Obtaining consent from both parents for pediatric research: what does "reasonably available" mean?

Abstract:

OBJECTIVE:Circumstances surrounding parental availability and decision-making were examined in the setting of a research protocol involving newborn screening (NBS) for fragile X syndrome, in which the institutional review board (IRB) had determined that consent (permission) was required from both parents. METHODS:A survey was conducted with 3001 families who were approached to participate in optional NBS. In addition to basic demographics, observational notes detailed the reasons why fathers were not present or deemed "not reasonably available" (per IRB regulations), and content analysis identified the factors for this lack of availability. Logistic regression models estimated the likelihood that both parents would agree to enroll their infant in the screening project. RESULTS:Fathers were not present in 589 cases, including 158 in which fathers were ultimately determined to be not reasonably available. Primary reasons for father's unavailability were deployment with the military, incarceration, living out of state, or not involved in the mother's life. In cases in which both parents were available, 64% agreed to enroll in the NBS study. Criteria to guide researchers in making required determinations were developed from consultations with IRB officials and legal counsel. CONCLUSIONS:In a large-scale population-based study, 19.6% of fathers were absent for the consent process. Scenarios encountered underscore the complexity of parental relations and their implications for obtaining consent for research involving children. The algorithm developed may serve as a useful tool for others in applying the regulatory requirements for dual parental permission.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Nelson DK,Skinner D,Guarda S,Choudhury S,Sideris J,Barnum L,Ten Haagen K,Heyward Q,Bailey DB Jr

doi

10.1542/peds.2012-1278

subject

Has Abstract

pub_date

2013-01-01 00:00:00

pages

e223-9

issue

1

eissn

0031-4005

issn

1098-4275

pii

peds.2012-1278

journal_volume

131

pub_type

杂志文章
  • Prospective evaluation of residents on call: before and after duty-hour reduction.

    abstract:BACKGROUND:On July 1, 2009, in Ontario the maximum period of continuous duty that residents were permitted to work was reduced from 28 to 24 hours. We evaluated the effect of regulation on residents in 3 eras: 2 before (2005 and early 2009) and 1 after (late 2009) the duty-hour reduction. METHODS:On-call pediatric res...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2010-1955

    authors: Bismilla Z,Breakey VR,Swales J,Kulik DM,Pai N,Singh N,Parshuram CS

    更新日期:2011-06-01 00:00:00

  • Trends in Candida central line-associated bloodstream infections among NICUs, 1999-2009.

    abstract:OBJECTIVES:To assess trends in incidence of Candida spp. central line-associated bloodstream infections (CLABSIs) in US NICUs, 1999-2009. METHODS:Data from NICUs participating in the National Nosocomial Infections Surveillance (1999-2004) and National Healthcare Safety Network (2006-2009) were analyzed. Overall and bi...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2011-3620

    authors: Chitnis AS,Magill SS,Edwards JR,Chiller TM,Fridkin SK,Lessa FC

    更新日期:2012-07-01 00:00:00

  • Sleep deprivation for pediatric sedated procedures: not worth the effort.

    abstract:OBJECTIVE:Sleep deprivation is commonly used to enhance the effectiveness of pediatric sedation and to decrease sedation failures. We reviewed our sedation database to evaluate the efficacy of sleep deprivation. METHODS:The entire pediatric sedation unit database (n = 5640) was reviewed retrospectively. Patients witho...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.113.5.1204

    authors: Shields CH,Johnson S,Knoll J,Chess C,Goldberg D,Creamer K

    更新日期:2004-05-01 00:00:00

  • Reducing violent injuries: priorities for pediatrician advocacy.

    abstract::A basic framework for developing an advocacy plan must systematically break down the large task of policy development implementation into manageable components. The basic framework described in detail in this paper includes three steps: Setting policy objectives by narrowing the scope of policy, by reviewing policy op...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:

    authors: Dolins JC,Christoffel KK

    更新日期:1994-10-01 00:00:00

  • Risk of respiratory illness associated with day-care attendance: a nationwide study.

    abstract::The risk of respiratory and other illnesses in children (age groups: 6 weeks through 17 months, 18 through 35 months, and 36 through 59 months) in various types of day-care facilities was studied. Children considered exposed to day care were those who were enrolled in day care with at least one unrelated child for at ...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Hurwitz ES,Gunn WJ,Pinsky PF,Schonberger LB

    更新日期:1991-01-01 00:00:00

  • Booster seat laws and fatalities in children 4 to 7 years of age.

    abstract:OBJECTIVE:To determine whether state booster seat laws were associated with decreased fatality rates in children 4 to 7 years of age in the United States. METHODS:Retrospective, longitudinal analysis of all motor vehicle occupant crashes involving children 4 to 7 years of age identified in the Fatality Analysis Report...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2012-1058

    authors: Mannix R,Fleegler E,Meehan WP 3rd,Schutzman SA,Hennelly K,Nigrovic L,Lee LK

    更新日期:2012-12-01 00:00:00

  • Standardizing the Evaluation of Nonaccidental Trauma in a Large Pediatric Emergency Department.

    abstract:BACKGROUND AND OBJECTIVES:Variability exists in the evaluation of nonaccidental trauma (NAT) in the pediatric emergency department because of misconceptions and individual bias of clinicians. Further maltreatment, injury, and death can ensue if these children are not evaluated appropriately. The implementation of guide...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2017-1994

    authors: Riney LC,Frey TM,Fain ET,Duma EM,Bennett BL,Murtagh Kurowski E

    更新日期:2018-01-01 00:00:00

  • Pediatrician identification of Latino children at risk for autism spectrum disorder.

    abstract:BACKGROUND AND OBJECTIVES:Latino-white disparities in age at autism spectrum disorder (ASD) diagnosis may be modified by primary care pediatrician (PCP) practices and beliefs. The objectives of this study were to assess ASD and developmental screening practices, attitudes toward ASD identification in Latino children, a...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2013-0383

    authors: Zuckerman KE,Mattox K,Donelan K,Batbayar O,Baghaee A,Bethell C

    更新日期:2013-09-01 00:00:00

  • Who are the primary caretakers of children born to HIV-infected mothers? Results from a multistate surveillance project.

    abstract:OBJECTIVE:To determine the primary caretakers of children born to women with human immunodeficiency virus (HIV) infection. METHODS:We interviewed women at least 18 years of age who have been reported with HIV infection or acquired immunodeficiency syndrome to local health departments in 10 cities and states regarding ...

    journal_title:Pediatrics

    pub_type: 杂志文章,多中心研究

    doi:

    authors: Schable B,Diaz T,Chu SY,Caldwell MB,Conti L,Alston OM,Sorvillo F,Checko PJ,Hermann P,Davidson AJ

    更新日期:1995-04-01 00:00:00

  • National trends in the management of cardiovascular disease risk factors in children: second NHLBI survey of primary care physicians.

    abstract:BACKGROUND:The evidence that atherosclerosis begins during adolescence has led to the belief that primary prevention of cardiovascular disease (CHD) should commence in childhood. Although several national guidelines have been issued for the detection and treatment of CHD risk factors in children, concerns continue to b...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.102.5.e50

    authors: Kimm SY,Payne GH,Stylianou MP,Waclawiw MA,Lichtenstein C

    更新日期:1998-11-01 00:00:00

  • Cortical hyperostosis: a complication of prolonged prostaglandin infusion in infants awaiting cardiac transplantation.

    abstract:BACKGROUND:Infants awaiting heart transplantation for congenital heart disease frequently require prostaglandin E1 (PGE1) infusion for prolonged periods. As a result, complications of prolonged PGE1 infusion, such as cortical hyperostosis, are being encountered more commonly. OBJECTIVE:To determine the incidence and s...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Woo K,Emery J,Peabody J

    更新日期:1994-03-01 00:00:00

  • Intrauterine rubella, head size, and intellect.

    abstract::The assumption that congenital rubella is commonly associated with microcephaly and mental retardation was examined. Among a rubella clinic population of 111 children, 92 children had vision sufficient to allow testing by the Leiter International Scale. The mean IQ for this group was 99.46 (SD, 19.5). Head circumferen...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Macfarlane DW,Boyd RD,Dodrill CB,Tufts E

    更新日期:1975-06-01 00:00:00

  • QTc interval prolongation and severe apneas associated with a change in infant positioning.

    abstract::For more than a decade there has been considerable interest in the role of QT interval prolongation in the pathogenesis of sudden infant death syndrome. It has been proposed that the QT interval is a surrogate marker for autonomic instability and can be used to identify infants at risk for significant morbidity and mo...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2012-4005

    authors: Ellsworth MA,Ulrich TJ,Carey WA,Colby CE,Ackerman MJ

    更新日期:2013-12-01 00:00:00

  • Guidelines for developing admission and discharge policies for the pediatric intensive care unit. American Academy of Pediatrics. Committee on Hospital Care and Section of Critical Care. Society of Critical Care Medicine. Pediatric Section Admission Crite

    abstract::These guidelines were developed to provide a reference for preparing policies on admission to and discharge from pediatric intensive care units. They represent a consensus opinion of physicians, nurses, and allied health care professionals. By using this document as a framework for developing multidisciplinary admissi...

    journal_title:Pediatrics

    pub_type: 指南,杂志文章

    doi:

    authors:

    更新日期:1999-04-01 00:00:00

  • Marijuana and Tobacco Coexposure in Hospitalized Children.

    abstract:BACKGROUND:The impact of secondhand marijuana smoke exposure on children is unknown. New methods allow for the detection of marijuana smoke exposure in children. METHODS:We studied children who were hospitalized in Colorado and had a parent participating in a smoking cessation study; all children had urine samples rem...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2018-0820

    authors: Wilson KM,Torok MR,Wei B,Wang L,Lowary M,Blount BC

    更新日期:2018-12-01 00:00:00

  • Foreign body granuloma of the external auditory canal.

    abstract::External auditory canal polyps are most commonly inflammatory in nature but may also manifest more severe disease. Prolonged conservative therapy may delay the correct diagnosis and appropriate intervention. A case is presented of a child with chronic otorrhea treated for 4 months with topical drops and antibiotics. O...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.113.4.e371

    authors: Harris KC,Conley SF,Kerschner JE

    更新日期:2004-04-01 00:00:00

  • Expanding the availability of extracorporeal cardiopulmonary resuscitation.

    abstract::A healthy 14-year-old presented to an emergency department in Alaska, complaining of shortness of breath, chest pain, and 72 hours of malaise and headache. On admission, her blood pressure was 80/50 mm Hg, and she had cool extremities. Electrocardiography revealed wide-complex ventricular tachycardia. She underwent sy...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2011-2371

    authors: McMullan DM

    更新日期:2013-03-01 00:00:00

  • Candidate genes and cerebral palsy: a population-based study.

    abstract:OBJECTIVE:The objective of this study was to examine whether selected genetic polymorphisms in the infant are associated with later-diagnosed cerebral palsy. METHODS:A population-based case-control study was conducted of 28 single-nucleotide polymorphisms measured in newborn screening blood spots. A total of 413 child...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2007-3758

    authors: Gibson CS,Maclennan AH,Dekker GA,Goldwater PN,Sullivan TR,Munroe DJ,Tsang S,Stewart C,Nelson KB

    更新日期:2008-11-01 00:00:00

  • Occult spinal dysraphism: a series of 73 cases.

    abstract::The subject of occult spinal dysraphism or myelodysplasia is reviewed from standpoints of embryology, clinical manifestations, and treatment, and the management of 73 cases summarized. In general, these concealed lesions arise from developmental variants in the most distal part of the neural tube, a situation which ma...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Anderson FM

    更新日期:1975-06-01 00:00:00

  • Excess morbidity associated with interhospital transport.

    abstract::A prospective study was performed to determine whether excess morbidity occurred in critically ill and injured pediatric patients during interhospital transport compared with morbidity in a control group. Control observations were made during the first 2 hours of pediatric intensive care unit (PICU) care of patients e...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Kanter RK,Boeing NM,Hannan WP,Kanter DL

    更新日期:1992-12-01 00:00:00

  • Evidence from proton magnetic resonance spectroscopy for a metabolic cascade of neuronal damage in shaken baby syndrome.

    abstract:OBJECTIVE:The purpose of this study was to use proton magnetic resonance spectroscopy (MRS) as a metabolic assay to describe biochemical changes during the evolution of neuronal injury in infants after shaken baby syndrome (SBS), that explain the disparity between apparent physical injury and the neurological deficit a...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.99.1.4

    authors: Haseler LJ,Arcinue E,Danielsen ER,Bluml S,Ross BD

    更新日期:1997-01-01 00:00:00

  • Neurofibromatosis type 1 revisited.

    abstract::Neurofibromatosis type 1 (NF1) is an autosomal dominant condition with a worldwide incidence of approximately 1 per 2500 to 3000 individuals. Caused by a germ-line-inactivating mutation in the NF1 gene on chromosome 17, the disease is associated with increased morbidity and mortality. In the past several years, signif...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2007-3204

    authors: Williams VC,Lucas J,Babcock MA,Gutmann DH,Korf B,Maria BL

    更新日期:2009-01-01 00:00:00

  • A Centralized Approach for Practicing Genomic Medicine.

    abstract::Next-generation sequencing has revolutionized the diagnostic process, making broadscale testing affordable and applicable to almost all specialties; however, there remain several challenges in its widespread implementation. Barriers such as lack of infrastructure or expertise within local health systems and complex re...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2019-0855

    authors: Biswas S,Medne L,Devkota B,Bedoukian E,Berrodin D,Izumi K,Deardorff MA,Tarpinian J,Leonard J,Pyle L,Gray C,Montgomery J,Williams T,Fortunato S,Weatherly J,McEldrew D,Kaur M,Raible SE,Wilkens A,Spinner NB,Skraban C

    更新日期:2020-03-01 00:00:00

  • Policy statement--Child abuse, confidentiality, and the health insurance portability and accountability act.

    abstract::The federal Health Insurance Portability and Accountability Act (HIPAA) of 1996 has significantly affected clinical practice, particularly with regard to how patient information is shared. HIPAA addresses the security and privacy of patient health data, ensuring that information is released appropriately with patient ...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2009-2864

    authors: Committee on Child Abuse and Neglect.

    更新日期:2010-01-01 00:00:00

  • Benefits of Delayed Cord Clamping in Red Blood Cell Alloimmunization.

    abstract:BACKGROUND AND OBJECTIVE:Several studies have shown the benefits of delayed cord clamping (DCC) in preterm and in healthy newborns at short and long term. Our objective was to evaluate the potentials benefits and risks of DCC in red cell alloimmunization. METHODS:This was a comparative before/after study of all living...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2015-3236

    authors: Garabedian C,Rakza T,Drumez E,Poleszczuk M,Ghesquiere L,Wibaut B,Depoortere MH,Vaast P,Storme L,Houfflin-Debarge V

    更新日期:2016-03-01 00:00:00

  • "Greenlight study": a controlled trial of low-literacy, early childhood obesity prevention.

    abstract::Children who become overweight by age 2 years have significantly greater risks of long-term health problems, and children in low-income communities, where rates of low adult literacy are highest, are at increased risk of developing obesity. The objective of the Greenlight Intervention Study is to assess the effectiven...

    journal_title:Pediatrics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1542/peds.2013-3867

    authors: Sanders LM,Perrin EM,Yin HS,Bronaugh A,Rothman RL,Greenlight Study Team.

    更新日期:2014-06-01 00:00:00

  • A prospective study of the role of depression in the development and persistence of adolescent obesity.

    abstract:BACKGROUND:Adolescent obesity is a strong predictor of adult obesity, and adult obesity has been associated with depression, especially in women. Studies have also suggested an association between depression in adolescence and higher body mass index (BMI) in adulthood. Whether depression leads to obesity or obesity cau...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.110.3.497

    authors: Goodman E,Whitaker RC

    更新日期:2002-09-01 00:00:00

  • Unexplained reduced microbiological efficacy of intramuscular benzathine penicillin G and of oral penicillin V in eradication of group a streptococci from children with acute pharyngitis.

    abstract:OBJECTIVE:To evaluate the efficacy of oral penicillin V and intramuscular benzathine penicillin G (BPG) in eradicating group A streptococci from the upper respiratory tract. METHODOLOGY:Two randomized, single-blind, multicenter antibiotic efficacy trials in children using recommended doses of either oral penicillin V ...

    journal_title:Pediatrics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1542/peds.108.5.1180

    authors: Kaplan EL,Johnson DR

    更新日期:2001-11-01 00:00:00

  • The effect of zinc supplementation on linear growth, body composition, and growth factors in preterm infants.

    abstract:OBJECTIVE:The aim of our study was to evaluate the effect of zinc supplementation on linear growth, body composition, and growth factors in premature infants. DESIGN:Thirty-six preterm infants (gestational age: 32.0 +/- 2.1 weeks, birth weight: 1704 +/- 364 g) participated in a longitudinal double-blind, randomized cl...

    journal_title:Pediatrics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1542/peds.111.5.1002

    authors: Díaz-Gómez NM,Doménech E,Barroso F,Castells S,Cortabarria C,Jiménez A

    更新日期:2003-05-01 00:00:00

  • A pacifier increases the risk of recurrent acute otitis media in children in day care centers.

    abstract:OBJECTIVE:To follow up a previous retrospective analysis in which we found the use of a pacifier to be a risk factor for recurrent acute otitis media (AOM). METHOD:In the present prospective study, the occurrence of AOM and the use of a pacifier were recorded in 845 children attending day care centers during a 15-mont...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Niemelä M,Uhari M,Möttönen M

    更新日期:1995-11-01 00:00:00