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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.

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Conflict of interest in human subjects research

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
CoI Topics and Issues

  • Means of uniform public disclosure

  • Educating the public on CoI

  • Determining the effectiveness of CoI Management

  • Giving guidance for disposition of CoI in human subjects research


Reporting versus disclosing
“Reporting” versus “Disclosing”


Public disclosure websites
Public Disclosure Websites

  • Feds -- US Att’y Gen’l’s settlement with 5 device mfgrs

  • Feds -- Grassley & Kohl’s “Sunshine Act”

  • States -- Minnesota, Massachusetts, Vermont…

  • Companies -- Eli Lilly, Merck, Pfizer, Edwards, GSK, Medtronic,…others

  • AMCs -- Cleveland Clinic (went live, 10/28/08) Univ of Pennsylvania, Stanford,…others (pending)


Conflict of interest in human subjects research

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

Cell Biology

Staff/Professor

Lerner Research Institute

Vice Chair

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


Conflict of interest in human subjects research

Education & Fellowships

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

Specialty Interests

Lipoprotein oxidation, vascular diseases, lipoprotein-cell interactions, atherosclerosis.

Research & Publications

[Click through to PubMed]

Industry Relationships

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.


Conflict of interest in human subjects research

Consulting. Dr. Chisolm receives fees of $5,000 per year or more as a paid consultant or speaker for the following companies:

None listed

Royalty Payments. Dr. Chisolm has the right to receive royalty payments for inventions or discoveries related to the companies shown below:

None listed

Equity. Dr. Chisolm owns stock or stock options from the following companies for activities as a founder, inventor, or consultant:

None listed

Fiduciary Role. Dr. Chisolm serves in a fiduciary capacity, such as an officer or director, for the following companies:

None listed

Inventor Share. Dr. Chisolm may receive future financial benefits from the Clinic for inventions or discoveries related to the companies shown below:

None listed


Coi disclosure website working group cleveland clinic march 27 2009

Host: more as a paid consultant or speaker for the following companies:

Moderator:

State Government:

Device Industry:

Pharma Industry:

Public AMCs:

Private AMCs:

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 Medicine

CoI Disclosure Website Working Group Cleveland Clinic, March 27, 2009


Conflict of interest in human subjects research

What we learned from convening entities planning web-based disclosure

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!


Patient survey preliminary results
Patient Survey--Preliminary Results disclosure

Objective

  • To gauge patient perceptions of conflicts of interest due to physician relationships with industry

    Methods

  • Online survey of the Cleveland Clinic Patient Panel

  • Cleveland Clinic Patient Panel -- current patients of Cleveland Clinic who volunteer to assist the organization by participating in surveys that address topics related to healthcare.

    Study

    Study Description

    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


Preliminary results familiarity with coi
Preliminary Results: Familiarity with CoI disclosure

  • How familiar are you with the meaning of the term Conflict of Interest as it relates to health care institutions and physicians?


Preliminary results seeking industry relationship information
Preliminary Results: Seeking Industry Relationship Information

  • If it was available online, how likely would you be to seek information about the industry relationships of your past, current or potential physicians?


Information of interest
Information of Interest Information

  • What information do you want to know about your Cleveland Clinic physician’s relationships with business?


Preliminary results further disclosure wanted
Preliminary Results: Further Disclosure Wanted Information

  • What information about your physician’s business relationships do you feel is missing that you’d like to know?

    (Most common answers paraphrased)

    • Amounts of money

    • Other perks (vacations, gifts, meals,…)

    • Impact on patient treatment

    • Whether physician’s friends or family members are linked to the businesses

    • How long these relationships have been in existence

    • How much of the physician’s time is spent devoted to outside business activities


Limitations of patient panel method
Limitations of Patient Panel Method Information

  • Results represent Cleveland Clinic Health System (Main Campus, Family Health Center and/or Regional Hospital) patients only,…

  • NOT the general population.

  • The pre-existing patient-clinic relationship has likely affected the opinions in this report.


Conflict of interest in human subjects research

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.


Issue uniform public disclosure
Issue--Uniform Public Disclosure physician-industry ties that is likely pertinent to research subjects

  • Means of uniform public disclosure

    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

  • Recommendation--Encourage broad public disclosure, but determine template for uniformity and in best interests of research subjects, patients, public


Coi topics and issues1
CoI Topics and Issues physician-industry ties that is likely pertinent to research subjects

  • Means of uniform public disclosure

  • Educating the public on CoI

  • Determining the effectiveness of CoI Management

  • Giving guidance for disposition of CoI in human subjects research


Issue educating the public on coi
Issue--Educating the Public on CoI physician-industry ties that is likely pertinent to research subjects

  • Educating the public on CoI

    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.

  • Recommendation--Determine means to educate the public of the benefits of academic-industry partnerships in research, the CoI risks and “best practices” for effective CoI management


Coi topics and issues2
CoI Topics and Issues physician-industry ties that is likely pertinent to research subjects

  • Means of uniform public disclosure

  • Educating the public on CoI

  • Determining the effectiveness of CoI Management

  • Giving guidance for disposition of CoI in human subjects research


Cleveland clinic conflict of interest policies
Cleveland Clinic Conflict of Interest Policies physician-industry ties that is likely pertinent to research subjects

  • Conflicts of Commitment

  • CoIs in Business Affairs

  • Non-Human Subjects Research

  • Human Subjects Research

  • Institutional CoIs in Research

  • Consulting

  • [Clinical Practice]

  • [Education]

© The Cleveland Clinic Foundation 2009


Institutional coi in research
Institutional CoI in Research physician-industry ties that is likely pertinent to research subjects

  • Financial interests of Cleveland Clinic

  • Financial interests of CC’s leaders

    • (Department Chairs or higher; Trustees)


What are we looking for in coi evaluation
What are we looking for in CoI evaluation? physician-industry ties that is likely pertinent to research subjects

(SIGNIFICANT FINANCIAL INTEREST)

Are you receiving from an outside entity…

  • equity, stocks (options), “inventor share”

  • royalties

  • consulting or speaker fees > $10,000/yr

    (ACTIVITY)

    …while you are …

  • performing research related to that entity

  • making business decisions related to that entity

  • (practicing medicine related to that entity)

  • (educating trainees)


Conflict of interest in human subjects research

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…

  • Compelling circumstances (AAMC guidelines)

    • These vary among institutions (!)

    • Inventor--understanding the value of development

    • Low risk to human subjects

    • Unique capability/expertise

    • Patient population without options

  • A CoI Management Plan

    • Separate the influence of the money from the patient care and the research data

      (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


Issue effectiveness of coi management
Issue--Effectiveness of CoI Management physician-industry ties that is likely pertinent to research subjects

  • Determining the effectiveness of CoI Management

    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.

  • Recommendation-- Promote research that addresses the effectiveness of current “best practices” in overseeing/managing CoI


Coi topics and issues3
CoI Topics and Issues physician-industry ties that is likely pertinent to research subjects

  • Means of uniform public disclosure

  • Educating the public on CoI

  • Determining the effectiveness of CoI Management

  • Giving guidance for disposition of CoI in human subjects research


Issue common rules for coi in human research
Issue--Common rules for CoI in human research physician-industry ties that is likely pertinent to research subjects

  • Giving guidance for disposition of CoI in human subjects research

    AMCs are non-uniform in the application of multiple CoI guidelines to human subjects research. (Discussed by Dr. McKinney)

  • Recommendation-- (quoting Dr. McKinney…) Develop a “common rule” for CoI in clinical research [NIH, FDA, OHRP, DOD, etc.]


Recommendations
Recommendations physician-industry ties that is likely pertinent to research subjects

  • Encourage broad public disclosure, but determine template for uniformity and in best interests of research subjects, patients, public

  • Determine means to educate the public of the benefits of academic-industry partnerships in research, the CoI risks and effective CoI management

  • Promote research that addresses the effectiveness of current “best practices” in overseeing/managing CoI

  • (McKinney…) Develop a “common rule” for CoI in clinical research [NIH, FDA, OHRP, DOD, etc.]