Can research participants break from the chain of traditional data sharing consent?

By Vasiliki Rahimzadeh

In their recent article, Mann et al. propose to share biomedical research data more widely, securely and efficiently using blockchain technologies. Used to power cryptocurrencies such as Bitcoin, blockchain and the wider group of distributed ledger technologies provide new ways of exchanging data, including sensitive data such as health data, in that they create an un-editable record of information exchange. They furthermore can place patients themselves in control over how they health data are used and exchanged. The authors propose that such technologies are also evolving traditional approaches to consent that have, historically, been criticized for being risk-centered, overly technical and incomprehensible. Prosent, the authors propose, offers comparative advantages for research participants who may wish to “exercise their autonomy by sharing other data or sharing data with other trusted research or healthcare entities” through leveraging blockchain technologies.

Autonomy is among the bioethical principles that are fulfilled in the informed consent process, and one that also drives robust prosent processes to information sharingn using the blockchain. I argue that advancing technological capabilities is no doubt necessary, but on its own insufficient to re-invigorate distributive, procedural and social justice as guiding principles for consenting to biomedical research data sharing.  I offer three ‘pros’ and ‘cons’ of this model in effort to deepen its commitments to social justice ahead of its more widespread adaptation to institutional data sharing practices, with special attention to fairer distribution of research benefits to research participants from marginalized communities.

First, informed consent has a fraught history of failing to protect participants in the biomedical research context, particularly among participants from racial, ethnic and differently-abled groups. Thus to care about the negative effects of under- or over-representation of marginalized communities perpetuated by poor consent processes, you have to know these communities; to know them, you must interact them. With blockchain-enabled prosent, there may be fewer opportunities for interested participants to interact directly with study personnel who often answer study-related questions, explain overall aims of the research, and describe study procedures. Allowing smart contracts to replace people may in fact worsen participant’s understanding of how, and with whom their data are shared. In other words, the prosent process does not confirm that data contributors understand the short and long-term implications of their permissions, however transparent.

Second, the concept of individually owned and controlled data ignores how some communities view their data as shared resources where it is culturally appropriate to require consent from other stakeholders. This is especially true of research participants from indigenous communities. As currently designed, the blockchain does not allow for such community consent that may be culturally required to share research data involving such populations. In addition to building blockchain infrastructure, the proponents of the prosent model could consider greater stakeholder education and outreach to guide future data sharers and users on how to make the most responsible data sharing decisions.

Lastly, as its name suggests, the prosent model is future-oriented. It is an improvement to the current consent system in that it allows participants the option to share their data beyond the original purpose or study. Indeed, these secondary uses of data reduce the time and resources it would otherwise require to collect and analyze similar datasets. Yet, the prosent model does not, on its surface, address how it will obtain permission from participants who do not yet have the ability to make data sharing decisions. Children fall in this research participant group. It is quite possible that when they reach 18, pediatric research participants would make different data sharing decisions than their parents. It is currently unclear how the blockchain will transfer this decision-making authority from parents to children when they evolve the ability to do so.

Increased participation among historically marginalized groups in biomedical research is a scientific must if all patients are to benefit fairly from the benefits of new knowledge in science and medicine. Traditional informed consent has not been an especially successful tool for promoting social justice in research in this regard, but proposing a new model gives bioethicists and researchers a rare opportunity to improve.

 

Title: Pros and cons of prosent as an alternative to traditional consent in medical research

Author: Vasiliki Rahimzadeh

Affiliation: Stanford Center for Biomedical Ethics, Stanford University

Competing interests: None

Social media accounts of post author: @VNRahimzadeh

https://vnrahimzadeh.com

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