Research Conflicts of Interest

June 7, 2017

To:        University Hospitals / Case Western Reserve University Research Investigators

From:   Grace A. McComsey, MD
             Associate Chief Scientific Officer, University Hospitals

             Kim F. Bixenstine, JD
             Chief Compliance Officer, University Hospitals

Date:     June 6, 2017

It has come to our attention that there is some confusion regarding responsibilities relating to research-related conflicts of interest and their associated management plans. To offer clarification, we provide the following:

  1. The Case Western Reserve University Conflicts of Interest Committee will continue to take the lead with respect to research-related conflicts of interest management plans for grant-funded research that is awarded through the university.
  2. UH will take the lead with respect to research-related conflicts of interest management plans for grant-funded research that is awarded through UH (e.g., industry and foundation grants).
  3. All conflicts of interest management plans for UH-employed investigators must be approved by either the investigator’s chair (for UHMG physicians) or by the Institute leader or President of UH Physician Services (for UHMP physicians). All management plans must be approved by Grace McComsey, MD, Director, UH Clinical Research Center, and Kim Bixenstine, UH Chief Compliance Officer.

In addition, this is a reminder regarding the new UH Policy CE-20 requirements relating to consulting by principal investigators for a company sponsoring their research through UH. Investigators have the following options to mitigate or eliminate a conflict of interest based on other work for the industry sponsor:

  1. Resign as the principal investigator or co-principal investigator on the study creating the conflict.
  2. Reduce work and remuneration from the industry sponsor to under $5,000 annually.
  3. Request that UH Cleveland Medical Center enter into a contract with the company for any amounts over $4,999.99, and have such amounts deposited in a research or discretionary fund for the physician’s department or institute. (The Legal Department will assist with such contracts.)
  4. Consult your Chair for arrangements for an advance independent review of the enrollment of subjects in the study to ensure the absence of bias, as well as a review of study results if the investigator is involved in the analysis of study results.

Any questions should be directed to either of us Grace.McComsey@UHhospitals.org; Kim.Bixenstine@UHhospitals.org or to Cecelia Fugitt, Compliance Specialist and Information Analyst, at Cecelia.Fugitt@UHhospitals.org or 216-767-8224.



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