Ethics review

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This branch covers the ethics review a study goes through, from whether it needs review at all to the statement of approval and compliance a manuscript or clinical study report carries. Its parts divide by the step in hand: deciding whether a study needs review and which standards apply to it, how the committees that review it are organised and reason, writing the application a committee reads, and stating approval and compliance afterwards. It leaves the consent a participant gives, and the information they decide from, to informed consent materials for a clinical trial, the codes behind review to ethical standards in human research, what ICH E6(R3) makes the committee answerable for to roles, responsibilities and oversight in a clinical trial, and personal data to data protection in clinical research.

Deciding whether a study needs ethics review, and which standards apply — practice against research, whether an observational study needs ethics approval, the ethics approval a paediatric trial needs and why it is hard to obtain, which US studies need review board review under the Common Rule and the limited review some exempt ones get, and standards that stay contextual rather than harmonised
How ethics committees are organised and how they reason — institutional against central committees, what a committee protects, who sits on UK and US committees and what they review, how they reason from past cases, and the strain of decentralised trials and of diversity among participants and members
Writing an ethics application for the committee that reads it — choosing the route to approval and preparing early, a US review board application written for its lay member, and the lay sections of a UK application
Stating ethics approval and compliance in a report or manuscript — the approval, consent and registration statements the ICMJE and journals ask a manuscript to carry, which an editor may still look behind, and what a clinical study report can honestly say about compliance with good clinical practice

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Deciding whether a study needs ethics review, and which standards apply How ethics committees are organised and how they reason Stating ethics approval and compliance in a report or manuscript Writing an ethics application for the committee that reads it

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