Nina Varsava, Non-Consensual Disclosures, 47 BYU L. Rev. 219 (2021)
Abstract
In the course of biomedical research on humans—for example, flu, imaging, and genomic studies—researchers often uncover information about participants that is important to their health and wellbeing. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the “Common Rule.” I argue that human subjects researchers will often have strong ethical reason to disclose results even when participants did not consent to the disclosure in advance. I also show how the current regulatory scheme stands in the way of ethical disclosures, putting researchers in a difficult position where they might not be able to fulfill their ethical duties without transgressing legal ones. Although we need to contend with autonomy and welfare risks associated with returning results, not to mention financial and administrative costs, these downsides are similarly present in analogous scenarios where non-consensual warnings are legally permitted and sometimes even required. There does not appear to be any good reason to make a policy exception for biomedical researchers when it comes to issuing warnings in the form of information disclosure. To aid difficult determinations about which results warrant return, I suggest that policymakers should take advantage of the interest and willingness of the bioethics community to develop consensus norms and incorporate these norms into regulations such that the regulations would at least permit researchers to disclose results whenever consensus standards would recommend disclosure. In this way, the law would make space for ethically optimal conduct without necessarily compelling it. At the same time, bioethicists and researchers should train their attention on non-ideal consent settings—the focus of this Article—rather than continuing to assume or hope that participants will have a chance to consent to the disclosure of results in advance.
