Growing Concerns About Health Data Use
Researchers are increasingly concerned about the possibility that study participants’ data could be used in ways never intended when it was originally collected. The general public, too, is becoming more aware of this possibility. “It’s increasingly becoming more of a vocal topic amongst patients and advocates. There is a light being shined on these issues,” says Sally Okun, RN, executive director of the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke University and the FDA.
People are more aware of the potential for the use of artificial intelligence and large language models to manipulate their data in ways they did not expect to happen when they contributed their data for research. “Technological capabilities have gotten increasingly more sophisticated,” Okun says.
A study participant might have been assured, correctly, their data was de-identified. However, it is possible individuals within large data sets could be re-identified by third parties using advanced technological methodologies.
In light of growing concerns about these possibilities, leadership at PatientsLikeMe, a web-based patient research community, collaborated with patient members to create a declaration of commitments for ethically responsible behaviors.1
“As we moved into collecting not only their data but also their biospecimens as part of our research, we recognized just how incredibly vulnerable people’s data would be when all of those linkages could be made,” says Okun, lead author of the publication.
In addition to focus groups that included patient community members, PatientsLikeMe surveyed 718 patients. Based on this input, the group outlined ethical, legal, and societal standards for data collection, use, and reuse to which researchers, technology companies, and others can be held accountable. The statement assures people the stewardship of their data is taken seriously, and that the company is committed to using it ethically.
“It requires a moral compass. We can’t simply take these data and use [them] without recognizing the implications that are out there for inappropriate use at some point,” Okun says.
IRBs need sufficient expertise to evaluate researchers’ ability to protect participants’ data. “You may have some IRBs with members who are just not in a place to really understand some of these digitally focused emerging protocols,” Okun offers. “IRBs are starting to recognize that they need additional insight.” For example, some study protocols might include using novel technologies to collect study data via remote monitoring devices.
For researchers, there is a need to acknowledge and accept the risks and unknowns, and then communicate those honestly to study participants. “It’s a fallacy to promote the idea that we can fully protect people’s data completely,” Okun says.
At the Emory Winship Cancer Institute in Atlanta, investigators share participants’ anonymized data with other researchers. However, identifiable data are not shared unless participants give consent for researchers to do so.
“The one caveat is that genomic data must be put in a national database,” says Rebecca D. Pentz, PhD, professor of hematology and oncology in research ethics at the Emory University School of Medicine.
Although the data are anonymized, there is a small risk of identifying the person just from their genetic data. “For research staff, the ethical obligation is to specify that the research data could be shared, but it will be de-identified. Or, the co-collaborators with whom it will be shared are identified,” Pentz says.
1. Okun S, Hanger M, Browne-James L, et al. Commitments for ethically responsible sourcing, use, and reuse of patient data in the digital age: Cocreation process. J Med Internet Res 2023;25:e41095.
A group recently outlined ethical, legal, and societal standards for data collection, use, and reuse to which researchers, technology companies, and others can be held accountable. The statement assures people the stewardship of their data is taken seriously, and that the company is committed to using it ethically.
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