From September 2015 to 2018, the Petrie-Flom Center was part of a collaborative project funded by the Patient-Centered Outcomes Research Institute (PCORI) called the “Patient-Centered Outcomes Research Oversight Study,” or PCOROS, led by Principal Investigator Joel Weissman. The Petrie-Flom Center’s work on PCOROS was co-led by I. Glenn Cohen and Holly Fernandez Lynch. In March 2017, Luke Gelinas joined the project as Research Associate, splitting his time between PCOROS and work for Harvard Catalyst.

The primary focus of this project was to identify and address any novel or prevalent ethical and regulatory challenges posed by patient-centered outcomes research (PCOR) as relevant to human subjects protection and oversight. The goal was to engage with institutional review boards (IRBs), investigators, patients, and other stakeholders to better understand the practical realities of PCOR oversight: what are the barriers, ethical decision points, regulatory challenges, and outstanding questions calling for resolution?

During the duration of this project, we completed a qualitative research study (including interviews, focus groups, and case studies) to catalogue the practical and ethical challenges encountered by IRB members, patient research partners, and other stakeholders dealing with PCOR. A publication summarizing the findings of this research was accepted for publication in IRB: Ethics & Human Research, and appeared in the January-February 2018 issue.  We also collected data for a national survey of IRB members on PCOR and human subjects protection and oversight. 

In Fall 2017, we launched a Delphi process to develop and hone key recommendations for oversight of PCOR, which culminated in a whitepaper comprised of guidance for IRBs, investigators and other stakeholders. We focused on several areas of interest, including the participation of patients in non-traditional roles (beyond research subject) in PCOR, utilization of mHealth technologies, and overarching logistical issues. The 21 recommendations from the panel were published in Annals of Internal Medicine in September 2018.

In addition, the Petrie-Flom Center hosted a public conference in June, 2018.


I. Glenn Cohen

I. Glenn Cohen

Faculty Director, Petrie-Flom Center

James A. Attwood and Leslie Williams Professor of Law, Harvard Law School


Holly Fernandez Lynch

Executive Director, Petrie-Flom Center (2012 - 2017)




Luke Gelinas

Senior Researcher, Petrie-Flom Center (2015 - 2018)