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Newborn Screening Webinar Series

posted on Sat, Sep 1 2012 12:00 am by The Network for Public Health Law

Each year, millions of infants in the United States are routinely screened shortly after birth for early detection, diagnosis and treatment of certain life-threatening genetic and metabolic conditions. Most screening tests require the collection a few drops of blood from the newborn's heel. After the screening process, there may be some residual blood remaining which can be retained and used for quailty control and improvement, or made available to researchers seeking to improve public health.

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.

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

These webinars are jointly presented by the Newborn Screening Translational Network (NBSTRN), the Network for Public Health Law, the National Newborn Screening and Genetics Resource Center (NNSGRC) and the Association for Public Health Laboratories (APHL).

 

Introduction

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April 26, 2012

This session introduced the webinar series and covered newborn screening and follow-up; secondary uses of residual DBS (standard and nonstandard uses); government authority regarding use and disclosure of newborn screening specimens and associated data; and an overview of the array of laws that govern storage and use.

Presenters:

  • Michelle Lewis, M.D., J.D., research scholar, Genetic & Public Policy Center, Johns Hopkins Berman Institute of Bioethics
  • Brad Therrell, Ph.D., director, NNSGRC
  • Denise Chrysler, J.D., director, Network for Public Health Law - Mid-States Region

Moderator:

  • Amy Hoffman, M.P.H., project manager, NBSTRN

Ownership and Control of Specimens

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May 31, 2012

This session covered ownership and control of leftover newborn screening specimens, including litigation concerning ownership and control of tissues (Moore, Catalona, Greenberg, Havasaupi Tribe) and litigation specific to newborn screening specimens (Beleno v. Tex. Dept. of State Health Services, Bearder v. Minnesota). It also covered state statutes that provide for ownership and or control of newborn screening specimens and requests by parents – or adult children – to the return of blood specimens or their destruction after screening has been completed. It discussed government as a steward with regard to terms for providing specimens for research such as charging fees to recoup costs and determining acceptable uses of specimens, scientific merit of research proposals and priorities for the use of limited specimens for rare diseases.

Presenters:

  • Alissa Johnson, M.A., principal consultant, Johnson Policy Consulting
  • David Orren, J.D. chief legal counsel, Minnesota Department of Health
  • Piero Rinaldo, M.D., Ph.D., interim chair, Laboratory Genetics, Mayo Clinic

Moderator:

  • Barry H Thompson, M.D., M.S., F.A.A.P., F.A.C.M.G., Medical Director, American College of Medical Genetics and Genomics

Protection of Privacy

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June 28, 2012 

This session covered the basic question: are biological specimens identifiable? Presenters discussed the applicability of the HIPAA privacy rule, genetic privacy laws and other laws to the release of residual dried blood spots and associated data. It also covered potential safeguards to protect privacy while maximizing research potential, such as de-identification, the use of codes, honest brokers, certificates of confidentiality, data use and material transfer agreements, data suppression and protections against genetic discrimination.

Presenters:

  • Barry H Thompson, M.D., M.S., F.A.A.P., F.A.C.M.G., (Moderator), Medical Director, American College of Medical Genetics and Genomics
  • Ed Goldman, J.D., associate professor, University of Michigan Department of Obstetrics and Gynecology
  • Aaron Goldenberg, Ph.D., M.P.H., assistant director, Center for Genetic Research Ethics and Law, Case Western Reserve University
  • Ann Willey, J.D., director of cytogenetics, Wadsworth Center, New York State Department of Health

Protection of Human Research Subjects

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July 26, 2012

This session will cover the applicability of federal regulations for the protection of human research subjects (Common Rule) to use of residual DBS and associated data for public health surveillance and release for population, environmental and medical research. It will also cover the applicability of the Common rule to the development of biorepositories for potential research. It will include consent: opt-in; opt-out; no opportunity for consent/dissent; informed consent; and re-consent and criteria for approval when the Common Rule applies.

Presenters:

  • Harry McGee, M.P.H., IRB chair, Michigan Dept of Community Health
  • Rachel Nosowsky, J.D., principal counsel, University of California

Moderator:

  • Barry H Thompson, M.D., M.S., F.A.A.P., F.A.C.M.G., (Moderator), Medical Director, American College of Medical Genetics and Genomics

Ownership and Control of Research Results

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August 30, 2012

This session will consider collections of newborn screening specimens as a “public asset” or resource to benefit the public. What does this mean with regard to sharing research protocols and results with the public (transparency and community engagement) and other researchers (collaboration) while encouraging and supporting research? It will cover intellectual property rights, patents on genes (BRCA gene litigation) and the charitable trust model of biobanking. It will consider the rights, responsibilities and challenges of providing research and incidental findings to individual test subjects.

Presenters:

  • Natasha Bonhomme, vice president of strategic development, Genetic Alliance
  • Anne Comeau, Ph.D., deputy director, New England Newborn Screening Program, UMass Medical School
  • Denise Chrysler, J.D., director, Network for Public Health Law -- Mid-States Region

Moderator:

Barry H Thompson, M.D., M.S., F.A.A.P., F.A.C.M.G., (Moderator), Medical Director, American College of Medical Genetics and Genomics


Summary of Core Issues

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September 27, 2012

This session will summarize core issues that programs might want to address regarding retention and use of residual specimens. It will cover the role of transparency, parent education, community engagement and community advisory boards. To the extent time permits, this session might expand on issues covered in prior sessions or address additional legal and policy issues related to the development and operation of a program to manage the availability of residual newborn screening specimens for research.

Presenters:

  • Michelle Lewis, M.D., J.D., research scholar, Genetic & Public Policy Center, Johns Hopkins Berman Institute of Bioethics
  • Aaron Goldenberg, Ph.D., M.P.H., assistant director, Center for Genetic Research Ethics and Law, Case Western Reserve University
Moderator:
  • Barry H Thompson, M.D., M.S., F.A.A.P., F.A.C.M.G., (Moderator), Medical Director, American College of Medical Genetics and Genomics