UK to Allow Electronic Consent Forms for Trials
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will allow clinical trials of investigational medical products to use electronic signatures when obtaining consent from a patient to participate in a trial.The announcement comes as electronic ways to document informed consent, known as eConsent, are increasingly being adopted by sponsors and researchers either to supplement a paper-based consent design or, where appropriate, to replace it.
“The use of eConsent has the potential to improve participants’ understanding of what is involved in taking part in research and to make recruitment and consent procedures more efficient,” said Amanda Hun, joint head of policy at the Health Research Authority.
For clinical trials of investigational medicinal products (CTIMPs) and other research involving more than minimal risk, burden or intrusion, “Simple eSignatures that involve the participant tracing their handwritten signature using a finger or a stylus or biometric eSignatures should normally be used as they allow for direct comparison with eSignatures and/or wet-ink signatures previously used by the participant for the purpose of audit or where the consent is contested,” MHRA and the NHS Health Research Authority, among others, announced.
Still, the groups said that researchers should be mindful of the possibility that eSignatures may discriminate against those who are uncomfortable with or cannot use such technology.
“Alternative methods for the provision of information and/or documentation of consent should be available for those unable or unwilling to use electronic methods,” the groups said.
They also noted that the method of authentication of electronic signatures used in a study should be proportionate to the nature and the complexity of the research, the risks, burdens and potential benefits and the ethical issues at stake.
And for the majority of non-CTIMP research involving only negligible or minimal risk (i.e. face-to-face surveys or non-sensitive qualitative research), “Any simple electronic signature is normally adequate where it is appropriate to seek consent,” the groups said.
Joint statement on seeking consent by electronic methods