NDLI: Waiving informed consent in newborn screening research: balancing social value and respect.

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Waiving informed consent in newborn screening research: balancing social value and respect.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Tarini, Beth A. Burke, Wylie Scott, C. Ronald Wilfond, Benjamin S.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Tarini BA ( Division of Pediatrics, University of Michigan, Ann Arbor, MI 48109, USA. btarini@umich.edu)
Abstract	While newborn screening (NBS) programs have historically relied on presumptive benefit in deciding when to implement new tests, experience has demonstrated that this approach can lead to screening tests that lack efficacy or, worse yet, cause harm. Population-based NBS research provides an opportunity to evaluate safety and effectiveness of potential tests prior to widespread implementation. Using the example of Pompe disease, we argue that waiving the requirement for informed consent is appropriate for research evaluating the screening phase of potential NBS tests when data support the potential health benefits of testing and when other research safeguards are present. The regulatory requirement for informed consent can be waived if a research study meets criteria of minimal risk, protecting rights and welfare, and practicability. In population-based NBS research, the main risks are related to false positive results and results with ambiguous implications for treatment-risks that are comparable to those posed by many tests newly added to NBS programs without prior population-based NBS research. Waiving the informed consent requirement facilitates the development of flexible strategies for informing and educating parents about NBS research that reflect the logistics of population-based NBS screening. A strict interpretation of the regulatory requirement of informed consent may create significant logistical and financial barriers to adequate evaluation of NBS tests. Without a broader interpretation of this regulatory requirement in NBS research for which there is evidence of a clinically meaningful benefit from treatment, we may create incentives for the implementation of inadequately evaluated NBS tests.
File Format	HTM / HTML
ISSN	15524868
Issue Number	1
Volume Number	148C
e-ISSN	15524876
Journal	American Journal of Medical Genetics Part C: Seminars in Medical Genetics
Language	English
Publisher	Wiley
Publisher Date	2008-02-15
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Genetics Discipline Medical Informed Consent Neonatal Screening Ethics Methods Research Social Values False Positive Reactions Government Regulation Health Education Standards Humans Infant, Newborn Adverse Effects Legislation & Jurisprudence Parents Education Risk Assessment Sensitivity And Specificity United States Journal Article Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Genetics Genetics (clinical)

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