3. Legal information

We found within our pilot project that there were some legal guidelines and permissions that needed to be in place to allow us to use electronic consent methods for seeking, confirming and documenting informed consent. Below is some of the key legal areas you should be aware of before using electronic consent.

Please note as like any guidelines in clinical research, the below information is here as a guide but may change with time, the below information is up to date as from the July 2022 - please refer to the Health Research Authority website for the most recent guidelines. https://www.hra.nhs.uk/

Health Research Authority Governance

You need to check with your local Research and Development Governance team, to check what standard operating procedures are in place for doing electronic consent, below is a link to the ‘Governance review check HRA guidelines document’ which covers electronic consent or visit www.hra.nhs.uk

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GDPR

All electronic consent software packages and cloud-based video conferencing services you decide you use, will need to comply with the General Data Protection Regulation UK (GDRP)

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Sponsor approval

HRA and MHRA publish joint statement on seeking and documenting consent using electronic methods

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