Session A Moderator David H. Strauss, M.D.Austen Riggs CenterRead Bio The Ethical Foundations of the Disclosure Requirement Danielle Bromwich, Ph.D.University of Massachusetts Read Bio Joseph Millum, Ph.D., M.S.National Institutes of Health Clinical Center Read Bio Informed consent is an ethical requirement for most medical research involving human participants. The consent process typically involves providing potential participants or their surrogates with information about the study—including its purpose, procedures, and possible risks and benefits—as well as documenting their agreement through a signed consent form. Studies of participants enrolled in medical research, however, show highly variable and frequently poor understanding of key informed consent elements. These studies raise ethical concerns, suggesting not only that many participants were unaware of what they consented to, but that some may not have given valid consent at all. This concern prompts the question: what should participants be told, and what do they need to understand, from an ethical standpoint? In this presentation, Drs. Bromwich and Millum classify two distinct consent process goals that are facilitated by disclosing information to potential participants; for each goal, they identify ways in which disclosing information about a study can go awry. The first goal involves obtaining valid consent to the procedures that a study includes, an ethical requirement potentially violated when a person disclosing information to potential participants exercises illegitimate control over participants’ decision-making. To avoid this, researchers should disclose relevant decision information that participants would expect to be told, in a manner that gives participants a reasonable opportunity to understand. The second goal involves facilitating good decision-making by potential participants. This goal is ethically preferable, though not required; while facilitating good decision-making is a laudable goal of the informed consent process, it can’t be a requirement, competent adults maintain their right to make life decisions, however well or poorly they choose to do so. Although the studies that show poor understanding by research participants are troubling, they do not necessarily show that participants failed to give valid consent. Finally, Drs. Bromwich and Millum close by considering how researchers should prioritize the two goals for different types of research. The Reasonable Person Standard and Research Disclosure Rebecca Dresser, J.D.Washington University in St. LouisRead Bio Legal authorities adopted the “reasonable person” standard to evaluate the acceptability of individual conduct. The standard instructs those applying it to consider both societal safety and realistic expectations of human actors to determine whether defendants are negligent. In the legal system, the reasonable person standard is traditionally applied by a jury of the defendant’s peers. During the 1970s, however, judges began using this standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed procedural consent. Judges declared that the traditional standard for disclosure —what a reasonable medical professional would disclose— was insufficient with respect to a patient’s right to decide. Instead, they stated, professionals should disclose what reasonable patients would need and want to know about their options. The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Others are more positive and suggest that the rule revision could promote a more ethically defensible and effective study disclosure process. In this presentation, Ms. Dresser argues that the revised rule is not as radical as it might seem. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. Past application of the standard, however, has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this learning effort. Although the oversight system cannot turn to juries for guidance, experienced participants are peers of prospective subjects, with valuable knowledge of what ordinary people should understand before volunteering for research. Empirical Standards for Informed Consent Baruch Fischhoff, Ph.D. Carnegie Mellon UniversityRead Bio Researchers, ethicists, clinicians, and officials have made great progress in understanding the cognitive, affective, and social issues involved in achieving informed consent for medical treatment, in both clinical trials and normal practice. This talk by Dr. Fischhoff offers a behavioral decision research approach to determining whether the resulting procedures are adequate, in terms of whether: 1) procedures contain the information that patients—or potential trial participants—need, 2) said information exists in places that patients and participants can readily access, and (3) information resides in forms that they can understand. This talk will propose practical ways to translate these goals into a materiality standard for content, a proximity standard for accessibility, and a comprehensibility standard for understanding. Dr. Fischhoff will suggest infrastructure that HHS might create to facilitate applying these standards, one of which involves building on FDA’s Benefit-Risk Framework for identifying the key benefits, risks, uncertainties, and supplementary protections associated with medical treatments. This cognitively-oriented proposal is meant to complement the social and institutional supports that individuals require to achieve mastery of their medical decisions.