I. The Common Rule Revisions

The revised Common Rule adopts the reasonable person standard in two provisions addressing research disclosure. One is the provision setting forth general requirements for informed consent to study participation. To promote self-determination, study teams must give prospective participants or their legal representatives “information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.”⁵

The second provision adopting the reasonable person standard applies to researchers seeking a participant's “broad consent” to future studies involving identifiable personal data or biospecimens. The revised rule requires study teams to give people considering this option “a general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.”⁶

These revisions are not the first research regulations to incorporate the concept of reasonableness in defining when human studies are permissible. The 1991 Common Rule directed study teams to disclose to prospective participants “any reasonably foreseeable risks or discomfort,” as well as “any benefits to the subject that may reasonably be expected.”⁷ That version also required researchers and IRBs to ensure that any risks faced by study participants are “reasonable in relation to anticipated benefits.”⁸ The revised version retains these provisions, which means that experts and lay reviewers will continue to make these judgments. The new Common Rule requirements differ from the earlier ones in explicitly requiring the adequacy of study disclosure to be evaluated from the perspectives of ordinary people rather than those of the scientists, clinicians, and other experts who have the biggest role in designing, conducting, and reviewing human studies.

II. The Reasonable Person in Law

The reasonable person standard emerged early in the development of the common law.^{Reference Stern, Handler, Martin and Williams9} To determine when people should be legally responsible for unintentionally harmful conduct, courts considered whether defendants had behaved according to community standards for safety. It was fair, and realistic, to expect people to act with the same level of care that would be expected of a reasonably prudent community member. Those who failed to conform to the reasonable person standard behaved negligently and could be held liable for the harm they had caused.^{Reference Ben-Shahart and Porat10} Courts relied on fact finders in legal proceedings — typically juries, but sometimes judges — to interpret and apply the reasonable person standard. Because they faced similar situations in their own lives, members of the community could determine whether a defendant's behavior was acceptable or overly risky.^{Reference Rose11}

Medical malpractice cases presented a somewhat different situation. In those cases, it was the negligence of physicians that was in question. Physicians who failed to use reasonable care in conducting surgery, diagnosing illness, prescribing medication, and other parts of their medical practice could be found liable for any resulting harm to patients. Similarly, when physicians failed to use reasonable care in informing patients about risks and other important facts about proposed medical interventions, they could be found negligent for any harm resulting from the failure to secure patients' informed consent to medical care.^{Reference King12}

In ordinary medical malpractice cases, reasonable care was determined by professionals in the relevant medical field. Individual physician conduct was evaluated against the standard of care established by reasonably prudent physicians.^{Reference Berg, Appelbaum, Lidz and Parker13} But the usual reliance on physicians to establish the standard of care created problems in the informed consent context. If physicians ordinarily failed to inform patients of important information about a medical intervention, then individual physicians could not be held accountable for failing to disclose that information.¹⁴

Despite this problem, some jurisdictions adopted what is known as the professional standard to evaluate physician disclosure. In these jurisdictions, liability depends on whether defendant physicians gave patients the treatment information that a reasonable physician would disclose. Expert witnesses testify about the information customarily disclosed by physicians in the relevant medical field. Juries or judges decide whether the standard was met in specific cases.¹⁵

In other jurisdictions, however, legal authorities endorsed patient-centered standards to evaluate medical disclosures. In the ground-breaking case of Canterbury v. Spence,¹⁶ the judge criticized the professional standard as insufficiently protective of patients' decision-making rights. Professionals might not know or appreciate how patients think about medical procedures and their potential consequences. For patients to exercise genuine self-determination, they needed to learn the facts that a reasonable patient in their circumstances would consider relevant to the choice. Juries and judges should determine whether disclosures were sufficient to meet the reasonable patient's information needs.

Professional disclosure standards are established through collaboration among medical experts and professional organizations. It is relatively easy for physicians to find out what colleagues believe should be disclosed about particular medical interventions. The reasonable patient standard is less straightforward and can be more difficult for clinicians to ascertain. Although professional knowledge is certainly relevant to determining what reasonable patients would want to know, lay juries and judges applying the reasonable patient standard have the final say on what should be disclosed.^{Reference Berg17}

The reasonable patient standard presents challenges for physicians, but it is not the most demanding disclosure standard. A few jurisdictions have adopted the subjective standard, which requires physicians to tailor disclosure to the individual patient's personal, perhaps idiosyncratic, values and needs. This standard recognizes that particular patients might have atypical information needs, such as a violinist's need to know about remote risks involving loss of manual dexterity. Although the subjective standard is most respectful of individual autonomy, most courts and legislatures have rejected it because it is too burdensome for physicians. Legal authorities also fear that the subjective standard could create too many opportunities for injured patients to recover in cases where physicians failed to disclose information that most patients would consider irrelevant.^{Reference Berg18}

The revised Common Rule requirements reflect developments in medical disclosure law. But such developments are only a partial guide to applying the reasonable person standard to research disclosure. Although inadequate research disclosure can be the basis of a lawsuit, such cases are rare.^{Reference King19} Unlike the retrospective inquiry that occurs in informed consent lawsuits involving injured plaintiffs, the Common Rule's disclosure provisions operate prospectively, with the aim of ensuring that subjects receive the needed information. The provisions are interpreted and applied by interdisciplinary IRBs, rather than juries and judges. And substantive differences between clinical care and study interventions affect how the reasonable person standard should operate in research. The National Commission's work on disclosure standards specifically addresses disclosure in the research context.

III. The National Commission's Disclosure Deliberations

Decisions about research participation are different from decisions about personal medical care. Medical care is performed solely to benefit patients and delivered by physicians and other health care professionals guided by this objective. In contrast, the objective of human research is to produce knowledge. Sometimes subjects benefit from study participation, but this is uncertain and, in many studies, not even possible. These differences influenced the National Commission's deliberations on the proper disclosure standard for research.

In its influential Belmont Report, the Commission deemed the professional disclosure standard inadequate for research, on the grounds that the exploratory nature of research made it impossible for professionals to know and agree on the information prospective subjects should understand. Somewhat surprisingly, the Commissioners labeled the reasonable patient standard inadequate as well. That standard was insufficiently informative, the Commissioners declared, because “the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care.”²⁰

The Commissioners' preferred alternative was the “reasonable volunteer standard.” Under this standard, “the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge.”²¹ When studies do offer a prospect of direct benefit, “subjects should understand clearly the range of risk and the voluntary nature of participation.”²²

The Commission took this position after considering scholarly papers prepared to assist its deliberations. Analyses by research ethicists Robert Levine and Robert Veatch described court decisions on disclosure in the medical setting. Both writers favored a subject-centered standard over a professional standard for research disclosure. As Veatch put it, “[I]f the objective of the consent is to promote self-determination, then it is the subject population itself which must provide the standard for determining how much information is to be transmitted in order to exercise self-determination.”^{Reference Veatch23}

Veatch also supported a more individualized disclosure standard in certain circumstances. He acknowledged that some people might have individual information needs that differ from those of the general subject population. For those individuals, exercising self-determination requires going beyond the reasonable person standard. Veatch argued that if subjects express an interest in learning “more information than the reasonable citizen, then the patient's or subject's own standard of certainty must apply.”²⁴

Levine and Veatch both assigned to IRBs the responsibility to determine what reasonable persons would want to know about specific studies. But both also thought that laypersons were most qualified to make reasonable person judgments about what should be disclosed. Because IRBs were composed primarily of research professionals, they were ill-suited to making such judgments. Writers aware of this problem had previously proposed employing nonscientist “consent juries”^{Reference Levine25} or subject surrogates^{Reference Fost26} as potential remedies, but these mechanisms would be burdensome and expensive. Veatch offered his own solution — a two-committee system in which a group of professionals would apply their knowledge and values to study evaluations and a separate group of laypersons would evaluate studies based on the knowledge and values of reasonable community members. He contended that this system, or alternatively, a committee system in which professionals served in “a strictly technical advisory capacity,” would be necessary to put the reasonable person standard into research practice.^{Reference Veatch and Veatch27}

The laws governing medical disclosure, as well as the National Commission deliberations on research disclosure, help to explain why officials chose to make the reasonable person standard explicit in the revised Common Rule. But the analyses by Levine and Veatch also highlight IRB limitations in applying the reasonable person standard. Although IRBs attempt to consider disclosure from the reasonable person perspective, a committee dominated by research professionals will have limited success in doing so.

IV. The Reasonable Person in Research Disclosure: The Status Quo

Before it was revised, the Common Rule failed to include an explicit requirement for investigators to disclose study information a reasonable person would want to know. But even without this requirement, IRB members made reasonable person judgments about study disclosure. The literature on research oversight reveals committee efforts to adopt the ordinary layperson's perspective in evaluating the information that is presented to prospective research subjects.

Sociologist Laura Stark offers an enlightening account of this phenomenon. Stark conducted an in-depth study of IRB proceedings, observing and recording multiple IRB meetings at three different locations. In reporting her findings, she described how IRB members tried to “see like a subject” in their study evaluations. People made “claims to knowledge about participants by thinking of their friends, family members, students, neighbors, colleagues, and acquaintances.”^{Reference Stark28} Committee members — researchers and nonscientists alike — referred to “their own life experiences” in explaining how potential subjects could interpret study information.²⁹ Although this approach helped committees perform their study reviews, it had a negative impact, as well. As Stark points out, the “people whom board members called to mind when they imagined a research subject — a relative or a student, for example — reinforced the race, class, and gender biases of the board membership.”^{Reference Odwazny and Berkman30}

Stark's observations supplement those of IRB members. Many people serving on these committees, particularly the nonscientist and community members, see themselves as standing in and speaking for prospective research subjects.^{Reference Lidz31} But their judgments rest on speculation about subjects' perceptions. For example, in one set of interviews, most IRB members reported that they “had little knowledge of the values, expectations, and needs of those whom they are charged to protect.”^{Reference Cook, Hoas and Joyner32} Committee members, including nonscientists and laypersons, tend to be relatively well educated, financially secure, and knowledgeable about the research process. Many haven't personally experienced serious illness and thus are unfamiliar with the psychological effects that this can have on a person's decision making. These and other factors account for differences in the perspectives of prospective subjects and IRB members.

Some IRB members have participated in studies themselves, and others have close relatives with direct experience as subjects.^{Reference Dresser33} Yet these personal experiences don't necessarily qualify them to speak for the populations that will be recruited for specific studies. Moreover, the literature suggests that only a minority of IRB members have real-life experience with study participation.^{Reference Anderson34} As a result, professionals and other IRB members may be unaware of or downplay information that members of a study population would want to know.

Existing efforts to apply the reasonable person standard in research review fall short of what is needed to promote the self-determination principle underlying the informed consent requirement. Review board members look to people in their own lives as exemplars of the reasonable person, which can lead to circumscribed and biased conceptions of subjects' informational interests. Board members' judgments also lack a solid evidentiary foundation.^{Reference Furlow35}

In the current oversight system, IRBs members decide what they think prospective subjects should want to know, rather than determine what subjects actually want to know. And because most IRB members are researchers, clinicians, academics, and other experts, their reasonable person judgments don't necessarily reflect those of laypersons recruited to participate in research. The Common Rule's revised disclosure provisions call for improvements in researcher and IRB approaches to determining what prospective subjects should know about studies they are invited to join.

V. Improving Reasonable Person Judgments in Research Disclosure

As I reported earlier, people involved in research oversight are both uncertain about how to apply the reasonable person standard and skeptical of its value. But not everyone shares these negative views. One IRB administrator hopes the revised Common Rule's disclosure standard will serve as “a launching point for exploring what real people need and expect when making decisions about participation in research.”^{Reference Gearhart, Greenblum and Hubbard36} In the spirit of encouraging such exploration, I propose ways for researchers, IRBs, and oversight officials to develop a better sense of what reasonable people want and need to know about research.