Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

The use of deception for the purposes of research is a widespread practice within many areas of study. If we want to avoid either absolute acceptance or absolute rejection of this practice then we require some method of distinguishing between those uses of deception which are morally acceptable and those which are not. In this article I discuss the concept of counterfactual consent, and propose a related distinction between counterfactual-defeating deception and counterfactual-compatible deception. The aim is to show that this (...) proposed distinction will be useful in furthering the debate regarding the use of deception for the purposes of research. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

I want to argue for two propositions. First, I suggest that what some researchers may take to be a simple trade-off between minor violations of the truth for the sake of access to far greater truths represents a profound miscalculation with far-reaching and cumulative reverberations. Second, I submit that today's research environment, as demanding, competitive, and sometimes bewildering as it is, offers genuine scope for what Murdoch calls truth-seeking, for imagining and questioning, and for relating to facts through both truth (...) and truthfulness; but that, in so doing, it presents hard choices with respect to methods, and, in turn, to personal integrity—not only in particular research projects but also with respect to that fragile research environment in its own right. (shrink)

To learn whether criticism and regulation of research practices have been followed by a reduction of deception or use of more acceptable approaches to deception, the contents of all 1969, 1978, 1986, and 1992 issues of the Journal of Personality and Social Psychology were examined. Deception research was coded according to type of (non)informing (e.g., false informing, consent to deception, no informing), possible harmfulness of deception employed (e.g., powerfulness of induction, morality of the behavior induced, privacy of behavior), method of (...) deception (e.g., bogus device or role, false purpose of study, false feedback), and debriefing employed. Use of confederates has been partly replaced by uses of computers. "Consent" with false informing declined after 1969, then rose in 1992. Changes in the topics studied (e.g., attribution, socialization, personality) largely accounted for the decline in deception in 1978 and 1986. More attention needs to be given to ways of respecting subjects' autonomy, to appropriate debriefing and desensitizing, and to selecting the most valid and least objectionable deception methods. (shrink)

Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these (...) kinds of ethical issues that can arise in research on public health interventions. (shrink)

Some maintain that voluntariness is a value-neutral concept. On that view, someone acts involuntarily if subject to a controlling influence or has no acceptable alternatives. I argue that a value-neutral conception of voluntariness cannot explain when and why consent is invalid and that we need a moralized account of voluntariness. On that view, most concerns about the voluntariness of consent to participate in research are not well founded.

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they (...) believed it had a higher price. (shrink)

Research examining the possible effects of deceptive research participation on participants' perceptions of psychology has yielded equivocal results. The present study's goal was to clarify the possible effects of participation in mildly deceptive research on participants' impressions of scientific and applied psychology. Participants (N = 112) were randomly assigned to one of six experimental conditions: active groups receiving negative, positive, or no feedback, or passive groups receiving negative, positive, or no feedback. Following participation, participants completed measures of impressions of psychotherapy (...) and psychotherapists, researchers, and instructors. The manipulation did not affect attitudes toward psychology on any of the dependent measures, although gender effects resulted on one measure. Participants in general reported very positive attitudes toward the science and practice of psychology. Recommendations are offered for future research on the effects of more extensive deceptions. (shrink)

The use of deception in research is generally permitted so long as participants are debriefed at the conclusion of their participation. Several authoritative research ethics guidelines allow investigators to omit debriefing under certain circumstances, however. Here we examine various justifications for forgoing debriefing in deceptive research, including concerns about subject pool contamination, the risk that revealing the deception will be harmful or distressing to participants, and issues of practicability. We conclude that, contrary to current practice, omitting debriefing is ethically acceptable (...) only when debriefing is impracticable, the deception is innocuous, and no reasonable person would object to involvement in the research. (shrink)