Financial Conflict of Interest Requirements UW Oshkosh Grants & Research Workshop November 28th, 2017 Updated July 18, 2018 Kurt McMillen Interim Assistant Director, Grants & Proposals Office of Research & Sponsored Programs University of Wisconsin – Madison Kelly Schill Associate Director of Research Compliance Office of Sponsored Programs and Faculty Development University of Wisconsin Oshkosh 1/1/2019

Today’s Agenda Financial Conflict of Interest What is conflict of interest (COI) and/or financial conflict of interest (FCOI)? Policies & regulations governing COI on sponsored programs UW System policies Federal regulations FCOI regulation/policy requirements Investigator Responsibilities Training, disclosure, etc. Institutional Responsibilities Policy implementation, Disclosure review, monitoring, etc. FCOI Process on Sponsored Programs Few other items to keep in mind FCOI on non-federal projects FOCI on subawards Questions? 1/1/2019

What is a Conflict of Interest? 1/1/2019

What is a Financial Conflict of Interest? Exists when an investigator has a significant financial interest that could lead an independent observer to reasonably question whether the design, conduct or reporting of research might be influenced by the possibility of personal gain. It represents a state of affairs, not behavior. Frequently involve perceptions 1/1/2019

Where do Financial Conflict of Interests come from? Outside Activities UW System Faculty & Staff are encouraged to participate in outside activities, share expertise and transfer intellectual property to the private sector. Importance of such outside activities is captured in the ‘Wisconsin Idea’. Where knowledge gained from academic enterprise is shared to benefit society Participation in outside activities may generate the perception of a conflict between the needs of the institution and the outside entity. Financial Professional Others 1/1/2019

Recognize that Conflicts of Interests are… Common and frequently unavoidable Not necessarily “bad” Can often be appropriately managed 1/1/2019

Polices and Regulations Federal Regulations Public Health Service (NIH, CDC, etc…) Grants: 42 CFR Part 50, Subpart F Contracts: 45 CFR Part 94 Sponsor Policies/Requirements Section 4.1.10 of the NIH GPS State of Wisconsin Statutes Admin Code, Section UWS 8.025 UW Board of Regent Policy Regent Policy Document 20-7 UWO FCOI Policy UWO UW System Individual Sponsor Policies Federal Regulations State of Wisconsin Admin Code 1/1/2019

What is the Purpose of these Regulations? “promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.” Ensure the public’s trust that federally-supported research is conducted with the highest scientific and ethical standards 1/1/2019

Public Health Service Regulations 42 CFR Part 50, 45 CFR Part 94 Who does this apply to? Establishes standards to be followed by institutions that apply for or receive research funding from PHS Awarding Components (NIH), for grants, cooperative agreements, and research contracts. Any Investigator planning to participate in or participating in the research. Investigator – “Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of a research project that is federally funded or proposed for such funding.” What's Required? Investigators are informed (i.e. training). Investigators engaging in, or proposing to engage in, federally funded research are required to report all significant financial interests held by themselves or their immediate families. Institutions must review disclosures and manage potential conflicts. Institutions must report to funding agencies when a conflict does exist. Institutions should monitor investigators with federal funding at least annually. 1/1/2019

PHS FCOI Regulations Framework Implement FCOI Policy Evaluate Disclosures Identification of FCOI & Management if needed Report to Federal Agency Institution Take training Disclosure of significant financial interests Comply with Institutional Policy Investigator Oversight Federal Agency (NIH) 1/1/2019

Institutional Responsibilities Public Accessibility Institution must implement an FCOI policy that is in compliance with 42 CFR Part 50. FCOI policy must be made available via a publicly accessible Web site. UWO FCOI Policy: https://uwosh.edu/sponsoredprograms/fcoi/ Requirements outlined in the UWO Policy: How training should be completed. When/How disclosure should be completed. How disclosures will be evaluated. Overall FCOI Process on sponsored projects. Before spending funds for PHS-supported research, an Institution shall ensure public accessibility of information on certain significant financial interests (SFIs) that the Institution has determined are related to the PHS-funded research and are FCOI. 1/1/2019

Investigator Responsibilities Training Investigators must complete training on conflict of interest regulations prior to engaging in research related to any federally funded sponsored project. Completed through the CITI Program which includes a module with UW Oshkosh specific guidelines. CITI FCOI training: https://uwosh.edu/sponsoredprograms/fcoi/ Training must be renewed at least every four years. 1/1/2019

Investigator Responsibilities Disclosure Who? Investigators (PI, Co-PI, Key Personnel) engaging in, or proposing to engage in, federally funded research are required to report all significant financial interests held by themselves or their immediate families that reasonably appear to be related to the investigator's institutional responsibilities. When? - Disclosure is required: At the time of application for a federally sponsored project Annually – For investigators with federal funding Ad Hoc - within 30 days of discovering or acquiring any new or additional Significant Financial Interest How? Disclosure is completed by completing a Financial Disclosure Form and submitting it to the Office of Sponsored Programs 1/1/2019

Investigator Responsibilities Disclosure Financial Interest A financial interest that is held: (1) by an individual or a member of an individual’s immediate family; or (2) by a business entity that is controlled or directed by an individual or a member of an individual’s immediate family. Exclusions: Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education. If the individual does not directly control the investment decisions made in these vehicles. Excludes income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator 1/1/2019

Investigator Responsibilities Disclosure Significant Financial Interest To be significant, the financial interest has to reasonably be related to the individual’s institutional responsibilities at UWO, AND also needs to meet at least one of the follow criteria: For publicly traded entities: The value of payments received from the entity in the twelve months preceding the disclosure in combination with the value of any equity interest in the entity as of the date of disclosure exceeds $5,000. If Payment + Equity ≥ $5,000, It’s significant For non-publicly traded entities: The value of any payment received from the entity in the twelve months preceding disclosure, when aggregated, exceeds $5,000. Or, The investigator holds any equity interest in the entity. Payments ≥ $5,000, It’s significant Any equity interest = Its significant Service in positions with fiduciary responsibility. This includes executive positions, senior management, or membership on boards of directors; and Reimbursed or sponsored travel. 1/1/2019

Investigator Responsibilities Disclosure Significant Financial Interest A financial interest that is held: (1) by an individual or a member an individual’s immediate family; or (2) by a business entity that is controlled or directed by an individual or a member of an individual’s immediate family. Related to the individual’s institutional responsibilities. Entity Type: Publically traded company: Payment + Equity ≥ $5,000, It’s significant Non-publically traded company: Payments ≥ $5,000, It’s significant Any equity interest = Its significant Service in positions with fiduciary responsibility; Its significant. This includes executive positions, senior management, or membership on boards of directors. Intellectual property rights and interests (e.g., patents, copyrights, and royalties from such rights) 1/1/2019

Investigator Responsibilities Disclosure Additional disclosure resource UW-Madison developed a table of common reportable and non-reportable financial interests. This table can be accessed via this link: https://research.wisc.edu/kb-article/?id=33363#Table located in section 1.3 “What to Report” 1/1/2019

Institutional Responsibilities Evaluation of SFI Office of Sponsored Programs will preform a cursory review of disclosure. If a significant financial interest is disclosed, the Provost (Institutional Official for Research) will conduct a review to determine if a possible FCOI exists. If so, an Ad Hoc Research Responsibility Committee is formed to: Verify that an FCOI exists and Recommend a management plan 1/1/2019

Institutional Responsibilities Management Plan If a FCOI exists, committee will recommend a management plan to manage, reduce, or eliminate the COI. Key elements that have to be addressed in a management plan: Publication and presentation disclosure. Disclosure to students, staff and co-investigators. Cannot have oversight of any purchases from outside entity. Complete annual review of management plan with Department Chair and/or Dean. The investigator must agree to the management plan before research can move forward. 1/1/2019

Institutional Responsibilities Reporting If a FCOI is found to exist, the institution must report back to the granting agency. Elements of this report must include: Name of PD/PI Name of Investigator with the FCOI Name of the entity with which the Investigator has a FCOI Value of the financial interest Nature of FCOI, e.g., equity, consulting fees, honoraria A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research Key elements of the Institution’s management plan 1/1/2019

Institutional Responsibilities Monitoring & Non-compliance Investigators with federal funding must submit an annual disclosure, at a minimum. If an Investigator submits and ad-hoc disclosure, the institution will review the SFI within 60 days and determine if a FCOI truly exists. Compliance with management plans will be monitored. If a non-compliance is found… Institution will report to the agency. Institution may suspend all relevant activities and/or take disciplinary action. Research Responsibility Committee will complete a Retrospective Review to determine if the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research. If bias is determined during the Retrospective Review, the Institutional Official will create an action plan and update any reports as required by the funding agency. 1/1/2019

FCOI Process on Sponsored Projects When submitting a new proposal, all ‘investigators’ need to complete a financial disclosure from. Must be submitted to Sponsored Programs with proposal Completion and documentation of the CITI training is also required at that time Disclosures are reviewed by Institutional Official for Research (Provost) If it is determined that no FCOI exists, no further action is necessary If FCOI appears to exist, Research Responsibility Committee reviews disclosures A management plan is crafted to manage, reduce or eliminate FCOI If proposal is funded, UWO will report the applicable FCOIs to the funding agency Award is set-up when all FCOI requirements are completed 1/1/2019

FCOI Process on Sponsored Projects 1/1/2019

FCOI Requirements for Non-Federal Funding Some non-federal sponsors have applied the federal regulations to their award terms and conditions. The FDP maintains a list of these non-federal entities: http://sites.nationalacademies.org/PGA/fdp/PGA_070596 Just because its non-federal funding doesn’t mean you are exempt from these requirements. Review each funding announcement for FCOI requirements.

FCOI on Subawards If receiving a sub-award where the primary sponsor is a federal entity, federal FCOI requirement do apply. Same requirements and process as if we were receiving the funding directly from the federal agency. If issuing an outgoing sub-award, its UWO’s responsibility to ensure that the subrecipient has/does: An up to date FCOI policy that is in compliance with the FCOI regulations If they don’t, they can agree to use UWO’s policy and process. If they determine an FCOI exists, with the subrecipient investigator(s), they must report that to UWO. Its then UWO’s responsibility to report back to the federal funding agency 1/1/2019

Questions? Kurt McMillen Interim Assistant Director, Grants & Proposals Office of Research & Sponsored Programs University of Wisconsin – Madison Email: Kurt.McMillen@wisc.edu Kelly Schill Associate Director of Research Compliance Office of Sponsored Programs University of Wisconsin Oshkosh Schillk@uwosh.edu 1/1/2019