Triall has been awarded an R&D grant to develop a blockchain-based electronic Consenting (‘eConsenting) solution together with its strategic partner Sphereon. We will be the first in the world to digitise informed consent using privacy-preserving technologies for self-sovereign identity (SSI) and verifiability (cornerstones of Web3), and to apply these for solving the complex issues surrounding guardianship of incapacitated persons. In this article, we explain the context and key deliverables of this joint development project.
Why we depend on a steady influx of affordable new medicine
The pandemic has exemplified our critical dependency on clinical trials — research studies that test the safety and efficacy of new medicines in humans. Society will continue to be challenged by new or re-emerging medical emergencies, demanding timely and effective medical countermeasures when the need arises. Sound and efficient clinical trials are key to a timely influx of safe, effective, and affordable new medical solutions into society. Without them, our health and well-being are at immediate risk.
Clinical trials: increasingly digital, increasingly decentralised
The clinical trial industry has been digitising at a rapid pace. For decades, paper files were (and in some cases still remain) the industry standard for collecting and managing clinical trial documents and data. Over the past 5–10 years, many clinical trial professionals have started digitizing key trial procedures and adopting mobile technologies for collecting data. This trends was accelerated by the COVID-19 lockdowns and restrictions, forcing many to work remotely.
Clinical trials are also becoming more and more decentralised. While the traditional centralised clinical trial model weighs heavy on patients traveling to sites, the decentralised (or ‘virtual’) trial model leverages mobile technologies to enable patients to participate from their own homes.
Our R&D grant
As part of the R&D grant, Triall and Sphereon will digitise and decentralise one of the most crucial parts of clinical trial conduct: the informed consent process. In the next section, we’ll explain what this process exactly entails, why it matters so much for sound, ethical, and reliable clinical research, and how digitizing informed consent with SSI technologies forms a logical stepping stone in our development roadmap.
Informed consent explained
So what is informed consent? Here’s a definition provided by TransCelerate BioPharma Inc. (2017): "The foundation of an effective informed consent process for clinical research studies is to provide study participants with the information that they need to make an informed decision whether to participate in the study. This includes an open discussion between the investigative site staff and potential clinical research study participant, with the informed consent form (ICF) serving as a tool for enhancing that dialogue and documenting that the participant provided consent."
Informed consent is essential for patient safety, ethical research conduct, and regulatory compliance. It involves a rigorous, time-consuming, and expensive procedure that often proves a bottleneck in clinical trial execution. Informed consent must be performed and documented for each study participant, and must be updated for each study protocol amendment. Inaccuracies are easily introduced in practice, especially in large and international trials, which renders a subject’s participation unacceptable.
Guardianship in informed consent
The informed consent procedure is further complicated in the special case of guardianship. Clinical trial regulations stipulate that the consent of a guardian is required if a patient cannot decide for himself. Such is the case for instance when clinical trials involve young children, the very sick, or elderly people with dementia.
It regularly happens that the authority of a guardian cannot be determined properly or in time; that too much privacy-sensitive information is collected in the process; or that it is difficult to get patient and guardian in the same room to perform informed consent.
Self-sovereign identity (SSI) and informed consent
Triall and Sphereon will be the first organisations in the world to digitise informed consent using privacy-preserving technologies for self-sovereign identity (SSI) and verifiability — cornerstones of the emerging Web 3.0 — and to apply these for solving the complex issues surrounding guardianship of incapacitated persons.
Guardianship in informed consent provides a most complex case from a technical, organisational, ethical, and legal/regulatory perspective. Solving precisely this case will lay the groundwork for solving many of the other issues that are targeted by Triall’s digital ecosystem.
To illustrate, storage of Informed Consent Forms requires the highest security in terms of identity and access management. Therefore, the mechanisms that are developed in this R&D project will by definition be applicable for other targeted use cases, such as filing, exchanging and inspecting audit forms, consulting clinical research KPIs, or comparing protocols remotely.
Building a decentralised eConsenting module
The ultimate deliverable of this project is a software application for clinical trial investigators (doctors), patients and their guardians. The application uses Decentralised Identifiers (DIDs) and Verifiable Credentials (VCs) to coordinate the informed consent process in a digital, privacy-respecting, and fully auditable way.
In simple terms, each stakeholder receives a digital decentralised identity with a wallet of credentials. This allows the authorization of data subjects to be checked with a minimum amount of data, which directly determines what the rights of this person are within the digital environment. This is essential to be able to controllably handle highly sensitive data in a digital ecosystem.
