Policies & Guidelines

Sharing the overall results of studies with study participants fulfills an important ethical responsibility to those who take part in research and acknowledges their contribution. PCORI is dedicated to facilitating the return of aggregate study results to participants enrolled in each funded research project

We ask that awardee institutions make every reasonable effort to ensure that study participants receive these results, which they helped make possible. Awardees can accomplish results return by providing participants with the lay language results summary PCORI prepares upon completion of the study. This summary is provided to the PI and posted to the PCORI website within 90 days from when PCORI accepts the final research report.

As of 2020, applicants for PCORI research funding can budget for up to $2500 to support results return. Awardees funded prior to 2020, with ongoing projects, may request up to $2500 to support return of their research findings upon study completion.

• Instructions to Awardees for Requesting PCORI Funds to Support Return of Aggregate Results to Study Participants – for Awardees funded prior to 2020
• Blog post: Increasing Our Support for Sharing Research Results with Study Participants
• Frequently Asked Questions
• For Reference: PCORI Peer Review and Release of Findings Process (2015) – see page 10, section 2b

This policy calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI’s commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.

• PCORI Policy for Data Management and Data Sharing
• Data Sharing Exemption Request Form
• Data Sharing Awardee Report
• Data Management and Data Sharing FAQs

Comparative clinical effectiveness research is commonly performed in real-world settings that require thoughtful planning to balance the extent of experimental control with more naturalistic (or "pragmatic") study conduct. Applicants for PCORI funding and PCORI awardees should refer to this guidance for important factors in weighing whether and how pragmatic research features best serve the study question and purpose.

• Guidance on the Design and Conduct of Trials in Real-World Settings: Factors to Consider in Pragmatic Patient Centered Outcomes Research

This policy assures broad access to these findings, improving the quality of information available to support decisions about health and health care as consistent with PCORI’s mandate. Under this policy, Awardees may request funds to cover the public access fees that journals charge. Awardees will also be asked to deposit their accepted manuscripts in PubMed Central, if the journal that is publishing their manuscript has not already done so.

• Policy: Public Access to Journal Articles Presenting Findings from PCORI-Funded Research
• Instructions for Awardees to Request PCORI Payment of Public Access Fees for Journal Articles
• Instructions for Awardees for Depositing Manuscripts in PubMed Central Following Journal Acceptance
  • Please note, some publishers automatically submit your article to PMC on your behalf. Before initiating the deposit process as described in our instructions, please first check PMC to confirm if your article is already online. Some publishers submit at a later point; you can learn if this is the case by searching your journal on the PMC Journals webpage.

This Policy outlines the requirements of the Patient-Centered Outcomes Research Institute (PCORI) for data and safety monitoring related to research funded by PCORI.

• PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research
• Data and Safety Monitoring FAQs

This document provides guidance and other related guidelines for proper usage of PCORI's names and logos.

• Guidelines for Use of PCORI Names and Logos

This document provides guidance and other related guidelines for proper usage of PCORnet’s name and logos.

• Guidelines for Use of PCORnet Name and Logos