Charles W. Lidz

The therapeutic misconception: informed consent in psychiatric research

The process by which informed consent has become an accepted part of medical and psychiatric research is reflected in the evolution of the voluminous professional literature on the subject. Early papers, focusing on the existence of ethically improper research,’ soon gave way to discussions of informed consent as a tool for satisfying ethical imperatives and protecting research subjects.2 Researchers themselves weighed in next with concerns about the impact of informed consent on the conduct of research.3 At the same time, as federal regulations firmly established informed consent as an integral part of research with human subjects, a plethora of empirical studies began to appear. Some fought a rear guard action, challenging the applicability of the doctrine on the grounds that subjects could not comprehend or utilize the information researchers were now obliged to disclose;4 others investigated a variety of approaches for improving subject comprehension.5 Conspicuous by the relative inattention it received in this process was a detailed consideration of the actual material to be disclosed to prospective research subjects. Accepting the ethical and legal importance of informed consent, what information must be communicated to achieve the desired ends? Many writers on the subject cite the items enumerated in the regulations of the U.S. Department of Health and Human Services, which govern most research with human subjects in the United States, as if they provide a satisfactory answer to this question. Yet, the requirement that prospective subjects be pro-

Clinical Trials and Medical Care: Defining the Therapeutic Misconception

A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment.

The therapeutic misconception: problems and solutions.

Background.The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research. Objectives.This paper analyzes the nature and origins of the therapeutic misconception and suggests some ways in which researchers can overcome this problem when obtaining a subject’s consent to participation in research. Research Design.A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken. Results.Research and clinical care involve different standards for how the patient/subject is to be treated. The confusion of the two often leads to profound misunderstandings on the part of the patient/subject. Discussion.A method for describing to patients/subjects the differences between research and treatment is proposed as a potential solution to the therapeutic misconception. Research is needed to determine whether this or any other change in the nature of the disclosure is effective in reducing the therapeutic misconception.

Barriers to informed consent.

The law of informed consent seeks to actively involve patients in decision making. Most authorities agree that this involvement has not occurred but disagree about why. Some suggest that patients are incapable of understanding medical issues and others that physicians have not explained issues clearly or extensively enough. We observed decision making in several hospital settings and found other significant barriers to patient participation. These barriers include the fact that treatment decisions take place over a long period; there are often many decisions to be made; although patients want information about treatment, they typically believe that decision making is the physicians task; physicians do not understand the rationale for the patients role in decisions; and the medical decision-making process often involves so many people that the patient does not know who is responsible.

A comparison of actuarial methods for identifying repetitively violent patients with mental Illnesses

This is a progress report on the development of practical methods for the actuarial prediction of violence. The literature indicates that actuarial prediction is more accurate than clinical prediction, but in practice actuarial methods seem to be used rarely. Here we address two obstacles to the clinical use of actuarial prediction methods. First, clinicians may be averse to actuarial methods that require calculations. To remedy this, we developed a regression tree screen that presents actuarial information about violence in a series of yes/no questions. Second, using actuarial methods to identify the small minority of violent patients in a general psychiatric population may be too costly. To remedy this, we developed a method to prescreen patients for intensive evaluation using an inexpensive assessment. We evaluated regression trees and two-stage screening by comparing their accuracies against conventional actuarial methods. The results showed that actuarial predictions based on regression trees and two-stage screens were as accurate as regression-based methods in identifying repetitively violent patients. These easier-to-use methods may therefore be useful techniques for actuarial predictions.

Substance use and community violence: a test of the relation at the daily level.

Prior research has consistently demonstrated an association between substance use and involvement in violence among individuals with mental illness. Yet little is known about the temporal quality of this relationship, largely because longitudinal data required to address this issue are not readily available. This study examined the relationship between substance use (alcohol, marijuana, and other drug use) and violence at the daily level within a sample of mentally ill individuals at high risk for frequent involvement in violence (N = 132). Results support the serial nature of substance use and violence, with an increased likelihood of violence on days following the use of alcohol or multiple drugs, but not the inverse relationship. Implications for the utility of substance use as a risk marker for the assessment of future violence are discussed.

Psychiatric symptoms and community violence among high- risk patients : A test of the relationship at the weekly level

Given the availability of violence risk assessment tools, clinicians are now better able to identify high-risk patients. Once these patients have been identified, clinicians must monitor risk state and intervene when necessary to prevent harm. Clinical practice is dominated by the assumption that increases in psychiatric symptoms elevate risk of imminent violence. This intensive study of patients (N = 132) at high risk for community violence is the first to evaluate prospectively the temporal relation between symptoms and violence. Symptoms were assessed with the Brief Symptom Inventory and threat/control override (TCO) scales. Results indicate that a high-risk patient with increased anger in 1 week is significantly more likely to be involved in serious violence in the following week. This was not true of other symptom constellations (anxiety, depression, TCO) or general psychological distress. The authors found no evidence that increases in the latter symptoms during 1 week provide an independent foundation for expecting violence during the following week.

Voluntariness of Consent to Research: A Conceptual Model

A good deal of policy and practice in human subjects research aims to ensure that when subjects consent to research, they do so voluntarily. To date, however, voluntariness and its impairment have been poorly conceptualized and studied. The legal doctrine of informed consent could provide a useful model.

Clinical considerations in the prediction of dangerousness in mental patients

Abstract Despite continued evidence of the extreme difficulty of successfully predicting future violent behavior, this task is still required of many clinicians assessing mental patients. The present review is an effort to assist clinicians in this situation by presenting information about: (1) the factors that empirical research suggests should be considered in such assessments and the demonstrated utility of these factors, and (2) the factors that appear to be most often considered by clinicians assessing the dangerousness of mental patients. While there is no set of heretofore unknown valid predictors that can be presented as a result of this review, there is a large amount of information from several areas that clinicians would do well to consider. An examination of studies documenting the clinical decision making process regarding dangerousness, however, suggests that there are probably only a few factors that are regularly attended to by clinicians.

A direct comparison of research decision-making capacity: Schizophrenia/schizoaffective, medically ill, and non-ill subjects

To characterize predictors of impairment in research decision-making capacity, we undertook a direct comparison of schizophrenia/schizoaffective (n=52), medically ill (diabetic; n=51), and non-ill (n=57) subjects. Scores on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Positive and Negative Syndrome Scale (PANSS), Mini-Mental State Examination (MMSE), and Short-Form-36 (SF-36). Across diagnoses, cognitive capacity, physical functioning, and a diagnosis of mental illness had the greatest impact on decision-making capacity, with level of education also having an impact. 69-89% of schizophrenia/schizoaffective subjects attained MacCAT-CR subscale scores achieved by almost all comparison (98-100%) and medically ill (94-100%) subjects. Positive, negative, and general psychotic symptoms correlated with poorer scores. Prior research experience, number of queries used during interview, and emotional functioning also predicted MacCAT-CR scores. These data suggest that investigators and IRBs should consider a number of variables, many of which reach across diagnoses, as they decide which populations and individual subjects may require more intensive screening for decisional impairment or educational interventions to improve their abilities to make capable decisions about research participation.