Reconnecting the Dots
It’s time to change the paradigm to allow patients to track their contributions to biomedical research.
Over the last 50 years, bioethics has demanded that medical care and research be separated as a matter of human rights protection — a critical reaction to atrocities committed in the name of science throughout the 20th century.
Today, we uphold the distinction between science and medicine by requiring biosamples to be stripped of patients’ names and other details before they are shared with researchers. “De-identification” policies, incorporated into both HIPAA and the Common Rule, seek to maximize the value of biomedical discovery while minimizing privacy risks for patients whose biosamples are used.
While substantial knowledge has advanced as a result, one consequence of this approach is that patients never find out what becomes of their samples — even if their tissues lead to findings that might be clinically actionable or world-changing discoveries.
What if a new technology eliminated the trade-off between research benefits and patient privacy? Could we establish a new norm — one in which patients both contribute to and benefit from research in real time?
As a Hecht-Levi postdoctoral fellow at the Johns Hopkins Berman Institute of Bioethics, my research centered on de-identification and the potential for blockchain-based innovations to inform new ethical standards. My colleagues and I demonstrated how key principles underlying research and clinical ethics alike — respect for persons, beneficence and justice — are compromised when patients have no means to benefit directly from their contributions.
Considering the health care disparities that continue to plague our nation, de-identification appears even more dubious, as it exploits the clinical byproducts of our most vulnerable patients without any assurances that distribution of research benefits will be timely or equitable. Meanwhile, de-identification frustrates the transparency that is so critical for promoting marginalized communities’ trust and inclusion in research.
After learning that breast cancer researchers far and wide were identifying BRCA mutations in de-identified tissue samples without any way to inform the patient or their physician, we knew closing this lethal information asymmetry was urgent. We also realized that new technology would be required to change the paradigm in a scalable way.
My team and I are now building a decentralized biobank platform that enables patients to track and learn about their research donations. Our app’s “biowallet” leverages blockchain technology’s shared, tamperproof, encrypted ledger to keep patients connected to their biosamples, wherever they go. The system is backed by nonfungible tokens (NFTs), immutably unique digital assets that use cryptography to allow us to prove that a patient is the owner of their samples, while ensuring their identities stay hidden from researchers.
Together, NFTs and blockchain technology offer an innovative solution to reconnect individuals with their contributions to research without compromising privacy or provenance. We are testing this system through a pilot program for patients with breast cancer and researchers at the University of Pittsburgh’s Institute for Precision Medicine in collaboration with faculty members at Johns Hopkins’ Berman Institute, and we plan to add more populations across Pitt and Johns Hopkins in the coming year.
This new approach to NFT-backed biobanking also holds benefits for the research enterprise. Right now, de-identification means that researchers aren’t aware if they are studying samples from the same patient, resulting in many missed opportunities to connect the dots. Our system will allow scientists using the same donor’s samples to track their collaborators and combine forces, in addition to sharing results with and requesting updates from the patient themselves — accelerating translational research and unlocking the future of precision medicine.
Marielle Gross is affiliate professor of bioethics at Johns Hopkins’ Berman Institute and an ob/gyn at the University of Pittsburgh. She created a startup, heny Inc., to extend personalized biobank access to all research participants within and beyond the current pilot population described here. It operates with the support and ethical oversight of Berman Institute Director Jeffrey Kahn.