A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered Research

Annals of Internal Medicine
16 October 2018 Vol: 169, Issue 8
http://annals.org/aim/issue

A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered Research
Special Article
Robert M. Califf, MD
This issue of Annals includes recommendations on ethical and regulatory issues related to the involvement of patients in the research process (1). The recommendations, which were produced by a panel funded by the Patient-Centered Outcomes Research Institute (PCORI), are organized into 3 categories: a description of roles for patients and oversight of those roles, oversight of the inclusion of emerging technologies in research protocols, and identification and engagement of patients in research. The panel used a Delphi process, beginning with extensive surveys of and interviews with relevant members of the research community. Based on these exchanges, draft recommendations were produced, after which a series of Delphi exercises included a group of patients, researchers, and regulators to achieve consensus on the final recommendations. The panel did not address traditional roles of patients in research in the context of patient-centeredness, citing extensive discussions stemming from challenges made to the SUPPORT trial (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) (2, 3)