Research Conflicts of Interest: Identifying and Minimizing COI from the Perspective of Faculty July 30, 2009 PonJola Coney, MD Senior Associate Dean for Faculty Affairs Professor of Obstetrics & Gynecology School of Medicine

Definition “Industry” refers to any person or company seeking to do or doing business with VCUHS including any pharmaceutical, medical device, medical publishing or medical equipment companies.

Conflicts of Interest A conflict of interest could undermine the integrity of judgment in the evaluation or presentation of scientific data, or the integrity of a medical recommendation in the clinical setting.

Conflicts of Interest Three key factors have prompted the medical profession to carefully consider the interactions between physicians and industry:  Media reports  Drug costs  Direct-to-consumer (DTC) advertising

Clinical Trials  Of 107 clinical trials published in 1984, industry- sponsored studies were: 5 times more likely to favor new therapy 11 times more likely to reach favorable conclusions  In 70 articles debating the efficacy of calcium-channel antagonists (CCAs), supportive authors were more likely to have: relationships with manufacturers of CCAs than were neutral or critical authors ties with competitor manufacturers as well as any manufacturer American Medical Association

What does this suggest about the interests and obligations of physicians and industry in industry-sponsored clinical trials and articles? Physician Independent, objective evaluation Patient benefit Obligation to share promising information Industry Positive interpretation Market dominance and return on investment Patent protection These data bring into question the objectivity of industry-sponsored trials and articles written by physicians on behalf of industry, emphasizing the importance of mechanisms put in place by medical journals, such as peer review and disclosure of research funding.

Conflicts of Interest There is the potential for: dual loyalties subjectivity in conflict with objectivity varying accountability

Media Reports on “Patterns of Nondisclosure”

Potential “COI” Activities Conducting Industry-sponsored research Conducting non-Industry sponsored research with products of industry while in a consultant role to Industry Consultant Roles for industry  Paid Consultant  Financial Interest in the Company or Product Speaking or writing on behalf of industry Board Membership  Scientific Advisory Board  Corporate Board Member/Officer

Research The guidelines for consulting for industry and for conducting research for industry have many similarities. Before participation in any research activity, the researcher: Must have received Institutional Review Board approval of the protocol Should consult institutional policies and guidelines, federal and state laws and regulations

Conducting Research for Industry Physicians who participate in industry-sponsored research should ensure: integrity of research and protection of human subjects sound medical judgment is not influenced by third- party interests compensation is related to services performed compliance with ethical guidelines on potential conflicts of interest adherence to funding, review, or publishing disclosure requirements

Conflicts of Interest When you have a conflict, potential conflict, or perceived conflict of interest, the best action is to… a) Avoid the conflict b) Disclose the conflict c) Mitigate or manage the conflict

Research vs Consulting  Sponsored Projects should be reported via “Conflict of Interest Disclosure” Process  Outside consulting should be reported and approved according to the Policy On Outside Professional Activity on CP-1 Form.

Consulting A paid professional or service provided in the interests of an outside party that is beyond the scope of the University employment responsibilities. This service should not interfere with regular employment responsibilities, compete with activities offered by the University or exceed the allowable time (one day per seven day week) for outside consulting by eligible faculty and employees. An approved, time limited, written agreement defining services, tasks and/or deliverables and fair market compensation must be approved by the department chair or designee and Dean before the activity takes place. All compensation exceeding 10,000 from any one source must be reported

Are the physicians acting as true consultants?  Service Legitimate need of service? True exchange of professional services? Appropriate use of specified services?  Contract Written contract or agreement? Services specified in contract? Compensation specified in contract?  Compensation Specified basis for compensation? Fair market value compensation? Compensation established in advance?  Other Considerations Appropriate meeting venue? Appropriate reason to meet? Independent of referral value or volume?

Consulting When consulting, the employment status may be identified but you shall not speak, act or make representations on behalf of the University or express university endorsement in relation to the activity or use the university name for marketing purposes. Participation on “advisory boards” must comply with this policy.

Policy on Outside Professional Activity “any service rendered by a faculty member to persons or organizations external to the university, without university sponsorship, for the purpose of advancing, applying, or transferring knowledge in a field of endeavor related to the faculty member's employment at the university.” VCU requires School of Medicine faculty who accept a full-time faculty appointment to commit their principal professional effort to the university.

Examples: Outside “Professional” Activities  Providing professional advice to external entities.  Serving on nonprofit and for profit entity boards  Speaking on behalf of pharmaceutical and medical device companies  Giving expert testimony Formal approval process is required for these “consulting” activities

Examples: Outside “Professional” Leadership Activities  Serving in offices or on committees of academic or professional societies or professionally-related civic and nonprofit organizations  Participating in accreditation visits to other institutions  Serving on governmental advisory committees or study sections  Holding national level office in an academic society or professional organization  Editing a professional journal  Giving occasional lectures at other institutions  Presenting papers at professional meetings  Participating in or conducting continuing education short courses, seminars, workshops directed toward specific professional or other groups No formal approval process is required for professional leadership activities.

Outside Professional Activity  Attending an international, national or regional professional society conference is not an outside activity.  A distinguishing characteristic of outside professional activities is that the University does not provide travel and/or other financial support to a faculty member when undertaking the activity.

OPA: Time Allowance  With appropriate approvals, a faculty member may commit no more than one day, on average, of his/her time per calendar (7-day) week to outside professional activities for which extra compensation is received.  This time allowance applies to both outside professional leadership activities and outside professional consulting activities.  A faculty member assumes full liability for all outside professional activities which are not part of the faculty member’s university teaching, research and service responsibilities.

OPA: Reporting  Full-time faculty are also required to report annually to the Department Chair and the Dean on all outside professional activities regardless of whether compensation is received.  When the faculty member is compensated for an outside professional consulting activity, the faculty member must obtain written approval from the Department Chair and the Dean prior to engaging in the outside activity.  When the amount of compensation is $10,000 or greater for a single activity or a series of recurring activities, the faculty member must also disclose the amount of compensation to be received prior to engaging in the outside activity.

University OPA Policy  Must receive advance permission by completing Form CP-1.  At the end of the contractual year, faculty members who have engaged in outside activity for compensation, must report it on CP-2 Form

Principles of Conflict Does the conflict in any way affect the research performed and what mitigating actions should be taken?  No action beyond disclosure  Disclosure and Management Physician Payment Sunshine Act  Prohibition of the activity

Annual reporting of Outside Professional Activities is facilitated through the School of Medicine web-based Outside Professional Activities reporting system.

TAKE HOME MESSAGE 1.Physicians are professionals and retain unique responsibilities. 2.The “fiduciary” nature of the patient-physician relationship requires physicians to act according to high standards of conduct. 3.Physicians should ensure that interactions with industry are free of any conflicts of interest that could compromise or appear to compromise their judgment. 4.All financial arrangements with industry should be reviewed to verify that they conform to ethical guidelines and applicable policies.

SUMMARY  Service agreements should satisfy applicable guidelines when consulting, conducting research, or speaking or writing on behalf of industry.  Guidelines must be followed to satisfy policies and regulations.