The Final Common Rule: What Does It Mean for Health and Life Sciences Stakeholders?


To view the archived presentation slides, please click here.
To view the archived webinar, please click here.

Please join us for a lunch hour webinar discussion on the recently published US Department of Health and Human Services (HHS) Final Common Rule. McDermott partners Bernadette Broccolo, Jiayan Chen and Jennifer Geetter will outline what this means for stakeholders now and in the future, including these notable changes:

  • Creation of biorepositories and other future research uses
  • Definition of “human subject” and agency policy position on identifiability of biospecimens and genomic data
  • Coordination and harmonization with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
  • Jurisdictional scope and federal-wide assurances
  • Updates to exempt categories of research
  • Changes to scope of and approach to securing institutional review board (IRB) review

CLE credit for this program is pending in the following states: California, Illinois and New York. A Uniform Certificate of Attendance will be made available to participants requesting CLE credit in all other states. Credit shall be awarded only for attendance of the entire webcast; no partial credit shall be awarded for attending a portion of the webcast. Please note that in accordance with applicable state MCLE rules regarding attendance validation, each attendee seeking credit must log in to the webcast individually. Credit will not be granted for multiple attendees using one log in. Please be advised that CLE credit will not be approved for on demand/recorded viewings of this program in the states listed above. Attendees seeking credit in other states should consult their state CLE accrediting agency to determine whether self-study credit can be earned for on demand/recorded viewing of this program.

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