Conflict of Interest andConflict of Interest and

Technology TransferTechnology Transfer

Sherrie Settle Sherrie Settle

Assistant Director, Research Compliance ProgramAssistant Director, Research Compliance Program

Institutional Conflict of Interest OfficerInstitutional Conflict of Interest Officer

March 5, 2009March 5, 2009

What Is It?What Is It?

Conflict of interest relates to situations in Conflict of interest relates to situations in which financial or other personal which financial or other personal considerations may compromise, may considerations may compromise, may involve the potential for compromising, involve the potential for compromising, or may have the appearance of or may have the appearance of compromising an employee’s objectivity compromising an employee’s objectivity in meeting University duties or in meeting University duties or responsibilities, including research responsibilities, including research activities.  activities. 

- UNC Policy Manual- UNC Policy Manual

Academic-Corporate Academic-Corporate Relationship ContextRelationship Context

Go, do!Go, do! Bayh-Dole ActBayh-Dole Act Economic Economic

development development mandatemandate

Institutional support Institutional support of entrepreneurial of entrepreneurial activitiesactivities

Policy on External Policy on External Professional Professional Activities for PayActivities for Pay

Wait, stop!Wait, stop! Public/MediaPublic/Media

– High profile casesHigh profile cases– SkepticismSkepticism

Professional Professional Association Association GuidelinesGuidelines

LegislationLegislation LegislatorsLegislators Sponsor regulationsSponsor regulations

So how do I eliminate So how do I eliminate Conflicts of Interest Conflicts of Interest while working with while working with corporate partners?corporate partners?

You don’t. You don’t.

You minimize and manage You minimize and manage them.them.

Conflict is Inherent to Conflict is Inherent to Research EnterpriseResearch Enterprise

COI is a COI is a situationsituation, a confluence of , a confluence of potentially competing factors that potentially competing factors that arise when roles and relationships arise when roles and relationships have different objectives have different objectives

COI is not a reflection of character or COI is not a reflection of character or integrityintegrity

Entrepreneurial faculty will have these Entrepreneurial faculty will have these conflictsconflicts

Not Everyone Sees It Not Everyone Sees It That Way….That Way….

What Do You Do?What Do You Do?

University:University: Write and direct Write and direct

research protocolsresearch protocols Grants and Grants and

contractscontracts PublishPublish Precept traineesPrecept trainees Supervise staffSupervise staff Develop and patent Develop and patent

new technologiesnew technologies

Company:Company: EquityEquity Royalties/LicensingRoyalties/Licensing Office/BoardOffice/Board ConsultingConsulting PromotionPromotion Develop and patent Develop and patent

new technologiesnew technologies

Any of these may introduce conflicts of interest Any of these may introduce conflicts of interest when company responsibilities intersect with when company responsibilities intersect with University dutiesUniversity duties

Personal Financial Personal Financial InterestsInterests

Anything of real Anything of real or potentialor potential value value IncomeIncome EquityEquity Royalties/licensing feesRoyalties/licensing fees Indirect – family memberIndirect – family member

Non-Financial InterestsNon-Financial Interests

Board membershipBoard membership Executive positionExecutive position Scientific or technical advisorScientific or technical advisor TrusteeTrustee

What are the Potential What are the Potential Problems?Problems? ““Pipelining” of University technologiesPipelining” of University technologies Biased Research Biased Research

– SBIR/STTRSBIR/STTR Placing Study Subjects at RiskPlacing Study Subjects at Risk Exploiting Students/TraineesExploiting Students/Trainees Use of University resources to advance Use of University resources to advance

personal interests personal interests Unfair Purchasing/Contracting Unfair Purchasing/Contracting Gifts exert influenceGifts exert influence

Management Management PrinciplesPrinciples TransparencyTransparency SeparationSeparation IndependenceIndependence Protection of Human SubjectsProtection of Human Subjects Protection of Trainee ExperienceProtection of Trainee Experience

Management ToolsManagement Tools

Management AgreementsManagement Agreements Public DisclosurePublic Disclosure

– PublicationsPublications– PresentationsPresentations– Research GroupResearch Group

Independent Review PanelsIndependent Review Panels Monitoring CommitteesMonitoring Committees Facilities Use AgreementsFacilities Use Agreements Alternative Options for TraineesAlternative Options for Trainees

Best PracticesBest Practices

All agreements negotiated All agreements negotiated independently by appropriate independently by appropriate University offices (OTD, Sponsored University offices (OTD, Sponsored Research, OCT, University Counsel)Research, OCT, University Counsel)

Clear separation of personnel, funds Clear separation of personnel, funds and supplies and supplies

Transparent boundaries between Transparent boundaries between University and company activitiesUniversity and company activities

Care of each party’s confidential Care of each party’s confidential informationinformation

The Problem with The Problem with Wearing Multiple Wearing Multiple Hats…Hats………is that you only have one is that you only have one head.head.

Your role in any transaction Your role in any transaction determines whose interests you determines whose interests you represent and what resources you represent and what resources you can command.can command.

So What Happens?So What Happens?

Declare external relationships prior Declare external relationships prior to licensing negotiationto licensing negotiation

Policy: Individual who holds equity in, is an officer or director of, or provides consultative services to an entity that has licensed or otherwise acquired rights to University invention(s) will be deemed to have a Conflict of Interest

So What Happens?So What Happens?

Review what University activities Review what University activities could be affected:could be affected:– Research activityResearch activity– Trainee projectsTrainee projects– Other supervisory rolesOther supervisory roles– Administrative responsibilitiesAdministrative responsibilities

Develop plan to manageDevelop plan to manage

Who Is Involved?Who Is Involved?

University Researcher – criticalUniversity Researcher – critical SupervisorSupervisor Technology DevelopmentTechnology Development School COI CommitteesSchool COI Committees Monitoring CommitteesMonitoring Committees COI OfficerCOI Officer

This team protects the University’s This team protects the University’s interests interests andand the inventor the inventor

Not All Conflicts Not All Conflicts Can Be ManagedCan Be Managed Complexity of relationships Complexity of relationships

obscures boundary between obscures boundary between University and company activity, University and company activity, decision-making and accountabilitydecision-making and accountability

Rebuttable presumption that Rebuttable presumption that investigator may not participate in investigator may not participate in human subjects research in which human subjects research in which s/he has a financial interests/he has a financial interest

Conflicts of Conflicts of CommitmentCommitment Primary responsibility to the Primary responsibility to the

UniversityUniversity External Professional Activities for PayExternal Professional Activities for Pay Approval by chair or deanApproval by chair or dean No entitlement to a specific number of No entitlement to a specific number of

days for external activitiesdays for external activities Uncompensated activities also Uncompensated activities also

take timetake time

Institutional COIInstitutional COI

University financial interests:University financial interests:– Royalties/licensing feesRoyalties/licensing fees– EquityEquity– Personal interests of decision-makersPersonal interests of decision-makers

Concerns:Concerns:– Biased reviewBiased review– Unfair business practiceUnfair business practice– Risk to study subjectsRisk to study subjects

Management Not CureManagement Not Cure

Who’s Looking?Who’s Looking?

Government Government Sponsors Sponsors Competitors/peer institutionsCompetitors/peer institutions Employees/colleaguesEmployees/colleagues MediaMedia PublicPublic

SafeguardsSafeguards

Transparency Transparency – Institution (event-based disclosures)Institution (event-based disclosures)– Supervisor (annual review)Supervisor (annual review)– StaffStaff– TraineesTrainees

Maintain boundariesMaintain boundaries Adhere to management Adhere to management

plansplans

How does all of that How does all of that really work?really work?

Dhiren R. Thakker, PhDDhiren R. Thakker, PhD

UNC Eshelman School of UNC Eshelman School of PharmacyPharmacy

Questions?Questions?