Tissue donors can keep track of what scientists do with their samples while maintaining privacy, through a pilot program launched in October by researchers at the Johns Hopkins Berman Institute for Bioethics and the University of Pittsburgh’s Precision Medicine Institute. The program uses blockchain technology to offer patients this opportunity through the University of Pittsburgh’s Breast Disease Research Repository, while ensuring that their identities remain anonymous to researchers.
A blockchain is a tamper-proof digital ledger of transactions that are replicated and distributed over a computer system network. When a transaction occurs with a patient sample, multiple stakeholders can track it while the identity of the owner remains encrypted. The private certificates, called “non-fungible tokens,” or NFTs, represent unique patient samples on a trusted and widely used blockchain that promotes transparency.
Blockchain can be used to notify people if cancer researchers discover that they have certain risk factors.
said Julius Bogdan, vice president of analytics for North America at the Healthcare Information and Management Systems Society (HIMSS), a global technology nonprofit based in Chicago. “NFTs allow patient data to be encapsulated into a patient-controlled digital asset.” He added that this technology allows for a safer and more informed way to participate in clinical and research trials.
Without this technology, de-identifying patient samples during biomedical research has the unintended consequence of preventing them from discovering what the researchers find — even if that data might be beneficial to their health. A solution is desperately needed, said Marielle Gross, associate professor of obstetrics, gynecology, reproductive sciences and bioethics at the University of Pittsburgh School of Medicine.
said Gross, who is also an affiliate assistant professor at the Berman Institute. “There is no good reason for it to stay the way it is.”
For example, blockchain can be used to notify people if cancer researchers have discovered that they have certain risk factors. Gross estimated that less than half of breast cancer patients are tested for mutations in the BRCA1 and BRCA2 genes — tumor suppressor genes important in fighting cancer. With normal function, these genes help prevent breast cells, ovaries, and other cells from multiplying in an out-of-control fashion. If researchers find mutations, she said, they are relevant to the patient’s and family’s follow-up care — a prime example of how this newly designed app could play a life-saving role.
Liz Burton was one of the first patients at the University of Pittsburgh to opt for the app — called de-bi, short for Decentralized Biobank — before undergoing a mastectomy for early-stage breast cancer in November, after it was diagnosed on a routine mammogram. She is often involved in medical research and looks forward to tracing her own tissues.
“Anytime there’s a scientific experiment or study, I’ll get involved quickly—to enhance my overall wellness and knowledge,” said Burton, 49, a life insurance service representative who lives in Carnegie, Pennsylvania. “This is a great way to contribute.”
Liz Burton was one of the first patients at the University of Pittsburgh to choose the app before undergoing a mastectomy for early-stage breast cancer.
The pilot program raises the question of what the researchers might owe the study participants, especially since some populations, such as blacks and Indigenous peoples, have not historically been treated in an ethical manner for scientific purposes. “It’s a really commendable effort,” Tamar Schiff, a postdoctoral fellow in medical ethics at New York University Grossman School of Medicine, said of the endeavor. “The research participants are beautifully influencing.”
Lauren Sancari, a bioethicist and associate director of the Neuroethics Program at Cleveland Clinic, agrees that the pilot program provides increased transparency for study participants regarding how scientists use their tissues while acknowledging the contributions of individuals to the research.
However, she added, “It may require researchers to develop a process for continuous communication so that it responds to additional input from research participants.”
Schwartz, professor of medicine and director of the Center for Bioethics at Indiana University in Indianapolis, said the program is promising, but he wonders what would happen if a patient had concerns about a particular research project involving their own tissue.
“I can imagine a situation where a patient would object to their sample being used for some illness they’ve never heard of, or that carry some kind of stigma like mental illness,” Schwartz said, noting that researchers have to assess how they react. “There is no simple answer to these questions, but the technology must be evaluated taking into account the problems it can raise.”
To make a real difference, blockchain must enable broad patient consent, not just de-identification.
As a result, Schiff said, researchers may need to consider how much information to share with patients and how to explain it. There are also concerns that when their samples are tracked, patients could tell others what they’ve learned before researchers are willing to release that information publicly. However, Bogdan, vice president of the nonprofit organization HIMSS, believes only a minimal amount of the study ID will be stored in the NFT, not patient data, research results, or any kind of private trial information.
Some patients may be confused by the blockchain and are reluctant to adopt it. “The complexity of NFTs may prevent ordinary citizens from taking advantage of their potential or sellers wanting to participate in the blockchain network,” Bogdan said. “Blockchain technology is also expensive in terms of computational power and energy consumption, which contributes to greenhouse gas emissions and climate change.”
In addition, this emerging and pioneering technology is immature and vulnerable to data security flaws, disputes over intellectual property rights, and privacy issues, although it offers basic protections to maintain confidentiality. To make a real difference, said Robyn Shapiro, a bioethicist and founding attorney at Health Sciences Law Group near Milwaukee, blockchain must enable broad patient consent, not just the removal of identity.
Shapiro noted that the story of Henrietta Lacks is a prime example. While being treated for cervical cancer at Johns Hopkins, Lacks tissue was derecognized (though not entirely, since her cell line, Hela, bears her initials). After her death, these cells were replicated and distributed for important and lucrative research and product development purposes without her knowledge or consent.
Still, Shapiro believes the University of Pittsburgh-Johns Hopkins initiative has the potential to solve some of the ethical challenges involved in the research use of biosamples. “Compared to a system that allowed Lacks cells to be used without their permission,” Shapiro said, “a blockchain technology that uses non-fungible tokens that allows patients to keep track of their samples may promote transparency, accountability, and respect for the people who contribute their tissues and clinical data to research.”