Decentralized Biobanking: A Next-Generation Platform for Biomedical Research and Precision Medicine
By Marielle S. Gross, Amelia J. Hood, Jeffrey Kahn, Adrian Lee, Mario Macis, Balaji Palanisamy, Roberto Bellido Diaz, Diana Mendoza-Cervantes, William Sanchez, Josh Rubin, and Robert C. Miller.
Biobanking today: A diaspora of data
Biobanks are the heart of a healthcare system that maximizes learning from patient care. Human tissues and other biosamples they store become the lifeblood of research. Biosamples unlock precision medicine: a transformative approach that personalizes treatment by examining individuals’ biological, genetic, lifestyle, and environmental data. Growing value of biosamples has inspired hospitals, universities, and governments to invest billions in biobanking.
Although we call them “banks,” no one would put their money in a bank that treated their assets the way biobanks treat biosamples. After signing a one-time, all-or-nothing consent form, biosamples are de-identified by stripping patients’ personal details. In the name of privacy protection, biobanks act as one-way supply chains that guard and occasionally dole out slivers of de-identified tissue with limited accompanying data.
As a result, patients have no idea what is collected from their bodies or to whom it is distributed (if at all). Meanwhile, the most obvious path for translation of findings is blocked by policies which prevent researchers from re-identifying and contacting their subjects. Patients do not share in benefits of their contributions, even when clinically actionable information, like BRCA mutations, arises in research contexts. This asymmetry exemplifies structural injustice and exacerbates disparities in healthcare.
Likewise, two researchers studying the same patient never know as much, let alone cross-reference their findings. Researchers’ subjects are Sybils, isolated from respective individuals’ increasingly rich, multisource digital and biological datasets. Science advances in silos, via inefficient data architecture that discourages collaboration and alienates parties from their common goal.
Further, access to biosamples is typically limited to local faculty, and most potential users are not aware that they even exist. Indeed, the vast majority of our biosample collections go unused: frozen assets. Convoluted permissions trap them in limbo between institutional stakeholders whose incentives are misaligned with donors’ intentions. With patients out of the picture, biosample ownership is ambiguous, and while they are costly to maintain, there is no vested party to ensure that they get put to use. This biobank model is not economically sustainable, and impedes the commercialization steps necessary to realize precision medicine at scale.
From consent to consensus:
Informed consent is an innovation designed to counteract information and power asymmetry between patients and researchers or physicians. This intentional friction does not scale for today’s data-driven research applications. Digitization renders informed consent as a checkbox: “accept the cookies for biomedical research.”
Consensus is the next stage in the evolution of consent as a moral technology. A peer-to-peer blockchain solution can unlock the potential of our collective biosample stockpiles via decentralized consensus protocols. Next, we advance our NFT-backed decentralized biobanking model, and illustrate how empowering patient ownership of their biosamples may facilitate sustainable biobanking as a cornerstone of precision medicine.
Consensus empowers patients to actively participate, leverage their bioassets in collaboration, and confers a positive right to benefit from their use. Our scalable, NFT-backed ecosystem will reveal for patients the richness and value produced from ongoing collaborations with researchers who use their tissues and other biosamples.
At the core of our program is a series of individual biobanks which each represent dense, stable atomic networks of patients and researchers who are already invested in one another. These collaborators work with a shared mission but have no means to communicate. Using a suite of web3 technologies, we are building an onramp by which existing consent mechanisms can be harnessed to wrap decentralized autonomous organizations (DAOs) around existing biobank protocols. Formalizing these communities onto a web3 platform can support trust between patients and research institutions via transparency of research activities and dynamic engagement.
How we get there: Informed consent as a utility token
First, we tokenize the informed consent forms that patients signed when they agreed to participate in existing biobank protocols. Signatures on these forms indicate an individual’s decision to join a donor community. The consent forms themselves codify institutional and researcher obligations to the individual and collective (e.g., to protect privacy, to avoid misuse of samples).
More diverse authentication is possible, as well: informed consent forms contain the name and contact information for the project’s Principal Investigator, approved by the Institutional Review Board, administered by research staff dedicated to obtaining consent (often co-signing with patients during the encounter), and uploaded and maintained by other staff. This consent typically occurs in the context of a clinical encounter, with the patient’s doctors, nurses or other clinical team members present, and is documented in auditable electronic medical records. Each of these diverse stakeholders are participants in the authentication of the consent form, creating a community-based process for recovery of patient ownership of their biosamples based on intersectional, real-world relationships that may grow in strength over time.
After authentication, a token is minted for the individual patient. This token is represented by a digital artwork derived from the form itself, a representation of the non-fungibility and non- transferability of both on-and-off-chain objects (a soul-bound token). Including a portion of their actual signature makes this token identifiable to the patient, but not to others (see image 1). The token is held in an externally owned account for that particular biobank, representing the fiduciary relationship between the biobank and its donor. Minting this utility token confers a right for patients to “unlock” more information about their participation in the biobanking protocol, including information about the samples they’ve contributed, how they were used, and the outcomes of that research.
Decentralized Biobanking: Empowering the biobank donor community as a DAO
Our system eases the transition from the status quo by enabling new functionality to emerge from the legacy deidentified systems. We utilize end-to-end encryption and secure computation models compliant with data security standards while still enabling provenance, minimizing tradeoffs between privacy and utility of bioassets. Biosamples themselves, and corresponding identifying information is kept off chain; the identities of patients remain encrypted. This system is compatible with existing protocols that leverage de-identified samples. Terms of engagement are governed by smart contracts.
Disintermediation of patients and researchers will unlock mutual access to existing value and create opportunities for all biobank stakeholders to maximally contribute to and benefit from their shared mission. Creating communities around existing research protocols offers opportunities for accumulating additional layers of value.
For example, researchers could issue unique images of individuals’ tissues as personalized tokens of appreciation for the tissue donors for a particular study. In return, patients might offer advocacy services, and in the future, a means to share additional data, biosamples, clinical updates, wearable inputs or genomic results to enrich the research quality and insight.
Further, patients are able to network and build community with each other, empowering the collective in addition to providing individual support. Our system provides opportunities for patients to self-organize and form cohorts around their research questions, which can then be used to “recruit” a researcher and create a formal study. This offers patients an avenue to have their values and priorities recognized by the research enterprise, and offers institutions an avenue to learn from yet unused samples.
With the patient as the vested authority, they can participate dynamically, throughout their lifetime and beyond, realizing opportunities for real stakeholdership in the research. We will raise expectations of patients as “suppliers” who are entitled to know how their bioassets are used and empower them to invest in personally meaningful research and to reap rewards of their investments, whether personal, financial or health related.
This can be accomplished without sacrificing privacy, and offers distinct advantages over today’s de-identification standards in which individuals lose the entitlement to benefits, together with the ability to have a say in how their biosamples are used. Auditability will reinforce trust and enable existing ethical and legal oversight to occur more efficiently and effectively.
The utility and value of humanity’s collective bioassets increases via tokenization and trades over a robust decentralized marketplace that maintains provenance and integrity of holistic human datasets. Both commercial and academic uses of biospecimens are accommodated by this system, and improved integration of these pathways is essential for advancing clinical care.
Our Vision: web3 for the “biomediverse”
Each individual’s self-ownership of their body is the foundation of human rights. Even those born poor in financial assets are endowed with a wealth of tissues and other bodily products. Human tissues are equitably distributed assets, with inborn uniqueness, inherent scarcity, immutable provenance, and decentralized ownership: the “original” NFTs.
These non-fungible human tissues are curated in biobanks. They hold the power to unlock precision medicine, but their potential is constrained by a system in which individuals do not benefit from their tissues. Our decentralized biobanking (“de-bi”) model empowers patients as the owners of their biosamples, unfreezing assets dormant within existing infrastructure. Smart contract automation will be leveraged to facilitate the timely distribution of value to patients and others who invest in research protocols.
Realizing precision medicine as the standard-of-care requires direct, seamless translation of learning from an individual’s body into their treatment. De-bi democratizes biomedical science by reuniting patients with their biosamples, creating bootstraps for precision medicine enabled healthcare infrastructure. Our system empowers individuals as contributors to research, incentivizing collaboration and optimizing utility via tokenization and decentralized exchange. The de-bi platform will allow researchers to obtain biosamples, improve access to holistic datasets, and transparently ensure permissions, while preserving patient ownership.
Clarifying ownership of biosamples has the potential to align incentives for stakeholders across healthcare and biomedical research, an essential first step towards a “biomediverse” in which we are united as co-investigators in our mutual mission of advancing health and wellbeing. This framework disintermediates relationships between patients, researchers and physicians via a privacy-friendly tokenized ecosystem (see Image 2).
The biomediverse is the virtual collective of the living world — a federation of 8 billion, united via fundamental equality as owners of exactly one human body, with soulbound rights to life, liberty and the pursuit of health. Our use case embodies the ideals of a non-transferrable, non-financialized application of NFTs to facilitate a “transformative, pluralist future of increasing returns across social distance.” Importantly, this model is compatible with legacy biobank and research protocols, and yet supports novel forms of collective action and cumulative layers of health benefits, financial profits and personal meaning. A global, next-generation decentralized biobank offers a promising foundation of a legitimate and durable web3.
Acknowledgment: Our research is funded by the Emerson Collective, the Beckwith Institute, and the Pitt Innovation Institute.
Disclosure: Several of the authors are involved in heny, Inc., a startup they have formed to empower patients as the owners of their biosamples.