On today’s episode of More than Meets the IRB, we talk with PRIM&R Executive Director Elisa Hurley about the controversial elements of the NPRM and those which ultimately made it into the final rule. This episode considers challenging questions about the future of research: what might change in how we build policy within the United States? Dr. Elisa Hurley is the Executive Director of Public Responsibility in Medicine and Research. Dr. Hurley holds a PhD in philosophy from Georgetown University and held a Greenwall fellowship in bioethics and health policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute of Ethics. How Appropriate is the Consent Process? Recent advances in science and research methods have demanded a renewed engagement in the principles that guide ethical research, which Dr. Hurley cites as an occasion to “rethink how we operationalize this basic principle of respect for persons.” This is also an opportunity to engage with the degree to which IRB work is, or can be considered, a “conversation.” One challenge brought on by these advances is the distance—sometimes literal, in the case of remote review boards—they put between the reviewer and the research. One of the advantages of IRBs has always been their ability to locate research within the context of the community in which it takes place to evaluate important ethical questions; this is less the case in the era of big data and biobanking. As Dr. Hurley says, “there aren’t algorithms to answer these questions about ‘is this an ethical study or not,’ or is ‘this a just way of finding your subjects or not.’ The idea was a group of people, who come with different backgrounds and expectations, are going to have a conversation and arrive at judgment.” What is the future of research education? What should it be? The focus then turns to how the public is educated about research and how that needs to change. Identified in particular is the problem wherein many people’s first interaction with research is when they are given a “25-page informed consent document,” which represents an effort to “educate [the subject] and get [him/her] on board all at once.” This is an inadequate model of education, according to Dr. Hurley, and exacerbates already difficult questions of respect for persons. What is needed, according to Dr. Hurley, is a more systematic and widespread commitment to education about research, implemented nationwide, to bring future potential participants and partners in the research endeavor to a level of understanding that enables them to be able to make educated and appropriate decisions about participation in research well before the official informed consent process begins.