Although actively integrating patients into more roles in medical research is intended to produce data that matter to patients, the ethical and regulatory parameters around this approach are unclear. A Delphi expert panel developed recommendations in 3 key areas of patient engagement, according to a report published in the Annals of Internal Medicine.
The intended targets of the Delphi panel’s recommendations comprise mainly research investigators, regulators, and institutional review boards. The recommendations arose from the multiphase Patient-Centered Outcomes Research Oversight Study, which involved focus groups, interviews, case studies, a survey given to institutional review board chairs at large research institutions throughout the United States, and several iterations of assessment and feedback to develop agreement among participants.
A total of 21 recommendations emerged from the panel, fitting within 3 main categories. One category consisted of 10 recommendations addressing patients and their advocates or caregivers in study roles that do not involve being the subject of study. Considerations involved classifying patients in research roles, appropriate technical and ethical training for patients in these roles, movement between roles, compensating patients for research contributions, and preserving scientific integrity.
A second category contained 6 recommendations providing guidance around protecting privacy, data gathering, and consent in areas of emerging technologies — particularly relating to social media, wearable devices, and mobile applications.
A third realm of 5 recommendations targeted ways to assign and engage patient partners in the research process, considering issues such as patient diversity and addressing possible financial conflicts of interest, such as between company partners and patient advocacy groups.
Overall, the recommendations address the goal of balancing patient perspectives that are informed by filling multiple roles while upholding scientific integrity and protecting patient safety and security.
Gelinas L, Weissman JS, Lynch HF, et al. Oversight of patient-centered outcomes research: recommendations from a Delphi panel [published online September 25, 2018]. Ann Intern Med. doi: 10.7326/M18-1334