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

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

medical law, research ethics committees, child participants, clinical trials, research
0003-9888
915-917
Angell, Emma
6a40a4d4-b6c8-4c41-9ea7-f34e988f674b
Biggs, Hazel
d0d08de6-6cae-4679-964c-eac653d7722b
Gahleitner, Florian
4be83303-fd24-45b4-a99e-fdd360a29d6a
Dixon-Woods, Mary
fab3d555-3223-46f5-96ee-73ce7dafccce
Angell, Emma
6a40a4d4-b6c8-4c41-9ea7-f34e988f674b
Biggs, Hazel
d0d08de6-6cae-4679-964c-eac653d7722b
Gahleitner, Florian
4be83303-fd24-45b4-a99e-fdd360a29d6a
Dixon-Woods, Mary
fab3d555-3223-46f5-96ee-73ce7dafccce

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

Record type: Article

Abstract

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

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Submitted date: 2010
Keywords: medical law, research ethics committees, child participants, clinical trials, research
Organisations: Southampton Law School

Identifiers

Local EPrints ID: 148997
URI: https://eprints.soton.ac.uk/id/eprint/148997
ISSN: 0003-9888
PURE UUID: edad60bb-f369-45e1-be47-00664d25add7

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Date deposited: 29 Apr 2010 14:07
Last modified: 18 Jul 2017 19:31

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