4
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: not found
      • Article: not found

      NIH Policy on Single-IRB Review — A New Era in Multicenter Studies

      , ,

      New England Journal of Medicine

      New England Journal of Medicine (NEJM/MMS)

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Related collections

          Most cited references3

          • Record: found
          • Abstract: found
          • Article: not found

          A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.

          Institutional review boards (IRBs) are integral to the U.S. system of protection of human research participants. Evaluation of IRBs, although difficult, is essential. To date, no systematic review of IRB studies has been published. We conducted a systematic review of empirical studies of U.S. IRBs to determine what is known about the function of IRBs and to identify gaps in knowledge. A structured search in PubMed identified forty-three empirical studies evaluating U.S. IRBs. Studies were included if they reported an empirical investigation of the structure, process, outcomes, effectiveness, or variation of U.S. IRBs. The authors reviewed each study to extract information about study objectives, sample and methods, study results, and conclusions. Empirical evidence collected in forty-three published studies shows that for review of a wide range of types of research, U.S. IRBs differ in their application of the federal regulations, in the time they take to review studies, and in the decisions made. Existing studies show evidence of variation in multicenter review, inconsistent or ambiguous interpretation of the federal regulations, and inefficiencies in review. Despite recognition of a need to evaluate effectiveness of IRB review, no identified published study included an evaluation of IRB effectiveness. Multiple studies evaluating the structure, process, and outcome of IRB review in the United States have documented inconsistencies and inefficiencies. Efforts should be made to address these concerns. Additional research is needed to understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Central Institutional Review Board Review for an Academic Trial Network

            Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Evidence gaps and ethical review of multicenter studies

                Bookmark

                Author and article information

                Journal
                New England Journal of Medicine
                N Engl J Med
                New England Journal of Medicine (NEJM/MMS)
                0028-4793
                1533-4406
                December 15 2016
                December 15 2016
                : 375
                : 24
                : 2315-2317
                Article
                10.1056/NEJMp1608766
                5234329
                27974026
                8ae5c0ad-fc11-47e1-8816-8c843f5c91f1
                © 2016
                Product

                Comments

                Comment on this article