Patient-Centered Outcomes Research Oversight Study
Since September 2015, the Petrie-Flom Center has been 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 has been 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 is 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 is 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?
To date, we have 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 has been accepted for publication in IRB: Ethics & Human Research, forthcoming 2017. We are also in the midst of data collection on a national survey of IRB members on PCOR and human subjects protection and oversight. Beginning in Fall 2017, we will launch a Delphi process to develop and hone key recommendations for oversight of PCOR, which will culminate in a whitepaper comprised of guidance for IRBs, investigators and other stakeholders, and a public event in Spring 2018. We anticipate focusing 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.
In addition, the Petrie-Flom Center will host a public conference in 2018.
Faculty Director, Petrie-Flom Center