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Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. [ABSTRACT FROM AUTHOR]

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function. [ABSTRACT FROM AUTHOR]

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research. [ABSTRACT FROM AUTHOR]

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. [ABSTRACT FROM AUTHOR]

The Clubhouse Model has been in existence for over sixty-five years; however, a review that synthesizes the literature on the model is needed. The current study makes use of the existing research to conduct a systematic review of articles providing a comprehensive understanding of what is known about the Clubhouse Model, to identify the best evidence available, as well as areas that would benefit from further study. Findings are summarized and evidence is classified by outcome domains. Fifty-two articles met the selection criteria of Randomized Clinical Trials (RCT's), quasi-experimental studies, or observational studies for domains of employment (N = 29); quality of life/satisfaction (N = 10); reductions in psychiatric hospitalization(s) (N = 10); social relationships (N = 10); education (N = 3); and health promotion activities (N = 2). RCT results support the efficacy of the Clubhouse Model in promoting employment, reducing hospitalization(s), and improving quality of life. Quasi-experimental and observational studies offer support in education and social domains. The findings from this review indicate that Clubhouses are a promising practice but additional studies using rigorous methods that report the strength of the outcomes are needed to evaluate Clubhouse programs with fidelity to the Clubhouse Model. [ABSTRACT FROM AUTHOR]

Decisions about the appropriate use of animals in research are largely made by Institutional Animal Care and Use Committees (IACUCs). Several commentators claim that scientists exert excessive influence on IACUC decisions. We studied 87 protocol reviews from 10 IACUCs to assess whether any group of participants appeared to dominate the protocol discussions. Audio recordings of the meetings were coded to capture the topics of the discussions. We found that animal research scientists made the largest total number of topic mentions while community members made the fewest. On a per person basis, chairpersons and attending veterinarians made the most mentions. Scientists presented the largest number of protocols, and the subsequent discussions tended to contain the same topics mentioned in the presentations. The large number of protocols presented by scientists and their total number of comments made during protocol discussions suggest that scientists may significantly influence IACUC decision making. [ABSTRACT FROM AUTHOR]

Objective: Youth and young adults with serious mental health conditions have particularly poor records of stable employment, but stable employment is a key to recovery. Employment specialists have a key role in supported employment services in assisting them with employment. This article describes the thoughts and concerns of employment specialists about finding and supporting employment for youth and young adults with serious mental health conditions. Method: The authors undertook 12 intensive interviews with supported employment specialists in two states. These interviews were transcribed and coded by the authors. A number of themes were identified and prototypical examples identified and included in the findings. Results: Although the employment specialists varied in their enthusiasm and optimism about the job, they agreed on key problems that they face in supporting employment for young adults that include employer resistance to hiring people with mental illness, increasing use of online applications, larger organizations not making hiring decisions locally and thus the decisions are not responsive to the employment specialist, resistance from family and mental health professionals and the young adults themselves to full-time employment and putting benefits at risk, and resistance from young adults to disclosing their disability to coworkers and thus being unwilling to take supported employment positions. Conclusions and Implications for Practice: These interviews suggest that some of the features of supported employment practice might need to be modified if young adults with serious mental health issues are to gain employment that over time could lead to significant careers and recovery. [ABSTRACT FROM AUTHOR]

Background:Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated.Methods:This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation.Results:On average, participants endorsed 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment.Conclusions:Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed. [ABSTRACT FROM PUBLISHER]

Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial. [ABSTRACT FROM PUBLISHER]

Background:The validity of results from clinical trials depends on both clinical researchers and participants consistently and strictly following research protocols. However, clinical trial researchers are also expected to provide excellent medical care to the participants. These two commitments may conflict under some circumstances.Methods:A questionnaire previously used for a national Internet-based survey was adapted to conduct in-depth, semistructured interviews in order to further explore reported attitudes and/or behaviors that indicated that patient well-being sometimes took precedence over strict adherence to the study protocol. We conducted 96 interviews with researchers working on Phase II and/or Phase III clinical trials in a variety of medical fields at four major academic medical centers.Results:Due to concerns for the welfare of their patients, the researchers we interviewed described decisions that involved “individualized” rather than protocol-driven decisions about recruitment, protocol implementation, and termination. The individualized decisions could threaten the validity of the trials.Conclusions:Clinical researchers should be strongly encouraged to carefully document and report selective recruitment, implementation, and termination decisions so that it will be easier to evaluate to whom the results of research studies apply. Those who design clinical trials should be careful to construct them so that the clinicians who carry them out will not feel that implementing the protocol will violate their commitments to good clinical care. [ABSTRACT FROM AUTHOR]

Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection. [ABSTRACT FROM AUTHOR]

Objective: The authors compared the predictive accuracy of two risk assessment methods that are feasible to use in routine clinical settings: brief risk assessment tools and patients' self-perceptions of risk. Methods: In 2002-2003, clinical interviewers met with 86 high-risk inpatients with co-occurring mental and substance use disorders (excluding schizophrenia) to carefully elicit the patients' global rating of their risk of behaving violently and to complete two brief risk assessment tools—the Clinically Feasible Iterative Classffication Tree (ICT-CF) and the Modified Screening Tool (MST). Two months after discharge, patients were reinterviewed in the community to assess their involvement in violence. Results: Patients' self-perceptions of risk performed quite well in predicting serious violence (area under the curve [AUC]=.74, sensitivity=50%), particularly compared with the ICT-CF (AUC=.59, sensitivity=40%) and the MST (AUC=.66, sensitivity=30%). Self-perceived risk also added significant incremental utility to these tools in predicting violence. Conclusions: Patients' self-perceptions hold promise as a method for improving risk assessment in routine clinical settings. Assuming it replicates and generalizes beyond the research context, this finding encourages a shift away from unaided clinical judgment toward a feasible method of risk assessment built on patient collaboration. [ABSTRACT FROM AUTHOR]

Background The goal of this investigation is to discover whether or not patients with psychiatric diagnoses are less likely to be prescribed opioids for pain in emergency departments compared with other patients. Methods Pain-related visits to US emergency departments were identified using reason-for-visit and physician diagnosis codes for 13 years (1993e2005) of the National Hospital Ambulatory Medical Care Survey. The outcome measure was the prescription or administration of an opioid analgesic. Results Roughly 10 million pain-related visits were made by persons with psychiatric diagnoses in the USA between 1993 and 2005. Across all years, only 18% (95% CI 16 to 20) of pain-related visits by patients with psychiatric diagnoses resulted in an opioid prescription, whereas 33% (95% CI 32 to 34) of visits by other patients did. Lower prescription rates for patients with psychiatric diagnoses were seen for every year of the survey and this difference occurred at every level of pain severity. Controlling for confounding factors did not attenuate this difference. In a multivariate model, patients with psychiatric diagnoses were about half as likely as other patients to be prescribed opiates (adjusted OR 0.49; 95% CI 0.44 to 0.56). Major limitations of the study include the uncertain precision of psychiatric and drug/alcohol diagnoses and the lack of detail about each patient visit. Conclusion Having a psychiatric diagnosis was associated with a lower likelihood of receiving an opioid among persons presenting with pain to the ED. [ABSTRACT FROM AUTHOR]

The article tackles a study which described the contributions of community members, or unaffiliated members, who serve on institutional review boards (IRB) at large medical research centers in comparison with other members. Discussions among 216 IRB members and 47 staff at 20 IRB meetings taking place at 10 academic medical centers were observed and recorded. Results showed the community members acted as laypeople and acted as nonscientific members who focused on a particular subset of issues.

In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation's most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic. [ABSTRACT FROM PUBLISHER]

Objective: Psychiatric symptoms play a crucial role in psychology and psychiatry. However, little is known about how dimensions of symptoms—other than symptom level—relate to psychiatric outcomes. Until recently, methods for measuring dynamic aspects of symptoms have not been available to clinicians or researchers. The authors sought to test whether systematic patterns of change in psychiatric symptoms can be recovered across weekly assessments of individuals at high risk for violence. A secondary objective was to explore whether dynamic features of symptoms (specifically, oscillation speed and dysregulation) are concurrently associated with violence, an important indicator of functional impairment for these individuals. Method: Participants (N=132) were drawn from a sample of patients evaluated at the emergency room of an urban psychiatric hospital, Patients actuarially classified as being at high risk for violence were eligible for participation in the study. Participants and collateral informants were interviewed weekly for 26 weeks following an acute psychiatric evaluation. Psychiatric symptoms were assessed using the Brief Symptom Inventory. Measures of symptom fluctuation and regulation were derived using dynamical systems models. Involvement in violence was assessed using self, informant, and official reports. Results: Individuals' symptom dynamics were recovered by a linear oscillator model that described how quickly symptoms oscillated and whether symptoms were amplifying or moving back toward equilibrium across time. Patterns of rapid symptom fluctuation and symptom amplification were concurrently associated with violence. Conclusions: Psychiatric researchers and clinicians have long been interested in adopting more dynamic approaches to understanding symptom change. This study is the first to demonstrate that systematic fluctuations in symptom patterns may be captured by dynamic models. Moreover, the concurrent association between symptom dynamics and violence suggests avenues for future research to test how features of symptom fluctuation could affect behavior. [ABSTRACT FROM AUTHOR]

The article discusses the application of the legal doctrine of informed consent as a model for voluntariness of consent to human subjects research. Informed consent to research derives from a legal doctrine that calls for potential research subjects to have meaningful choice, and it comprises three elements that include relevant information on voluntariness that is provided to a person who is competent to make a decision, and who is situated to do so voluntarily. The article describes the constraints on voluntariness that may appear in the research setting and suggests a research agenda to advance understanding of voluntariness in practice.

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

Empirical studies of violence and mental illness have used many different methods. Current state-of-the-art methods gather information from both subject and collateral interviews as well as official records. Typically these sources are treated as additive. Any report of a violent incident from any source is treated as true and all reported incidents are added to generate estimates of frequency. This paper presents a new statistical technique that uses the level of agreement between the sources of data to adjust those estimates. The evidence suggests that, although the additive technique for using multiple sources correctly estimates how many people are involved, it substantially underestimates the number of incidents. The new technique substantially reduces both false negatives and false positives. [ABSTRACT FROM AUTHOR]

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the “strong” model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the “therapeutic misconception” posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests. Copyright © 2006 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Greater attention is being focused on the willingness and motivations of potential subjects who are recruited for research protocols. Given the importance of subjects' abilities to choose freely and reason through their decisions about entering psychiatric research, empirical researchers have been developing assessment and education tools that address the potential vulnerabilities of research subjects. In this study subjects' responses and reasons for or against participation were elicited as part of an assessment of their research decision making. Fifty-two persons diagnosed with a thought disorder were asked to consider a hypothetical research study using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Their responses were documented, coded for content, and correlated with demographic characteristics and scores on scales rating psychosis, cognition, and health-related quality of life. Subjects expressed common considerations that have been identified by other psychiatric investigators, as well as by those studying nonpsychiatric protocols. In general, reasons were both appropriate to the study being considered and appropriately linked to common considerations that flowed logically from the study. However, elements of the therapeutic misconception were evident as well. Willingness to participate was correlated with higher MacCAT-CR scores on certain scales, better education, and lower levels of psychosis and cognitive impairment. These findings highlight both the strengths and weaknesses of the decision making of research subjects with thought disorder. Research protections and assessments may consequently be appropriately targeted to specific vulnerabilities. Because of differences in severity of illness, cognition, and reasoning among subjects who decline to participate in research, greater attention to this population appears warranted. [ABSTRACT FROM PUBLISHER]

To address several key questions in social science research, repeated interviews of individuals drawn from difficult populations are required. This article describes an approach for addressing the challenges associated with longitudinal interview studies, including locating research participants, obtaining reliable and valid interview data over time, and retaining participants across the course of the study. We applied this approach to conduct a study designed to identify changeable risk factors for violence among high-risk people with mental illness. To successfully conduct weekly interviews of these individuals in the community across a 6-month period, we developed a flexible and personalized interview format; carefully selected, trained, and supervised staff; and developed incentives to maximize participant retention. Each of these three steps is discussed as a guide for future longitudinal studies that involve interviewing difficult populations. [ABSTRACT FROM AUTHOR]

Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. [ABSTRACT FROM AUTHOR]

Examines the mental patients' revisions of their beliefs about the need for hospitalization. Interviews with patients about their hospitalization; Reinterview of patients after their discharge; Stability of patients' perception of coercion; Ungratefulness of coerced patients for the experience of hospitalization.

Narrates the experience of research professor Charles W. Lidz during his study of the legal and ethical doctrine of informed consent. Interesting things about informed consent; Limitations of the study conducted by professor Lidz and colleagues; Major difference that research can do in presenting facts.

The prevalence of family violence reported in psychiatric emergency rooms is relatively undocumented, despite the clinical and legal concern for dangerousness. This study assesses the prevalence of aggression incidents reported to clinicians and physicians during evaluation interviews (n = 389). Two-thirds of the total number of subjects reported being involved in an "aggression" incident sometime in their past. Only 8% reported being the victim of such incidents. About one-half of the cases involved physical assaults; nearly one-half of these assaults had family members as victims. One third of the total cases had been assaultive within 3 months; one sixth had been assaultive within 2 weeks of visiting the hospital. Clinicians and researchers are urged to consider more systematically family violence in psychiatric settings. [ABSTRACT FROM AUTHOR]

We administered a semi-structured interview to 157 patients shortly after their admission to a psychiatric hospital. In the first, and open-ended, part of the interview, patients were asked to talk about what had been going on in their lives that led to their coming into the hospital. Then, in a more structured format, they were asked more specific details about who was involved, the patients' relationships with those involved, whether any attempts were made to influence the patient to come into the hospital, and whether such attempts were perceived as fair by the patient. This article presents a qualitative review of the transcripts of a subset of these interviews. It attends specifically to patients' perceptions of the morality of attempts by others--primarily family members, friends and mental health professionals--to influence them to be admitted to the hospital, and of the morality of the process by which these influence attempts resulted in admission. [ABSTRACT FROM AUTHOR]

Legal and extra-legal coercion are pervasive in mental hospital admission and there are sharp disputes about its appropriate role. This article presents two scales for measuring psychiatric patients' perceptions of coercion during hospital admission and reports data on these scales' internal consistency. We measure patients' perceptions of coercion by asking questions, in either an interview or questionnaire format, about their experience of lack of control, choice, influence, and freedom in hospital admission. Patients' responses to questions about their perceptions of coercion were highly internally consistent. The internal consistency of the scale was robust with respect to variation in site, instrument format, patient population, and interview procedure. Correspondence analysis was used to construct two numerical scales of perceived coercion. [ABSTRACT FROM AUTHOR]

This paper describes the prevalence of coercive and non-coercive efforts to influence patients' admission decisions in a psychiatric emergency room. The findings are based on previously collected transcripts of the interaction between patients and families and emergency room staff in 405 cases. Although a significant perceptive of the patients were involuntarily admitted, otherwise the most prominent pressures were efforts by attending physicians to persuade patients about what would be the most appropriate disposition. However, a detailed qualitative analysis of the interaction suggest that the clinical staff's power to commit patients against their will affects the way all parties interpret the staff's ‘persuasion’ in such a way that it may be understood as quite coercive. [ABSTRACT FROM AUTHOR]

The rise in the mental health movement coincides with a decline in prestige and importance of criminal law. While this may, in part, reflect the greater effectiveness of mental health treatment in dealing with overlapping problems, it also reflects certain problems that criminal law has with the individualistic values of modern society and the value-attractiveness of the mental health professions' commitment to helping the individual. However, many of the same value problems inherent in criminal punishment also apply to some aspects of mental health treatment, especially the paternalism of the doctor-patient relationship and involuntary treatment. Informed consent can be seen as a response to these value conflicts as well as part of the general extension of citizenship rights to the less privileged members of the society. This paper analyzes some of the conflicts inherent in the application of informed consent to mental health treatment from the above perspective. [ABSTRACT FROM AUTHOR]

Presents a study to determine what predicts patients' perceptions of coercion in the psychiatric hospital admission process. How data was collected for the study; What was used to determine whether coercion-related behaviors occurred around the time of admission; Methods to use for determining whether behaviors might affect the occurrence of perceived coercion; Results of the study.

Assesses the accuracy of clinicians in predicting violence in mental patients. Attempt to determine if clinicians can predict violence when variation in rates of violence attributable to age, race and sex is controlled; Finding that overall accuracy was modest and particularly low for female patients; Frequency of diagnostic groups among predicted and comparison patients; Schizophrenia; Affective disorder; Substance abuse; More.

This article focuses on the doctrine of informed consent that has emerged over the past several decades as the preeminent method of protecting research subjects against potential exploitation and harm. Succinctly stated, the informed consent doctrine requires prospective subjects be apprised of the project's nature, purpose, and procedures, as well as its risks, benefits and alternatives. Following the disclosure of this information, it is assumed that potential subjects will then be able to make rational and independent decisions regarding study participation. Since the mid 1960s, Department of Health, Education, and Welfare regulations have required informed consent for the use of human subjects in nearly all forms of medical research. These regulations apply to all universities, medical schools, hospitals, and other institutions receiving federal research funds. As might be expected, the emergence of the informed consent requirement has engendered considerable controversy within the medical research community and elsewhere.

Mental health professionals contribute in important ways to both the clinical and ethical issues raised by cases of elder mistreatment. Their clinical competencies contribute to improving quality of life by diminishing psychological suffering and the symptoms of mental illness. They are also used for managing the ethical issues raised by these cases. The ethics of mental health care are based on the values of beneficence, nonmaleficence, autonomy, and justice. The value of autonomy in mental health care gives priority to an individual's long-term ability to act as independently, rationally, and fully in all aspects of life as possible. The concepts of legal and clinical competence also aid in managing the ethical problems represented by cases of elder mistreatment. The ethical protocols of mental health professionals may be distinguished from some other disciplines by the premium given to long-term autonomy and by the aim of insuring treatment for all persons involved in cases of elder mistreatment, rather than limiting treatment responsibilities to the victim. [ABSTRACT FROM PUBLISHER]

This article focuses on social control of heroin. A central theme of sociological theory in the last two decades has been the revival of interest in societal development. This had led to a revival of interest in and an elaboration of earlier evolutionary theories. There is clear distinction between psychiatry and criminal law as systems of social control. While criminal law has understood deviance as a willed act and the sanction of the criminal justice system, punishment, has been legitimated usually only as a response to deviant acts, psychiatry formulated its conceptions of deviance around the actor and its sanction, treatment, was the appropriate response to deviant properties of the "actor," not the act. Psychiatry and social work have gained jurisdiction where rationality is not reflected in the agent's actions. For various classes of behavior, including the use of illegal drugs, plausible cases can be made both ways. Heroin may be thought to be so pleasurable that all the disadvantages of use are rationally justifiable to the addict. In this view, stiffer punishments are needed to prevent further use.

Discusses the barriers to the implementation of the doctrine that emerged from extensive social scientific observations of medical and surgical decision making. Provisions of the regulations for the decision-making process in medical treatment; Elements of the legal model of informed consent; Information on the general barriers to informed consent; Reasons for the need of patients to have access on their medical information.

The reliability and validity of the application of legal criteria for commitment were investigated as part of a larger study. Evaluations of 411 patients by 96 different clinicians showed good interrater reliability for assessment of dangerousness and committability. A strong relationship between ratings of committability and ratings of dangerousness suggests that clinicians were conforming to the logic of the commitment law. Discrepant cases involved patients who desired voluntary admission or whose commitment was completed elsewhere. Results suggest fair application of commitment standards but that two issues of statutory interpretation confused participating clinicians. [ABSTRACT FROM AUTHOR]

Although the recent development of a measure for perceived coercion has led to great progress in research on coercion in psychiatric settings, there still exists no consensus on how to measure the existence of real coercive events or pressures. This article reports the development of a system for integrating chart review data and data from interviews with multiple participants in the decision for an individual to be admitted to a psychiatric hospital. The method generates a “most plausible factual account” (MPFA). We then compare this account with that of patients, admitting clinicians and other collateral informants in 171 cases. Patient accounts most closely approximate the MPFA on all but one of nine dimensions related to coercion. This may be due to wider knowledge of the events surrounding the admission. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Saleem Shah played a major role in the development of both policy and research concerning the prediction of dangerousness to others over two decades. During that period his commitment to the welfare of people with mental illness led him first to challenge the legitimacy of such predictions and later to support research to improve them. His ideas were central to most of the research that has been done in this area. This article suggests a direction for future research concerning the prediction of dangerousness to others that elaborates and extends his thinking by focusing on the research necessary to help individuals with mental illnesses to minimize their involvement in violence. [ABSTRACT FROM AUTHOR]