December 16, 2016: Comparison of Different Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

December 16, 2016: Comparison of Different Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

Topic

Comparison of Different Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

Presenters

Kevin Weinfurt, PhD, Psychiatry and Behavioral Sciences, Psychology and Neuroscience, and Duke Clinical Research Institute

Jeremy Sugarman, MD, MPH, MA, Bioethics and Medicine, Johns Hopkins Berman Institute of Bioethics

Keywords

Pragmatic clinical trials, Research ethics; Informed consent; Notification and authorization; Clinical decisionmaking; Qualitative research; Comparative effectiveness research; Common medical practices

Key Points

  • The objective of this study was to compare, using hypothetical research scenarios, different models of patient notification and authorization used in comparative effectiveness research. Respondents were asked about their willingness to participate, acceptability of the notification and authorization approach, their understanding of the research, perception of personal risks or benefits, and trust.
  • The approaches to notification and authorization included:
    - Written consent
    - Oral consent with and without an information sheet
    - General notification with opt-out
    - Post-notification after the study is done
  • One finding of the study is that people have difficulty understanding aspects of pragmatic trials of commonly used medical practices. There are misconceptions about both research and clinical care.

Discussion Themes

To gain more evidence about the effectiveness of alternative approaches, we need to design and conduct nested comparisons within pragmatic trials. Depending on the nature of the trial, one could compare oral versus written consent or general notification versus oral consent—and then evaluate the outcomes.

With respect to understanding and willingness to participate, what influence does the relationship between participant and clinician play? In other words, how important is the role of providers?

Different people want different amounts of information. What are the barriers to reducing the size of consent documents?

For More Information

Read more about the complexities of conducting pragmatic clinical trials in healthcare systems in Clinical Trials (Anderson et al. 2015).

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