(PPT) Conflict of Interest for Research Administrators August 2007 Susan MacNally Compliance Coordinator, Research Integrity Research and Graduate Studies - DOKUMEN.TIPS (2023)

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• Slide 1
• Conflict of Interest for Research Administrators August 2007Susan MacNally Compliance Coordinator, Research Integrity Researchand Graduate Studies
• Slide 2
• Please create a conflict of interest Yes, I really mean this.Please conduct research, write papers, give talks, consult, publishbooks, serve on boards and panels, invent, start companies,testify, collect honoraria... do the things that create a healthy,vibrant campus where research and scholarship thrive. As a result,you will often create conflicts of interest. Good for you. James A.Roberts, Vice Provost for Research and Graduate Studies[emailprotected], May, 2006
• Slide 3
• A Conflict of Interest is the possibility, from the perspectiveof an independent observer, that an individuals private financialinterests or his or her families interests, may influence theirprofessional actions, decisions or judgments.
• Slide 4
• Conflict of Interest in the Headlines New York Times, August 1,2006 Tough-Talking Journal Editor Faces Accusations of Leniency ByDONALD G. McNEIL Jr. In one case, the authors of a study on the useof antidepressants during pregnancy, published in JAMA in February,neglected to disclose fees and research money from drug makers. Thestudy found that pregnant women who stopped taking antidepressantsrisked renewed depression. In another case at JAMA, the authors ofa study saying that women with migraines were more likely to getheart disease did not mention they had received money fromcompanies that make painkillers. The authors of a study linkingsome arthritis drugs to cancer omitted mention of speakingfees.
• Slide 5
• Appearance, Reality and COI The existence of a COI does notmean that unethical behavior has occurred The existence of a COIcan cast doubt on integrity An undisclosed COI has great potentialfor damage The existence of a COI does not mean that unethicalbehavior has occurred The existence of a COI can cast doubt onintegrity An undisclosed COI has great potential for damage
• Slide 6
• Individual and Institutional Integrity What is at Stake?Perceptions that Public funds have been used for private gain Aninvestigators research may be biased An investigator has behavedunethically KU is a poor steward of public funds KU research maynot be credible KU is not fulfilling its mission
• Slide 7
• The University recognizes that Conflicts may be inherent intrying to balance various roles Failure to disclose is a breach ofpolicy Employees may be able to act in dual roles if an approvedmanagement plan is in place Conflicts may be so profound that theyrequire severance of relationship
• Slide 8
• In other words, the University recognizes that Conflicts happenSome conflicts can be managed Some conflicts must be eliminatedDisclosure is an individual responsibility
• Slide 9
• How does COI affect research administrators? Policies who,what, how often Processes reporting and COIC Compliance reviews,consequences
• Slide 10
• Policies Federal PHS, NSF 1995-federal standards InstitutionsInvestigators
• Slide 11
• Policies Kansas Board of Regents KBOR PHS, NSF 1995-Compatiblewith federal Broader than federal Sets reporting requirements
• Slide 12
• Policies All KBOR PHS, NSF KU F/US Handbook Supplementalpolicies
• Slide 13
• WHO has to file? Faculty and Unclassified Staff (KBOR) ALLFull-time Some Part-time researchers, those with conflict Facultyand Unclassified Staff (KBOR) ALL Full-time Some Part-timeresearchers, those with conflict Investigators (PHS/NSF) Anyoneresponsible for the design, conduct or reporting of research Caninclude Adjuncts, USS, Students Investigators (PHS/NSF) Anyoneresponsible for the design, conduct or reporting of research Caninclude Adjuncts, USS, Students
• Slide 14
• HOW Often are COI reports required? Upon employment Annually,on academic year cycle Ad hoc, whenever ones circumstances changeAll of the above
• Slide 15
• KBOR COI Forms Declaration Form A Question B.1. Have you readthe Regents COI Policy? Yes Form A has 6 yes/no questions. Only onehas a correct answer.
• Slide 16
• KBOR COI Forms Disclosure Form B Each section in Form Bcorresponds to a question on Form A If you declare that you have asignificant interest on form A, then you must disclose details onForm B
• Slide 17
• KBOR COI Forms Disclosure Form BDeclaration Form A ~92% +~8%
• Slide 18
• WHAT information is disclosed? Significant financial interestsof employee or other household member which exceed definedthresholds AND which an independent observer could concludeinfluences or potentially conflicts with employees research oreducational activities. Office Ownership CompensationFees/Commissions Office
• Slide 19
• KU/KBOR COI Reporting Process Declare Form A Management PlanCOI Committee Review/Response Disclose Form B If Yes Must beresolved before award expenditures In compliance for proposalsubmission If No RI
• Slide 20
• Checking COI compliance for proposal submission Review WHO hasto file PI makes the call as to who is an Investigator Checkcompliance in CTS system All F/US Others PI Decides Check COI inCTS/COI Lite Note PI decision in file Yes No COI Forms
• Slide 21
• Checking COI compliance for proposal submission Up to date, nodisclosures Not up to date Good to go! Must verify they have begunto file by proposal submission date Not in database No fully-signedreport on file RI will follow up Contact RI immediately Stop!Message
• Slide 22
• Checking proposal for COI disclosures If disclosed interest isinvolved as a sponsor, subcontractor, provider of services, contactRI RI will check to see whether a management plan is in place and,if not, will work with PI and COIC to create one The funding agencymay have to be notified.
• Slide 23
• KU COI information on the web www.rgs.ku.edu/rcrWeb-facilitated reporting Download forms Policies FAQs
• Slide 24
• Web-facilitated COI Reporting New employees fill out paperforms All others via website View prior reports Confirm no changesFill out new reports Print reportshttps://webapp.research.ku.edu/COI/home.html
• Slide 25
• Web-facilitated COI Reportinghttps://webapp.research.ku.edu/COI/home.html
• Slide 26
• Web-facilitated COI Reporting secure KU loginhttps://webapp.research.ku.edu/COI/home.html
• Slide 27
• Web-facilitated COI Reporting Users reports Prior reportsScroll down to begin new report or confirm most recent report
• Slide 28
• Web-facilitated COI Reporting Confirm no changes Fill out newreports https://webapp.research.ku.edu/COI/home.htmlWeb-facilitated COI Reporting- Users reports
• Slide 29
• Confirm or Begin New Report? Confirm most recent report Donecompletely online no printouts, no signatures required.Fully-executed hard copy of prior report must be on file atRI.
• Slide 30
• I get an error when I try to confirm RI does not have afully-signed hard copy of your prior report. Print out your priorreport. All signatures required. Confirm or Begin New Report?
• Slide 31
• Confirm or Begin New Report??? Begin new report online If youhave a new significant interest to disclose. Print both Form A andForm B. All signatures required.
• Slide 32
• In Compliance = Fully Executed 3 Required Signatures*Individual Chair, Director or Unit Head Dean or Vice Provost *someadministrators require only one signature
• Slide 33
• Frequently Confused with COI Consulting Policy Overseen byOffice of the Provost Forms on Provosts website Send forms toOffice of the Provost
• Slide 34
• Frequently Confused with COI State of Kansas Statement ofSubstantial Interests Very similar to COI questions Required ofcertain State employees Notification from Provost every April Sentdirectly to Topeka
• Slide 35
• Why Comply with COI? Preserve credibility, reputation Sanctionsfor non-compliance Individual can be barred from submittingproposals May be noted on employee record This follows them for therest of their life. Dr. Catherine D. DeAngelis, Editor in Chief,JAMA
• Slide 36
• Disclose and Manage it works So, go out there and createproductive and ethical conflicts of interest. Just make sure youfully disclose and have a management plan that will protect KU'sintegrity and yours. James A. Roberts Vice Provost for Research andGraduate Studies
• Slide 37
• Questions about COI Susan MacNally Compliance CoordinatorResearch Integrity, RGS 864-4148 [emailprotected] William SharpDirector Research Integrity, RGS 864-7430
• Slide 38
• Conflicts of Financial Interest can arise with significantlevels of Ownership Compensation Office or Directorship Fees andCommissions
• Slide 39
• Examples of disclosures You have 10% ownership in a company.The company is worth less than $10K. The company business is notrelated to your research. You have equity in excess of $10,000 in acompany. Your hold only 1% ownership in the company. The company isrelated to your area of research. Your spouse is employed by acompany that does R&D in your field of research. S/he receivesover $100K in salary. S/he does not have an officer position withthe company. You have 10% ownership in a company. The company isworth less than $10K. The company business is not related to yourresearch. You have equity in excess of $10,000 in a company. Yourhold only 1% ownership in the company. The company is related toyour area of research. Your spouse is employed by a company thatdoes R&D in your field of research. S/he receives over $100K insalary. S/he does not have an officer position with thecompany.
• Slide 40
• What is disclosable? Your live-in lover is an officer ordirector of a company. S/he is paid $2K per year. The companys workis relevant to your area of research. Your spouse is an independentconsultant in your area of research. S/he receives $20K per annumfor consulting. You have many speaking engagements due to yourexciting discovery. Over the course of the year, your speaking feesadd up to $15K.
• Slide 41
• Conflicts of interest can pose risks to: Direction and Controlof Research Publication and Dissemination of Research Education andDirection of Student Research and Career Development Appointmentsand Promotions University Commitment Use of University Facilitiesand Resources Service on University Committees
• Slide 42
• University values that guide management of conflicts Ensuringunbiased research Maintaining a free marketplace of ideas Directingeducation of students Ensuring best use of public funds Preservingour identity as a university
• Slide 43
• Some Management Plan Strategies Public disclosure of relevantfinancial interests In publications and oral presentations, tolaboratory students and staff, to collaborating colleaguesDisqualification from participation in some portion of research /development program PI status on University research funded bycompany Monitoring of research by independent reviewersModification of research plan Divestiture of significant financialinterest Severance of relationships that create conflicts
• Slide 44
• Allowable? Manageable? PI Walter Wiggle invents a widget. KUpatents widget and licenses it to WidgetWorks. Dr. Wiggle has noownership in WidgetWorks. Dr. Wiggle receives royalties through KU.Dr. Wiggle participates on Scientific Advisory Board. Dr. Wiggleswife Wanda is the CFO of WidgetWorks. Dr. Wiggle is offered a BoDposition. WidgetWorks wants to employ Dr. Ws GRAs.
• Slide 45
• Allowable? Manageable? PI Samuel Script creates artificialintelligence software. KU copyrights software. Dr. Script createsstart-up, Scriptel, to develop and market the software. KU licensessoftware to Scriptel.Dr. Script and KU are owners of Scriptel. Dr.Script and KU receive royalties from Scriptel. Dr. Script pursuesfurther research on the software. What roles can Dr. Script assumeat Scriptel? Scientific Advisor? Board of Directors? COO? Scriptelfunds research project to develop software. Can Dr. Script act asPI? WidgetWorks wants to employ Dr. Ws GRAs. What roles can Dr.Script assume at Scriptel? Scientific Advisor? Board of Directors?COO? Scriptel funds research project to develop software. Can Dr.Script act as PI? WidgetWorks wants to employ Dr. Ws GRAs.
• Slide 46
• Management Plan Elements Background Details of outside interestand relation/involvement with employees work at KU Managementstrategies to implement (as appropriate) Separation of time Use ofUniversity facilities and resources Public disclosure Recusal /disqualification from participation Employment of students inoutside interest Monitoring of research, transactions with outsideinterest Oversight person or committee Timetable (if appropriate)Dated signatures of employee, unit head, dean / vice provost