Project: 

In September 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School joined a collaborative project called the “Patient-Centered Outcomes Research Oversight Study,” or PCOROS, led by Principal Investigator Joel Weissman, PhD. The project is funded through a contract from the Patient-Centered Outcomes Research Institute to The Brigham and Women’s Hospital, Inc., with a subward to the Petrie-Flom Center.

PCOROS brings together researchers from across Harvard and Harvard-affiliated research institutions.  Reflecting the principles of patient centered outcomes research (PCOR), the project is informed by input from an advisory committee that includes ethics thought leaders, patient advisors, human subjects protection professionals, and investigators. 

There is a substantial gap in evidence regarding the novel ethical challenges that may be posed by PCOR as relevant to human subjects protection and oversight.  The goal of this project 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?

Key objectives include:

  • A qualitative research study that will catalogue the practical and ethical challenges encountered by IRB members, patient research partners, and other stakeholders dealing with PCOR.  This will be accomplished through focus groups, interviews, and in-depth case studies.

  • A national survey of IRB members on PCOR and human subjects protection and oversight.

  • Development of an ethical framework and evidence-based policies to guide investigators, sponsors, institutions, and IRBs in the conduct and oversight of PCOR.

  • Public conferences, events, and publications to facilitate discussion of ethical issues related to PCOR and to solicit feedback from stakeholders on the proposed ethical framework and policy recommendations.

In addition to participating in the empirical research projects, the Petrie-Flom Center will lead the development of the ethical framework and recommendations, and will host a public conference in 2018.

Staff

I. Glenn Cohen

I. Glenn Cohen

Faculty Director, Petrie-Flom Center

 


 

Holly Fernandez Lynch

JD, MBioethics

Executive Director, Petrie-Flom Center

Faculty, Center for Bioethics, Harvard Medical School