6-9-086-9-08

““Promoting Integrity in the Research Promoting Integrity in the Research Enterprise. – A Shared Responsibility”Enterprise. – A Shared Responsibility”

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

Co-Founder, CITI Program.Co-Founder, CITI Program.www.citiprogram.orgwww.citiprogram.org

6-9-086-9-08

““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

6-9-086-9-08

Talking PointsTalking Points

• Why does integrity in the Research Enterprise Why does integrity in the Research Enterprise matter?matter?

• The Responsible Conduct of Research and the Public The Responsible Conduct of Research and the Public TrustTrust

• Responsible Conduct of Research.Responsible Conduct of Research.– Research misconductResearch misconduct– Authorship issuesAuthorship issues– Conflicts of InterestConflicts of Interest

• Case StudiesCase Studies• CITI ProgramCITI Program

6-9-086-9-08

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

IntegrityIntegrity

6-9-086-9-08

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.

6-9-086-9-08

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; 45CFR46) specifically require Federal Regulations (AWA; 45CFR46) 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 and toHelp investigators conduct research responsibly and to

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

6-9-086-9-08

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

• Federal inquiry / intervention/ audit / suspensionFederal inquiry / intervention/ audit / suspension• 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 groups with Justification and / or vindication for groups with

anti-research agenda. (PETA, ALF)anti-research agenda. (PETA, ALF)

6-9-086-9-08

Integrity in ResearchIntegrity in Research

• Starts with Institutional CommitmentStarts with Institutional Commitment• Promoted and nurtured by the IRB, IACUCPromoted and nurtured by the IRB, 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 

6-9-086-9-08

The Responsible Conduct of The Responsible Conduct of ResearchResearch

6-9-086-9-08

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

• Accepted practices can vary from discipline to Accepted practices can vary from discipline to discipline. discipline.

• 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 Research is demonstrated by Integrity in the Research is demonstrated by the RCR.the RCR.

““IntegrityIntegrity” Fredric Terral 2007” Fredric Terral 2007

6-9-086-9-08

The Responsible Conduct of The Responsible Conduct of ResearchResearch

• Research MisconductResearch Misconduct• Data Acquisition and ManagementData Acquisition and Management• Responsible AuthorshipResponsible Authorship• Responsible Peer ReviewResponsible Peer Review• Human Subjects ProtectionHuman Subjects Protection• Lab Animal WelfareLab Animal Welfare• MentoringMentoring• Conflicts of InterestConflicts of Interest• Responsible Collaborative ResearchResponsible Collaborative Research

6-9-086-9-08

Research integrity is a shared Research integrity is a shared responsibilityresponsibility

• Promoting integrity is the responsibility of:Promoting integrity is the responsibility of:– Lab Technicians.Lab Technicians.– Students.Students.– Data managers.Data managers.– Research administrators.Research administrators.– Nurse study coordinators.Nurse study coordinators.– Clinical scientist collaborators.Clinical scientist collaborators.– Principle InvestigatorPrinciple Investigator– Institutional Official Institutional Official

6-9-086-9-08

Practicing Responsible ConductPracticing Responsible Conduct

• Responsibility of all members of Responsibility of all members of the research teamthe research team

• All members of the research team All members of the research team must understand the ethical “Rules must understand the ethical “Rules of the Road”.of the Road”.

• Research ethics education and Research ethics education and training should include:training should include:– Knowledge baseKnowledge base

– Problem solving skillsProblem solving skills

– Decision making skills.Decision making skills.

By David Zinn. From By David Zinn. From Introduction to the Responsible Introduction to the Responsible Conduct of Research.Conduct of Research. by Nicholas H. Steneck by Nicholas H. Steneck

6-9-086-9-08

Is RCR education and training of Is RCR education and training of investigators sufficient?investigators sufficient?

CITI RCR Satisfaction Survey CITI RCR Satisfaction Survey

6-9-086-9-08

I believe that it is very important that the entire research team and not just the I believe that it is very important that the entire research team and not just the PI, should have a clear understanding of the responsible conduct of research.PI, should have a clear understanding of the responsible conduct of research.

0%

10%

20%

30%

40%

50%

60%

% R

es

po

nd

ers

(n

=1

29

0)

1 2 3 4 5 6 7 8 9Strongly disagree Strongly agree

7%7% 79%79%

RCR Course Satisfaction Survey 8-27-07 to 4-2-08RCR Course Satisfaction Survey 8-27-07 to 4-2-08

6-9-086-9-08

The Responsible Conduct of The Responsible Conduct of ResearchResearch

• Research MisconductResearch Misconduct– Reporting potential instances of misconductReporting potential instances of misconduct

• Data Acquisition and ManagementData Acquisition and Management• Responsible AuthorshipResponsible Authorship• Responsible Peer ReviewResponsible Peer Review• Human Subjects ProtectionHuman Subjects Protection• Lab Animal WelfareLab Animal Welfare• MentoringMentoring• Conflicts of InterestConflicts of Interest• Responsible Collaborative ResearchResponsible Collaborative Research

6-9-086-9-08

What is Research Misconduct?What is Research Misconduct?

• FabricationFabrication– Making up data or results and recording or reporting Making up data or results and recording or reporting

them. them. • FalsificationFalsification

– Manipulating research materials, equipment, or Manipulating research materials, equipment, or processes, or changing or omitting data or results processes, or changing or omitting data or results such that the research is not accurately represented such that the research is not accurately represented in the research record. in the research record.

• PlagiarismPlagiarism– The appropriation of another person's ideas, The appropriation of another person's ideas,

processes, results, or words without giving processes, results, or words without giving appropriate credit. appropriate credit.

6-9-086-9-08

Research Misconduct is NOTResearch Misconduct is NOT

Honest errors, inadvertent Honest errors, inadvertent miscalculations, unintentional miscalculations, unintentional

oversights or differences of opinion. oversights or differences of opinion.

6-9-086-9-08

John John IIoannidis - 2005 oannidis - 2005 “… flawed findings, for the most part, stem not from fraud or formal “… flawed findings, for the most part, stem not from fraud or formal misconduct, but from more mundane misconduct, but from more mundane misbehaviormisbehavior: miscalculation, poor study design or : miscalculation, poor study design or self-serving data analysis.” self-serving data analysis.”

"There is an increasing concern that in modern research, false findings may be the majority "There is an increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims," or even the vast majority of published research claims,"

"A new claim about a research finding is more likely to be false than true.""A new claim about a research finding is more likely to be false than true."

6-9-086-9-08

Most Published Research Findings Are False—But a Most Published Research Findings Are False—But a Little Replication Goes a Long WayLittle Replication Goes a Long Way

Ramal MoonesingheRamal Moonesinghe, Muin J. Khoury, A. Cecile J. W. Janssens , Muin J. Khoury, A. Cecile J. W. Janssens PLoS Med 4(2): e28 PLoS Med 4(2): e28 doi:10.1371/journal.pmed.0040028doi:10.1371/journal.pmed.0040028 February 27, 2007February 27, 2007

• Mathematically analysis by CDC Investigators.Mathematically analysis by CDC Investigators.• Supports Ioannidis’ findings that most published research findings Supports Ioannidis’ findings that most published research findings

are false.are false.• Especially true in studies linking genetic anomalies and diseases.Especially true in studies linking genetic anomalies and diseases.

• Replication of research findings enhances the positive predictive Replication of research findings enhances the positive predictive value of a research finding being true.value of a research finding being true.

6-9-086-9-08

Research Misconduct at the Research Misconduct at the University of WisconsinUniversity of Wisconsin

6-9-086-9-08

Research Misconduct Case StudyResearch Misconduct Case Study

"No news, may not be good news""No news, may not be good news"Go to Case 1.

6-9-086-9-08

Responsible AuthorshipResponsible Authorship

• Publication of ones own work is the Publication of ones own work is the demonstration of professionalism. demonstration of professionalism. – Research is just hobby until it is published.Research is just hobby until it is published.

• Doing science professionally is contributing new Doing science professionally is contributing new discoveries to the “corpus” of knowledge.discoveries to the “corpus” of knowledge.

• Publication brings recognition, fame and Publication brings recognition, fame and acceptance by peers.acceptance by peers.

• Peer review and publication promotes the Public Peer review and publication promotes the Public TrustTrust– Grants, Contracts, Intellectual PropertyGrants, Contracts, Intellectual Property

• Promotion, $$Promotion, $$• Tenure.Tenure.

6-9-086-9-08

• Who is an author.Who is an author.• Who is 1Who is 1stst, 2, 2ndnd or last author. or last author.• Acknowledgement vs. AuthorshipAcknowledgement vs. Authorship• Responsibilities of the first author.Responsibilities of the first author.• Deceptive authorship practices.Deceptive authorship practices.

– Guest authorships.Guest authorships.– Political authorships.Political authorships.– Authorship by authority.Authorship by authority.– Redundant publication and self plagiarism.Redundant publication and self plagiarism.– Fragmentation. Fragmentation.

Responsible AuthorshipResponsible Authorship

RULE OF THUMB: If you are willing to "TAKE CREDIT", you also must be willing to "TAKE RESPONSIBILITY."RULE OF THUMB: If you are willing to "TAKE CREDIT", you also must be willing to "TAKE RESPONSIBILITY."

6-9-086-9-08

Responsible AuthorshipResponsible Authorship

• Authorship Practices can vary considerably across disciplines.Authorship Practices can vary considerably across disciplines.• International Committee of Medical Journal Editors (ICJME).International Committee of Medical Journal Editors (ICJME).

• ““Uniform Requirements for Manuscripts Submitted to Biomedical Journals”Uniform Requirements for Manuscripts Submitted to Biomedical Journals”

– Authorship credit should be based on:Authorship credit should be based on: 1.1. Substantial contributions to conception and design, or acquisition of data, or Substantial contributions to conception and design, or acquisition of data, or

analysis and interpretation of data; analysis and interpretation of data;

2.2. Drafting the article or revising it critically for important intellectual content; Drafting the article or revising it critically for important intellectual content; and and

3.3. Final approval of the version to be published. Final approval of the version to be published.

– All authors should meet conditions 1, 2, All authors should meet conditions 1, 2, andand 3. 3.

6-9-086-9-08

Guest Authorship Case study Guest Authorship Case study Go to the Case Study

6-9-086-9-08

Guest Authorship and Ghostwriting in Publications Related to Guest Authorship and Ghostwriting in Publications Related to RofecoxibRofecoxib A Case Study of Industry Documents From Rofecoxib A Case Study of Industry Documents From Rofecoxib

LitigationLitigation Joseph S. Ross, MD, MHS; et. al ; Joseph S. Ross, MD, MHS; et. al ; JAMA.JAMA. 2008;299(15):1800-1812. 2008;299(15):1800-1812.

• Vioxx (Rofecoxib) COX-2 inhibitor. Typical non-steroidal anti-inflammatory Vioxx (Rofecoxib) COX-2 inhibitor. Typical non-steroidal anti-inflammatory drugs (NSAIDS)drugs (NSAIDS)– e.g., ibuprofen. e.g., ibuprofen.

• Court documents made available as a result of litigation between the Court documents made available as a result of litigation between the plaintiffs and Merck Pharmaceutical Co.plaintiffs and Merck Pharmaceutical Co.

• 1996 – 2004 Merck employees were ghost writing papers and review 1996 – 2004 Merck employees were ghost writing papers and review articles on Vioxx and then recruiting physicians from academia, with little or articles on Vioxx and then recruiting physicians from academia, with little or no involvement in the studies, to be first authors.no involvement in the studies, to be first authors.– Recruited physician often sole authors.Recruited physician often sole authors.– Merck employee or medical writer consultant not identifiedMerck employee or medical writer consultant not identified– Authors provided “honoria”Authors provided “honoria”

• Disclosed in 22/24 papersDisclosed in 22/24 papers

• Disclosed in 7/ 22 review articlesDisclosed in 7/ 22 review articles

6-9-086-9-08

Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment.or Cognitive Impairment. A Case Study Based on Documents From A Case Study Based on Documents From

Rofecoxib Litigation Rofecoxib Litigation Bruce M. Psaty, MD, PhD; Richard A. Kronmal, PhDBruce M. Psaty, MD, PhD; Richard A. Kronmal, PhD

JAMA.JAMA. 2008;299(15):1813-1817. 2008;299(15):1813-1817.

• Company misrepresented data and minimized the risks of Vioxx to Company misrepresented data and minimized the risks of Vioxx to subjects on trials to prevent or treat elderly patients.subjects on trials to prevent or treat elderly patients.

• ArticlesArticles– 2004, 8/11 authors Merck employees.2004, 8/11 authors Merck employees.

• No drug related deaths No drug related deaths • 11 "non-drug related deaths" 11 "non-drug related deaths"

– 9 deaths among 346 rofecoxib patients and 9 deaths among 346 rofecoxib patients and – 2 deaths among 346 placebo patients. 2 deaths among 346 placebo patients. – Deaths after 14 days of treatment not reportedDeaths after 14 days of treatment not reported

– Conclusions - Conclusions - • Well ToleratedWell Tolerated

6-9-086-9-08

Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment.or Cognitive Impairment. A Case Study Based on Documents From A Case Study Based on Documents From

Rofecoxib Litigation Rofecoxib Litigation Bruce M. Psaty, MD, PhD; Richard A. Kronmal, PhDBruce M. Psaty, MD, PhD; Richard A. Kronmal, PhD

JAMA.JAMA. 2008;299(15):1813-1817. 2008;299(15):1813-1817.

ArticlesArticles– 2005, 2005,

• 39 deaths were reported among patients taking study treatment or within 14 39 deaths were reported among patients taking study treatment or within 14 days of the last dose days of the last dose

• 24 among 725 rofecoxib patients 24 among 725 rofecoxib patients • 15 among 732 placebo patients 15 among 732 placebo patients • 22 deaths in the off-drug period 22 deaths in the off-drug period

– 17 in rofecoxib patients and 5 in placebo patients.17 in rofecoxib patients and 5 in placebo patients.

– Conclusions - Conclusions - • Well ToleratedWell Tolerated• Adverse events similar to those in earlier trials Adverse events similar to those in earlier trials

• April 2001, the company's internal intention-to-treat analyses of April 2001, the company's internal intention-to-treat analyses of pooled data from these 2 trials identified a significant increase in pooled data from these 2 trials identified a significant increase in total mortality total mortality – 3.4% for Vioxx and 1.2% for placebo3.4% for Vioxx and 1.2% for placebo– Long term mortality not made public or submitted to FDA Long term mortality not made public or submitted to FDA

6-9-086-9-08

Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

6-9-086-9-08

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 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.

6-9-086-9-08

Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

• All members of the scientific community are faced with balancing All members of the scientific community are faced with balancing conflicting interests. conflicting interests. – The New York TimesThe New York Times headlines that read "Doctors Reap Millions for headlines that read "Doctors Reap Millions for

Anemia Drugs" (5/9/2007) and Anemia Drugs" (5/9/2007) and – The Wall Street JournalThe Wall Street Journal "Gifts to Doctors are Widespread" (4/26/2007). "Gifts to Doctors are Widespread" (4/26/2007).

• Commitment to profit has resulted in a loss of integrity in Commitment to profit has resulted in a loss of integrity in Universities and research centers.Universities and research centers.– At One University, Tobacco Money Is a Secret; by ALAN FINDERAt One University, Tobacco Money Is a Secret; by ALAN FINDER

• www.nytimes.com/2008/05/22/us/22tobacco.html?pagewanted=1&_r=1&hpwww.nytimes.com/2008/05/22/us/22tobacco.html?pagewanted=1&_r=1&hp

6-9-086-9-08

Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

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

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

• A conflict of interest is A conflict of interest is notnot considered misconduct in considered misconduct in research, since the definition for misconduct is currently research, since the definition for misconduct is currently limited to fabrication, falsification, and plagiarism. limited to fabrication, falsification, and plagiarism.

6-9-086-9-08

Conflicts of Interest and CommitmentConflicts of Interest and Commitment

• Tangible CoITangible CoI– A University researcher holds an executive position with a A University researcher holds an executive position with a

company that stands to benefit from the research he is company that stands to benefit from the research he is conducted at the University. conducted at the University.

– A University researcher holds significant equity interest in a A University researcher holds significant equity interest in a company that stands to benefit from the research he is company that stands to benefit from the research he is conducting at the University. conducting at the University.

– A researcher receives significant consulting payments from a A researcher receives significant consulting payments from a company that will be affected by his research. company that will be affected by his research.

– Clinical researcher owns the company, conducts the trial, Clinical researcher owns the company, conducts the trial, consents the subjects.consents the subjects.

– University owns an equity interest in the company owned by University owns an equity interest in the company owned by the investigator, who conducts the trial, who consents the the investigator, who conducts the trial, who consents the subject.subject.

6-9-086-9-08

Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

• Intangible CoIIntangible CoI– CoI where $$$$ is not usually involved CoI where $$$$ is not usually involved

• Bias in judgment is very difficult to eliminate. Bias in judgment is very difficult to eliminate.

– Personal relationships / friendshipsPersonal relationships / friendships• Reluctance to do the right thing because of a friendship Reluctance to do the right thing because of a friendship

– Intellectual Bias.Intellectual Bias.• Peer review of contradictoryPeer review of contradictory

• Conclusions of a paper contradict the reviewers work.Conclusions of a paper contradict the reviewers work.

– Academic conflict of interest.Academic conflict of interest.• IRB or IACUC member’s protocols are reviewed.IRB or IACUC member’s protocols are reviewed.

6-9-086-9-08

Conflicts of CommitmentConflicts of Commitment

• Conflicts of commitment – A researcher is dedicating Conflicts of commitment – A researcher is dedicating time to outside activities in excess of the time time to outside activities in excess of the time permitted by institutional policy. permitted by institutional policy. For example:For example:– A faculty member dedicating to much time to personal A faculty member dedicating to much time to personal

consulting with a company or companies. consulting with a company or companies.

– A faculty member uses institution resources, to support A faculty member uses institution resources, to support of his or her personal consulting activities.of his or her personal consulting activities.

– Personal relationships may create a conflict between a Personal relationships may create a conflict between a friendship and doing the right thing for the employer. friendship and doing the right thing for the employer.

6-9-086-9-08

Conflicts of CommitmentConflicts of Commitment

• Conflicts of commitment :Conflicts of commitment :– A researcher’s teaching responsibilities may be A researcher’s teaching responsibilities may be

compromised if he/she uses graduate students on a compromised if he/she uses graduate students on a personal consulting project. personal consulting project.

• Graduate students may benefit, but, their participation Graduate students may benefit, but, their participation is primarily of personal benefit to the faculty member.is primarily of personal benefit to the faculty member.

• Misuse of a graduate student's time detracts from his Misuse of a graduate student's time detracts from his or her efforts to complete degree requirements. or her efforts to complete degree requirements.

• Furthermore, due to the intellectual property and Furthermore, due to the intellectual property and confidentiality provisions included in most consulting confidentiality provisions included in most consulting agreements, graduate students would be unable to agreements, graduate students would be unable to publish the results of their work.publish the results of their work.

6-9-086-9-08

Conflicts of CommitmentConflicts of Commitment

• Conflicts of conscienceConflicts of conscience– Religious beliefs might prevent objective review of an Religious beliefs might prevent objective review of an

embryonic stem cell project.embryonic stem cell project.– Political views could affect objectivity during the Political views could affect objectivity during the

review of a manuscript on a controversial social review of a manuscript on a controversial social science issue. science issue.

– Views regarding animal rights might affect a reviewers Views regarding animal rights might affect a reviewers objectivity of studies using NHPs. objectivity of studies using NHPs.

6-9-086-9-08

Conflict of Interest Case StudyConflict of Interest Case Study

Science Administrators and CoI.Science Administrators and CoI.Go to the CoI Case Study

•Mary is confronted by a serious ethical dilemma. What should she do?Mary is confronted by a serious ethical dilemma. What should she do?

6-9-086-9-08

SummarySummary

• The active promotion of integrity in The active promotion of integrity in the research enterprise is essential the research enterprise is essential to maintain the to maintain the Public TrustPublic Trust. . – Without the Public Trust there can be no Without the Public Trust there can be no

researchresearch

• Integrity in the research enterprise Integrity in the research enterprise requires the Responsible Conduct requires the Responsible Conduct of Research (RCR).of Research (RCR).

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

6-9-086-9-08

Conflicts of InterestConflicts of Interest

• Everyone is faced with CoI&C.Everyone is faced with CoI&C.– Impossible to avoid in the conduct and administration Impossible to avoid in the conduct and administration

of science.of science.

• Having a CoI&C is not misconduct.Having a CoI&C is not misconduct.– Some CoI could result in misconductSome CoI could result in misconduct

• CoI&C are not always recognized.CoI&C are not always recognized.– Some education and training is necessary to identify Some education and training is necessary to identify

CoI CoI

• Management strategies can prevent CoI&C from Management strategies can prevent CoI&C from becoming becoming – Questionable Research Practices Questionable Research Practices – Research Misconduct Research Misconduct

6-9-086-9-08

SummarySummary

• The Institution and regulatory committees The Institution and regulatory committees (IACUC, IRB, IBC) should do all they can to (IACUC, IRB, IBC) should do all they can to make it easy for investigators to be compliant. make it easy for investigators to be compliant. – Take a look at your process. Take a look at your process. – Reduce the time between submission and Reduce the time between submission and

approval.approval.

• The foundation of research integrity is The foundation of research integrity is education.education.– Early, often, multiple formatsEarly, often, multiple formats– Evaluate your education programs. Evaluate your education programs.

• Are they working? Are they working? • How do you improve them?How do you improve them?• Listen to the feedback from your learners.Listen to the feedback from your learners.

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

6-9-086-9-08

CITI ProgramCITI Programwww.citiprogram.orgwww.citiprogram.org

• Web based bioethics education program designed to Web based bioethics education program designed to promote the responsible conduct of research. promote the responsible conduct of research.

• June 2000 to meet the Federal education mandate.June 2000 to meet the Federal education mandate.• 8 Courses available to ~934 institutions8 Courses available to ~934 institutions

– Human subjects ProtectionHuman subjects Protection• Basic courses – BiomedicalBasic courses – Biomedical• Basic course – SBRBasic course – SBR• Refresher Courses - Biomedical and SBRRefresher Courses - Biomedical and SBR• Good Clinical PracticeGood Clinical Practice

– Lab Animal WelfareLab Animal Welfare– Health Information Privacy and Security (HIPS)Health Information Privacy and Security (HIPS)– RCRRCR

• 4 discipline specific courses4 discipline specific courses• Funded in part by ORIFunded in part by ORI

6-9-086-9-08

Overall CITI Program UsageOverall CITI Program Usage1-1-08 to 4-20-081-1-08 to 4-20-08

CourseCourse CCCC

HSR Basic HSRHSR Basic HSR 91,13091,130

Lab AnimalLab Animal 9,4169,416

HSR RefreshersHSR Refreshers 7,9987,998

RCRRCR 3,5973,597

GCPGCP 2,8322,832

HIPSHIPS 902902

TotalTotal 115,875115,875

6-9-086-9-08

CITI WorldwideCITI Worldwide

World wide n ~ 934International n = 43sites / 32 countries

6-9-086-9-08

No Ethics, No Ethics, No TrustNo Trust No Trust,No Trust, No Research No Research

No Research, No HealthNo Research, No HealthNo Health, No DevelopmentNo Health, No Development

Mulling , Goodman - 2005Mulling , Goodman - 2005

TrustTrust is Built on an Ethical is Built on an Ethical Foundation.Foundation.

6-9-086-9-08

CITI User Satisfaction CITI User Satisfaction SurveysSurveys

www.citiprogram.orgwww.citiprogram.org Announcements and FAQAnnouncements and FAQ

6-9-086-9-08

After completing the CITI RCR Course, I have a better understanding After completing the CITI RCR Course, I have a better understanding of why unethical research practices occur and thus, I am better of why unethical research practices occur and thus, I am better

prepared to prevent such practices from influencing my research.prepared to prevent such practices from influencing my research.

0%

5%

10%

15%

20%

25%

30%

%

Re

sp

on

de

rs (

n=

14

69

)

1 2 3 4 5 6 7 8 9Strongly disagree Strongly agree

8%8%

74%74%

6-9-086-9-08

Having completed the CITI Course in the Responsible Conduct of Research and obtained Having completed the CITI Course in the Responsible Conduct of Research and obtained a better understanding of how damaging research misconduct can be to students, to the a better understanding of how damaging research misconduct can be to students, to the

institutions and to other investigators, I am now more likely to “Report" clear acts of institutions and to other investigators, I am now more likely to “Report" clear acts of research misconduct.research misconduct.

0%

5%

10%

15%

20%

25%

30%

% R

esp

on

der

s (

n=

145

8)

1 2 3 4 5 6 7 8 9

Strongly disagree Strongly agree

2008 2007

6-9-086-9-08

I plan to take a more active role in promoting I plan to take a more active role in promoting ethical research practices by :ethical research practices by :

• I intend to do little more than I am currently doing.I intend to do little more than I am currently doing. 32%32%

• Becoming a mentor to a student or young faculty memberBecoming a mentor to a student or young faculty member 21%21%

• Attending more ethics related seminarsAttending more ethics related seminars 19%19%

• Encouraging my institution to adopt a formal RCR education Encouraging my institution to adopt a formal RCR education requirement for students and facultyrequirement for students and faculty 11%11%

• Taking an advanced research ethics courseTaking an advanced research ethics course 10%10%

• Adding a research Ethics module to a course I teachAdding a research Ethics module to a course I teach 8%8%

n=1892n=1892

6-9-086-9-08

SummarySummary

• Integrity is the cornerstone of the Integrity is the cornerstone of the research enterprise.research enterprise.

• The lack of integrity undermines the The lack of integrity undermines the Publics Trust.Publics Trust.

• The RCR is a demonstration of The RCR is a demonstration of professionalism and integrity.professionalism and integrity.

• Conflicts of interest and commitment Conflicts of interest and commitment are everywhere and effect everyone are everywhere and effect everyone in the research enterprise. in the research enterprise. – Requires training to recognize and Requires training to recognize and

manage CoI.manage CoI.

• Education and trainingEducation and training– Early, often and multiple formats.Early, often and multiple formats.

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

6-9-086-9-08

SummarySummary

• Promoting Integrity is everyone’s responsibility.Promoting Integrity is everyone’s responsibility.– Protect subjects.Protect subjects.– Leads to better science.Leads to better science.– Promotes compliance.Promotes compliance.– Protect the Public Trust Protect the Public Trust

• 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”.

6-9-086-9-08

““Promoting Integrity in the Research Promoting Integrity in the Research Enterprise. – A Shared Responsibility”Enterprise. – A Shared Responsibility”

Paul Braunschweiger Ph.DPaul Braunschweiger Ph.DProfessor Radiation OncologyProfessor Radiation OncologyCo-Founder, CITI Program.Co-Founder, CITI Program.

www.citiprogram.orgwww.citiprogram.org

FAQ an AnnouncementsFAQ an Announcements