1 PHS/NIH Proposed Rule Changes Financial Conflict of Interest What’s different, what did the community have to say, and how will UNC respond?

2 Why is NIH Proposing Changes?  Regulations unchanged since issued in 1995  Accelerated pace of translational research and commercialization  Growth of multidisciplinary teams involving the private sector  Increasing complexity of interactions between government agencies, research institutions, other public agencies and private enterprise  Public scrutiny, OIG findings, Congressional pressure

3 Definition of Financial Conflict of Interest (FCOI)  Remove SBIR/STTR exclusion  Reduce de minimis threshold from $10,000 to $5,000  No de minimis threshold for equity in privately held company  Lists ‘paid authorship’ and ‘travel reimbursement’ as forms of compensation  Exclusion for teaching, advisory committees and review panels limited to government agencies and institutions of higher education

4 Investigator Disclosure to Institution  At least once per year  All interests related to ‘institutional responsibilities’  Covers 12 calendar months prior to disclosure  Disclosures must be updated annually or when new financial interests are obtained

5 Determination of Relatedness  Previously declared by the investigator  Institutional responsibility to determine the relationship between declared interests and each PHS-funded project

6 Public Disclosure Requirement  Publicly accessible web site listing current FCOI related to PHS-funded research  Include investigator name, nature and dollar value (in specified ranges) of each FCOI  Applies to individuals identified by the Institution as senior/key personnel  Update annually and retain for five years from last update  Timelines correspond to reporting to NIH: before spending any funds of a new award or within 60 days of new determination

7 Required Training New requirement for all investigators to be trained on the institution’s COI policies:  Prior to engaging in PHS-funded research  At least once every two years thereafter

8 Management Plans and Mitigation Plans  Requirement for written management agreements for identified FCOI  Additional requirements, including mitigation plans, for ensuring objectivity when FCOI is not identified, evaluated and reported to NIH within prescribed timelines.

9 Subrecipients  Subcontract requires explicit statement of whether subrecipient has is own CFR-compliant process or will be covered by prime grantee process  Specify timelines for submission of financial disclosures or FCOI determinations to prime grantee

10 Project/Investigator Change of Institution Solicited comment on additional requirements to address investigator or project inter-institutional transfers:  Formal requirement to review prior institutions’ public postings  Formal requirement to review institution’s own prior reviews/management of the relationship

11 Oh, We Thought You Knew  Expectation that FCOI determinations be reported to NIH upon renewal, whether competing or non- competing  If the grantee institution deems additional interests beyond the CFR definition to be FCOI, those also must be reported to the NIH  Will also apply to web posting requirement

12 Questions??? Answers???