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.