By Avni Gupta
Patient-Centered Outcomes Research (PCOR) is characterized by patients participating in various research roles other than merely the subjects. The Patient-Centered Outcomes Research Institute (PCORI), a major funder of PCOR research, defines patient engagement as including patients in all stages of research, “from topic selection through design and conduct of research to dissemination of results.”
However, while the concept of patient engagement in research and its potential for benefitting science are increasingly recognized by funders and investigators, IRBs’ comfort with patients in non-traditional roles in research protocols lags behind.
IRBs’ familiarity with patients in research has traditionally been with patients who are study participants or subjects, and are considered “vulnerable.” Therefore, many IRBs’ review process focuses on ensuring that adequate protective measures are in place to “protect” the patients, including measures such as a detailed written informed consent, continuing review, confidentiality measures, and so on.
One challenge of Patient Centered Outcomes Research is to make sure the patient voice isn’t “captured.”
Register here for this weeks’s event, “Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight”
By Paul McLean
In a previous life I was a headline writer, so I have to give props for the title of this Friday’s Petrie-Flom panel: “Patients and Conflict of Interest: How Can We Keep the Patient’s Voice from Being ‘Captured’?
That is, how do you avoid “capturing” the patient voice when “capturing” the patient voice is the whole point of Patient Centered Outcomes Research? And yet this is a central challenge to bringing expertise unique to the receiving end of medicine and research into all levels of the process.
By I. Glenn Cohen
The Patient Centered Outcomes Research Institute (PCORI) was established under the Affordable Care Act. Its goal is to fund and encourage Patient-Centered Outcomes Research (PCOR), understood as evaluating questions and outcomes that are meaningful not just to researchers, but to patients and caregivers as well.
One key way of achieving this is to involve patients 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.
But where do these patients come from? How representative are they of the patients who will ultimately participate in the study?
Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted.
Such efforts hold great promise, but also raise potential challenges for ethical oversight.
How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups?
This symposium will bring together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.