The updated clinical trials regulations offer sponsors of clinical trials that meet certain conditions the option to use simplified arrangements for seeking and evidencing informed consent.
We’ve been working with an advisory group to help us develop principles that will support sponsors and research team members to use simplified arrangements when seeking and evidencing informed consent in low intervention clinical trials.
These principles are intended to support proportionate approaches to the information provided to participants, the conduct of consent discussions, and the methods used to evidence consent, ensuring that consent remains informed, freely given, and explicit.
The principles have now been published and are available as part of our suite of clinical trials regulations guidance.
We will work with you to understand how these new arrangements can help you do your research in a way that people can trust - please do get in touch.