This news story was published on 12 July 2017. We published a joint statement with the Medicines and Healthcare products Regulatory Agency on seeking and documenting consent using electronic methods (eConsent) on 24 September 2018.
The use of electronic signatures and authorisations is becoming increasingly common. We’ve had queries about their validity in protocols and other documents and we’d like to clarify that we accept them as an alternative to ink signatures.
Working with the Devolved Administrations we have issued the following statement:
“The HRA welcomes efficient methods of document transfer in the research approvals and study set-up process. Applications to RECs and HRA Approval are made electronically from IRAS, and applications to CAG should be made by email. Applications in IRAS have electronic authorisation. Other documents may include electronic signatures. HRA does not require ink signatures on any research approval documents. Some sponsors continue to prefer ink signatures where other arrangements would be disproportionate or impractical.
In relation to NHS site set up, HRA encourages use of time efficient methods of exchange of contracts and agreements, including exchange of confirmation by email. HRA does not stipulate use of ink signatures.”
This statement has been agreed across the Health Research Authority (HRA), Health and Social Care in Northern Ireland (HSC), NHS Research Scotland and Health and Care Research Wales.
Use of electronic signatures in seeking research approvals is distinct from electronic consent for participants in clinical trials. We are planning to issue joint statement with the MHRA on this in the next few weeks.