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 and sometimes even the wellbeing of others. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. For example, when the first U.S. Covid-19 case appeared in Washington in early 2020, a group of researchers had already been collecting nasal swabs for the Seattle Flu Study and possessed thousands of recent samples. The researchers believed that they had an ethical duty to test their samples for the coronavirus and disclose results, and they accordingly proceeded to do so, despite regulatory obstacles and agency disapproval. Many samples tested positive, and the team reported their findings to public health officials and affected research participants. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the “Common Rule,” which requires researchers to inform study participants, at the consent stage, whether individual findings will be returned to them. The Seattle Flu Study’s consent materials naturally did not inform participants that they might receive coronavirus results. Arguably, then, the consent materials did not support the return of those results, and the researchers violated the Common Rule when they disclosed them. 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, and not only in the context of a public-health emergency. The Covid example shows how high and urgent the stakes can be, but should not be seen or treated as an exception to a rule against returning results. The current regulatory scheme stands in the way of ethical disclosures, putting researchers in a perilous position, where they might not be able to fulfill their ethical duties without violating 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 is no 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 argue that policy makers should take advantage of the interest and willingness of bioethicists, biomedical researchers, and others to develop consensus norms, and incorporate these norms into regulations through a process that I call “gentle” incorporation. The upshot is that the regulations would permit researchers to disclose results whenever consensus standards would recommend disclosure. In this way, the law would make space for ethical 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 assuming or hoping that participants will have a chance to consent to the disclosure of results in advance.
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