Expanding Public Access to PCORI's Research Results

We at PCORI are committed to doing all we can to see that the results of our funded research are disseminated widely and taken up in practice. This part of our mission is essential to the improvements in health and patient outcomes that are the goals of our research funding.

So we’re pleased to announce our latest effort in this area—a policy to enhance public access to the scientific papers that summarize the results of the patient-centered comparative clinical effectiveness (CER) studies we support.

PCORI now joins the ranks of other major research funders that require awardees to have their published papers deposited in the National Library of Medicine’s PubMed Central (PMC) online archive. And we go a step further. Because it can take up to 12 months for such papers to be made freely available in PMC, we’ll provide funds to see that papers summarizing awardees’ final study results are available free to all on the day they’re published, whenever possible.

This new policy is part of our broader open science initiative, which includes a range of current and planned activities designed to provide meaningful professional and public access to research findings as quickly as possible. Many scientists, policy makers, patient advocates, and others have focused on this issue as a way to promote greater transparency in research and share study findings far more widely, amplifying their potential impact and likelihood of influencing practice.

We also continue to move ahead with implementation of our process for peer reviewing and making our research findings widely available through our website. Finally, we are developing policy and processes to make data and protocols from our studies available.

Public Access to Journal Articles

Publication in peer-reviewed journals is an essential means of dissemination; it provides trusted access to research for many audiences, including researchers and clinicians at major institutions. However, many journal articles are available only to those who belong to professional societies, have academic affiliations, or can afford to purchase costly subscriptions or individual articles. Many patients, private practice clinicians, and others have difficulty accessing the articles.

We announced our new public access policy for journal articles during our April 26 Board of Governors meeting. We will now require all awardees to deposit the articles resulting from our funded studies in PMC when they are accepted for publication by peer-reviewed journals. Articles in PMC are more accessible and can be better integrated with other research findings, improving the quality of information available to help patients, clinicians, researchers, and other stakeholders make informed decisions about health, health care, and research priorities. Instructions for Awardees to request PCORI payment of public access fees for journal articles are available here.

Each final, peer‐reviewed manuscript must be deposited within four weeks of its acceptance by a journal. PubMed Central makes the articles available online free of charge no later than 12 months after journal publication.

To further enhance the availability of the findings of our funded studies, we will cover the fees many journals charge for free real-time public access to published papers. We expect to support public access for one or two articles summarizing the final results of a project. This means awardees will continue to be able to submit their papers to any journal they wish, at any time they wish, with the assurance that there is a path to making articles immediately available to all. We already provide free access links on our website to dozens of articles resulting from our funded projects, but our new policy will expand that level of access substantially.

Peer Review and Public Release of Research Findings

Our new public access policy complements one of the cornerstones of our open science efforts—the mandated process for peer reviewing the results of our funded research and making those findings available through our website.

Our Board approved our proposed peer review and public release process last year, and we’re pleased to tell you that we’re implementing it right now. We’ve engaged a highly experienced team at the Oregon Health and Science University in Portland to assist us with this task, which is as complex as it is essential. And we’re making great progress.

Under this process, scientists, statisticians, and methodology experts will review our awardees’ final research for scientific integrity and to be sure their projects adhered to the PCORI Methodology Standards. In addition, we will ask patients and other healthcare stakeholders to provide their perspectives on the research, with a particular focus on patient centeredness, engagement, and relevance to their particular interests and needs.

Once the review is completed and the final reports revised to our satisfaction, we’ll work with our awardees to briefly describe the study results for both professional and consumer audiences and put the findings—whether positive, negative or inconclusive—in context. That information will be posted on our website within 90 days of our accepting the final report. Then, generally within 12 months, depending on discussions with our awardees, we’ll post the complete final report. We’ll include anonymized peer reviewer comments and awardees’ responses, so anyone can see the underlying discussion.

We’re test-driving this process with our 50 PCORI Pilot Projects. We funded these in 2012, as a way to improve our understanding of how to conduct patient-centered CER and disseminate research findings in ways that are more responsive to the needs of patients and the healthcare community. We expect the first write-ups of results to be available on our website within the next few months.

Getting Ready for Data Sharing

Open access to source data and study protocols can provide independent researchers with the tools they need to reproduce an original study’s analyses, thereby improving the integrity of research findings. It also can encourage use of the data in additional analyses, which augments the knowledge generated from the original study.

To this end, we are developing a policy to facilitate and manage access to data from PCORI-funded studies. We plan to make a draft of that policy available for public input in the near future. We also are planning a pilot project in which some of our early studies will work with a few established data repositories to explore what processes work best and what challenges may arise when it comes to putting the concept of data sharing into practice.

Let us know your ideas for increasing the availability and usefulness of our projects’ findings.

Editor's Note: At the time that this blog post was published, Joe V. Selby, MD, MPH, was PCORI's Executive Director and Evelyn P. Whitlock, MD, MPH was PCORI's Chief Science Officer.