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Background. DSM-IV identifies three stress response disorders (acute stress Disorder (ASD), post-traumatic stress Disorder (PTSD) and adjustment disorders (AD)) that derive from specific life events. An additional condition of complicated grief (CG), well described in the literature, is triggered by bereavement. This paper reports on the reliability and validity of the Structured Clinical Interview for Trauma and Loss Spectrum (SCI-TALS) developed to assess the spectrum of stress response. The instrument is based on a spectrum model that emphasizes soft signs, low-grade symptoms, subthreshold syndromes, as well as temperamental and personality traits comprising clinical and subsyndromal manifestations. Methods. Study participants, enrolled at 6 Italian Departments of Psychiatry located at six sites, included consecutive patients with PTSD, 44 with CG and a comparative group of 48 unselected controls. Results. We showed good reliability and validity of the SCI-TALS. Domain scores were significantly higher in participants with PTSD or CG compared to controls. There were high correlations between specific SCI-TALS domains and corresponding scores on established measures of similar constructs. Participants endorsing grief and loss events reported similar scores on all instruments, except those with CG who scored significantly higher on the domain of grief reactions. Conclusion. These findings provide strong support for the internal consistency, the discriminant validity and the reliability of the SCI-TALS. These results also support the existence of a specific grief-related condition and the proposal that different forms of stress response have similar manifestations.

We are currently developing and testing an instrument that can potentially open up voluntariness to further study and reasoned policy-making. To substantiate the necessity and usefulness of efforts to protect the voluntariness of consent requires a valid and reliable way of assessing such voluntariness. Relatedly, e.g., the development of just such an instrument has opened up research on decisional competence, permitting more informed policy discussions. Presently, no reliable and valid measure of voluntariness exists. A few studies have examined, sometimes based on as a little as a single question, subjects' perceptions of whether they felt free to make participation decisions or would face sanctions for refusal. Yet no two studies have used the same methods, or reliable and valid instruments. Challenges arise in developing a measure: subjects' experiences and perceptions may not fully correlate with objective independent assessments, and constructs (e.g., "pressures") can be hard to operationalize. We are conducting open-ended interviews with researchers and subjects to identify reasons subjects offer for participation, determinants that may shape their choices (e.g., offers, pressures, and threats), and variations across populations. We are then drafting an instrument to assess determinants of subjects' decisions, and will be piloting it, demonstrating reliability and validity with subjects in clinical trials in 3 areas: substance abuse, HIV, and metastatic cancer, determining test-retest reliability, and convergent validity using 2 existing measures. We will discuss results from initial interviews with recruiters that suggest that, e.g., monetary and other incentives, rather than 'altruism,' play major roles in subjects' decisions. To begin to explore these issues in these ways can potentially contribute substantially to understanding the issues involved.

The essential elements of informed consent to research include the provision of relevant information to a person who is competent to make a decision, and who is situated so as to be able to do so voluntarily. The nature of the requirement of voluntariness has been resistant to exploration. Concerns about voluntariness are usually invoked under the rubrics of coercion or undue influence. Coercion can be conceptualized as the use of morally unjustified threats to bring a person to consent to research participation. Undue influence in the research context typically involves the use of affirmative inducements to persuade a person to ignore what would otherwise be their preferences regarding research participation. Talcott Parsons [1] noted four means by which influence may be exercised, involving respectively the use of appeals to shared goals, inducement, persuasion, and power. In the context of human subjects research, evocation of shared goals may be manifest by appeals to altruism; inducement by offers to provide incentives; persuasion by the application of interpersonal pressure or by an exhortation to self-interest; and power by the issuance of threats. Appeals to altruism, if honestly framed, are unlikely ever to constitute illegitimate constraints on choice, but the other categories can be more problematic. A final component of this conceptualization of voluntariness is the recognition that constraints on decision-making can be actual or perceived. Actual offers, pressure, or threats reflect the behavior of other people who are trying to affect the subject's decision. However, there is often a dichotomy between the behaviors of others and a subject's perception of those behaviors. Hence, both actual and perceived constraint are relevant. Perceptions are the mediating variable between behaviors of others and their impact on subjects' decisions; this approach has proven fruitful in studies of voluntariness in other contexts.

The 1960s and 1970s were a time of substantial changes in approaches to involuntary hospitalization and treatment in the United States, a process that was also reflected elsewhere in the world. Objections to the use of coercion in psychiatry became widespread, rooted in concerns about the reality of mental illnesses, the effects of institutional treatment, financial considerations, and growing attention to patients' rights. This movement led to narrowed criteria for civil commitment (from criteria based on need for treatment to dangerousness-based criteria), along with increased procedural protections. Committed patients were given unprecedented rights to refuse treatment in many jurisdictions. Advocates envisioned steady progress towards a community-based, essentially consensual system of care. In the early 21st century, however, it has become apparent that, even as coercive treatment in institutions has diminished, new forms of coercion have developed to enforce treatment in the community. These include mental health courts, probation and parole requirements, outpatient commitment, and use of informal leverage over patients' money, housing, parenting rights, and the like. Coercive treatment in psychiatry has not disappeared, and may not even have diminished. Rather it has moved from the institution to the community. This presentation will describe this evolution and consider the lessons that may be drawn regarding the future of psychiatric treatment and systems of care.