Anya E.R. Prince,
Disclosing Privacy and Discrimination Protections in Informed Consent,
33 Health Matrix
Available at: https://scholarlycommons.law.case.edu/healthmatrix/vol33/iss1/2
Recent empirical work shows that providing greater detail about limitations of genetic anti-discrimination protections in informed consent documents is likely to lower individuals’ willingness to participate in research studies. This article presents these empirical findings and analyzes the implications of the findings for clinical care and for privacy and discrimination risks beyond genetic discrimination. While the paper argues that further research is needed to fully understand the potential implications of disclosure of legal protections in the clinical setting, there are clear implications in the research setting. Since individuals are likely to alter their decision to participate in research based on the depth of information provided, informed consent should contain detailed information about privacy and discrimination risks. However, for participants to truly understand the risk of loss of privacy and potential for discrimination that flows from information disclosures in research, they arguably must have a robust understanding of both when and how information may be shared, but also the legal protections and limitations that govern use of that data. Now, more than ever, it is essential to understand the privacy risks associated with joining a study since research trends related to big data and secondary research are vastly increasing the privacy risks for participants. Yet, while it is easy to state that individuals should be told of both privacy and anti-discrimination laws and their respective limitations, disclosing these in practice is much more complex. For every law, there are countless limitations that could be enumerated, but such disclosures would quickly make informed consent unwieldy and counterproductive. Thus, this paper argues that institutional review boards (“IRBs”) can help to find a limiting principle to the disclosures by assessing the likelihood of harm and contextualizing the risks to the study population. This will balance between over- and under-disclosure of legal protections and limitations while still fulfilling important foundational goals of informed consent.