Today it is not unusual for patients to expect to be engaged in making decisions about their own health care, in consultation with their doctors. This is commonly referred to as patient-centered care, and recognizes that patients are the best source of information about their needs and preferences.
A relatively newer concept is patient involvement in research on healthcare.
Traditionally, healthcare research has focused on critical events like death or complications, or physiological data from laboratory tests. But patients may be equally (and sometimes more) concerned about harder-to-measure results like quality of life, time spent at home with their families, or the ability to return to work.
Patient-centered outcomes research (PCOR) recognizes that to better understand these kinds of issues, scientists should consult patients about the design and conduct of research. Therefore, PCOR is quickly becoming the standard.
“Compelling reasons, both practical and ethical, support engaging patients in healthcare research,” write Garces and co-authors. “Patients are the ultimate user of healthcare research findings and the most important stakeholder.”
Involving patients as partners in research ensures a focus on outcomes important to patients, provides insight to patient decision-making, inserts a valuable perspective of personal experience with the condition under study, and can provide helpful input on language and cultural issues to make dissemination campaigns more effective.
The Patient Centered Outcomes Research Institute, or PCORI, was established under the Affordable Care Act, and defines PCOR, as, “the evaluation of questions and outcomes meaningful and important to patients and caregivers.”
In typical PCOR research, investigators will form partnerships with patients to get their input on the research, by asking them to get involved in other ways than as the research subject. This may occur whenever patients are named 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.
While patient engagement has obvious benefits, it may also raise concerns about the ethical conduct of research. For example, if the principal investigator of the project interviews a patient research partner on the team, does that patient need to provide informed consent? What conflicts might arise if patients serve as both advisors and also participate as subjects? How can we protect the rights of patients without getting in the way of their meaningful participation? These questions are of particular interest to Institutional Review Boards (IRBs), which are the bodies at major research centers who primary purpose is to protect the rights and welfare of human subjects involved in research activities.
The Patient-Centered Outcomes Research Oversight Study (PCOROS) is a federally-funded study tasked with investigating these and other related issues. Using focus groups, case studies of major research institutions, stakeholder interviews, and a national survey of IRB chairs, we 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.
Next week, as we near the end of the project, we will lead a Symposium at the Petrie-Flom Center at Harvard Law School. There we will present our findings on the responsibilities of IRBs, the challenges associated with the review and oversight of PCOR, and recommendations for managing ethical and regulatory oversight issues that arise.
In a forthcoming series of blog posts, we will also discuss some of our findings and recommendations.
Research reported in this publication was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (ME-1409-21701). The views presented are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.