On-Demand

Return of Individual Results: CLIA and HIPAA Considerations

As the field of “translational genomics” continues to grow, the issue of returning individual research results places IRBs at the boundary of research and clinical care. A common legal and ethical dilemma faced by investigators, institutions, and IRBs is whether to return (or allow return of) research test results of potential clinical significance that were not obtained in a laboratory with Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification.

This session will provide an overview of both the ethical and legal considerations behind the question of whether to return individual results, as well as suggest best practices for investigators and IRBs seeking to navigate this common ethical and regulatory dilemma.

This webinar is pre-approved for 1.0 contact hours of continuing education credit for the Certified IRB Professional (CIP) certification, and for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certifications

About the Webinar

  • Ethical principles influencing the determination of when to return results
  • Federal regulations related to returning individual test results
  • The 2014 HIPAA and CLIA amendments – Patients’ Access to Test Reports
  • The IRB role in reviewing plans for returning research results
  • Best practices for investigators and IRBs

About the Speaker:
Michelle Grienauer, JD, MPH, CIP

Michelle GrienauerMs. Grienauer provides guidance and consultation on legal and regulatory matters to Quorum Review and Kinetiq clients, drawing on her extensive knowledge of Food and Drug Administration (FDA) regulations, Office of Human Research Protection (OHRP) regulations, the Health Insurance Portability and Accountability Act (HIPAA), federally funded research, investigator-initiated research, and pediatric research. She is a member of the Washington State Bar Association, has a Master’s in Public Health (MPH), and is a Certified IRB Professional (CIP).

Continuing Education Credits
This webinar is pre-approved for 1.0 contact hours of continuing education credit for the Certified IRB Professional (CIP) certification, and for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certifications. If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements. Information for CE credits for SOCRA can be found here. Visit our Webinars Help page for more information on certification credits.

Certificate of Attendance
You must watch this webinar in its entirety to receive a certificate of attendance. The certificate will include your full name and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to earn CE credits for this webinar, each person must register for and watch the webinar in its entirety in order to receive a certificate. Visit our Webinars Help page for more information on certificates of attendance.

 

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Return of Individual Results — CLIA and HIPAA Considerations