What Big Data Means for Human Subjects in Federal Research

New data analysis technology could help federally-funded researchers crunch more information, leading to scientific breakthroughs. But it could also potentially expose their human test subjects' personal information, a new proposal suggests.  

Several federal groups -- including the departments of Homeland Security, Energy, Agriculture, Health and Human Services and Education -- are proposing that regulations surrounding human test subjects be revised to reflect new research methods. For instance, where appropriate, researchers should be required to hand out consent forms to potential subjects, informing them that their leftover biological samples and data culled from them could be used in future projects.

While many federal and federally funded studies don't require investigators to interact with research subjects directly, they may use powerful computers to churn through information from medical, education, administrative claims and criminal justice records, among other sources. When combined, information that was "treated as nonidentified can now be re-identified," the proposal claimed. 

The risks for human subjects involved in such studies are "largely informational, not physical," the proposal stated, resulting "primarily from the inappropriate release of information. . . Nonetheless, those harms can be significant."

Two years ago, scientists demonstrated they could determine the identity of individual research subjects based on several types of genomic data, including some information that was publicly available. Even if biospecimens are stripped of personal information, "the possibility of fully identifying biospecimens . . . has grown," the agencies claimed.

In an effort to update the consent process, the agencies have proposed several adjustments to the "Common Rule," a more than decades-old process that oversees federal research on human subjects. 

For instance, test subjects would be allowed to sign one-time, broad consent forms giving researchers permission to use a blood sample, for example, for "future unspecified research uses," the new rules suggest.

The group also proposes developing a Web-based tool that researchers can use to automatically determine which consent processes they need to follow. 

Relatively recent developments in scientific research -- including the use of analytics services on human specimens and the increasing use of large volumes of electronic health data -- have changed patients' expectation of privacy, the proposal said. 

"Yet, these developments have not been accompanied by major change in the human subjects research oversight system, which has remained largely unchanged over the last two decades," the new proposal stated. "The sheer volume of data that can be generated in research, the ease with which it can be shared, and the ways in which it can be used to identify individuals were simply not possible, or even imaginable, when the Common Rule was first adopted."

Despite the risks, more people want to participate in research, the proposal claimed. This "participatory model" has evolved alongside the "widespread use of social media, in which Americans are increasingly sharing identifiable personal information and expect to be involved in decisions about how to further share the personal information, including health-related information that they have voluntarily chosen to provide."

(Image via Maksim Kabakou/Shutterstock.com)