What’s Going on in theConflict of Interest World?

Michelle Evans

Research Integrity Office

February 16, 2011

Conflict of Interest Discussion

Today, we will discuss:Today, we will discuss:

AgendaAgenda IntroductionsIntroductions What is COI?What is COI? Importance of ReportingImportance of Reporting Federal Guidelines and Duke COI PolicyFederal Guidelines and Duke COI Policy Recent NIH DevelopmentsRecent NIH Developments Institutional COIInstitutional COI Examples of COI - CasesExamples of COI - Cases Take It Away, CharlotteTake It Away, Charlotte

Importance of Reporting

Transparency NIH funding Duke Internal Audit Change in national

culture

Why Do We Care about COI?

Protection of human subjects.Protection of human subjects.Protection of our faculty and institution.Protection of our faculty and institution.Federal regulations and requirements.Federal regulations and requirements.Maintain the public’s trust.Maintain the public’s trust.Complete transparency.Complete transparency.Cases like the ones we will discuss today.Cases like the ones we will discuss today.

Where Does Duke Stand Nationally?

1) One of the largest portfolios of management plans.

2) Only program using the DSMBplus model.

3) Generally, 10% of all conflicts reported to NIH (eRA Commons) are from Duke.

4) MIDDLE OF THE ROAD – Much more flexible than most academic medical centers.

Defining Conflict of Interest Defined: A conflict of interest involves the abuse -- actual,

apparent, or potential -- of the trust that people have in professionals. The simplest working definition states: A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. An apparent conflict of interest is one in which a reasonable person would think that the professional’s judgment is likely to be compromised. A potential conflict of interest involves a situation that may develop into an actual conflict of interest.

*It is important to note that a conflict of interest exists whether or not decisions are affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood.

Office of Research Integrity, Health and Human Services

Types of Conflict Personal vs. InstitutionalPersonal vs. Institutional Financial vs. OtherFinancial vs. Other

-Prestige-Prestige

-Promotion/Tenure-Promotion/Tenure

-Reputation-Reputation

-Belief in idea/theory-Belief in idea/theory

-Purchasing-Purchasing

-Nepotism-Nepotism

-Clinical-Clinical

What is Disclosure?

Reporting vs. DisclosureReporting vs. DisclosureTypes of DisclosureTypes of Disclosure

-Consent documents-Consent documents-Publications-Publications-Presentations-Presentations-Contracts-Contracts-FDA-FDA-NIH-NIH

NIH Requirements for COINIH requires grantees and investigators to comply with requirements of NIH requires grantees and investigators to comply with requirements of

42 CFR Part 50, Subpart F for research where PHS funding is 42 CFR Part 50, Subpart F for research where PHS funding is sought.sought.

Organizations mustOrganizations must:: Have a written and enforced administrative Have a written and enforced administrative

process to identify and manage, reduce, or process to identify and manage, reduce, or eliminate conflicting financial interests with eliminate conflicting financial interests with respect to research projects for which NIH respect to research projects for which NIH funding is sought.funding is sought.

Before spending any NIH funds awarded under Before spending any NIH funds awarded under a new award, inform the Grants Management a new award, inform the Grants Management Officer (GMO) of the existence of any conflicting Officer (GMO) of the existence of any conflicting financial interests.financial interests.

NIH Requirements

When informing the GMO that a financial COI When informing the GMO that a financial COI has been identified, ensure the interest has has been identified, ensure the interest has been addressed in accordance with the been addressed in accordance with the regulations by indicating whether the conflict has regulations by indicating whether the conflict has either been managed, reduced, or eliminated.either been managed, reduced, or eliminated.

Continue to make similar reports on Continue to make similar reports on subsequently identified conflicts within 60 days subsequently identified conflicts within 60 days of identifying them.of identifying them.

Make additional information available to NIH, Make additional information available to NIH, upon request, as to how it handled conflicting upon request, as to how it handled conflicting interests in accordance with regulations.interests in accordance with regulations.

For NIH – Who Must Disclose?

Investigators must have submitted at time of Investigators must have submitted at time of application for PHS funding.application for PHS funding.

Investigators include principal investigators and Investigators include principal investigators and any other person who is responsible for the any other person who is responsible for the design, conduct, or reporting of research funded design, conduct, or reporting of research funded by PHS, or proposed for such funding.by PHS, or proposed for such funding.

Update on an annual basis or as new reportable Update on an annual basis or as new reportable significant financial interests are obtained.significant financial interests are obtained.

NIH has a $10,000 de minimis (threshold).NIH has a $10,000 de minimis (threshold).

Duke COI Policy Faculty and required staff

submit an electronic COI reporting form annually and within 10 days of a change of status. Form is routed to the Research Integrity Office.

Report any extramural relationships with entities that may conduct business with Duke and an IRS Form 1099, W-2, or K-1 is received.

Duke COI Policy

Examples of relationships that may present a potential COI

-Royalties -Advisory board position

-Consulting -Speaking honoraria

-Equity -Intellectual property

-Options -Gifts

*Some Duke people submit an administrative COI form.

COI Ranges$0 to $9,999 $0 to $9,999 Report; no managementReport; no management

$10,000 to $24,999$10,000 to $24,999 Report; management plan (MP) req’dReport; management plan (MP) req’dTypically disclosure Typically disclosure

$25,000 and above$25,000 and above Report; management plan requiredReport; management plan requiredRestrictions imposedRestrictions imposed

Publically-traded equityPublically-traded equity Report; MP required if $10K or >5%Report; MP required if $10K or >5%

Privately-held equityPrivately-held equity Report; MP required and treated like >$25KReport; MP required and treated like >$25K

Intellectual propertyIntellectual property Report; MP required if licensedReport; MP required if licensed

Institutional COIInstitutional COI Management plan may be required Management plan may be required May require external oversightMay require external oversightsuch as DSMBplus and external IRBsuch as DSMBplus and external IRB

Duke Proposal Application Form Financial relationships. Investigator should always mark the DPAF for COI questions. DPAF asked about a relationship with that particular

organization. DPAF routing process.

eIRB Application Financial relationships. Investigator should always mark the eIRB

application for COI questions. IRB routing process.

New COI Frontiers

NIH Notice of Proposed Rule MakingChange in de minimis to $5,000.Institution decides about COI rather than investigator.Management plan must be issued timely. If not, mitigation plan required.More info about COI reported.

New COI Frontiers Continued

Annual updates to NIH about the COI.SBIR/STTR carve-outs are now included.FCOI training for investigators.

BIGGEST IMPACT – no grant funds released until grant is reviewed by RIO for COI.

Institutional COI

Policy effective January 1, 2010.Policy effective January 1, 2010.Duke is one of the only a few national Duke is one of the only a few national

programs developing systems for ICOI.programs developing systems for ICOI.

Covers the following conflicts Duke may have:Covers the following conflicts Duke may have:1)1) GiftsGifts2)2) Covered OfficialsCovered Officials3)3) Intellectual propertyIntellectual property

Institutional COI

Possible Management StrategiesPossible Management Strategies1)1)Disclosure.Disclosure.2)2)DSMBplus/Oversight.DSMBplus/Oversight.3)3)External IRB (Duke is secondary External IRB (Duke is secondary reviewer.).reviewer.).4)4)Patient advocate.Patient advocate.

MORE TO COME SOON!MORE TO COME SOON!

Case Scenarios

Dr. Smith consults for Good Time Dr. Smith consults for Good Time Pharmaceuticals receiving $15,000 in Pharmaceuticals receiving $15,000 in 2010. GTP sponsors 2 clinical trials on 2010. GTP sponsors 2 clinical trials on which Dr. Smith serves as PI.which Dr. Smith serves as PI.

Dr. Happy serves on the advisory board Dr. Happy serves on the advisory board for Miller Medical Devices and is paid for Miller Medical Devices and is paid $30,000. Dr. Happy has an NIH-funded $30,000. Dr. Happy has an NIH-funded study that includes comparing three study that includes comparing three medical devices, one of which is medical devices, one of which is manufactured by Miller.manufactured by Miller.

Case Scenarios

Dr. Johnson created a new assessment Dr. Johnson created a new assessment scale for evaluating bi-polar disorder and scale for evaluating bi-polar disorder and is listed on the copyright for the scale. is listed on the copyright for the scale. The scale has been licensed to Feel Good The scale has been licensed to Feel Good Pharma. Feel Good pays Dr. Johnson Pharma. Feel Good pays Dr. Johnson royalties as a result of the license. What royalties as a result of the license. What type of role can Dr. Johnson have in type of role can Dr. Johnson have in ongoing research related to the scale? Is ongoing research related to the scale? Is this also an potential ICOI?this also an potential ICOI?

Case Scenarios

Dr. Adamson received $50,000 in Dr. Adamson received $50,000 in consulting income from the Sunshine consulting income from the Sunshine Company for consulting. Dr. Adamson’s Company for consulting. Dr. Adamson’s wonderful grant administrator emailed RIO wonderful grant administrator emailed RIO to ask about his positive DPAF for a new to ask about his positive DPAF for a new clinical trial. clinical trial.

Guess what happened?Guess what happened?

We Need Your Help!

Make certain correct email address are in Enterprise Directory.

Chasing folks to report. Gift inquiries. Transfer PI positions. Work with IRB to change consents. Send RIO reports from your DSMBplus

and external IRB.

We Need Your Help!

Notify the Research Integrity Office of any possible conflicts of interest and ask investigator to update their reporting form.

Feel free to call with any questions.

Who Do You Call?

Research Integrity OfficeRoom 110, Seeley G. Mudd

Michelle Evans 684-6739Susan Brooks 684-6757Angie Solomon 684-1822

COI Website http://www.medschool.duke.edu/modules/som_interests/index.php?id=1

IRB Perspective on Financial COI Disclosures

IRB Perspective on Financial COI Disclosures

Charlotte ColeyDirector, IRB Educational Programs

Charlotte ColeyDirector, IRB Educational Programs

IRB Responses to COI IRB Responses to COI

Inclusion in Consent Form

External IRB Use Phase III, IV multi-site, industry

sponsored studies Institutional COI

Inclusion in Consent Form

External IRB Use Phase III, IV multi-site, industry

sponsored studies Institutional COI

IRB COI LanguageIRB COI Language

"Dr. _________ has received personal compensation from the sponsor of this study in the past for his/her work on ____________________ and may receive personal compensation from the sponsor in the future.”

"Dr. _________ has received personal compensation from the sponsor of this study in the past for his/her work on ____________________ and may receive personal compensation from the sponsor in the future.”

Institutional COI DefinitionInstitutional COI Definition

Institutional Conflict of Interest in Research: An Institutional COI in Research may occurwhenever the financial interests of the institution, or of an institutional official who has authority to act on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of research.

Institutional Conflict of Interest in Research: An Institutional COI in Research may occurwhenever the financial interests of the institution, or of an institutional official who has authority to act on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of research.

Institutional COI – Covered Officials

Institutional COI – Covered Officials

Board of Trustees, President, Chancellor & Vice Chancellors Provost & Vice-Provosts Deans & Vice-Deans Associate Deans & Other Institutional administators

Board of Trustees, President, Chancellor & Vice Chancellors Provost & Vice-Provosts Deans & Vice-Deans Associate Deans & Other Institutional administators

IRB Responses to COIIRB Responses to COI

Follow Management Plan

Management Plan shared with IRB Primary Reviewer

Follow Management Plan

Management Plan shared with IRB Primary Reviewer

Swiss Cheese Theory of LearningSwiss Cheese Theory of Learning

Charlotte Coley 2010

SAE reportingPI Responsibilities

Protocol

Deviations

Definitions

QA/QI

33

COI

IRB Responses to COI Need for Training

IRB Responses to COI Need for Training

Additional One on One Training

Attend an IRB Meeting

Additional One on One Training

Attend an IRB Meeting

Resources Resources

IRB Website: http://irb.duhs.duke.edu/

IRB HRPP Policies: http://irb.duhs.duke.edu/modules/irb_pols/index.ph

p?id=3

eIRB Home: https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D

IRB Website: http://irb.duhs.duke.edu/

IRB HRPP Policies: http://irb.duhs.duke.edu/modules/irb_pols/index.ph

p?id=3

eIRB Home: https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D

Contact Information Contact Information

Charlotte Coleycoley007@mc.duke.edu668-5111 IRB Office Main #668-5119 My direct #

Charlotte Coleycoley007@mc.duke.edu668-5111 IRB Office Main #668-5119 My direct #