Investigating Conflicts of Interest in Patient-Centered Outcomes Research

By I. Glenn Cohen

The Patient Centered Outcomes Research Institute (PCORI) was established under the Affordable Care Act. Its goal is to fund and encourage Patient-Centered Outcomes Research (PCOR), understood as evaluating questions and outcomes that are meaningful not just to researchers, but to patients and caregivers as well.

One key way of achieving this is to involve patients as personnel in research projects as advisors, consultants, or team members involved in any aspect of research, from topic development through study design, implementation, interpretation, and dissemination.

But where do these patients come from? How representative are they of the patients who will ultimately participate in the study?

The Patient-Centered Outcomes Research Oversight Study (PCOROS) is a federally-funded study tasked with investigating ethical issues in research oversight of PCOR.

Using focus groups, case studies of major research institutions, stakeholder interviews, and a national survey of Institutional Review Board (IRB) chairs, the members of the study gathered evidence over the last three years about policies and practices in the hopes of informing the development of recommendations for investigators, their institutions, and patients.

As part of a day-long Symposium at the Petrie-Flom Center at Harvard Law School next week, will discuss what we found and our recommendations. My talk at the event will focus on the subject of patients and conflicts of interest, which a panel of colleagues including Joe Selby, Andrew Nierenberg, Paul McLean and Emily Largent, will respond to.

Among the questions this panel will be addressing are:

  • To what extent does industry influence patient advocacy groups, from which many PCOR patient personnel are drawn?
  • How should we understand what counts as a “representative” group of patient personnel? What axes of identity should we focus on? How do we trade-off representativeness and expertise or effectiveness?
  • To what extent are IRBs or other institutional officials considering potential patient representative conflicts of interest? Should such conflicts be reported? How might they be mitigated? Should the rules be the same as for the non-patient researchers? What guidance currently exists?
  • Is there a concern that patient representatives become so “professionalized” in their role that they are “captured” by the researcher perspective? That is, might they stop being true bell-weathers of what patients want and instead adopt perspectives too close to the researchers?

We hope you will join us to learn more. Please register here if you haven’t already.

 

I. Glenn Cohen

I. Glenn Cohen

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

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