What are reviewers examining during the peer-review process?
Each project’s draft final research report will be reviewed. This report includes the background, methods, results, and conclusions for the complete PCORI-funded study protocol. It should include all aims, analyses, and outcomes. The instructions for preparing the report and a description of the report’s content is here.

Where should awardees submit the draft final research report?
Awardees should submit the draft final research report in a peer-review system on the Editorial Manager^® platform. Two to three months before the draft final research report is due, PCORI’s Peer Review Contractor, the PCORI Editorial Office, will send an email notification that it is time to submit your structured abstract describing your study and listing key personnel and their affiliations. About two weeks before your draft final research report due date, you will receive another email from our Editorial Office inviting you to submit your draft final research report. The email will contain an individual link to the peer-review system, but awardees may also submit the draft final research report by logging into Editorial Manager^® here. Instructions for submission can be found here.

What happens after the awardee submits the report?
Once submitted, the draft final research report will enter pre-peer review. A pre-peer-review editor will review the report to make sure that the draft final research report has clearly provided the information required in the draft final research report instructions. They will be looking to see whether it is written so that a general scientist audience can understand it well enough to evaluate the underlying science content. A PCORI program officer will also determine whether the report describes all of the aims, outcomes, and changes to the study protocol that the awardee planned and completed in the study. The editor sends his or her determination and any requests for revisions to the author within two weeks of receiving the draft final research report for review and asks for the awardee to return the revisions in two weeks.

How long does the peer-review process take?
Once the draft final research report passes pre-peer review, the initial round of external peer review can last about 60 days from sending the draft final research report to external peer reviewers to completion of the synthesis letter. The length of peer review depends on the number of revisions the associate editor requests and in the final PCORI review of the report. Our goal is to complete peer review in six months.

How will I get the results of the peer review?
The authors will receive all peer-review decisions through email. The synthesis letter, sent after external peer review, includes the associate editor’s summary of the main issues reviewers identified, the unedited critiques from external peer reviewers, and instructions for submitting any revisions. The editor may also send a copy of the draft final research report with marginal comments or tracked changes for the authors to review.

How long do awardees have to respond to reviewers’ comments?
As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings, awardees have 45 working days, about 9 weeks, to respond to reviewers’ comments. However, we are willing to work with awardees to adjust these deadlines. If editors request additional revisions, awardees will have two to four weeks to respond, depending on the extent of the edits.

What happens after we revise our report?
When authors complete their revisions, they submit the clean, revised draft final research report, and a tracked-changes version, into Editorial Manager®, along with a response letter where they address reviewers’ comments. All revisions will be submitted in the same manner, except for the final PCORI review. This will be sent directly to the Program Director for Peer Review.

What is the difference between the draft final research report and the final research report?
Answer: We consider the submitted report to be a draft until it has been peer reviewed, revised if necessary, and accepted by PCORI. After acceptance, the final research report will be copyedited and posted on our website.

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II. Preparing Draft Final Research Reports

What is the difference between the final progress report and the draft final research report, both of which are due at the end of the study?
The final progress report documents the final phase of the study. It includes how the study was completed; whether the team met the milestones set forth in the contract; any challenges encountered; remedial actions taken in mitigating and resolving concerns, including risks to study completion; and notable accomplishments. Study findings are not necessarily included in the final progress report. PCORI staff review the final progress report, but it is not publicly disclosed.

In contrast, the draft final research report documents all of the work completed in the PCORI-funded study. This report must include a detailed description of the study’s background, methods, results, and conclusions, consistent with PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings. The draft final research report goes through external peer review and the awardee may revise it before PCORI accepts it as the final research report. This final report will post on the PCORI website on the project’s web page and be available for anyone to download and use.

What information should I include with the draft final research report?
The Instructions to Awardees provides a detailed description of the information to include. Along with the draft final research report, your submission should include a copy of your study protocol, the checklist of the PCORI Methodology Standards, and the Ancillary Information Form identifying conflicts of interest for you and the institution.

How polished must the draft final research report be?
Awardees should submit their best version of a final research report. It should include all sections outlined in the Instructions to Awardees, as well as any necessary ancillary information. The report should include all analyses and results planned in the study protocol. If the report is not ready for peer review, a pre-peer-review editor will ask for additions or other changes, which will delay the peer- review process and completion of the project’s contracted milestones.

A manuscript with our study’s main findings has been peer reviewed and published in a journal. Can I submit that as my report?
No. The draft final research report must follow a specific format for consideration as being adequate for peer review. Peer-reviewed journal articles also tend to focus on only part of the research conducted in a funded study, but the draft final research report should include a full accounting of the methods and analyses planned in the study protocol.

Can I use parts of the published manuscript in the draft final research report, such as tables and figures already published?
The draft final research report can include information, such as tables, figures, and sections of text, from previously published journal articles. Cite the source of the material, including any long sections of text, taken directly from such publications. Awardees are responsible for checking with the journal publisher and, if necessary, getting permission for reprinting or using any part of the published article in the final research report, which will be made publicly available on PCORI’s website following peer review and finalization. Authors should conform with any stipulations the journal publisher sets regarding reuse of materials. Please note that the permissible use of previously published content may depend on the length of text and whether the authors transferred copyright to the journal as part of the author agreement. Please include a copy of any relevant copyright permissions or licenses for PCORI’s records as a separate file with your submission of the draft final research report. Remember that the author, not PCORI, is liable for any unauthorized duplication of material from previously published articles that is in the final research report.

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III. Research Publication

What will be posted on PCORI’s website after the peer-review process is complete, and when?
​As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings document, approved by the Board, within 90 days of accepting the final research report, PCORI will post the following:

• A public-facing summary developed by PCORI’s Translation Center after review by the awardee (With audio and Spanish translations available)
• A 500-word abstract for medical professionals
• A link to the study results tables on ClinicalTrials.gov (as applicable)
• Ancillary Information required by law:
• identity of the entity and investigators conducting the research
• conflicts of interest reported by the entity and investigators conducting the research
• any direct or indirect links the entity has to industry
• A summary of the peer-review process

Within 12 months of accepting the final research report, PCORI will post the following:

• The final research report with accompanying tables and figures
• The final study protocol

What is posted online about the peer review of my draft final research report?
As with any peer-review process, the editors and content experts who review the draft final research reports often ask the researchers to address concerns about the way they conducted the project, their results, and their conclusions. Awardees usually revise the report to address these concerns to the reviewers’ satisfaction, and PCORI posts a summary of that process along with public and professional abstracts of the study results.

On rare occasions, researchers disagree with a reviewer comment key to interpreting the study results. When that disagreement cannot be resolved, PCORI describes it in the peer-review summary but invites awardees to submit a brief explanation of their reasoning if they wish. We limit such statements to 200 words and they are subject to review by PCORI program staff. Any such awardee response will be posted with the peer-review summary.

We do not expect awardees to ask to write a response to the peer-review summary when there are no unresolved issues. But if an awardee does so, or asks for changes to the summary for clarification, we will consider such requests on a case-by-case basis.

After findings post to the PCORI website, is there an opportunity to submit additional results?
Yes, awardees may update or otherwise refine the information posted at pcori.org, for example, to align with information in other publications or updates submitted to ClinicalTrials.gov, or to provide new or updated material.

Is posting results tables to ClinicalTrials.gov considered prior publication? What about the summaries or abstracts that PCORI posts on the PCORI’s website?
Most journals do not consider posting of results on a registry like ClinicalTrials.gov, or in summaries of 500 words or less to be prior publication. Our policy regarding the posting of these results conforms to the recommendations of the International Committee of Medical Journal Editors (ICMJE):
The ICMJE will not consider as prior publication the posting of trial results … if results are limited to a brief (500 word) structured abstract or tables (to include patients enrolled, key outcomes, and adverse events).

If a journal editor raises concerns, please let us know so we can contact the editor directly to discuss the concerns.

Similarly, the ICMJE does not consider as prior publication the author’s requirements under the Food and Drug Administration Amendments Act of 2007, U.S. Public Law 110-85, Title VIII, to post results tables on ClinicalTrials.gov. For more information, see:

• ICMJE Statement: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
• ICMJE FAQ: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

Are there any restrictions on where awardees can publish articles based on PCORI-funded research? For example, are awardees expected to publish only in open-access journals?
Awardees may publish articles resulting from PCORI-funded projects in any journal at any time. We ask, however, that awardees notify us when they submit manuscripts to journals and when journals accept those manuscripts for publication. We also ask that awardees inquire about open-access options because of our interest in linking to the published articles from our website. For more information about PCORI’s policy, refer to Public Access to Journal Articles Presenting Findings from PCORI-Funded Research.

Does PCORI peer review manuscripts submitted before the completion of the study?
PCORI does not peer review manuscripts submitted to journals at any time. As noted above, we ask awardees to keep PCORI informed of their plans for publication.

If the final research report posts no later than 12 months after acceptance, what will happen if a manuscript describing that work has not yet published in a peer-reviewed journal? Most journals require that the information in submitted manuscripts has not been published previously.
PCORI will work closely with awardees, investigators, and journals to coordinate posting of the final report with publication of papers in press. However, we must balance journal publication with our obligation under our authorizing law, affirmed through public comments on our draft Peer-Review Process document, to make the results of PCORI-funded research widely available to the public as expeditiously as possible. The document states, “PCORI will keep all final research reports on file, coordinating their public release on PCORI’s website with Awardee Institutions and principal investigators based on planned publication of journal articles resulting from the study, to avoid disqualifying manuscripts from their consideration for publication by a journal.”

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IV. Completing the Ancillary Information Conflicts of Interest (COI) Disclosure Form

Who needs to complete and sign the COI Disclosure Form?
The Ancillary Information Conflicts of Interest (COI) Disclosure Form captures COI information related to the study and final research report (FRR) as listed in our authorizing legislation:

--PUBLIC AVAILABILITY.—The Institute shall make available to the public and disclose through the official public Internet website of the Institute the following: … The process and methods for the conduct of research, including the identity of the entity and the investigators conduc[t]ing such research and any conflicts of interests of such parties, any direct or indirect links the entity has to industry, and research protocols, including measures taken, methods of research and analysis, research results, and such other information the Institute determines appropriate concurrent with the release of research findings. [42 U.S.C. § 1320e(h)(3), italics added for emphasis.]

The institution that received the study funding (i.e., awardee institution) is responsible for completing the COI form, and a principal investigator and an administrative official from the awardee institution must sign the conflict of interest form for it to be considered complete.

What does PCORI consider to be a conflict of interest?
PCORI has modeled aspects of the COI form based on the NIH Grants & Funding policy.  For more information on this policy please go to: https://grants.nih.gov/grants/policy/coi/index.htm

What should be disclosed regarding conflict of interest includes: any financial or business associations or personal associations related to health care. For example, if you or someone in your immediate family has worked for, owned stock in, received payment for a medical device patent or manufacture, or volunteered for a healthcare-related organization.)

Do all key personnel from the study have to be on the same form?
All current key personnel on the research project should be listed on the same COI form. If you have had any changes in key personnel, we encourage you to inform your assigned program officer or program associate so they can make the appropriate updates in the project record.

Do we need to include personnel from other institutions on the same COI form that the official from the awardee institution signs? Can we submit a separate COI form for each institution involved in this project?
You must submit one COI form with your DFRR that includes all of the key personnel, regardless of institution. The awardee institution is responsible for the collection of COI statements from all key personnel of the research project. All key personnel should be listed on one form, but if necessary, you can add additional pages to list all potential COI.

Do we have to submit our COI form at the same time as the DFRR?
In general, you should submit your Ancillary Information COI form at the same time as your DFRR. However, PCORI understands that different institutions have different processes for signing off on conflict disclosure documentation. If your conflict of interest form is not complete by the time you are due to submit your DFRR, please contact the PCORI Peer Review Office at [email protected] to make them aware.

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