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

Full Abstract

BACKGROUND:
Ethical problems are quoted as a reason not to perform clinical trials in children. Little is known about the views of researchers regarding ethics.

OBJECTIVES:
A pilot study was conducted to assess the applicability of a questionnaire design containing trial scenarios to examine views regarding the use of children in drug trials and to elicit possible international differences.

SETTING:
Paediatricians and researchers in the United Kingdom and Canada.

METHODS:
Responders were presented with a questionnaire containing direct questions and six trial scenarios, each containing an ethical dilemma. Responders were asked regarding their own approval and their perceived opinion of whether an ethical review board (ERB) would approve.

RESULTS:
One hundred questionnaires (50 each country) were received. Few responders had research ethics training (14% United Kingdom and 8% Canada). Most (80 and 88%) felt children could be harmed by participation in trials and half (47 and 59%) felt children should only participate if they receive direct benefit. Many (58 and 61%) disagreed with payments beyond travel expenses. In the trial scenarios, 34% of responders were willing to enter healthy children in a pharmacokinetics study of an antibiotic for cystic fibrosis and 22% considered their ERBs would approve. Only a third (33%) would enter children in an analgesia trial that was placebo-controlled.

CONCLUSION:
Using healthy children and placebos in trials caused concern. Similar views were found between the two countries. The majority had no training in research ethics. The study highlights the usefulness of a questionnaire with clinical trial scenarios to try to elicit views on the ethics of conducting research in children.

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Author information

Author/s: Sammons, H M (HM); Malhotra, J (J); Choonara, I (I); Sitar, D S (DS); Matsui, D (D); Rieder, M J (MJ);

Affiliation: Academic Division of Child Health, University of Nottingham, Medical School, Derbyshire Children's Hospital, Uttoxeter Road, Derby, DE22 3DT, UK. helen.sammons(-atsign-)nottingham.ac.uk

Journal and publication information

Publication Type: Comparative Study; Journal Article

Journal: European journal of clinical pharmacology (Eur J Clin Pharmacol), published in Germany. (Language: eng)

Reference: 2007-May; vol 63 (issue 5) : pp 431-6

Dates: Created 2007/04/13; Completed 2007/08/09; Revised 2007/11/15;

PMID: 17364191, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Attitude of Health Personnel
Canada
Child
Controlled Clinical Trials as Topic - ethics
Cross-Cultural Comparison
Ethics Committees, Research
Ethics, Research
Great Britain

Associated Chemicals: Placebos (0)

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