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