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FINANCIAL CONFLICTS OF FINANCIAL CONFLICTS OF INTEREST IN RESEARCHINTEREST IN RESEARCH

Avoiding Adverse Consequences by Disclosing, and then Avoiding Adverse Consequences by Disclosing, and then Reducing, Eliminating or Managing ConflictsReducing, Eliminating or Managing Conflicts

Susan H. Frey, J.D.Susan H. Frey, J.D.Assistant Provost for Research Compliance and Health Information Assistant Provost for Research Compliance and Health Information

PrivacyPrivacy88 E. Newton Street M-84088 E. Newton Street M-840

Boston UniversityBoston UniversityPh: 1-617-414-4736Ph: 1-617-414-4736Fx: 1-617-414-4738Fx: 1-617-414-4738

September 2009September 2009http://www.bu.edu/research/compliance/financial-conflict/index.shtmlhttp://www.bu.edu/research/compliance/financial-conflict/index.shtml

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Learning objectivesLearning objectives What is a conflict of interest affecting research?What is a conflict of interest affecting research?

How can conflicts of interest adversely affect the How can conflicts of interest adversely affect the integrity and credibility of your research-related integrity and credibility of your research-related decision?decision?

How to comply with BUMC policies by filing How to comply with BUMC policies by filing Investigators’ Project-Specific Disclosures (PSD)Investigators’ Project-Specific Disclosures (PSD) How to work with the Advisory Committee on Investigators’ How to work with the Advisory Committee on Investigators’

Conflicts of Interest if you file a positive disclosureConflicts of Interest if you file a positive disclosure

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UNIVERSITYRESEARCH PROGRAM

COMPANY or

INTELLECTUAL PROPERTY

INVESTIGATOR

FINANCIAL INTEREST

Should I decide for University about its research-related activities in which I have a personal, external financial interest?

Should I decide for University about its research-related activities in which I have a personal, external financial interest?

Professor X

RESEARCHCOULD AFFECT

FINANCIAL INTERESTS

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Examples of Investigators’ Examples of Investigators’ DecisionsDecisions

Conflicted Decisions as an investigator on Conflicted Decisions as an investigator on research projects could affect:research projects could affect: Your research (design, conduct, Your research (design, conduct,

reporting)reporting) Your selection of research aimsYour selection of research aims Your protection of human subjects Your protection of human subjects

and patient populationsand patient populations Your involvement of traineesYour involvement of trainees

Public scrutiny of conflicts of Public scrutiny of conflicts of interest that interest that appear toappear to affect affect

decisions in research involving decisions in research involving drugs, devices and diagnostics drugs, devices and diagnostics

in development or on the in development or on the market.market.

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News FlashNews Flash

Senator Grassley of Iowa – Senator Grassley of Iowa – InvestigatingInvestigating

payments to physicians for consulting to drug payments to physicians for consulting to drug companies (whose drugs being studied)companies (whose drugs being studied)

Question: Are Institutions and NIH adequately Question: Are Institutions and NIH adequately managing COI?managing COI?

New NIH rules are now under consideration.New NIH rules are now under consideration.

BUMC Policies on BUMC Policies on Investigators’ COI Investigators’ COI

Filing PSDsFiling PSDs

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Policies on Investigators’ Conflicts of Policies on Investigators’ Conflicts of InterestInterest (BU & BMC) (BU & BMC)

•Requires Project Specific Disclosures (PSD) on potential conflicts affecting institutional research projects

http://www.bu.edu/handbook/policies/ethics/conflict.html

http://internal.bmc.org/policies/display_policy.asp?policy_id=692

Investigators=Investigators=Individuals responsible for “designing, conducting or reporting” BUMC researchIndividuals responsible for “designing, conducting or reporting” BUMC research

Examples of individuals who would normally be considered Investigators Examples of individuals who would normally be considered Investigators include:include: All faculty BU/BMC researchers on the projectAll faculty BU/BMC researchers on the project All non-faculty BU/BMC researchers on the project who willAll non-faculty BU/BMC researchers on the project who will

Make a significant intellectual contribution to the researchMake a significant intellectual contribution to the research Have independent responsibilities that could significantly affect the Have independent responsibilities that could significantly affect the

integrity of design, conduct or reporting of the researchintegrity of design, conduct or reporting of the research Be included as authors on any presentation or publication of the Be included as authors on any presentation or publication of the

researchresearch Be listed on an IRB protocol for the research project Be listed on an IRB protocol for the research project andand have have

independent responsibilities that could significantly affect the independent responsibilities that could significantly affect the integrity ofintegrity of

data management and analysis, subject recruitment or data management and analysis, subject recruitment or enrollment, data collection, or any other aspect of subject safety enrollment, data collection, or any other aspect of subject safety and welfare or scientific integrity.and welfare or scientific integrity.

PI is responsible for appending PSDs from all InvestigatorsPI is responsible for appending PSDs from all Investigators

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Project Specific Disclosure (PSD)Project Specific Disclosure (PSD)When & where must PSD be filed?When & where must PSD be filed?A PSD must be filed at the time of:A PSD must be filed at the time of:

Funding applications submitted to Research Administration Funding applications submitted to Research Administration (BUMC or BMC) – (BUMC or BMC) – submit PSDs to OSP-MED or to BMC Grants submit PSDs to OSP-MED or to BMC Grants AdministrationAdministration

BUMC IRB applications – BUMC IRB applications – submit PSDs, only if unfunded, to submit PSDs, only if unfunded, to Compliance Office, Attn. M. Johnson, Fax: 617-414-4738Compliance Office, Attn. M. Johnson, Fax: 617-414-4738

Any unfunded research project affected by significant financial Any unfunded research project affected by significant financial interest – interest – submit PSDs to Compliance Office, Attn. M. Johnson, Fax: submit PSDs to Compliance Office, Attn. M. Johnson, Fax: 617-414-4738617-414-4738

Material change not previously disclosed (more below) – Material change not previously disclosed (more below) – submit submit supplemental information to Compliance Office, Attn. M. Johnson, Fax: supplemental information to Compliance Office, Attn. M. Johnson, Fax: 617-414-4738617-414-4738

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You should answer “Yes” on the You should answer “Yes” on the PSD if your answer is yes to PSD if your answer is yes to bothboth

parts parts of the questionof the question

““Do you, your spouse, or dependent children Do you, your spouse, or dependent children

1. have a “significant financial interest (SFI)”?1. have a “significant financial interest (SFI)”?ANDAND 2. that could reasonably appear to be 2. that could reasonably appear to be

affected by the research?affected by the research?

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First part of PSD question: First part of PSD question: Have a SFI?Have a SFI?

Yes, if the Yes, if the detailed definitiondetailed definition of SFI on the of SFI on the PSD form applies– PSD form applies– err on the side of err on the side of disclosuredisclosure

Common Common examplesexamples of a SFI: of a SFI: You expect to earn consulting income from a You expect to earn consulting income from a

company interested in the research in excess of in excess of $10,000 in the past or coming twelve months$10,000 in the past or coming twelve months

You have any equity in a You have any equity in a company interested in the research

You have rights in intellectual property used or You have rights in intellectual property used or studied in the researchstudied in the research

University base salary and financial University base salary and financial interests in mutual funds are not SFIinterests in mutual funds are not SFI

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Second part of PSD question:Second part of PSD question:SFI SFI could reasonably appear to be affected could reasonably appear to be affected

by the research?by the research?

Common examples :Common examples : Company sponsors the researchCompany sponsors the research Company will have access to pre-publication results Company will have access to pre-publication results

of the researchof the research Company has rights in product, invention, device, Company has rights in product, invention, device,

drug, program, IP, etc. studied in the research.drug, program, IP, etc. studied in the research. You have rights in intellectual property being used or You have rights in intellectual property being used or

studied in the research.studied in the research.

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Disclosure of Material ChangesDisclosure of Material Changes

Investigators must disclose material changesInvestigators must disclose material changes

by filing an updated PSD or other notification by filing an updated PSD or other notification with the research administration office and with the research administration office and the Committee, the Committee, ifif:: ““No” disclosure scenario changes to “Yes”No” disclosure scenario changes to “Yes” A COI management plan (more below) is based A COI management plan (more below) is based

on facts which materially change. E.g.on facts which materially change. E.g.Human subjects or trainees were not, and Human subjects or trainees were not, and

now will be, involvednow will be, involvedAn interested company is formedAn interested company is formed

BUMC ReviewBUMC Review of “Yes” PSDs of “Yes” PSDs

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CRC & BUMC Advisory CRC & BUMC Advisory Committees on Investigators’ Committees on Investigators’

Conflicts of InterestConflicts of Interest

Appointed in December, 2003, by University Appointed in December, 2003, by University Provost, Medical Campus Provost and BMC Provost, Medical Campus Provost and BMC PresidentPresident

Composed of investigators (in diverse Composed of investigators (in diverse departments) and administrative departments) and administrative representativesrepresentatives

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Committee ReviewCommittee Review

1. Conflict of Interest:1. Conflict of Interest:Could SFI directly and significantly affect Could SFI directly and significantly affect

University research?University research?

2. If so, impose conditions or restrictions:2. If so, impose conditions or restrictions:How can we eliminate, reduce or manage the How can we eliminate, reduce or manage the

conflict of interest?conflict of interest?

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Conditions or Restrictions:Conditions or Restrictions:Reduce?Reduce?

Reduction of COIReduction of COI Generally means reducing Generally means reducing the magnitude of the financial interestthe magnitude of the financial interest

Usually is applies only if the SFI can be Usually is applies only if the SFI can be reduced below the $10,000 threshold for reduced below the $10,000 threshold for consulting incomeconsulting income

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Conditions or Restrictions:Conditions or Restrictions:Eliminate?Eliminate?

Elimination generally means divestiture of the Elimination generally means divestiture of the SFISFI

BUMC policy requires the Committee to BUMC policy requires the Committee to presume that a COI affecting human subjects presume that a COI affecting human subjects research must be eliminated, research must be eliminated, unlessunless::Compelling circumstances warrant Compelling circumstances warrant

managing rather than eliminating the COI.managing rather than eliminating the COI.

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Compelling circumstancesCompelling circumstances

Strict scrutiny must be given by the Strict scrutiny must be given by the Committee to all relevant factors in the COI Committee to all relevant factors in the COI scenarioscenario

Compelling circumstances likely to exist Compelling circumstances likely to exist where all factors together indicate: where all factors together indicate: Low potential for harm to human subjects Low potential for harm to human subjects

and patient populations; andand patient populations; andHigh potential for loss of important early High potential for loss of important early

stage research due to stage research due to uniqueunique qualification qualification or situation of conflicted investigator. or situation of conflicted investigator.

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Conditions or Restrictions:Conditions or Restrictions:Management?Management?

Management Plans are developed by the Management Plans are developed by the Committee with investigator input and Committee with investigator input and reviewed with Investigators before being reviewed with Investigators before being recommended to the Provost or Presidentrecommended to the Provost or President

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Elements of Management Plans Elements of Management Plans may include (without limitation):may include (without limitation):

1. Disclosure to chairman and dean1. Disclosure to chairman and dean2. Disclosure to all co-workers on the project or in the 2. Disclosure to all co-workers on the project or in the lab ( Colleague Disclosure letter)lab ( Colleague Disclosure letter)3. Disclosure of SFI in publications and presentations of 3. Disclosure of SFI in publications and presentations of results or in expert testimonyresults or in expert testimony4. Independent Reviewer of data safety and integrity.4. Independent Reviewer of data safety and integrity.5. Independent monitor for co-investigators, trainees 5. Independent monitor for co-investigators, trainees and graduate students supervised by the conflicted and graduate students supervised by the conflicted investigator; approval for involvement of students as investigator; approval for involvement of students as being academically appropriatebeing academically appropriate

6. Recusal (in whole or in part) and substitution of an 6. Recusal (in whole or in part) and substitution of an unconflicted independent investigator responsible for unconflicted independent investigator responsible for human subject welfare and/or data integrity and human subject welfare and/or data integrity and analysis.analysis.

On-line periodic reporting on On-line periodic reporting on your compliance with your your compliance with your

Management PlanManagement Plan

Committee requests reports, including Committee requests reports, including uploading evidence of disclosure in uploading evidence of disclosure in journals, and reports from any required journals, and reports from any required independent reviewers, etc.independent reviewers, etc.

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Management:Management:Informed ConsentInformed Consent

BUMC policy at present: BUMC IRB BUMC policy at present: BUMC IRB determines whether SFI should be determines whether SFI should be disclosed in informed consentdisclosed in informed consent

BUMC Advisory Committee on BUMC Advisory Committee on Investigators’ Conflicts of Interest copies Investigators’ Conflicts of Interest copies IRB on all decisions affecting projects of IRB on all decisions affecting projects of human subjects research.human subjects research.

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Audit and EnforcementAudit and Enforcement Failure to report a SFI or to comply with a Failure to report a SFI or to comply with a

decision of the Committee may be detected in decision of the Committee may be detected in a number of ways:a number of ways:

Whistleblowers, agencies reviews, internal Whistleblowers, agencies reviews, internal audit, Committee requests for periodic audit, Committee requests for periodic reportsreports

Depending on the seriousness of non-Depending on the seriousness of non-compliance, corrective action or sanctions are compliance, corrective action or sanctions are recommended to the institutional officials.recommended to the institutional officials.

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Disclosure Protects You!!Disclosure Protects You!! Inevitable human errors occur in the Inevitable human errors occur in the

management of science in our increasingly management of science in our increasingly complex environment.complex environment.

When an error occurs, you want to be When an error occurs, you want to be “squeaky clean”“squeaky clean”

““My conflict of interest was fully disclosed and My conflict of interest was fully disclosed and has been monitored and managed in has been monitored and managed in accordance with federal and University accordance with federal and University policies.”policies.”