Literature DB >> 24437000

Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they?

David Wendler1.   

Abstract

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Year:  2013        PMID: 24437000      PMCID: PMC4142753     

Source DB:  PubMed          Journal:  IRB        ISSN: 0193-7758


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  21 in total

1.  Evaluating the risks of clinical research.

Authors:  Annette Rid; Ezekiel J Emanuel; David Wendler
Journal:  JAMA       Date:  2010-10-06       Impact factor: 56.272

Review 2.  Eliminating the daily life risks standard from the definition of minimal risk.

Authors:  D B Resnik
Journal:  J Med Ethics       Date:  2005-01       Impact factor: 2.903

3.  In defense of a single standard of research risk for all children.

Authors:  Robert M Nelson; Lainie Friedman Ross
Journal:  J Pediatr       Date:  2005-11       Impact factor: 4.406

4.  Protecting subjects who cannot give consent: toward a better standard for "minimal" risks.

Authors:  David Wendler
Journal:  Hastings Cent Rep       Date:  2005 Sep-Oct       Impact factor: 2.683

5.  SACHRP recommendations for review of children's research requiring DHHS secretary's approval.

Authors:  Celia B Fisher; Susan Z Kornetsky
Journal:  IRB       Date:  2005 May-Jun

6.  Determining risk in pediatric research with no prospect of direct benefit: time for a national consensus on the interpretation of federal regulations.

Authors:  Celia B Fisher; Susan Z Kornetsky; Ernest D Prentice
Journal:  Am J Bioeth       Date:  2007-03       Impact factor: 11.229

7.  Pediatric research and the federal minimal risk standard.

Authors:  Lainie Friedman Ross; Robert M Nelson
Journal:  JAMA       Date:  2006-02-15       Impact factor: 56.272

8.  In loco parentis. Minimal risk as an ethical threshold for research upon children.

Authors:  B Freedman; A Fuks; C Weijer
Journal:  Hastings Cent Rep       Date:  1993 Mar-Apr       Impact factor: 2.683

9.  Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians.

Authors:  E J Susman; L D Dorn; J C Fletcher
Journal:  J Pediatr       Date:  1992-10       Impact factor: 4.406

10.  Empirical examination of the ability of children to consent to clinical research.

Authors:  N Ondrusek; R Abramovitch; P Pencharz; G Koren
Journal:  J Med Ethics       Date:  1998-06       Impact factor: 2.903

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  5 in total

1.  Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics.

Authors:  David DeGrazia; Michelle Groman; Lisa M Lee
Journal:  J Med Philos       Date:  2017-04-01

2.  Body matters: rethinking the ethical acceptability of non-beneficial clinical research with children.

Authors:  Eva De Clercq; Domnita Oana Badarau; Katharina M Ruhe; Tenzin Wangmo
Journal:  Med Health Care Philos       Date:  2015-08

3.  Examining the Social Benefits Principle in Research with Human Participants.

Authors:  David B Resnik
Journal:  Health Care Anal       Date:  2018-03

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

Authors:  Dan Kabonge Kaye
Journal:  BMC Pediatr       Date:  2019-07-02       Impact factor: 2.125

5.  Non-beneficial pediatric research: individual and social interests.

Authors:  Jan Piasecki; Marcin Waligora; Vilius Dranseika
Journal:  Med Health Care Philos       Date:  2015-02
  5 in total

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