JRO releases guidance on electronic consent in clinical trials

Read the JRO's summary.

The MHRA / HRA statement aims to promote best practice where eConsent is used for clinical trials, ensuring continued provision of key information in a clear way to trial participants.

It confirms that electronic methods – e.g. a tablet, computer or smartphone – may be used for seeking, confirming and documenting informed consent for research participation and also outlines the expectations regarding the use of electronic signatures in clinical trials of investigational medical products (CTIMPs).

The primary focus of the guidance is CTIMPs but the basic principles can be applied to all types of research where informed consent is required and is conducted within the UK.

The JRO encourages researchers to engage early with us if they are considering using Epic for electronic consenting to studies. Researchers should contact Mona Hassan, Research Quality and Safety Manager (mona.hassan1@nhs.net) as well as the generic JRO e-mail address (uclh.randd@nhs.net) to discuss this further.

Any changes to methods first need to be approved as a substantial amendment to a research project.

For further information, read the full MHRA / HRA joint statement.