conflict of interest: yesterday, today and tomorrow sherrie settle assistant director institutional...
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Conflict of Interest:Conflict of Interest:Yesterday, Today Yesterday, Today
and Tomorrowand Tomorrow
Sherrie Settle
Assistant Director Institutional Research Compliance Program
Conflict of Interest Officer
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
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 potentially competing factors
Careers, lives, institutions with Careers, lives, institutions with multiple facets will have these multiple facets will have these conflictsconflicts
COI is not a reflection of character or COI is not a reflection of character or integrity integrity
COI in the MediaCOI in the Media
Student Loan ProgramsStudent Loan Programs Study Abroad ProgramsStudy Abroad Programs ‘‘De-Duking’ of the NIEHSDe-Duking’ of the NIEHS Congressional scrutiny of Congressional scrutiny of
pharmaceutical company influence pharmaceutical company influence on physicians and biomedical on physicians and biomedical researchersresearchers
Boston Legal episode questions Boston Legal episode questions perceived influence of “unrestricted” perceived influence of “unrestricted” giftsgifts
Who Cares?Who Cares?
University and UNC SystemUniversity and UNC System SponsorsSponsors Federal GovernmentFederal Government PublicPublic
Key ElementsKey Elements
Federal requirementsFederal requirements UNC-CH policiesUNC-CH policies Internal Processing FormsInternal Processing Forms RAMSeS/eCOIRAMSeS/eCOI
Code of Federal Code of Federal RegulationsRegulations
CFR Title 42CFR Title 42Each Institution must: Each Institution must:
Require that Require that by the time an application is by the time an application is submittedsubmitted to PHS to PHS each Investigator who is each Investigator who is planning to participateplanning to participate in the PHS-funded in the PHS-funded research has submitted to the designated research has submitted to the designated official(s) a listing of his/ her known official(s) a listing of his/ her known Significant Financial Interests (and those of Significant Financial Interests (and those of his/her spouse and dependent children): (i) his/her spouse and dependent children): (i) That would reasonably appear to be affected That would reasonably appear to be affected by the research for which PHS funding is by the research for which PHS funding is sought; and (ii) In entities whose financial sought; and (ii) In entities whose financial interests would reasonably appear to be interests would reasonably appear to be affected by the research. affected by the research.
UNC-CH ApproachUNC-CH Approach
Yesterday: Annual disclosure of Yesterday: Annual disclosure of everythingeverything
Today: Project-specific, event-Today: Project-specific, event-basedbased
– Screening questions determine if Screening questions determine if detailed report is neededdetailed report is needed
– Screening through IPF and IRB Screening through IPF and IRB ApplicationApplication
– PI answers for research teamPI answers for research team
AssumptionsAssumptions
PI knows the entire research PI knows the entire research team’s circumstancesteam’s circumstances
PI knows what’s on the IPFPI knows what’s on the IPF
Is it Working?Is it Working?
Good startGood start Weak correlation between electronic IPF Weak correlation between electronic IPF
and paper IRB answers for same projectand paper IRB answers for same project Missed positives in IPF screening from:Missed positives in IPF screening from:
– Inadequate information provided to Research Inadequate information provided to Research AdministratorAdministrator
– Project team information not known to PIProject team information not known to PI Positive IPF answers don’t prompt next Positive IPF answers don’t prompt next
stepstep Screening is electronic, but disclosures Screening is electronic, but disclosures
are notare not
Introducing eCOIIntroducing eCOI
Each investigator answers Each investigator answers screening questions for screening questions for himself/herselfhimself/herself
If positive, investigator can If positive, investigator can continue to disclosure or continue to disclosure or complete latercomplete later
Connects to RAMSeS and IRBISConnects to RAMSeS and IRBIS
Good News and Bad Good News and Bad NewsNews COI questions removed from IPFCOI questions removed from IPF All investigators must reply to All investigators must reply to
screening questions before screening questions before proposal can be submittedproposal can be submitted
How Does it Work?How Does it Work?
Log-in with UserID and ONYENLog-in with UserID and ONYEN Select IPF or IRB recordSelect IPF or IRB record Select Yes/No for screening Select Yes/No for screening
questionsquestions
If All Replies are “No”If All Replies are “No”
If One or More “Yes” If One or More “Yes” Replies Replies
What Will Research What Will Research Administrators See?Administrators See? Investigator certification status in Investigator certification status in
RAMSeSRAMSeS Review/approval status under Review/approval status under
“Compliance” tab“Compliance” tab
Fit with Federal Reg?Fit with Federal Reg?
CFR Title 42CFR Title 42Each Institution must: Each Institution must:
Require that Require that by the time an by the time an application is submittedapplication is submitted to PHS to PHS each Investigatoreach Investigator who is planning to who is planning to participate in the PHS-funded research participate in the PHS-funded research has submitted to the designated has submitted to the designated official(s) a listing of his/ her known official(s) a listing of his/ her known Significant Financial Interests (and Significant Financial Interests (and those of his/her spouse and dependent those of his/her spouse and dependent children)children)
Does the NIH Mean It?Does the NIH Mean It?
FY2006 Targeted Site Review FY2006 Targeted Site Review Report Report
Grant applications submitted prior Grant applications submitted prior to collecting significant financial to collecting significant financial interests from investigators interests from investigators
Grant funds expended prior to Grant funds expended prior to reporting identified financial reporting identified financial conflicts of interest to NIHconflicts of interest to NIH
Other Changes FYIOther Changes FYI
Disclose financial interest of Disclose financial interest of anyany valuevalue Disclosure may be sufficient to Disclosure may be sufficient to
manage many conflicts in basic manage many conflicts in basic researchresearch
Presumption that interest of any value Presumption that interest of any value precludes engagement in human precludes engagement in human studies research studies research
New modules for technology transfer, New modules for technology transfer, management rolesmanagement roles
Tomorrow Brought to Tomorrow Brought to You By:You By: Provost’s Task ForceProvost’s Task Force University CounselUniversity Counsel Office of Research Information Office of Research Information
SystemsSystems
