Why Data Silos Need Uniform Disclosure Regulations

Biospecimens and health data typically enter the research realm through 1 of 3 types of people: consumers, patients, and research participants. But once their information is swept up, it could land in unexpected places.

“Data are going from private industry to academia, and then data and samples are going from academia back to private industry,” Kayte Spector-Bagdady, JD, MBioethics, said last week at a US Department of Health and Human Services symposium on privacy in the digital age.

The University of Michigan Medical School researcher and ethicist said the arrangement calls for consistent informed consent and disclosure regulations, which currently vary depending on which path the data take. Time and again, research has suggested that donors are interested in who might benefit from their medical information and how they might profit, Spector-Bagdady said. A uniform set of disclosure standards across the direct-to-consumer, clinical, and research fields could better educate data and biospecimen contributors.

On the consumer-facing end, the genetic testing company 23andMe discloses how its customers’ data might be used through contracts. But sometimes that method can go awry, Spector-Bagdady said. She pointed to a recent NFL game during which a firm promised to examine spectators’ genetic information. In the dozen-or-so single-spaced pages, consumers who bothered to read the terms and conditions would have found that their data were destined for research, Spector-Bagdady said.

Patients, on the other hand, lose ownership of their de-identified biospecimens, she noted. As long as people have no “direct privacy interest” in them, the materials belong to the institution. And that’s true even if researchers plan to perform genomic sequencing, since that’s not recognized by the Health Insurance Portability and Accountability Act, Spector-Bagdady said.

Research participants may directly engage with investigators, or through their identifiable data or biospecimens. Proposed regulations that could soon take effect would require those individuals to be notified that their data and samples could be de-identified and use in future research, Spector-Bagdady said.

What contributors care most about, she went on, is use. They want to know if investigators are going to de-identify the data, who’s going to use it, and for what purpose.

Access to de-identified medical information made 9% of respondents uncomfortable if it were going to be used by a university, 16% for drug companies, and 48% for insurance companies, according to 1 recent study. Meanwhile, 68% of another report’s base agreed to blanket consent, but 70.4% became unwilling when presented with a specific controversial research scenario.

Most people don’t believe they have an ethical obligation to participate in health research, Spector-Bagdady noted, citing another study. Roughly 67% of people believe it’s important for institutions to tell contributors whether their biospecimens will be commercialized, and 77% felt uncomfortable with hospitals using “leftover biological specimens to generate income,” according to her presentation.

By telling patients the smallest legally required amount of information regarding their data and its profit potential, researchers might discourage them from signing on, Spector-Bagdady said. Why? Because when, say, a biobank uses money earned through donor data to sustain its operations, contributors approve of the expenditure, she said. They like altruism, whether that be funding a nonprofit’s daily work or reinvesting in research.

“These are things that very well may be worth disclosing,” she said.

In the end, Spector-Bagdady went on, contributor comprehension is most important. That principle must be maintained across all 3 silos, she said.

To accomplish that, healthcare research might need to return to the drawing board: What do people care about? How do investigators, providers, and for-profit companies help them best understand what's at stake? And if corporations aren’t legally required to disclose information that might affect someone’s decision, what can providers do?

Many of these questions are empirical, Spector-Bagdady said, which means that their answers can be found and built into regulations.