The OHRP and SUPPORT (original) (raw)

SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies

Chris Feudtner

The Hastings Center report, 2015

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Ethical Issues in Neonatal and Pediatric Clinical Trials

Beth Tarini

Pediatric Clinics of North America, 2012

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Ethical and legal issues in neonatal research

Neena Modi

Seminars in Neonatology, 1998

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Institutional Review Board Guidance on Pediatric Research: Missed Opportunities

Leslie Wolf

The Journal of Pediatrics, 2005

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Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context

Myron Genel

International Journal of Pediatric Endocrinology, 2011

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The legal ethics of pediatric research

Doriane Coleman

Duke law journal, 2007

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Harmonization of Ethics Policies in Pediatric Research

Valarie Blake

The Journal of Law, Medicine & Ethics, 2011

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Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 2 of 2)

Carlos Rose

Pediatrics, 2017

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The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care

Dan Kaye

BMC Pediatrics

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Ethics, minimal harm and non-therapeutic research in newborns

Dominic Wilkinson

Archives of Disease in Childhood , 2019

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Regulatory and Ethical Issues in Pediatric Clinical Research: Recommendations From a Panel Discussion

Dr. Roli Mathur

Journal of clinical pharmacology, 2017

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Infants and clinical research: legal and ethical perspectives

May Ng

2014

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Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees

joe brierley

Archives of Disease in Childhood, 2014

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Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations

Celia Fisher

The American Journal of Bioethics, 2007

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Knowledge of regulations governing pediatric research: a pilot study

Annemarie Stroustrup

IRB

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The Potential Harms and Benefits from Research on Medical Practices

David Magnus

Hastings Center Report, 2015

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Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406

Ana Iltis

Accountability in Research, 2007

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When is waiver of consent appropriate in a neonatal clinical trial?

John Lantos

Pediatrics, 2014

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Protecting a vulnerable population with little regulatory framework: a comparative analysis of international guidelines for pediatric research ethics

Heather Cook, JD, MA, RYT 500

The Journal of contemporary health law and policy, 2013

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SUPPORTing Premature Infants

John Lantos

Pediatrics, 2013

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Children in Clinical Research: A Conflict of Moral Values

Vera Sharav

The American Journal of Bioethics, 2003

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Insisting on prospective consent in paediatric critical care research may be throwing the baby out with the bathwater

Craig McBride

Journal of Paediatrics and Child Health

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Ethics, Science, and Oversight of Critical Care Research

Greg Koski

American Journal of Respiratory and Critical Care Medicine, 2004

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Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research

Merle Spriggs

The Medical journal of Australia

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Why even inappropriate parental consent might be enough to justify minimal risk pediatric research without clinical benefit

David Hunter

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Institutional Review Board Practices Regarding Assent in Pediatric Research

David Wendler

PEDIATRICS, 2004

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Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 1 of 2)

Carlos Rose

Pediatrics, 2017

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When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population

Jeff S Matsler

The American Journal of Bioethics, 2020

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