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Informational NBS Webinar on Notice of Proposed Rulemaking: The Common Rule

November 9, 2015

APHL’s Legal and Legislative Issues in Newborn Screening Workgroup of the Newborn Screening and Genetics in Public Health Committee will be hosting an informational webinar on the Notice of Proposed Rulemaking: the Common Rule - Summary of Changes and Potential Implications for Newborn Screening Public Health Programs. The webinar will be held on Monday November 9 at 11:00 am ET.

Background: A notice of proposed rulemaking (NPRM) was released by the U.S. Department of Health and Human Services (HHS) in early September 2015 to announce proposed revisions to the regulations protecting human subjects in research. The NPRM follows an advanced notice of proposed rulemaking (ANPRM) that was released in 2011 which outlined the various changes and gave an opportunity for the public to provide significant input relating to ethics, safety, and oversight of human research protections, generally referred to as the Common Rule. The proposed changes address the need to protect individuals who participate in research as technology advances, the scope and breadth of clinical trials deepens and increased concern arises over individuals making informed decisions about participating in research. The NPRM addresses the feedback received from the ANPRM and presents the major changes proposed. The full NPRM can be found linked here.

This webinar will delve deeper into the summary and potential implications of the proposed changes to the common rule, specifically related to public health newborn screening programs. The webinar slide presentation is located linked here.

Date: Monday November 9, 2015 at 11:00 am ET
Duration: 90 minutes
Webinar information: 866.740.1260, passcode 4852701 | Webinar Link: https://cc.readytalk.com/r/drtvuugxgilv&eom
Speaker: Michelle Huckaby Lewis, M.D., J.D.
Recorded Webinar: linked here.
Transcript of Webinar: linked here.

Michelle Huckaby Lewis is a pediatrician and an attorney with training in bioethics and health services research. She joined the Berman Institute of Bioethics in 2010. Lewis’ current research focuses on the retention and use of residual newborn screening blood samples. Lewis received a B.A. in English and History from Stanford University, a J.D. from Vanderbilt University School of Law in 1992 and an M.D. from Tulane University School of Medicine in 2000. She completed a residency in Pediatrics at the David Geffen School of Medicine at UCLA in 2003. 

Webinar archive to be made available following the webinar.