On January 18, 2017, the Federal Policy for the Protection of Human Subjects, or Common Rule, was updated for the first time since its publication in 1991. The explicit goal of these revisions—the result of collaboration between the US Department of Health and Human Services and 15 other Federal Departments and Agencies—is to reduce administrative burden and better protect subjects in the modern research context.

 

Through its Focus on the Revised Common Rule resources and programs, PRIM&R provides you with comprehensive in-person and online education and resources to help you understand the new provisions and what they mean for your human research protections program.

This webinar will discuss new elements of the Rule impacting informed consent, including:

  • Changes in the basic and additional elements of the informed consent
  • New requirement that consent documents begin with a concise presentation of key information, presented in a manner that facilitates the subject's understanding
  • New broad consent option for the collection, storage, and secondary research use of biospecimens or identifiable private information
  • Changes in the criteria for waiver of informed consent related to screening/recruitment and research involving the use of identifiable biospecimens and/or data
  • Clarifications regarding the determination of who is a legally authorized representative
  • Increased clarity regarding requirements/methods for documentation of informed consent
Seminar Information
Date Presented:
June 01, 2017 1:00 PM Eastern
Length:
1 hour, 30 minutes
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Focus on the Revised Common Rule: Informed Consent
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