Results Summary

What was the project about?

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.

What did the research team do?

The research team used the Delphi method, which helps a panel of experts reach agreement about a certain topic. The Delphi method uses rounds of discussion and voting among panelists. This study included 17 panelists representing IRBs, PCOR researchers, patients, and leaders in the study of bioethics, law, and policy.

Panelists gave feedback on a list of 21 recommendations to guide IRBs about PCOR. The research team drafted this list based on an earlier study.

Panelists first looked at the list of recommendations and gave feedback. The research team used this feedback to draft a new list of revised recommendations. Then, panelists used a survey to vote on whether the new recommendations were correct, needed, and practical.

Panelists then discussed and voted again on the recommendations during an online video meeting. Before the meeting, the research team gave panelists a summary of the earlier meetings’ results and the results of the survey. The team also reminded each panelist of how they voted in earlier meetings.

Patients, researchers, IRB members, and ethics leaders provided input throughout the study.

What were the results?

The final set of 21 recommendations focused on three topics:

  • New study roles. Ten recommendations were about patients, advocates, and caregivers serving in new roles on research studies. Topics included standards for training and payments to those serving in new roles.
  • Technology use. Six recommendations were about patient safety oversight and privacy when studies use technology such as phone apps and social media.
  • Patient engagement. Five recommendations were about how researchers identify and involve patients in studies.

What were the limits of the project?

The Delphi method hasn’t been widely used for topics like IRB oversight. Researchers can’t say for sure if it works as well as it does in other areas.

Future research could explore whether these recommendations improve oversight of PCOR studies.

How can people use the results?

IRBs can use the recommendations from this study to guide the way they provide oversight for PCOR studies.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The reviewers found the report to be excellent, clearly written, and well organized. They found the researchers’ conclusions to be well supported by the findings. The reviewers did request updates to the methodology standards section, and the researchers revised the section as requested. The reviewers also suggested relatively minor textual edits and made suggestions that could be helpful in future work. The researchers gave an in-depth response to each reviewer comment.

Conflict of Interest Disclosures

Project Information

Joel S. Weissman, PhD
Partners Healthcare Brigham and Women's Hospital
$1,412,732
10.25302/08.2020.ME.140921701
Research Ethics in Patient-Centered Outcomes Research

Key Dates

April 2015
December 2019
2015
2019

Study Registration Information

Tags

Has Results
Award Type
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: April 12, 2024