By Sebastian Porsdam Mann.

Nearly 20 systematic or scoping reviews were published on blockchain pilots in medical contexts in 2019 alone. Our paper is the first to call attention to the need for bioethical analysis of potential blockchain implementations in healthcare and health research. These are urgent questions, since different implementation and design choices can lead to diametrically opposite effects on our values and principles.

Blockchain technologies are sophisticated systems for distributing information with high fidelity, transparency, and pseudonimity. For Bitcoin, the first implementation of the underlying blockchain technology, this information concerned financial transfers so these could be made in a quick and secure way. However, the set of technologies which collectively make up a blockchain may be used for other types of information, too, including health data and metadata.

Due to the complexity of its component technologies and the wide variety of uses to which blockchains could be put, it is essential to realize that differences in design and implementation strongly modulate their likely impact on a range of ethically significant parameters and principles.

As electronic health records systems and care data have shown, it is important to anticipate the ethical, legal and practical consequences of design and implementation before systems are launched.

For example, blockchain technologies might eventually be used to eliminate publication bias, publication delay, statistical and scientific malpractice such as changing the protocol (e.g. to change the primary or secondary outcomes measured); failing to document or adequately obtain informed consent, and, with the aid of multiparty secure computing in which algorithms are ‘sent’ to several data owners or repositories, performing automated statistical analyses on these data at their origin. The resulting ‘shards’ of information can then be aggregated without revealing the identity of anyone involved and without removing or copying data. Yet our paper describes how these very same technologies could equally well be used radically enhance control over medical data for those who possess it.

We also coin the term prosent, which refers to the blockchain-enabled ability of all stakeholders in biomedicine and healthcare, including patients, to pseudonymously request, grant, aggregate, analyze and share data and expertise without revealing their identities or compromising the data involved.

Background

Respecting patients and their autonomy, a primary obligation of medical professionals, is increasingly important in the digital age. Yet biomedical and bioethical researchers have raised concerns over the barriers to access to previously stored medical data useful for epidemiological and other data-driven medical research. These barriers were introduced to protect the privacy and autonomy of patients but have had the unintended consequence of widespread and often severe selection bias, undermining research quality. Various modifications to these rules have been suggested, including broad-, meta- and opt-out consent models. However, none of these proposals directly improve the safety of patient data nor fully allows for its autonomous control by individuals.

Introducing blockchain

We introduce novel advances in computer science and cryptography, notably blockchain, as a proposed solution to the dilemmas raised by consent requirements to retroactive epidemiological research.

We also demonstrate how clinical trial integrity can be enhanced through the use of blockchain-enabled smart contracts, which are self-executing pieces of code that are triggered at crucial points during trial conduct. Finally, we coin and describe the term ‘prosent,’ which refers to the blockchain-enabled ability to condition consent at trial enrollment upon key elements of trial integrity, including adherence to the statistical and procedural protocol as well as data release agreements following trial completion. Prosent can also be used to refer to the blockchain-enabled bi-directional pseudonymous communication between researchers, citizens and data owners.

Implications for society and the advancement of biomedical knowledge

Ethics and the law of most nations allow for consent waivers for research with minimal risk. If implemented properly, blockchain and smart  contract based tools could reduce the privacy risk of most, if not all, records-based research to minimal, thus potentially freeing up the legislative space for a large-scale facilitation of records-based research. Importantly, the technology described in this paper could also be used to radically enhance the control that patients and other data owners have over their pseudonymous medical data. These insights are critical to the increasingly important policy issues concerning access to, and control over, biomedical data.

Smart contracts and prosent additionally present novel ways to improve adherence to protocols and trial integrity more generally, making them of interest to those interested in evidence-based policymaking and the reduction of waste in biomedical research.

These affordances of novel technologies should be widely discussed in the medical and policy professions to ensure that they are used for the furtherance of ethical principles.

Paper: Blockchain, consent and prosent for medical research

Authors: Sebastian Porsdam Mann,1,2 Julian Savulescu,1,3,4 Philippe Ravaud,5,6 Mehdi Benchoufi5

Affiliations:

1 Oxford Uehiro Center for Practical Ethics
2 Dept of Communication, University of Copenhagen
3 Monash University
4 St Cross College, Oxford
5 Paris Descartes University Hospital
6 Stanford Center for Meta-Research

Competing Interesting: None declared