Parental Permission for Pilot Newborn Screening Research: Guidelines From the NBSTRN

被引：21

作者：

Botkin, Jeffrey R. ^{[1
]}

Lewis, Michelle Huckaby ^{[2
]}

Watson, Michael S. ^{[3
]}

Swoboda, Kathryn J. ^{[1
]}

Anderson, Rebecca ^{[4
]}

Berry, Susan A. ^{[5
]}

Bonhomme, Natasha ^{[6
]}

Brosco, Jeffrey P. ^{[7
]}

Comeau, Anne M. ^{[8
]}

Goldenberg, Aaron ^{[9
]}

Goldman, Edward ^{[10
]}

Therrell, Bradford ^{[11
]}

Levy-Fisch, Jill ^{[12
]}

Tarini, Beth ^{[10
]}

Wilfond, Benjamin ^{[13
]}

机构：

[1] Univ Utah, Salt Lake City, UT 84112 USA

[2] Johns Hopkins Univ, Baltimore, MD USA

[3] Amer Coll Med Genet & Genom, Bethesda, MD USA

[4] Nebraska Med Ctr, Omaha, NE USA

[5] Univ Minnesota, Minneapolis, MN USA

[6] Genet Alliance, Washington, DC USA

[7] Univ Miami, Miller Sch Med, Miami, FL 33136 USA

[8] Univ Massachusetts, Sch Med, Worcester, MA USA

[9] Case Western Reserve Univ, Cleveland, OH 44106 USA

[10] Univ Michigan, Ann Arbor, MI 48109 USA

[11] Univ Texas Hlth Sci Ctr San Antonio, San Antonio, TX 78229 USA

[12] Save Babies Screening Fdn, Cincinnati, OH USA

[13] Seattle Childrens Hosp, Seattle, WA USA

来源：

PEDIATRICS | 2014年 / 133卷 / 02期

基金：

美国国家卫生研究院;

关键词：

newborn screening; research; research ethics; informed consent; parental permission; INFORMED-CONSENT; CYSTIC-FIBROSIS; EXPERIENCE; HEALTH;

D O I：

10.1542/peds.2013-2271

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

There is broad recognition of the need for population-based research to assess the safety and efficacy of newborn screening (NBS) for conditions that are not on current panels. However, prospective population-based research poses significant ethical, regulatory, and logistical challenges. In the context of NBS, there have been a variety of approaches that address parental decision-making in pilot studies of new screening tests or conditions. This article presents an ethical and legal analysis of the role of parental permission by the Bioethics and Legal Work Group of the Newborn Screening Translational Research Network created under a contract from the National Institute of Child Health and Human Development to the American College of Medical Genetics and Genomics. Circumstances are outlined in which a waiver of documentation of permission or a waiver of permission may be ethically and legally appropriate in the NBS context. These guidelines do not constitute American Academy of Pediatrics policy.

引用

页码：E410 / E417

页数：8

共 22 条

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