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What do research ethics committees say about applications to conduct research involving children?
  1. E Angell1,
  2. H Biggs2,
  3. F Gahleitner3,
  4. M Dixon-Woods1
  1. 1Department of Health Sciences, University of Leicester, Leicester, UK
  2. 2School of Law, University of Southampton, Highfield, Southampton, UK
  3. 3Children's Department, Leicester Royal Infirmary, Leicester, UK
  1. Correspondence to Emma Angell, Research Associate, Social Sciences Research Group, Department of Health Sciences, University of Leicester, 2nd floor, Adrian Building, Leicester LE1 7RH, UK; elj1{at}le.ac.uk

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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Footnotes

  • Funding This project was funded by the National Research Ethics Service (NRES). NRES had no involvement in the study design, in the collection, analysis and interpretation of data, in the writing of this paper, or in the decision to submit the paper for publication.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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