Precision Medicine Research: An Exception or An Exemplar?

Abstract

The Journal of Law, Medicine & Ethics, 47 (2019): 149-151. © 2019 The Author(s) DOI: 10.1177/1073110519840494 Precision medicine is “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”1 There is growing interest in precision medicine research as an alternative to traditional research because it holds the potential to identify interventions tailored to the needs of particular patients rather than to the needs of the average patient. Precision medicine has been described as “a paradigm shift”2 and “a new era of medicine.”3 This perception of novelty has, in turn, led some to call for new approaches to precision medicine research oversight to ensure that participants are protected and that scientific progress is not impeded.4 Such calls demand our attention because legal, regulatory, ethical, and even technical challenges could erect barriers to major precision-medicine initiatives like the All of Us Research Program and hamper medical advancement. Hammack and colleagues make a welcomed contribution to the field by studying the risks to and protections for precision medicine research participants from the perspective of precision medicine thoughtleaders.5 They focus on the subset of risks and protections related to participant privacy and confidentiality. These are important findings, as privacy and confidentiality have been identified as essential to the sucess of precision medicine research. These findings suggest that precision medicine research is not exceptional so much as it is an exemplar of the inadequacy of protections for participant privacy and confidentiality more generally. Consider the following examples: First, identifiability of data is not solely a concern in precision medicine research. It has, for example, been demonstrated that the proliferation of publicly available databases — in combination with increasingly powerful computing technology — makes it possible to re-identify “anonymized” data (e.g., by combining two or more datasets to find the same user in both). Questions about identifiability also arise in biospecimens research. In these other contexts, as with precision medicine research, the fundamental concern is not just identification per se but subsequent harms that may arise as a result. This leads to a second, closely-related point. Genes are not the only research data to give rise to concerns about potential misuse, particularly discrimination. For example, researchers are presently moving toward a biomarker-based understanding of Alzheimer’s disease. As recently pointed out by Arias et al. in this journal, current laws — including the Genetic Information Nondiscrimination Act — do not provide meaningful protections from discrimination based on Alzheimer’s disease biomarkers.6 Further, it merits noting that research data do not have to be novel to be highly sensitive. Think of pregnancy status and the persistence of pregnancy-based discrimination.7 Third, questions about the value of institutional review board (IRB) oversight are not limited to precision medicine research. There is a substantial body of literature documenting IRB inefficiency and inconsistency, which leads to fundamental questions about whether IRBs are effective in achieving their goals of advancing ethical research and protecting research participants.8 commentary Precision Medicine Research: An Exception or An Exemplar?