Where should awardees submit the DFRR?
Awardees should submit the DFRR via the Editorial Manager® platform (the peer-review system). Two to three months before the DFRR 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 DFRR due date, you will receive another email from our Editorial Office inviting you to submit your DFRR. The email will contain an individual link to Editorial Manager®, but awardees may also submit the DFRR by logging into Editorial Manager® here. Instructions for submission can be found here.
What happens after the awardee submits the report?
Once submitted, the DFRR will enter pre-review. A pre-review editor will review the report to make sure that the DFRR has clearly provided the information required in the DFRR instructions. This editor will be looking to see whether the DFRR is written so that a general scientist audience can understand it well enough to evaluate the underlying scientific 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 with PCORI funding. The pre-review editor sends his or her determination and any requests for revisions to the author within two weeks of receiving the DFRR for review and asks the awardee to return the revisions in two weeks.
How long does the peer-review process take?
Once the DFRR enters external peer review, the process will take about six months. This includes review by external reviewers and associate editor; two months for the author’s response; final associate editor comments; and final review by Dr. Sox plus final revisions. Peer review will take more than six months if the associate editor or Dr. Sox find that more than one revision is necessary, or if there are delays in submitting the revisions.
How will authors get the results of the peer review?
Authors will receive all peer-review decisions via email. The synthesis letter, sent after external peer review, includes the associate editor’s summary of the main issues that the reviewers identified, the unedited critiques from external peer reviewers, and the instructions for submitting any revisions. The associate editor may also send a copy of the DFRR with comments or tracked changes for the authors to review. Authors will receive any further associate editor comments and requests for revisions via email, with a link in the message to submit revisions via Editorial Manager. Dr. Sox’s reviews will also be sent via email.
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 two months) 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 authors revise their report?
When authors complete their revisions, they submit the clean, revised DFRR as well as a tracked-changes version via Editorial Manager®, along with a response letter in which they address the reviewers’ comments. All revisions will be submitted in the same manner, except for the final PCORI review; this will be sent directly via email to Dr. Sox.
What is the difference between the DFRR and the final research report (FRR)?
We consider the submitted report to be a draft until it has been peer-reviewed, revised if necessary, and accepted by PCORI (i.e., completed Dr. Sox’s review). After acceptance, the FRR will be copyedited and posted on our website.
II. Preparing Draft Final Research Reports
What is the difference between the final progress report and the DFRR, 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 DFRR 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 DFRR goes through external peer review and the awardee may revise it before PCORI accepts it as the FRR. This final report will be posted on the PCORI website on the project’s web page and will be available for anyone to use.
What attachments should awardees include with the DFRR?
The Instructions to Awardees provide a detailed description of the attachments to include. Along with the DFRR, your submission should include a copy of your study protocol, the PCORI Methodology Standards Checklist, the Ancillary Information COI Disclosure Form identifying conflicts of interest (COIs) for you and the institution, and the Ancillary Information Return of Aggregate Research Results Form. The Research Results Form collects information about the awardee’s completed and/or planned efforts to return complete study results to research participants. For more information about this form, please review the frequently asked questions at the PCORI Help Center. Finally, include a file with high-resolution copies of any figures that you include in your DFRR. This helps us make sure that peer reviewers have clear copies of the figures and improves the quality of the report when we prepare it for posting.
How polished must the DFRR be?
Awardees should submit their best version of a final research report, following the formatting guidelines outlined in the Instructions to Awardees. The submitted DFRR should be carefully edited to make sure that the report is clear and understandable by general scientist readers. The report should include all analyses and results planned in the study protocol and statistical analysis plan. If the report does not meet the submission requirements, it may be returned for revisions before moving forward to review.
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 DFRR must follow the Instructions to Awardees to be considered adequate for peer review. Peer-reviewed journal articles also tend to focus on only part of the research conducted in a funded study, whereas the DFRR 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 DFRR, such as previously published tables and figures?
The DFRR can include information, such as tables, figures, and sections of text, from previously published journal articles (see the Instructions to Awardees for detailed recommendations on including these materials). 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 FRR, which will be made publicly available on PCORI’s website following peer review and finalization. Authors should comply 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 DFRR. Remember that the author, not PCORI, is liable for any unauthorized duplication of material from previously published articles that appears in the FRR.
III. Completing the Ancillary Information COI Disclosure Form
Who needs to complete and sign the Ancillary COI Disclosure Form?
The Ancillary Information Conflicts of Interest (COI) Disclosure Form captures COI information related to the study and FRR as listed in our authorizing law:
--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 COI 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 visit https://grants.nih.gov/grants/policy/coi/index.htm
Regarding COIs, awardees should disclose any financial or business associations or personal associations related to health care (e.g., if you or someone in your immediate family has worked for or volunteered for a healthcare-related organization, or received payment for or owned stock in a medical device patent or manufacture.)
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, even if they are not all listed as authors on the DFRR. If you have had any changes in key personnel, please inform your assigned program officer or program associate so they can make the appropriate updates in the project record.
Do awardees need to include personnel from other institutions on the same COI form that the official from the awardee institution signs? Can awardees submit a separate COI form for each institution involved in this project?
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, awardees may add additional pages to list all potential COI statements.
Do awardees have to submit their COI form at the same time as the DFRR?
In general, awardees should submit their COI form at the same time as their DFRR. However, PCORI understands that different institutions have different processes for signing off on conflict disclosure documentation. If the COI form is not complete by the time you are due to submit your DFRR, please notify the PCORI Peer Review Office (email@example.com) .
IV. Posting of Peer-Reviewed Materials
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 of Governors, PCORI will post the following within 90 days (3 months) of accepting the FRR:
- A public-facing summary developed by the PCOR 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 COI Disclosure Form
Within 12 months of accepting the FRR, PCORI will post the following:
- A summary of the peer-review process
- The FRR with accompanying appendices if applicable
- The final study protocol, if available
What information is posted online about the peer review of the DFRR?
As with any peer-review process, the editors and content experts who review the DFRRs 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 that is 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 online 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 the FRR is posted to the PCORI website, may awardees submit additional results?
Yes, awardees may update or otherwise refine the information posted on the project page for their FRR, for example, to align with information in other publications or updates submitted to ClinicalTrials.gov, or to provide new or updated material. PCORI may decide to re-review the materials if there is a significant change to the final report or any changes to the study conclusions.
Is posting results tables to ClinicalTrials.gov considered prior publication? What about the summaries or abstracts posted on 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).”
Please let us know if a journal editor raises concerns so that we can contact him or her directly to discuss them.
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 expect that awardees will 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, please 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 FRR 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 not be published previously.
PCORI will work closely with awardees, investigators, and journals to coordinate posting of the FRR with publication of manuscripts 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 may delay posting beyond 12 months to coordinate posting with publication of a peer-reviewed journal version of study findings."
Posted: March 27, 2017; Updated: December 16, 2020