Conflict of Interest in Human Subjects Research. Guy M. Chisolm, III, Ph.D. Vice Chair, Lerner Research Institute Cleveland Clinic Presentation to the Secretary’s Advisory Committee on Human Research Protections SACHRP Arlington, Virginia July 22, 2009. CoI Topics and Issues.
Related searches for Conflict of Interest in Human Subjects Research
Guy M. Chisolm, III, Ph.D.
Vice Chair, Lerner Research Institute
Presentation to the
Secretary’s Advisory Committee on Human Research Protections
July 22, 2009
Go to www.clevelandclinic.org …
Click on ‘FIND A DOCTOR…
Guy Chisolm, Ph.D.
Professional Staff Affairs Office
Director, Innovation Management and Conflict of Interest Program
Lerner Research Institute
Phone: (216) 444-5854
Location: Cleveland Clinic Main Campus
Mail Code NB21
9500 Euclid Avenue
Cleveland, OH 44195
* Brief Biosketch * Research & Publications
* Education & Fellowships * Request an Appointment
* Specialty Interests * Industry Relationships
Fellowship: Karolinska Institute, Stockholm, Sweden
Fellowship: Massachusetts Institute of Technology, Cambridge, MA
Other Education: (Doctorate)University of Virginia, Charlottesville, VA
Other Education: (Masters)University of Virginia, Charlottesville, VA
Other Education: (Undergraduate)University of Pennsylvania, Philadelphia, PA
Lipoprotein oxidation, vascular diseases, lipoprotein-cell interactions, atherosclerosis.
Research & Publications
[Click through to PubMed]
Cleveland Clinic physicians and scientists report if they have any collaborations with the pharmaceutical or medical device industries as part of the Cleveland Clinic’s procedures. The Cleveland Clinic publicly discloses payments for speaking and consulting of $5,000 or more per year, and any equity, royalties, and fiduciary relationships in companies with which they collaborate. In publicly disclosing this information, the Cleveland Clinic tries to provide information as accurately as possible about its doctors’ connections with industry and those of their immediate family members. As of 6/26/2008, Dr. Chisolm has reported no financial relationship with industry that is applicable to this listing. Patients should feel free to contact their doctor about relationships with industry and how the relationships are overseen by the Cleveland Clinic. To learn more about the Cleveland Clinic’s policies on collaborations with industry and innovation management, go to our Integrity in Innovation page.
Consulting. Dr. Chisolm receives fees of $5,000 per year or more as a paid consultant or speaker for the following companies:
Royalty Payments. Dr. Chisolm has the right to receive royalty payments for inventions or discoveries related to the companies shown below:
Equity. Dr. Chisolm owns stock or stock options from the following companies for activities as a founder, inventor, or consultant:
Fiduciary Role. Dr. Chisolm serves in a fiduciary capacity, such as an officer or director, for the following companies:
Inventor Share. Dr. Chisolm may receive future financial benefits from the Clinic for inventions or discoveries related to the companies shown below:
Host: more as a paid consultant or speaker for the following companies:
Guy M. Chisolm, Ph.D. Cleveland Clinic
Susan Ehringhaus, J.D. AAMC
James Daniel, MPH State of Massachusetts
Christopher White, Esq. AdvaMed
Bruce P. Garren Edwards Lifesciences Corp
Kathy E. DiGiorno Medtronic
Jack Harris, M.D. Eli Lilly
Geralyn S. Ritter Merck & Co., Inc.
Cathryn M. Clary, M.D., MBA Pfizer, Inc.
Jeffrey Paden GSK
Raymond Hutchinson, M.D. University of Michigan Medical School
Deborah Biggs, J.D. UNC Chapel Hill School of Medicine
Neal Cohen, M.D., MPH, MS UCSF School of Medicine
Barry D. Burgdorf, J.D. The University of Texas System
Lynn Zentner University of Minnesota
Ross McKinney, M.D. Duke University School of Medicine
Claudia Adkison, JD, PhD Emory University School of Medicine
Julie Gottlieb, M.A. Johns Hopkins University School of Medicine
Marianne Hockema Mayo Clinic
Christopher Clark, J.D. Partners Health Care (B&W, MGH, Harvard)
Glen Gaulton, Ph.D. University of Pennsylvania School of Medicine
Harry Greenberg, M.D. Stanford University School of MedicineCoI Disclosure Website Working Group Cleveland Clinic, March 27, 2009
It is very clear that over the next two years there will be multiple websites for disclosure set up by the federal government, state governments, companies and academic medical centers that disclose industry relationships of physicians in various and non-uniform fashion.
Discrepancies are inevitable!
Survey Timeline June 19, 2009 – June 24, 2009
Panel Members Invited 2,319
Completed Surveys 1,153 to date
Completion Rate 49.7% to date
Median Survey Time 9 minutes
Participation Incentive Raffle of (25) $50 USD Checks
(Most common answers paraphrased)
What we learned from asking our patients about physician-industry ties that is likely pertinent to research subjects
It is clear that patients and their families (arguably a similar population to those typically asked if they would volunteer to be research subjects) want much more information than they have.
While disclosure is endorsed by all, and the public is hungry to know more, the non-uniformities in the making will confuse research subjects and their families rather than help them
The public does not clearly recognize benefits of industry-academic partnerships in research, how these must be balanced against risks of bias from CoI, and how these are being evaluated and processed.
© The Cleveland Clinic Foundation 2009
(SIGNIFICANT FINANCIAL INTEREST)
Are you receiving from an outside entity…
…while you are …
To get “approval” to perform physician-industry ties that is likely pertinent to research subjects human subjects research related to a company and have a financial interest in the company, you need…
(disclosure!!!; data analysis; patient selection; patient consent; multi-center; alternate principal investigator; external data & safety monitoring; no phase III, etc…)
© The Cleveland Clinic Foundation 2009
AMCs are quickly developing the infrastructure and processes to identify and evaluate CoI, then eliminate, reduce or manage them. This is being done with only inferential reliance on the effectiveness of these endeavors.
AMCs are non-uniform in the application of multiple CoI guidelines to human subjects research. (Discussed by Dr. McKinney)