PCORI Announces Funding Opportunities for Human Subjects Protections Research

By Jason Gerson, PhD

The Patient-Centered Outcomes Research Institute (PCORI) supports research that provides high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community. PCORI funds clinical comparative effectiveness research (CER) that engages patients and other stakeholders throughout the research process. The research we fund aspires to answer real-world questions about what works best for patients, based on their circumstances and concerns.

From PCORI’s start, supporting methodological research has been a priority; it is highlighted as such in our authorizing legislation. We think broadly about what constitutes “methods,” which includes issues related to ethics and human subjects protection that arise in the design and conduct of CER. There are particular issues that come up in the types of studies we fund—pragmatic clinical trials, cluster randomized trials, studies conducted in learning health systems, to name a few—that warrant further attention, deeper examination, and new approaches.

While we already support a handful of projects on these topics, we want to inform the PRIM&R community that we’re making such research a particular focus of an upcoming funding announcement. On August 15, 2016, PCORI will release its Cycle 3 2016 Improving Methods for Patient-Centered Outcomes Research Funding Announcement. It will offer specific funding opportunities on “Research Related to the Ethical and Human Subjects Protection Issues in PCOR/CER.” More details can be found here.

Priorities described in the funding announcement include (a) research on consent for participation in clinical trials in the context of PCOR/CER study designs, including research on options for altered consent processes; (b) research on the evaluation and determination of (minimal) risk in pragmatic clinical trials; and c) research on review and monitoring of PCOR/CER, including institutional review board processes, protocol adherence, and adjudication of study outcomes.

For those considering submitting a proposal, we note the following: first, we are looking for proposals that include a strong empirical component. Proposals that are primarily or entirely conceptual or theoretical are much less attractive to us. Second, we’ll give preference to proposals that seek to develop or test new approaches, rather than those that conduct primarily descriptive work (e.g., surveys and interviews or focus groups regarding attitudes about current policies or practices).

Letters of Intent are due September 14, 2016. Please direct any questions, concerns, or other inquiries to pfa@pcori.org.

Dr. Gerson is senior program officer for the Comparative Effectiveness Research Methods Program at PCORI. He is responsible for providing intellectual and organizational leadership in the design and implementation of methods-related initiatives. He also leads some of PCORI’s efforts in open science.