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Return of Results from Research Using Newborn Screening Dried Blood Samples
Michelle Huckaby Lewis1, Aaron J Goldenberg2
1Research Scholar in the Berman Institute of Bioethics at Johns Hopkins University. She received her B.A. degree in English and History from Stanford University, her J.D. degree from Vanderbilt University, and her M.D. degree from Tulane University School of Medicine. Her research focuses on legal and ethical issues related to genomic research.
Insights
Returning research findings from newborn screening dried blood samples (DBS) to parents is explored. This article examines conditions for result return and how newborn screening programs can facilitate this, considering impacts on primary screening missions.
Area of Science:
- Medical Ethics
- Public Health Genomics
- Biomedical Research
Background:
- Newborn screening programs collect dried blood samples (DBS) for vital health checks.
- Research utilizing residual DBS samples raises questions about returning incidental findings.
- Ethical considerations and logistical challenges exist for returning research results to families.
Purpose of the Study:
- To examine the ethical and practical considerations for returning research results from DBS to parents.
- To explore potential mechanisms for facilitating the return of research findings.
- To assess the implications of returning research results on the core mission of newborn screening programs.
Main Methods:
- Literature review of ethical guidelines and best practices.
- Analysis of existing newborn screening program structures and capabilities.
- Case study exploration of potential return-of-results scenarios.
Main Results:
- Compelling reasons exist for returning a subset of research results.
- State newborn screening programs may have roles in facilitating result return.
- The scope of responsibility must balance research ethics with primary screening goals.
Conclusions:
- Careful consideration of circumstances and mechanisms is crucial for returning DBS research results.
- Integrating research result return requires assessing potential impacts on public health screening.
- Ethical frameworks must guide the practice of returning research findings from residual DBS samples.
Abstract:
There may be compelling reasons to return to parents a limited subset of results from research conducted using residual newborn screening dried blood samples (DBS). This article explores the circumstances under which research results might be returned, as well as the mechanisms by which state newborn screening programs might facilitate the return of research results. The scope of any responsibility to return results of research conducted using DBS should be assessed in light of the potential impact on the primary mission of state newborn screening programs.
