in biomedical research, and the issues in biomedical research, and the environmental and societal environmental and societal impacts of scientific researchimpacts of scientific research


Instructional ComponentsInstructional Components3.3. Faculty ParticipationFaculty Participation

– Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Full faculty participation.instruction in responsible conduct of research. Full faculty participation.

4.4. Duration of instructionDuration of instruction– ““Substantive contact hours”. Substantive contact hours”. Acceptable programs generally involve at least eight contact hours.Acceptable programs generally involve at least eight contact hours. – Semester long program maybe better than a one day 8 hr workshop.Semester long program maybe better than a one day 8 hr workshop.

5.5. Frequency of instruction.Frequency of instruction.– “…“…at the undergraduate, post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels.at the undergraduate, post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels.””– ……. . Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once

every four yearsevery four years..

• Grant applications must address all 5 components. Grant applications must address all 5 components.


Peer reviewPeer review• Applications Applications lacking a plan lacking a plan for instruction in responsible conduct for instruction in responsible conduct

of research will be considered of research will be considered incompleteincomplete and may be delayed and may be delayed in the review process or not reviewed.in the review process or not reviewed.

• Applications with a “Plan”Applications with a “Plan”– Reviewers will specifically address the five Instructional Reviewers will specifically address the five Instructional

Components (Format, Subject Matter, Faculty Participation, Components (Format, Subject Matter, Faculty Participation, Duration and Frequency) .Duration and Frequency) .

– Review panel’s evaluation of the plan will not be a factor in Review panel’s evaluation of the plan will not be a factor in the determination of the impact/priority score. the determination of the impact/priority score.

– Plans and past record will be rated as Plans and past record will be rated as ACCEPTABLE ACCEPTABLE or or UNACCEPTABLE. UNACCEPTABLE.

– Regardless of Priority Score, applications with Regardless of Priority Score, applications with unacceptable unacceptable plans plans will not be funded until the applicant provides an will not be funded until the applicant provides an acceptable, revised plan. acceptable, revised plan.

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ComplianceCompliance

• NIH policy NIH policy requires participation in and successful completion requires participation in and successful completion of of instruction in responsible conduct of research by individuals instruction in responsible conduct of research by individuals supported by any NIH training/research education/fellowship supported by any NIH training/research education/fellowship /career award. /career award.

• It is expected that It is expected that course attendance is monitored course attendance is monitored and that a and that a certificate or documentation of participation is available upon certificate or documentation of participation is available upon course completion. course completion.

• NIH does not require certification of compliance or submission of NIH does not require certification of compliance or submission of documentation, but documentation, but expects institutions to maintain records expects institutions to maintain records sufficient to demonstrate that NIH-supported trainees, fellows, sufficient to demonstrate that NIH-supported trainees, fellows, and scholars have received the required instruction.and scholars have received the required instruction.

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ResourcesResources• The The NIH Research Training website NIH Research Training website ((

http://grants.nih.gov/training/extramural.htm) includes additional ) includes additional information on instruction in responsible conduct of research.information on instruction in responsible conduct of research.

• Office of Research Integrity Office of Research Integrity ((http://ori.hhs.gov/), links to ), links to instructional materials, and examples of programs that have been instructional materials, and examples of programs that have been regarded as good models for instruction in responsible conduct of regarded as good models for instruction in responsible conduct of research (research (http://bioethics.od.nih.gov/researchethics.html). ).

• The National Academy Press The National Academy Press has just published the 3rd. edition has just published the 3rd. edition of the classic, of the classic, On Being a ScientistOn Being a Scientist, and is available online at , and is available online at http://books.nap.edu/catalog.php?record_id=12192..

• The CITI Program The CITI Program www.citiprogram.org , On-line program in the , On-line program in the RCR. Text, case studies, video vignettes and quizzes in the nine RCR. Text, case studies, video vignettes and quizzes in the nine topic areas of RCR. Training data management.topic areas of RCR. Training data management.

• Responsible Conduct of Research Education Committee Responsible Conduct of Research Education Committee ((RCRECRCREC) ) http://rcrec.org

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http://grants.nih.gov/training/extramural.htm

http://ori.hhs.gov/

http://bioethics.od.nih.gov/researchethics.html

http://books.nap.edu/catalog.php?record_id=12192

http://www.citiprogram.org/

http://rcrec.org/

What is the RCRWhat is the RCR

What is involved in RCR educationWhat is involved in RCR education

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.

• Some shared values for the RCR that bind all Some shared values for the RCR that bind all researchers together: researchers together: – HonestyHonesty - conveying information truthfully and - conveying information truthfully and

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

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

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

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

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

““IntegrityIntegrity” Fredric Terral 2007” Fredric Terral 2007

Integrity in Research EnterpriseIntegrity in Research Enterprise

• Starts with Institutional CommitmentStarts with Institutional Commitment• Promoted and nurtured by the IACUC, IRB, IBC, CoIC, ESCROPromoted and nurtured by the IACUC, IRB, IBC, CoIC, ESCRO• Promotes of scientifically valid dataPromotes of scientifically valid data• Avoids or minimizes all COIsAvoids or minimizes all COIs• 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

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• 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..

The Public TrustThe Public Trust

• New Regulations are not the result of good or ethical behavior.New Regulations are not the result of good or ethical behavior.• Federal Regulations specifically requireFederal Regulations specifically require

– AccountabilityAccountability– Documentation of ethical behaviorDocumentation 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.

• Without the Public’s Trust there is no researchWithout the Public’s Trust there is no research

Betrayal of the Public Trust Brings Betrayal of the Public Trust Brings RegulationRegulation

• 1984 Univ. Penn. Head Trauma Study.1984 Univ. Penn. Head Trauma Study.– PETA and ALF alleges inhumane research practices.PETA and ALF alleges inhumane research practices.– VideosVideos– NIH investigated. Research activities not conducted according NIH investigated. Research activities not conducted according

the existing policies.the existing policies.• Lack of adequate anesthesia and analgesia.Lack of adequate anesthesia and analgesia.• Lack of sterile technique. Lack of sterile technique. • Lack of supervision by PI.Lack of supervision by PI.• Lack of training of laboratory personnel.Lack of training of laboratory personnel.

– NIH Shut down the project.NIH Shut down the project.• Research Project permanently shut down.Research Project permanently shut down.

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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 • FinesFines• Justification and / or vindication for Justification and / or vindication for

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

A.L.F.RCR 12-29-07

The Foundation of Ethical The Foundation of Ethical Research Practices is Research Practices is

Research Ethics EducationResearch Ethics Education

Promoting integrity in the Promoting integrity in the Research EnterpriseResearch Enterprise

• Teaching the Responsible Conduct of Teaching the Responsible Conduct of ResearchResearch– Books, Journal articlesBooks, Journal articles– Classroom experienceClassroom experience– Seminars and conferencesSeminars and conferences

• Professional SocietiesProfessional Societies

– Web based courses and tutorials.Web based courses and tutorials.– Mentoring Mentoring

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The Responsible Conduct of The Responsible Conduct of ResearchResearch

1.1. Research Misconduct.Research Misconduct.2.2. Data Acquisition and Management.Data Acquisition and Management.3.3. Responsible Authorship.Responsible Authorship.4.4. Conflicts of Interest.Conflicts of Interest.5.5. Responsible Peer Review.Responsible Peer Review.6.6. Human Subjects Protection.Human Subjects Protection.7.7. Lab Animal Welfare.Lab Animal Welfare.8.8. Mentoring.Mentoring.9.9. Responsible Collaborative Research.Responsible Collaborative Research.10.10. Financial responsibility.Financial responsibility.11.11. Environmental ethics.Environmental ethics.

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Data Acquisition and ManagementData Acquisition and Managementstudy designstudy design

• Humane endpointsHumane endpoints– Minimizing Pain and distress Minimizing Pain and distress

• Statistically justified sample size determinations.Statistically justified sample size determinations.• Data security – Data security –

– Photography and video in animal experimentation.Photography and video in animal experimentation.

• Data acquisition and usage,Data acquisition and usage,– Data obtained from studies where unapproved Data obtained from studies where unapproved

procedures have been used.procedures have been used.

• Pilot studiesPilot studies– When does a pilot study cease being a pilot study.When does a pilot study cease being a pilot study.

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Responsible AuthorshipResponsible Authorship• Who on the research team deserves to be listed Who on the research team deserves to be listed

in the byline of the paper and who should be an in the byline of the paper and who should be an author.author.

• According to the ICMJEAccording to the ICMJE– Design of the experiments.Design of the experiments.– Writing and/or editing the paperWriting and/or editing the paper– Approval of the manuscript before submission to the Approval of the manuscript before submission to the

journal.journal.

• Which can can be ethically published.Which can can be ethically published.• Publishing negative dataPublishing negative data

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MentoringMentoringThe social fabric of scienceThe social fabric of scienceExcellent approach to teaching Excellent approach to teaching

research ethics and lab animal welfare.research ethics and lab animal welfare.

The Ideal MentorThe Ideal Mentor

• ““The truly complete mentor." This is "a The truly complete mentor." This is "a single individual who is able to serve as an single individual who is able to serve as an advisor/guide, developer of talent/coach, advisor/guide, developer of talent/coach, opener of doors/advocate, role model, opener of doors/advocate, role model, interpreter of organizational or professional interpreter of organizational or professional rules, protector, rule setter/boss - and rules, protector, rule setter/boss - and carries on all of these functions on a long carries on all of these functions on a long term basis." term basis."

Silen, "In Search of the Complete Mentor," in Mentations, Volume 5-Fall Silen, "In Search of the Complete Mentor," in Mentations, Volume 5-Fall 1998,at 1998,at http://www.hms.harvard.edu/dcp/mentations/fall_98/searchofmentor.html

Ideal mentoring may require input from more than one person! Ideal mentoring may require input from more than one person!

http://www.hms.harvard.edu/dcp/mentations/fall_98/searchofmentor.html

MentoringMentoring

• Most mentors are not well trained.Most mentors are not well trained.• Confusion, Res. Advisors vs. Mentors.Confusion, Res. Advisors vs. Mentors.• Trainees often learn unethical practices Trainees often learn unethical practices

and short cuts from the mentor / research and short cuts from the mentor / research advisor.advisor.

• Taking short cuts can get the students Taking short cuts can get the students and fellows in trouble with the IACUC.and fellows in trouble with the IACUC.

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Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

Conflicts of Interest and CommitmentConflicts of Interest and Commitment• 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 considerations have the potentialthe potential to compromise or bias professional judgment to compromise or bias professional judgment and objectivity.and objectivity.

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

– A CoI A CoI exists whether or notexists whether or not decisions are affected by a personal interest. decisions are affected by a personal interest. – A potential CoI involves a situation that may develop into an actual conflict of interest. A potential CoI involves a situation that may develop into an actual conflict of interest. – A CoI is A CoI is notnot considered misconduct in research, since the definition for misconduct is considered misconduct in research, since the definition for misconduct is

currently limited to F.F&P.currently limited to F.F&P.– A CoI could lead to misconduct.A CoI could lead to misconduct.

Conflicts of Interest and Conflicts of Interest and Commitment.Commitment.

• Tangible conflicts of InterestTangible conflicts of Interest– Investigator has a financial stake in the outcome of Investigator has a financial stake in the outcome of

an experiment or trial.an experiment or trial.• CoIs require management strategiesCoIs require management strategies

– Disclosure by the investigator, Disclosure by the investigator, – CoIs managed by the institution, CoIs managed by the institution, – Reported to the Feds.Reported to the Feds.

WHAT DO THESE 4 PHYSICIANS WHAT DO THESE 4 PHYSICIANS HAVE IN COMMONHAVE IN COMMONDr. CharlesNemeroff

Harvard UniversityHarvard University$4 million in unreported $4 million in unreported consulting revenues from consulting revenues from Pharmaceutical Industry. Pharmaceutical Industry. Promoted antipsychotic drugs Promoted antipsychotic drugs in childrenin children

GOV. GRANTS GOV. GRANTS

Emory UniversityEmory UniversityTook >$500K in unreported Took >$500K in unreported consulting income from Glaxo. consulting income from Glaxo. Gov. Funded research on Gov. Funded research on Glaxo drugsGlaxo drugs

Conflicts of Interest and Conflicts of Interest and Commitment.Commitment.

• Conflicts of commitment.Conflicts of commitment.– Using institutional time for consulting.Using institutional time for consulting.– Using institutional resources for personal gain.Using institutional resources for personal gain.– Using graduate students/fellows for work on company Using graduate students/fellows for work on company

projects. projects.

• Other intangible conflicts of interest.Other intangible conflicts of interest.– Personnel and professional. Personnel and professional.

• IACUC, IRB, ESCRO.IACUC, IRB, ESCRO.• Personal relationships. Good and Bad.Personal relationships. Good and Bad.

– Conflicts of conscienceConflicts of conscience• Religious beliefs.Religious beliefs.• Philosophical differences (e.g., status of animals.)Philosophical differences (e.g., status of animals.)

CoI in Animal Research CoI in Animal Research ProgramProgram

Understanding and Understanding and Managing the Conflict of InterestManaging the Conflict of Interest

• The Public’s InterestsThe Public’s Interests

– Society demands medical advances.Society demands medical advances.– Society understands that animals as subjects:Society understands that animals as subjects:

• Can not understand the research. Can not understand the research. • Can not consent to participate in what may cause them Can not consent to participate in what may cause them

harm, pain or death.harm, pain or death.– Society demands documentation that animal research is Society demands documentation that animal research is

ethically designed and conducted. ethically designed and conducted.

Understanding and Understanding and Managing the Conflict of InterestManaging the Conflict of Interest •

• The investigator InterestsThe investigator Interests

– Get the data, publish the papers, get the grants, support their Get the data, publish the papers, get the grants, support their labs, get promoted, get a raise, buy the new boat. labs, get promoted, get a raise, buy the new boat.

• The Interests of the VeterinariansThe Interests of the Veterinarians– Animal welfare Vs. Helping investigators get their work done.Animal welfare Vs. Helping investigators get their work done.– Veterinarians as co-investigators, coauthor.Veterinarians as co-investigators, coauthor.

• Institutional interestsInstitutional interests– Institutions want the grants, patents and indirect costs.Institutions want the grants, patents and indirect costs.– IOs need to be willing to deal with problematic faculty regardless IOs need to be willing to deal with problematic faculty regardless

of the grant suppport. of the grant suppport.

The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the tensions and conflicts.tensions and conflicts.

The IACUC and Conflict ManagementThe IACUC and Conflict Management• IACUC has the oversight responsibility for all animal IACUC has the oversight responsibility for all animal

use at the Organization.use at the Organization.– Manages interests of the “Public” vs other competing interests.Manages interests of the “Public” vs other competing interests.– Makes sure the investigators consider the interests of the Makes sure the investigators consider the interests of the

animals.animals.– Reviews animal activities for sound experimental design and Reviews animal activities for sound experimental design and

the 3Rs.the 3Rs.– Insures the veterinary program is not unduly influenced by the Insures the veterinary program is not unduly influenced by the

organization. organization. – Insures that institutions commit appropriate funding to support Insures that institutions commit appropriate funding to support

the mission of the Animal Use Program.the mission of the Animal Use Program.– Independently investigates non-compliance.Independently investigates non-compliance.

• Can suspend activities that are not being conducted ethically and Can suspend activities that are not being conducted ethically and put animals at risk.put animals at risk.

The IACUC and Conflict The IACUC and Conflict ManagementManagement

• IACUC Reports the good, the bad and ugly to:IACUC Reports the good, the bad and ugly to:– Institutional OfficialInstitutional Official– OLAW and USDAOLAW and USDA– Follow - upFollow - up

• IACUC appointed by highest institutional authority.IACUC appointed by highest institutional authority.– Protect the University’s interestsProtect the University’s interests– Manage the CoIManage the CoI– Maintain the Public’s trustMaintain the Public’s trust

Research Ethics EducationResearch Ethics EducationCITI Program CITI Program

• Human Subjects ProtectionHuman Subjects Protection• Good Clinical Practice.Good Clinical Practice.• Lab Animal Welfare.Lab Animal Welfare.• Responsible Conduct of Research.Responsible Conduct of Research.• Bio-safety and Bio-securityBio-safety and Bio-security

– [email protected]@med.miami.edu– 305 243-7970305 243-7970

• Human Subjects ProtectionHuman Subjects Protection• Good Clinical Practice.Good Clinical Practice.• Lab Animal WelfareLab Animal Welfare..• Responsible Conduct of Research.Responsible Conduct of Research.• Bio-safety and Bio-security

CITI Laboratory Animal CITI Laboratory Animal Welfare ProgramWelfare Program

InvestigatorsInvestigatorsIACUC Members IACUC Members

Lab Animal Welfare Course Lab Animal Welfare Course Site UsageSite Usage

sites CRs CR per month % increase2009 311 49,566 4,506 32%2008 271 40,908 3,409

LAW Courses LAW Courses 20092009

Basic CoursesBasic CoursesWorking with the IACUCWorking with the IACUCWorking with the VA IACUCWorking with the VA IACUCEssentials for IACUC MembersEssentials for IACUC Members

Working With Animals In Biomedical Research - Refresher Working With Animals In Biomedical Research - Refresher CourseCourse

LAW Courses CompletedLAW Courses Completed20092009

Model Specific CoursesModel Specific CoursesWorking with Mice in ResearchWorking with Mice in ResearchWorking with Rats in Research SettingsWorking with Rats in Research SettingsReducing Pain and Distress in Laboratory Mice and RatsReducing Pain and Distress in Laboratory Mice and RatsAseptic surgeryAseptic surgeryWorking with Swine in Research SettingsWorking with Swine in Research SettingsWorking with Rabbits in Research SettingsWorking with Rabbits in Research SettingsWorking with Amphibians in Research SettingsWorking with Amphibians in Research SettingsWorking with Nonhuman Primates in Research SettingsWorking with Nonhuman Primates in Research SettingsWorking with Dogs in ResearchWorking with Dogs in ResearchWorking with Guinea Pigs in Research SettingsWorking with Guinea Pigs in Research SettingsWorking with Hamsters in Research SettingsWorking with Hamsters in Research SettingsWorking with Cats in Research SettingsWorking with Cats in Research SettingsWorking with Gerbils in Research SettingsWorking with Gerbils in Research Settings

www.citiprogram.orgwww.citiprogram.org

““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

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

the responsible conduct of research

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