This document discusses the potential for conflicts of interest between patients and advocacy groups that receive funding from medical companies. It proposes three recommendations to address this issue. First, it recommends ensuring a diverse mix of patient perspectives in research. Second, it recommends providing guidance on identifying and mitigating financial and non-financial conflicts of interest for patients involved in research. Third, it recommends disclosing any conflicts of interest that patients who are study personnel may have, as is done for other study staff. The goal is to prevent medical companies from inappropriately influencing or "capturing" the patient voice through advocacy organizations.

1. Patients and Conflict of Interest:
How Can We Keep the Patient’s Voice from
Being ‘Captured’?
I. Glenn Cohen, JD
Professor, Harvard Law School
Director, Petrie-Flom Center for Health
Law Policy, Biotechnology and
Bioethics
igcohen@law.harvard.edu

2.  Will not be promoting
unlabeled/unapproved uses of drugs,
devices, products, protocols, or
therapeutic strategies.
Disclosure

3.  Representation
 Capture
 Conflict of Interest
Rose SL, Highland J, Karafa MT, Joffe S. Patient
advocacy organizations, industry funding, and
conflicts of interest. JAMA Intern Med, 2017; 177:
344-50.
McCoy MS, Carniol M, Chockley K, Urwin JW,
Emmanuel EJ, Schmidt H. Conflicts of interest for
patient-advocacy organizations. N Engl J Med,
2017; 376: 880-5.
What’s the Potential Problem?

4. RECOMMENDATION 18
PCORI (or another funding or regulatory
body) should address the importance of
striving for a diverse mix of patient partners,
including, where appropriate, consideration
of characteristics such as race/ethnicity, sex,
socioeconomic status, advocacy group
affiliation, or health status.
Recommendations

5. RECOMMENDATION 19
PCORI (or another funding or regulatory
body) should provide guidance on identifying
and mitigating financial and non-financial
conflicts of interest among patients and
other stakeholders involved in research.
Recommendations

6. RECOMMENDATION 20
Investigators should identify and disclose
conflicts of interest among patients and
other stakeholders who are study personnel,
as with other study personnel, to the IRB.
Recommendations

7. RECOMMENDATION 21
IRBs should hold patients and other
stakeholders who are study personnel with
conflicts of interest to the same disclosure
and mitigation standards as other study
personnel.
Recommendations