The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have published a joint statement on seeking and documenting consent using electronic methods (eConsent).
The statement, which is supported and endorsed by the health departments in Northern Ireland, Scotland and Wales, sets out the legal and ethical requirements for eConsent, and joint expectations regarding the use of electronic signatures in clinical trials of investigational medicinal products (CTIMPS). However, the authorities say the basic principles can be applied to all research conducted within the United Kingdom.
The document advises that the type of electronic signature that should be used on eConsent forms depends on whether the recruitment and consent procedures taken as a whole (and considered as part of a proportionate approach) mean that the interviewer can trust that the person who signed is who they say they are, can trust that the form has not been altered and can trust when the signature was applied. Evidence of this trust must be demonstrated if required.
For type A trials, which involve risks no higher than that of standard medical care, any simple electronic signature may be used, including typewritten or scanned eSignatures. For type B and C trials including phase I healthy volunteer trials, simple eSignatures that involve tracing the participant’s handwritten signature using a finger or a stylus or biometric eSignatures should be used. Typewritten or scanned images of handwritten signatures should not normally be used.
The statement recognises that in clinical trials that are conducted remotely it may not always be possible to verify that the participant is who they say they are. In such circumstances it may be preferable to use an advanced or qualified electronic signature, the authorities say.