The study must comply with the Declaration of Helsinki. The research protocol must have been approved by the locally appointed ethics committee and informed consent must have been obtained from subjects (or their guardians).
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Ethics committee approval
Authors must explicitly state in the covering letter (on the first page of submission) that any necessary ethics committee approval was secured for the study reported. This fact should also be explicitly stated in the manuscript and authors should state the name and location of the approving ethics committee(s). The critical assessment of submitted papers will include ethical considerations.
Where there is doubt about research ethics approval, the editor may request copies of the correspondence between the authors and the research ethics committee and may contact the Chair directly.
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Further information about good research practice can be found by following these links:
- MRC good research practice (PDF)
- COPE guidelines
- Central Office for Research Ethics Committees (UK)
- Good Clinical Practice in FDA trials (USA)
- Responsible Conduct of Research NIH (USA)
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