A Faustian Bargain That Undermines Research Participants' Privacy Rights and Return of Results

Abstract

A 2018 committee report published by the highly respected National Academies of Science, Engineering, and Medicine issued recommendations that would strip research participants of crucial data privacy rights and discard decades of carefully deliberated consensus guidelines for the ethical return of results and data from research. This article traces these disturbing recommendations to three root causes: (1) a statement of task that blocked careful and impartial analysis of a disputed legal matter central to the report, (2) a piecemeal legal analysis that omitted relevant strands of law, and (3) the inappropriate conflation of two distinct concepts — the return of individual research results (the stated subject of the report) and privacy-enabling individual access rights, which have a nearly fifty-year legal history long predating the modern debate about return of results. The report’s recommendations would erect new barriers to the return of results and, simultaneously, dial back a core data privacy right that Americans — including many research participants — currently enjoy. We urge extreme caution in implementing this report’s flawed recommendations. Congress has elevated the right to see one’s personal information to the status of a civil right in many different data environments. Diminishing individual access in the research context erodes its status as a right more broadly.

Keywords: Data Privacy, Return of Results, Genomics, Biomedical Research, Civil RIghts, HIPAA, GINA, CLIA laboratory regulations

JEL Classification: K32, K23, K19