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

American Journal of Medical Genetics. Part C, Seminars in Medical Genetics
Beth A TariniBenjamin S Wilfond

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 ...Continue Reading

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Citations

Jan 4, 2012·European Archives of Psychiatry and Clinical Neuroscience·Hanfried Helmchen
Oct 27, 2012·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Donald B BaileyMyra Roche
Apr 7, 2012·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Lisa A ProsserJames M Perrin
Mar 15, 2012·Orphanet Journal of Rare Diseases·Stephanie Shifra WeinreichMarloes Louise Catharina Hagemans
Mar 13, 2015·Clinical Immunology : the Official Journal of the Clinical Immunology Society·Antonia KwanJennifer M Puck
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Aug 16, 2011·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Louise Moody, Kubra Choudhry
Aug 26, 2015·The American Journal of Bioethics : AJOB·Maureen KelleySandra Soo-Jin Lee
Feb 17, 2010·Nature Reviews. Urology·Nancy L BrackettJens Sønksen
Jan 18, 2008·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Lainie Friedman Ross

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