IRB Open House Conflicts of Interest and Financial Conflicts of Interest in Research May 19, 2017 Office of Policy Coordination, Division of Outside Interests Christina Doty, Director, Outside Interests Mary Donahue, Senior Disclosure Specialist Emily Branyon, Disclosure Specialist

Overview: Office of Policy Coordination Division of Outside Interests The JHU SOM encourages its faculty and researchers to engage in a variety of outside activities with industry and other organizations. However, the financial interests and time commitment associated with these outside activities have the potential to conflict with our faculty and researchers’ primary obligations to the institution. JHU and the SOM have adopted policies to comply with federal regulations and to ensure that research, teaching, and clinical practice are not subject to real or apparent conflicts of interest and/or commitment, thereby supporting the integrity of these efforts. The Division of Outside Interests in the Office of Policy Coordination administers these policies.

Overview: Conflict of Interest (COI) A COI exists when an investigator has a secondary interest that competes, may compete, or appears to compete with his or her primary responsibility to JHU Secondary interests include, but are not limited to: Intellectual interests Financial and/or fiduciary interests Primary responsibility to JHU involves the conduct of safe and objective research

Disclosure Requirements: Who Must Disclose? Individuals with full-time and salaried part-time faculty appointments at JH must disclose all outside activities and financial interests that are related to their institutional responsibilities. Non-faculty investigators must disclose all compensated outside activities and financial interests that are related to their institutional responsibilities. Individuals who are not investigators are not required to disclose. Institutional responsibilities refers to those responsibilities assigned to a faculty member/investigator in the course of his/her appointment to or employment by Johns Hopkins including, but not limited to, the following: Clinical practice Teaching Research Administrative responsibilities Committee service

Disclosure Requirements: Examples What to disclose Compensation for services such as: Consulting Speaking, teaching, lecturing, delivering seminars Advisory committee/board or review panel Publishing/editing/authoring Board of Directors, founder, officer/manager Intellectual property Inventor of licensed technology/IP Receipt of income from licenses, whether cash, equity, royalty, or other Entitlement to equity and/or royalty Stock, stock options, etc. When to disclose Prior to participating in an outside activity No later than the time of application for federally funded research Within 30 days of acquiring or discovering a new financial interest Update whenever a disclosed interest or activity changes or ends Where to disclose eDisclose: http://edisclose.jhu.edu

Related Research and Financial Conflict of Interest (FCOI) Related Research: An investigator’s financial interest is related to his/her research when it can reasonably be determined that the financial interest: Could be affected by the research OR Is in an entity whose financial interest could be affected by the research FCOI: Exists when an investigator’s significant financial interest (SFI) could directly and significantly affect either the design, conduct, or reporting of his/her research. SFI’s include the following: Income greater than $5,000 annually Entitlement to future royalty payments under a license or other agreement Royalty payments Ownership of public equity (stocks or stock options) worth more than $5,000 Ownership of any private equity Fiduciary roles (officer, manager, board of directors, etc.)

FCOI Example: Dr. Gonzalez’s and Dr. Smith’s Invention Dr. Gonzalez is a faculty member at the SOM; Dr. Smith is a clinical associate (non-faculty investigator) They are co-inventors of molecular targets with potential to advance therapies in wound healing Identified through federally funded basic research conducted at JH NewCo Start-up to further develop the technology Questions When to disclose for FCOI review? Concerns? Likely recommendation?

Phase I Study Dr. Gonzalez is proposing to be a PI on a new R01 application, and Dr. Smith will be a co-investigator on the study team The R01 will fund a Phase I study in humans NewCo will supply the product, which is based on the licensed molecular targets NewCo will also provide funding Questions When to disclose for FCOI review? Concerns? Likely recommendation?

Office of Policy Coordination Questions? Office of Policy Coordination http://www.hopkinsmedicine.org/Research/OPC/index.html 410-361-8667 policy@jhmi.edu Additional information regarding FCOIs: http://web.jhu.edu/conflict_of_interest/index.html