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Conflict of Interest Review and Management

Disclosures of financial interests are reviewed for the potential to create conflicts of interest with research and other Johns Hopkins responsibilities. Review for conflict of interest with research follows the JHU Policy on Financial Interests and Financial Conflicts of Interest with Research, which complies with PHS regulations on objectivity in research.

Disclosures are reviewed for:

  • potential of disclosed interests to directly and significantly affect the design, conduct, or reporting of research funded by a PHS Awarding Component or other sponsor ("financial conflict of interest" or "FCOI"); and
  • risks to the rights and safety of human research subjects; and
  • impact on the integrity of research data; and
  • risks to the rights and obligations of students and trainees participating in research; and
  • impact on the availability of research results to the scientific community for use in the public interest; and
  • appearance of a conflict of interest.

The goal of each review is to determine whether a disclosed financial interest relates to an individual's research, regardless of research sponsor, and, if so, whether it creates a conflict of interest with the research. A disclosed financial interest is considered related to one's research if the research could impact the value of the company in which the financial interest is held (or from which it derives) or the value of its products or those of its competitors.

Under PHS regulation, when the institution determines that a financial interest is related to PHS-supported research and could directly and significantly affect the design, conduct or reporting of the research, the institution has identified a financial conflict of interest (FCOI).  Regulation requires that FCOIs must be eliminated or managed to protect the integrity and objectivity of the research.

In most cases, a finding of conflict of interest will result in the imposition of conditions associated with participating in the research. In some cases, participating in the research will be conditioned on reducing the investigator's financial interest. And in some instances the conflict of interest will be deemed "unmanageable," and the investigator will be required to eliminate the financial interest as a condition of participating in the research. If the arrangement involves a PHS grant or contract and the institution determines that there is a FCOI that could "directly and significantly affect the design, conduct or reporting" of the research, the FCOI must be reported to the PHS awarding agency and other conditions apply. In cases where the arrangement is not determined to be an FCOI according to PHS standards, the arrangement nevertheless may be subject to administrative conditions.

All arrangements may be re-reviewed if circumstances change or there is new information.

The Committee on Outside Interests, which reviews most potential conflicts of interest, is advisory to the Dean (or the Dean's designee, the Vice Dean for Research) and, for proposed arrangements involving human subject research, to the Dean and the IRB.

Financial Interests and Your Research

Your financial interest in an entity could impact your research in a variety of ways, depending on two factors:

If you have any questions, please contact the Outside Interests Division of the Office of Policy Coordination at (410) 516-5560 or e-mail us at policy@jhmi.edu. We are available to give presentations about conflict of interest, conflict of commitment and/or outside services to departments, laboratories or faculty groups. We are also available to meet individually with faculty and staff who have general questions about outside activities, conflict of interest and/or conflict of commitment.

 

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