Research Ethics in Patient-Centered Outcomes Research (PCOR) [Methods Study], United States, 2015-2019 (ICPSR 39567)

Version Date: Nov 20, 2025

Cite this study |

Principal Investigator(s):
Joel Weissman, Brigham and Women's Hospital

https://doi.org/10.3886/ICPSR39567.v1

Version V1

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Summary

Patient-centered outcomes research, or PCOR, is a type of research that focuses on patient values and needs. PCOR includes patients in many parts of the research process, including helping to plan and conduct the study. Institutional Review Boards, or IRBs, oversee research studies to make sure patients participating in a study are protected from harm. But current IRB guidance may not address ethical issues that arise when patients are involved in other roles.

In this study, the research team created recommendations to guide IRB oversight of PCOR studies.

Citation

Weissman, Joel. Research Ethics in Patient-Centered Outcomes Research (PCOR) [Methods Study], United States, 2015-2019. Inter-university Consortium for Political and Social Research [distributor], 2025-11-20. https://doi.org/10.3886/ICPSR39567.v1

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Funding

Patient-Centered Outcomes Research Institute (PCORI) (ME-1409-21701)

Subject Terms

Geographic Coverage

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2015 -- 2019
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Study Purpose

To develop recommendations for human research oversight in PCOR. The specific aims were the following:

  • Aim 1: Describe the human subject-related challenges posed by PCOR and learn how, if at all, IRBs in major research institutions are responding to those challenges as well as determine the specific topics that need additional guidance.
  • Aim 2: Develop guidelines and recommendations for IRBs, investigators, and patient advisors to use when designing or reviewing the human subjects research aspects of PCOR.

Study Design

This study used a four-round modified Delphi panel review to develop guidance and recommendations for human research oversight in PCOR. A modified Delphi panel review is a consensus-building method that gathers multiple rounds of feedback from individuals with expertise on a topic.

Seventeen individuals served on the Delphi panel, including IRB chairpersons and directors of human research protection programs, PCOR investigators, patients and patient advocates, leaders in bioethics and law, and policy makers.

The panel provided feedback on 21 recommendations for human research oversight in PCOR that the research team developed in an earlier study. In each round, panelists provided feedback on the recommendations; this included making additional recommendations and revisions to existing ones. Then, in a survey, the panel voted on the correctness, necessity, and feasibility of each recommendation.

The last round of the Delphi panel included a half-day webinar facilitated by the research team, during which panelists discussed and re-voted on the recommendations. Prior to the webinar, each panelist received a summary of the previous round's results including median scores, the distribution of votes for each recommendation, a reminder of the panelist's own vote, and de-identified comments from previous rounds.

Patient advisors, researchers, IRB members, and ethics leaders helped with study design, recruitment, and conduct.

Universe

Institutional Review Board (IRB) professionals, patient-centered outcome research (PCOR) investigators, patients, and other PCOR professionals and stakeholders.

Data Source

Data collected through a Delphi panel of 17 participants, including IRB chairpersons and directors of human research protection programs, PCOR investigators, patients and patient advocates, experts in bioethics and law, and policy makers

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Original Release Date

2025-11-20

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Notes

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