Public More Protective Of Their Health Information Than Their Biospecimens
By Deborah Borfitz
September 14, 2022 | In the ongoing debate about whether biospecimens should be covered by human subjects research regulations, bioethicists at the University of Michigan recently added a critical datapoint in disproving one of the arguments—namely, that the public feels more protective of their biospecimens than their health information. In fact, the opposite is true, according to Kayte Spector-Bagdady, J.D., associate director of the Center for Bioethics & Social Sciences in Medicine at Michigan Medicine.
Writing in a research letter published in JAMA (DOI: 10.1001/jama.2022.9740), she and her colleagues report that a proportionately greater number of people are interested in notification if their health information will be used than if their biospecimen will be, and this is particularly true if the information is identifiable or to be shared with a commercial entity rather than a university. A minority (about 40%) are interested in notification for university use of deidentified health information or specimens.
Unbeknownst to most Americans, federal protections on clinical information do not generally extend to either health records or biospecimens that are deidentified, says Spector-Bagdady. “However, in 2015, in the wake of public response to the book, “The Immortal Life of Henrietta Lacks” (Nature, DOI: 10.1038/nature.2013.12689), the federal agencies that oversee human subjects research regulations proposed considering all human biospecimens to be readily identifiable.”
That then means that biospecimens would be subject to the same regulation as identifiable health information and, consequently, standards such as institutional review board (IRB) approval or waiver of the associated study protocol and informed consent from the individuals from whom those specimens were derived, Spector-Bagdady continues. “It also, by default, ended up treating specimens as something more deserving of protection than health information because the [proposed] change only applied to biospecimens.”
This “biospecimen exceptionalism” makes little sense since a test must be run on a vial a blood to generate health information, such as an individual’s HIV status or genetic makeup, she says. It otherwise “doesn’t tell you anything.”
The underlying claim is that the public feels more protective of their biospecimens than their health information and, until the JAMA study published, those who refuted it had no citation to bolster their case, says Spector-Bagdady. Now they do.
Scientists, researchers, research institutions, and some advocacy groups point to some concerning ramifications of the proposed regulatory change, she says. When people go to the emergency room with heart attack symptoms, for instance, someone would need to get their informed consent for future use of their blood specimen.
That is not only expensive because of the added paperwork and staffing, but also distracting to people arriving for clinical care who should be focused on the risks and benefits of the procedure that they are about to undergo, continues Spector-Bagdady. Moreover, it would limit the number of specimens available for research since some people will be unconscious or otherwise unable or unwilling to consent.
As Spector-Bagdady and her colleagues know from their and others’ previous research, people self-identifying from different demographic communities might consent to research use of their specimens in different ways. As they reported last December in Health Affairs (DOI: 10.1377/hlthaff.2021.01197), Black or African American, Asian, and Hispanic patients were almost twice as likely as White patients to decline enrollment in a University of Michigan databank. She also noted that Black or African American patients were less likely to be considered eligible to recruit for the biobank in comparison to White patients.
While it is no doubt true that some people feel more protective of their biospecimens than their health information for reasons that include the “racism structurally involved in our health system research,” she says, they found in their research that it was not true of the majority of people. “If we are going to
compromise on all these other things [via a regulatory change], we better be darn sure that we are achieving the goal of what patients prefer.”
Currently, human subjects research regulations require that informed consent be obtained when investigators are conducting an interventional clinical trial or any study using identified health information or biospecimens, Spector-Bagdady says. In the latter case, however, IRBs might waive the requirement for research that is low risk or would otherwise be impossible to do because the data is so old, or it would be hard to recontact individuals to obtain consent.
Researchers should be aware that many surveys as well as confirmatory interviews and focus groups have found that people generally expect to be asked for research use of their data and biospecimens, she adds. But many bioethicists, herself included, also believe that when the risk to the individual is extremely low and the community benefit is great “it really shouldn’t be a democracy... [and that] people have a moral obligation to participate as part of the living, learning health system where we continue to provide care and better that care for patients in the future.”
The latest study was conducted on a 2,000-person cohort who responded to a nationwide survey run telephonically and online by the National Opinion Research Center out of the University of Chicago, which has a standing panel of prospective participants who are generally representative of the U.S. population, Spector-Bagdady says. Respondents were almost evenly split between males and females and about 64% non-Hispanic White, with study results weighted to be generalizable.
Respondents all went through a brief educational exercise before answering the survey about situations where they might want to be notified, including a video about a fictitious patient and rules governing access to her data and samples. A four-point scale measured their agreement with the statement that they would want to be notified in eight different scenarios for the use of their own health information or biospecimens.
Spector-Bagdady says she caught the “data bug” after serving as associate director of Obama’s Presidential Commission for the Study of Bioethical Issues, established in parallel with the All of Us databank achieving unprecedented participation by historically excluded communities to ensure research is broadly applicable to many different types of people and situations. “I found it so fascinating and so important that I have been doing it ever since.”
Interest in her work has grown because of public outcry over several “commercialization scandals,” Spector-Bagdady says, including Project Nightingale involving the transfer of healthcare data from healthcare systems (including Ascension, the Mayo Clinic, and the University of Chicago Medical Center) to Google to create artificial intelligence and machine learning algorithms to improve care for future patients. One individual sued over allegations that confidential protected health information was shared with Google without being first being properly deidentified.
That case was ultimately dismissed, but it highlights a prevailing theme in the media of late—namely, hospitals selling or sharing patient data and specimens with commercial companies, she says. Her research has repeatedly found that people are likewise uniformly uncomfortable with university clinical researchers selling their information to companies for profit.
The backlash has given rise to several cryptocurrency-backed companies, including Nebula Genomics and Rejuve, attempting to give people greater ownership and control over their data and specimens. “One of the challenges of this model is that almost no one is Henrietta Lacks, so the value of any one person’s specimen or data is likely to be extraordinarily low... and much of this big-data research needs hundreds of thousands of participants,” says Spector-Bagdady.
At the same time, much more real-world data is being collected and shared by people in their everyday life that comes with its own potentially concerning privacy risks, she adds. Individuals may want to track their steps using an app with a geolocator that could also have the unintended effect of capturing “health proxy information” such as tracking them visiting an abortion clinic or psychiatric facility or stopping at a bar every day after work.
The upside is that health proxy data, such as from a Fitbit, can also be used for legitimate medical care as well as beneficial clinical research purposes, Spector-Bagdady says. These include being able to recognize heart attacks or other diseases and disorders early based on patterns picked up across thousands of wearable-equipped participants.