Donna Z. Bliss, PhD, RN, FAAN on behalf of the Wound Ostomy and Continence Nurses’ Society Center for Clinical Investigation
Clinician/Clinician Society
Somewhat Well
Very Clear
Somewhat Disagree
The Wound Ostomy and Continence Nurses’ Society Center for Clinical Investigation (WOCN Society CCI) agrees that PICORI’s proposed approach to adopt the procedure developed by the National Institutes of Health to implement the FDA Amendments Act (FDAAA) to post an abstract and a table of key results from PICORI funded studies through the National Library of Medicine’s clinical trials registry (ClinicalTrials.gov) adequately meets the law requiring dissemination of results within 90 days of study completion without jeopardizing an investigator’s potential for publishing the findings in top tier journals due to an impression of prior publication. We also support the embargo of 12 months after the final report is accepted before posting the full final report on the PICORI website for similar reasons and believe this should be adequate time for a peer-review journal to publish a submitted manuscript reporting the study results.
However, the proposed procedures for detailed peer review of the study’s methods in the draft final report after the study is completed seem misplaced considering PICORI was the funder of the research. We recommend that this type of review should take place when a proposal is submitted and prior to funding. In the draft final report, the review investigators should only need to explain any changes or deviations in methods or analyses from what were initially proposed and funded by PICORI. The review by PICORI after the study is completed should focus primarily on these changes. The rather extensive review of methods proposed seems more appropriate for to be conducted journal reviewers that did not have the opportunity to review them previously (prior to funding).
However, the proposed procedures for detailed peer review of the study’s methods in the draft final report after the study is completed seem misplaced considering PICORI was the funder of the research. We recommend that this type of review should take place when a proposal is submitted and prior to funding. In the draft final report, the review investigators should only need to explain any changes or deviations in methods or analyses from what were initially proposed and funded by PICORI. The review by PICORI after the study is completed should focus primarily on these changes. The rather extensive review of methods proposed seems more appropriate for to be conducted journal reviewers that did not have the opportunity to review them previously (prior to funding).