Conflict of Interest: Yesterday, Today and Tomorrow Sherrie Settle Assistant Director Institutional Research Compliance Program Conflict of Interest Officer

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

Conflict is Inherent to Research Enterprise COI is a situation, a confluence of potentially competing factors Careers, lives, institutions with multiple facets will have these conflicts COI is not a reflection of character or integrity

COI in the Media Student Loan Programs Student Loan Programs Study Abroad Programs Study Abroad Programs ‘De-Duking’ of the NIEHS ‘De-Duking’ of the NIEHS Congressional scrutiny of pharmaceutical company influence on physicians and biomedical researchers Congressional scrutiny of pharmaceutical company influence on physicians and biomedical researchers Boston Legal episode questions perceived influence of “unrestricted” gifts Boston Legal episode questions perceived influence of “unrestricted” gifts

Who Cares? University and UNC System University and UNC System Sponsors Sponsors Federal Government Federal Government Public Public

Key Elements Federal requirements Federal requirements UNC-CH policies UNC-CH policies Internal Processing Forms Internal Processing Forms RAMSeS/eCOI RAMSeS/eCOI

Code of Federal Regulations CFR Title 42 Each Institution must: Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/ her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) That would reasonably appear to be affected by the research for which PHS funding is sought; and (ii) In entities whose financial interests would reasonably appear to be affected by the research.

UNC-CH Approach Yesterday: Annual disclosure of everything Yesterday: Annual disclosure of everything Today: Project-specific, event-based Today: Project-specific, event-based –Screening questions determine if detailed report is needed –Screening through IPF and IRB Application –PI answers for research team

Assumptions PI knows the entire research team’s circumstances PI knows the entire research team’s circumstances PI knows what’s on the IPF PI knows what’s on the IPF

Is it Working? Good start Good start Weak correlation between electronic IPF and paper IRB answers for same project Weak correlation between electronic IPF and paper IRB answers for same project Missed positives in IPF screening from: Missed positives in IPF screening from: –Inadequate information provided to Research Administrator –Project team information not known to PI Positive IPF answers don’t prompt next step Positive IPF answers don’t prompt next step Screening is electronic, but disclosures are not Screening is electronic, but disclosures are not

Introducing eCOI Each investigator answers screening questions for himself/herself Each investigator answers screening questions for himself/herself If positive, investigator can continue to disclosure or complete later If positive, investigator can continue to disclosure or complete later Connects to RAMSeS and IRBIS Connects to RAMSeS and IRBIS

Good News and Bad News COI questions removed from IPF COI questions removed from IPF All investigators must reply to screening questions before proposal can be submitted All investigators must reply to screening questions before proposal can be submitted

How Does it Work? Log-in with UserID and ONYEN Log-in with UserID and ONYEN Select IPF or IRB record Select IPF or IRB record Select Yes/No for screening questions Select Yes/No for screening questions

If All Replies are “No”

If One or More “Yes” Replies

What Will Research Administrators See? Investigator certification status in RAMSeS Investigator certification status in RAMSeS Review/approval status under “Compliance” tab Review/approval status under “Compliance” tab

Fit with Federal Reg? CFR Title 42 Each Institution must: Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS- funded research has submitted to the designated official(s) a listing of his/ her known Significant Financial Interests (and those of his/her spouse and dependent children)

Does the NIH Mean It? FY2006 Targeted Site Review Report Grant applications submitted prior to collecting significant financial interests from investigators Grant applications submitted prior to collecting significant financial interests from investigators Grant funds expended prior to reporting identified financial conflicts of interest to NIH Grant funds expended prior to reporting identified financial conflicts of interest to NIH

Other Changes FYI Disclose financial interest of any value Disclose financial interest of any value Disclosure may be sufficient to manage many conflicts in basic research Disclosure may be sufficient to manage many conflicts in basic research Presumption that interest of any value precludes engagement in human studies research Presumption that interest of any value precludes engagement in human studies research New modules for technology transfer, management roles New modules for technology transfer, management roles

Tomorrow Brought to You By: Provost’s Task Force Provost’s Task Force University Counsel University Counsel Office of Research Information Systems Office of Research Information Systems

Questions??