Why is this important?
Obtaining consent is a fundamental requirement for enrolling participants in clinical studies, yet the Informed Consent process is not participant-friendly and involves multiple stakeholders, documents, and transactions, meaning it is often quoted as being in the top ten cited regulatory deficiencies in the clinical operations landscape. Some of this complexity, which uses paper-based methods for obtaining consent through Informed Consent Forms (ICFs), is being removed by the adoption of digital electronic-Consent (eConsent) solutions which streamline the process to a more participant-centric approach. Despite the benefits, eConsent platforms are centralized, raising questions around the privacy and access to participant data during and after a clinical trial.
Our solution for Informed Consent in clinical trials (BlockSent), implements key components of decentralized digital identities: Decentralised Identifiers (DIDs), Verifiable Credentials (VCs), and a blockchain registry. BlockSent enables participants to provide consent, be reconsented, and withdraw their consent to participate in a clinical trial. BlockSent provides participants, clinicians, and sponsors with an audit trail of all the transactions between relevant stakeholders in the clinical trial informed consent process ensuring regulatory compliance and enabling a real-time overview of the approvals and signature process. The project has developed the learning and system requirements so that others could adopt or build on BlockSent based on their own approach.
What will the project achieve?
The project will build a solution for Informed Consent in clinical trials (BlockSent), implements key components of decentralized digital identities: Decentralised Identifiers (DIDs), Verifiable Credentials (VCs), and a blockchain registry. BlockSent will:
- Provide participants with a simple system to participate in a clinical trial.
- Create an immutable audit trail for the Informed Consent process which is tamper-proof.
- Have the ability to integrate with existing third-party clinical trial data management systems.
- Deliver a publication highlighting BlockSent as a conceptual solution based on blockchain technology to enhance the electronic informed consent process in clinical trials.
If you would like to get involved or have further questions or feedback email the project manager, Richard Norman.