Item 30: Plans for seeking research ethics committee/institutional review board approval.

Example

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“The protocol, informed consent forms, and all other study material have been approved by the Ottawa Health Science Network - Research Ethics Board (20180452-01H). Each participating hospital’s Research Ethics Board (REB) has also approved the trial protocol. Consent material is available in French and English. … PRICE-2 will be conducted according to Good Clinical Practice and based on the principles of the second version of the Tri-Council Policy Statement ” [345]

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Explanation

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Before enrolling participants, a universal requirement for the ethical conduct of clinical trials is the review and approval of the protocol by qualified individuals who are not associated with the research team and have no disqualifying conflicts of interest as reviewers [46, 472]. The review is typically conducted by a formal Research Ethics Board/Committee (also called an Institutional Review Board) in accordance with jurisdictional policy.

The protocol should document where approval has been obtained, or outline plans to seek such approval at all sites.

Summary of key elements to address

• Plans to obtain research ethics committee/institutional review board approval