This two-day meeting convened stakeholders to discuss informed consent provisions of the 2014 Newborn Screening Saves Lives Reauthorization Act, and their interpretation, implications and impact on newborn screening.
The presentations below have been authorized to be posted on this website. Duplication is not authorized without the express written permission of the authors.
Sponsors
Association of Public Health Laboratories
Centers for Disease Control and Prevention, Newborn Screening and Molecular Biology Branch
Monday, June 1
Meeting Overview
-Jelili Ojodu, Association of Public Health Laboratories
Summary and Highlights of the National Institutes of Health Meeting on Informed Consent
-Tiina Urv, National Institutes of Health
Recommendations from the Advisory Committee on Heritable Disorders in Newborns and Meeting and Discussion of Implications
-Joseph Bocchini, Advisory Committee on Heritable Disorders in Newborns and Children
Overview of routine program activities in newborn screening as required for CLIA/CAP compliance, quality imporvement and program expansion
-Michele Caggana, New York State Department of Health
Food and Drug Administration laws pertaining to human research protection, the use of investigational devices and considerations for use of Laboratory Developed Tests (LDTs)
-Kellie, Kelm, Food and Drug Administration
Newborn Screening Programs Scenario Overview and Proposed Classifications
-Susan Tanksley, Texas Department of State Health Services
Tuesday, June 2
Recap of Day 1 and Discussion
- Dave Orren, Minnesota Department of Health
Experience from Texas
- Susan Tanksley, Texas Department of State Health Services
Experience from Massachusetts
- Anne Comeau, University of Massachusetts Medical School
Experience from Michican
- Carrie Langbo, Michigan Department of Health and Human Services
Open Discussion on items to consider when developing broad consent models for newborn screening research
- Michelle Huckaby- Lewis, Johns Hopkins University
-Dave Orren, Minnesota Department of Health
-Denise Chrysler, Network for Public Health Law
Communication Strategies for Newborn Screening- Where do we go from here?
-Natasha Bonhomme, Genetic Alliance
Saving Babies through Screening Educational Activities and Perspectives on Informed Consent
- Jill Levy-Fisch, Save Babies Through Screening Foundation
Engaging the Public/Parents and Enlisting Providers
- Carrie Langbo, Michigan Department of Health and Human Services
Awareness, Education, and Training on Newborn Screening
-Amy Gaviglio, Minnesota Department of Health