Melissa Goldstein Addresses Privacy Concerns in Human Research Regulations

As one of the policy experts involved in discussions regarding updates to the U.S. Common Rule for research with human participants during the Obama administration, Melissa Goldstein, JD is familiar with lingering concerns in the research community about the revisions that took effect in January. In a recent article in The Scientist, Goldstein shared her thoughts regarding privacy concerns in biospecimen research.

The goal of the revisions is to ensure that federally funded research conducted with human participants in done ethically while balancing the benefits of the use of human tissue in research.

Goldstein is the author of an analysis of the ethical issues underlying how the revised Common Rule permits researchers to use biological specimens. In The Scientist, she suggests addressing privacy concerns similarly to how governments or corporations that collect vast amounts of personal data do so. She points out that most conduct a risk assessment (some are legally required to do so) in which they estimate the probability of a data breach occurring and set security measures that reflect that risk.

At the heart of the issue is whether or not the source of the tissues used in research is identifiable, which is an issue that experts interviewed for The Scientist article say hasn’t been adequately addressed in the revised rule. As the article points out, we live in an age where technological advances have made it possible to identify the source of tissue through genetic sequencing.

“If you assume that these biospecimens or cell lines are identifiable, then you have to account for that,” Goldstein points out. For example, specimens could be protected through encryption and two-factor authentication in the same way as one would protect other personal data. Further, she argued that risk assessments should be undertaken for all biospecimens and personal data used in research, and not only certain tissue types, which the authors of a recent article suggest.

If regulators don’t address property, dignity, and privacy concerns sufficiently, it may ultimately come at a cost to science, Goldstein said. “I see it as a real risk that if we don’t treat those people right and the information that they give to us, they’re not going to buy into the enterprise,” and be discouraged from contributing tissue. “I think that is the biggest risk to us being able to conduct research in an appropriate manner.”

The entire article in The Scientist is available here.