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Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice

close-up of hand verifying data on screen using a stylus

In the GCP Inspectorate we receive a significant number of queries regarding the MHRA’s view of seeking consent electronically rather than by traditional paper methods, and it often comes up as a point of discussion at stakeholder meetings and the various conferences and symposia that we run ourselves and support externally. Despite this we have only seen this implemented in pilot trials on inspection.

The MHRA works closely with the Health Research Authority (HRA) to ensure a consistent approach to regulation, and this led to a series of discussions with HRA on exactly what we did think of consent by electronic means.

The result of these discussions came to fruition two weeks ago following the publication of a joint MHRA/HRA statement setting out the legal and ethical requirements for seeking and documenting consent using electronic methods.

The statement, which is supported and endorsed by the UK health departments in Northern Ireland, Scotland and Wales, confirms that electronic methods may be used for seeking, confirming and documenting informed consent for participation in research. It also sets out our joint expectations regarding the use of electronic signatures in Clinical Trials of Investigational Medicinal Products (CTIMPS).

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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