Literature DB >> 12943269

Healthy children as subjects in pharmaceutical research.

Gideon Koren1.   

Abstract

Recruitment of healthy children for drug research has emerged due in part to several new American laws and policies that have led to a surge in pharmaceutical research involving children-subjects. In this paper, I review the ethical and scientific issues and the arguments in favor and against this new practice.

Entities:  

Keywords:  Bioethics and Professional Ethics

Mesh：

Substances：

Year:  2003        PMID： 12943269     DOI： 10.1023/a:1024694828858

Source DB:  PubMed          Journal:  Theor Med Bioeth        ISSN： 1386-7415


  7 in total

1.  A moral theory of informed consent.

Authors:  B Freedman
Journal:  Hastings Cent Rep       Date:  1975-08       Impact factor: 2.683

2.  Use of healthy children as volunteers in drug studies: the ethical debate.

Authors:  Gideon Koren; Gregory L Kearns; Michael Reed; Gerrard Pons
Journal:  Clin Pharmacol Ther       Date:  2003-03       Impact factor: 6.875

3.  The package insert dilemma.

Authors:  H C Shirkey
Journal:  J Pediatr       Date:  1971-10       Impact factor: 4.406

4.  Altruism by proxy: volunteering children for bone marrow donation.

Authors:  L Delany; S Month; J Savulescu; P Browett; S Palmer
Journal:  BMJ       Date:  1996-01-27

5.  Maturity of children to consent to medical research: the babysitter test.

Authors:  G Koren; D B Carmeli; Y S Carmeli; R Haslam
Journal:  J Med Ethics       Date:  1993-09       Impact factor: 2.903

6.  Volunteering children for bone marrow donation. Children's views should have been represented in discussion.

Authors:  W E Osmun
Journal:  BMJ       Date:  1996-07-06

7.  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
  7 in total
  7 in total

1.  Age and gender related differences in children's evaluation of procedures experienced during participation in clinical research.

Authors:  Ole D Wolthers
Journal:  Eur J Pediatr       Date:  2004-10-02       Impact factor: 3.183

2.  A questionnaire on factors influencing children's assent and dissent to non-therapeutic research.

Authors:  O D Wolthers
Journal:  J Med Ethics       Date:  2006-05       Impact factor: 2.903

3.  British and Canadian views on the ethics of paediatric clinical trials.

Authors:  H M Sammons; J Malhotra; I Choonara; D S Sitar; D Matsui; M J Rieder
Journal:  Eur J Clin Pharmacol       Date:  2007-03-16       Impact factor: 2.953

4.  Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials.

Authors:  Wim Pinxten; Kris Dierickx; Herman Nys
Journal:  Eur J Pediatr       Date:  2009-01-14       Impact factor: 3.183

5.  Drug formulations that require less than 0.1 mL of stock solution to prepare doses for infants and children.

Authors:  Navjeet Uppal; Baseer Yasseen; Winnie Seto; Christopher S Parshuram
Journal:  CMAJ       Date:  2011-01-24       Impact factor: 8.262

Review 6.  Informed consent in pediatric research.

Authors:  Tom Leibson; Gideon Koren
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

7.  Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

Authors:  Navjeet K Uppal; Lee L Dupuis; Christopher S Parshuram
Journal:  Paediatr Drugs       Date:  2008       Impact factor: 3.022
  7 in total

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