What do research ethics committees say about applications to conduct research involving children?

Angell, Emma, Biggs, Hazel, Gahleitner, Florian and Dixon-Woods, Mary (2010) What do research ethics committees say about applications to conduct research involving children? Archive of Diseases in Childhood, 95, 915-917.


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Objective: to identify issues raised by Research Ethics Committees (RECs) in letters about applications to conduct research involving children.

Methods: analysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants.

Results: RECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientific design, and confidentiality. RECs focused on children’s status as ‘vulnerable’. They sought to ensure that children would be protected, that appropriate written language would be used to communicate with children and that an appropriate person would give consent for children to participate.

Implications: researchers should be attentive to issues of potential vulnerability when preparing applications. REC letters may be improved by giving clear and explicit reasons for their opinions

Item Type: Article
ISSNs: 0003-9888 (print)
1468-2044 (electronic)
Keywords: medical law, research ethics committees, child participants, clinical trials, research
Subjects: B Philosophy. Psychology. Religion > BJ Ethics
R Medicine > R Medicine (General)
Divisions : University Structure - Pre August 2011 > School of Law
Faculty of Business and Law > Southampton Law School
ePrint ID: 148997
Accepted Date and Publication Date:
Date Deposited: 29 Apr 2010 14:07
Last Modified: 31 Mar 2016 13:22
URI: http://eprints.soton.ac.uk/id/eprint/148997

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