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Research Methods & Reporting

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.e7586 (Published 09 January 2013) Cite this as: BMJ 2013;346:e7586

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Re: SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

We share Kremer's sentiment that prospective trial participants be afforded sufficient time to carefully consider the information about the research presented to them, and to have their questions answered. Nowhere do we suggest that a signed document should always be obtained at the initial encounter with representatives of the research team or prior to screening procedures.

As with the usual intent of examples, the Example schedule (Fig 1) provided in our paper needs to be tailored to individual studies. Kremer's second point about the obtaining of informed consent before implementation of study procedures is also an unnecessarily rigid extrapolation from one of the examples that we quoted verbatim from a specific trial protocol (Item 10, Eligibility criteria). An appropriate interpretation of the SPIRIT guidance is that a full description of consent-related processes be provided in the protocol, so that research ethics committees can evaluate their appropriateness.

Howard Mann and An-Wen Chan
on behalf of the SPIRIT authors

Competing interests: No competing interests

03 May 2013
An-Wen Chan
Clinical epidemiologist/Mohs surgeon
and Howard Mann, for the SPIRIT authors
Women's College Research Institute, University of Toronto
790 Bay St, Toronto, Canada, M5G 1N8