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      A Framework for Analysis of Research Risks and Benefits to Participants in Standard of Care Pragmatic Clinical Trials

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          Abstract

          Background/Aims

          Standard of care pragmatic clinical trials (SCPCTs) that compare treatments already in use could improve care and reduce cost but there is considerable debate about the research risks of SCPCTs and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate.

          Methods

          We developed a formal risk-benefit analysis framework for SCPCTs and then applied it to key provisions of the U.S. federal regulations.

          Results

          Our formal framework for SCPCT risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a SCPCT, the allocation ratios of treatments inside and outside a SCPCT, and the significance of some participants receiving a different treatment inside a SCPCT than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to SCPCTs.

          Conclusions

          Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of SCPCTs and can be used to clarify the implications for informed consent.

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          Author and article information

          Journal
          101197451
          32521
          Clin Trials
          Clin Trials
          Clinical trials (London, England)
          1740-7745
          1740-7753
          14 June 2016
          30 June 2016
          December 2016
          01 December 2017
          : 13
          : 6
          : 605-611
          Affiliations
          [1 ]Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
          [2 ]Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA
          Author notes
          Address correspondence to Dr. Kim at: Department of Bioethics, 10 Center Drive, 1C118, Bethesda, MD 20892-1156, scott.kim@ 123456nih.gov , Phone: 301.435.8706
          Article
          PMC5133165 PMC5133165 5133165 nihpa794199
          10.1177/1740774516656945
          5133165
          27365010
          04ccd125-9f23-4ef7-8fe4-53e7978f965f
          History
          Categories
          Article

          pragmatic randomized control trials,research ethics,research risk analysis,informed consent,Comparative effectiveness randomized control trials

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