What is required for electronic informed consent (eConsent)?

According to the MHRA Blog the GCP Inspectorate receives a significant number of queries regarding MHRA’s view of seeking consent electronically (eConsent) rather than by traditional paper methods.

As a result of discussions with the HRA (Health Research Authority) a joint MHRA / HRA statement setting out the legal and ethical requirements for seeking and documenting consent using electronic methods has been released.

The statement confirms that electronic methods may be used for seeking, confirming and documenting informed consent for participation in research. It also sets out joint expectations regarding the use of electronic signatures in Clinical Trials of Investigational Medicinal Products (IMPs). According to the agency, it has become evident that eConsent is an approach sponsors and researchers are increasingly keen to adopt and it 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. According to the agency 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

The agency says that "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".

Please also see the complete MHRA Inspectorate Blog on eConsent.

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