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.
Professional Abstract
Background
To generate findings that are important to patients, researchers deliberately involve patients in many aspects of patient-centered outcomes research (PCOR). For example, patients might contribute to proposals, data collection, and analysis. However, involving patients in roles other than research participant can raise challenging ethical issues for Institutional Review Boards (IRBs) and other oversight bodies charged with protecting participants in research studies.
Objective
To develop recommendations for human research oversight in PCOR
Study Design
| Design Element | Description |
|---|---|
| Design | Empirical analysis |
| Data Sources and Data Sets | 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 |
| Analytic Approach | Modified Delphi method with 4 rounds of soliciting feedback from panelists, panel voting, and consensus building |
| Outcomes | 21 recommendations to improve PCOR |
Methods
This study used a four-round modified Delphi panel review to develop guidelines 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.
Results
Panelists reached consensus on a revised list of 21 recommendations for PCOR human research oversight. These recommendations aligned with three domains:
- Nontraditional study roles. Ten recommendations were about nontraditional study roles for patients, patient advocates, or caregivers. Topics included standards for training and payments to those serving in new roles.
- Technology use. Six recommendations addressed oversight and privacy when researchers use technology such as phone apps and social media in PCOR.
- Patient partner engagement. Five recommendations addressed how researchers identify and engage patient partners in planning and conducting the study.
Limitations
The research team relied on Delphi guidelines from clinical research, because no such guidelines exist for using the Delphi method in bioethics. Applications of the Delphi method may be less reliable in bioethics research than for other research areas that have extensively used the Delphi approach.
Conclusions and Relevance
IRBs and other oversight bodies can use the recommendations from this study when considering guidance for monitoring human research in PCOR.
Future Research Needs
Future research could examine the effectiveness of these recommendations on improving the quality and safety of PCOR.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
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.