February 3, 2017: A Tentative Introduction to the Revised Common Rule for the Protection of Human Subjects

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February 3, 2017: A Tentative Introduction to the Revised Common Rule for the Protection of Human Subjects

Note: Only audio is available for this Grand Rounds. You can also view the slides here.

Slides: Slides

Topic

A Tentative Introduction to the Revised Common Rule for the Protection of Human Subjects

Presenter

Jeremy Sugarman, MD, MPH, MA, Harvey M. Meyerhoff Professor of Bioethics & Medicine, Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University

Keywords

Common Rule; Research ethics; Bioethics; Informed consent; Human subjects protection; Pragmatic clinical trials; Minimal risk

Key Points

  • Presentation provides a cursory introduction to the revised Common Rule, with a particular focus on those aspects that are relevant for those engaged in planning and conducting pragmatic clinical trials.
  • Changes to requirements for informed consent include a specified order of disclosure, emphasis on comprehension, a new basic element, and posting of consent forms
  • No change in definition of minimal risk.

For More Information

Resources from PRIM&R on the revised Common Rule

OHRP commentary in NEJM

Tags
#pctGR, #CommonRule, #InformedConsent
@PCTGrandRounds, @Collaboratory1