Providing Newborn Screening Specimens for Research: Legal Issues Faced by State Health Departments Webinar Series

States that store and provide residual dried blood spots (DBS) for secondary uses, or are considering storage and secondary uses, may face an array of legal issues. This webinar series is intended to cover these legal issues – and related ethical and policy issues – concerning secondary uses of DBS and associated data.

The intended audiences for this webinar are public health attorneys, newborn screening programs and laboratories, institutional review boards, HIPAA privacy boards, privacy officers, researchers, and others who have interest in legal, and ethical and policy issues related to secondary uses of residual DBS.

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Session 1: Introduction and Overiew of NBS and Research

This introductory webinar begins with an overview of newborn screening (NBS) in the United States. We are made aware of the variations in the screens that are done, policy regarding NBS, and the length for which residual dried bloodspots (DBS) are stored in each state. The speakers touch on the benefits of using DBS specimens for research, but also the differing laws and public opinion surrounding the process. Finally, the Michigan state health department is used as an example of how residual specimens are stored and used for research, and the legal, ethical, and policy issues that were developed during the process.

Bradford Therrell, Jr, PhD; Michelle Huckaby Lewis, MD, JD; Denise Chrysler, JD
Session 2: Ownership and Control of Specimens

The second webinar of the series discusses state public policies pertaining to the ownership and control of DBS specimens. These discussions included whether or not secondary use of the DBS specimens is permitted, if the state utilizes an opt-in or opt-out mechanism, and whether the residual specimens are property of the state or of individuals. The webinar also discussed a case of litigation in Minnesota, which resulted in a decision that an individual’s blood sample is genetic information and that it may only be obtained, stored, and used with informed consent. The webinar concludes with a discussion reinforcing the importance of research utilizing residual specimens, specifically in second tier testing, for metabolic autopsy, and for new test development.

Alissa Johnson, MS; Dave Orren, JD; Piero Rinaldo, MD, PhD
Session 3: Protection of Privacy

With a focus on privacy, this webinar discusses the roles of HIPAA, IRB regulations, consent, de-identification, and the honest broker in newborn screening. Presented are the overarching parental and public attitudes towards NBS and privacy, and the common positions held regarding identifiability and assumed risk. The webinar contains a brief description of the Genetic Information Non-Discrimination Act (GINA), and a detailed account of the policies of New York state for the access and use of NBS specimens.

Edward Goldman, JD; Aaron Goldenberg, PhD, MPH; Ann Willey, PhD, JD
Session 4: Protection of Human Subjects

Although DBS specimens are not traditionally considered human subjects, proposals have been made for broader protection of human research. This webinar covers federal regulations regarding research done with human subjects, how to identify this research, how to determine if the research is exempt from review, and what it means for an institution to be engaged in research. Michigan is used as an example demonstrating their consideration of these processes, and the formation of the Michigan BioTrust for Health. The Michigan BioTrust declared that residual DBS could be used for research, that this research was not human subject research, and established the importance of an informed consent process for research with samples.

Rachel Nosowsky, JD; Harry McGee, MPH
Session 5: Ownership and Control of Research Results

Similar to the second webinar, the penultimate session of the series discusses who owns, controls, and benefits from the results of research done with residual DBS. Three models for the ownership of this research are presented: Charitable Trust, Open Results, and Shared Ownership. The vice president of Genetic Alliance spoke about the biobank run by their advocacy group, and the importance of the sharing this information. The session concludes with another example, sharing the successful system for newborn screening in the state of Massachusetts, and the importance of maintaining privacy and confidentiality in the distribution of research results.

Denise Chrysler, JD; Natasha Bonhomme; Anne Marie Comeau, PhD
Session 6: Summary of Core Issues

The final webinar contains an overview of the series, stressing the importance of newborn screening as a public health initiative in the United States, and the necessity of informed consent, protection of privacy, and the consideration of other legal and bioethical issues in maintaining its success. A summary of biobanking, policy, and programs surrounding newborn screening research in California is given, and litigation in Minnesota and Texas dealing with these issues are recapped. Finally, recommendations and proposals to current procedures, as well as attitudes of parents and the public, are discussed and summarized.

Fred Lorey, MS, PhD; Aaron Goldenberg, PhD, MPH; Michelle Huckaby Lewis, MD, JD

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