PeRSEVERE project looks at withdrawal of consent in clinical studies

07 April 2022

PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch (PeRSEVERE)

The UKCRC Registered CTU Network’s PeRSEVERE project has developed principles to guide the preparation for and management of early end-of-participation in clinical trials and other research studies.

Laura Clifton-Hadley, Trials Group Lead for haematology and brain trials at the CTC, has been acting as a member of the steering group, which describes its work as follows:

Background

The right of research participants to withdraw informed consent and stop taking part in some or all of the research activities is a well-established, fundamental part of ethical clinical research. The PeRSEVERE project is about the practical implications of this right. The question at the heart of the project is: how should we design and carry out clinical trials and other research, given that we know some participants will stop participating early? In our project, we have considered things such as how research studies are designed, what information is given to trial participants about stopping participation early, and what exactly should happen when a participant says they want to stop or reduce their participation.

Outputs

The final PeRSEVERE principles, with explanatory guidance, can be found here. We encourage everyone involved in designing, running, funding or overseeing clinical trials to review our suggestions and consider how they could be put into practice. The PeRSEVERE collaboration intends to release more detailed guidance in due course regarding how the principles can be implemented.

More details on the PeRSEVERE project, including the list of the principles mentioned above, can be found here.

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