October 12, 2015

National Meetings to Address Changes to Human Subjects Research

Representatives from the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) Program and patient advocacy groups are collaborating to host four national one-day meetings in October and November to seek comment on proposals to better protect human subjects while facilitating valuable research and reducing burden, delay and ambiguity for investigators.

These meetings follow the Sept. 8, 2015, Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects, which was promulgated as a Common Rule in 1991. The NPRM was released by federal agencies including the U.S. Department of Health and Human Services.

The goals of these meetings are to:

  • Enhance understanding of the NPRM
  • Facilitate a robust exchange of ideas among a broad range of research stakeholders about the proposed changes and their implications
  • Promote informed public engagement in the policy making process

Attend via live webinar or join one or more of the following scheduled meetings in person:

  • Requiring Consent for Research with Biospecimens and Allowing Broad Consent

o   Nashville, TN

o   Date:  October 14, 2015

  • Streamlining IRB Review

o   Location:  San Diego, CA

o   Date:  October 29, 2015

  • Revising and Expanding the Scope of the Common Rule

o   Location: Chicago, IL

o   Date: November 5, 2015

  • Enhancing and Clarifying Consent Forms and Establishing Standard Safeguards

o   Location:  Philadelphia, PA

o   Date: November 18, 2015