MHRA/HRA Joint statement on seeking eConsent – A joint MHRA/HRA statement (eConsent Statement) has been published which sets out the legal and ethical requirements for

seeking and documenting consent using electronic methods.

It has become apparent that eConsent is an approach sponsors and researchers are increasingly keen to adopt and enables potential research participants to be provided with the information they need to make a decision via a tablet, smartphone or digital multimedia. It also enables their informed consent to be documented using electronic signatures.

This approach can be used to supplement the traditional paper-based approach or, where appropriate, replace it.

Using eConsent offers a number of potential benefits, such as:

  • improving understanding
  • testing and reinforcing participant comprehension
  • providing feedback on how consent materials could be improved
  • improving patient recruitment process and reducing dropout rates
  • enabling process efficiencies.

Both the MHRA Clinical Trials Unit (CTU) and MHRA GCP Inspectorate were involved in the formulation of this guidance and it is therefore endorsed by both the inspectorate and CTU in terms of the content. eConsent adds to the huge variety of new and emerging electronic ways of working in clinical trials; innovation that the MHRA inspectorate is keen to support with appropriate implementation to ensure the safeguarding of clinical trial participants. We look forward to seeing it in action in the future!

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