Legal pitfalls of psychiatric research

BACKGROUND: The increasing complexity of psychiatric research, including recent attempts to evaluate mental health legislation, suggests legal advice may be valuable in a wide range of research contexts. AIMS: We aim to illustrate both the legal pitfalls of research in psychiatry and the potential for solutions if the methods are carefully chosen. METHOD: Two examples of research are subject to legal analysis, one involving advance directives, the other the random discharge of compulsory out-patients. RESULTS: This analysis illustrates that participation in research may expose clinicians to additional forms of liability, but the legal risks can be minimised through changes in the methods or additional safeguards. CONCLUSIONS: Collaboration between academic law and psychiatry can enrich research agendas and avoid serious legal pitfalls. We argue that sound legal advice should be sought at the planning stage of research in psychiatry, but the fear of liability should not lead to overly defensive research practices. The aim should be to strike the right balance between avoiding unacceptable exposure to liability and stifling innovative research.     

Problems of subject inclusion in psychiatric research: observations from research with psychiatric inpatients.

In a recent study of psychiatric disturbance and decision making behaviour, it was observed that a significant number of psychiatric inpatients experienced difficulties in addressing themselves to the experimental tasks at hand. Despite the large number of studies that have used psychiatric inpatients as subjects, little, if any mention has been made of these difficulties. The following report describes the difficulties that have been observed in the above research project, and examines their possible implications for clinical assessment, research, and for clinical investigations and evaluation of treatment regimes (e.g. effectiveness of particular drug therapies), which use psychiatric inpatient populations as subject sources.     

Ethical guidelines in psychiatric research

Capacity to consent is a basic prerequisite for participation of patients as probands in research. However, mental illness often impairs this competence. Therefore, in psychiatric research, the first obligation is to assess a mentally ill patient's competence to consent. This is not a simple task. Informed consent should be viewed not only as a legal must, but also as a chance to build up a trusting patient-psychiatrist relationship. This is called for by respect for the autonomy and dignity of the patient. Specifically, competence to consent is related to the specific intervention; the validity of a consent requires that the patient understands the intervention-related medical information, comprehends its significance and consequences, and can appreciate its meaning for himself. Research with patients who lack this competence to consent validly meets a major problem: an uncovered need for research in frequent major psychiatric disorders exists, but a substantial number of patients with these illnesses cannot consent validly. Several guidelines for dealing with this problem will be discussed. Mentally ill patients who are willing to participate in needed research are a rare resource. This must be protected by the virtue of the clinical researcher who has to take great pains over the strict adherence to ethical guidelines.     

Mixture distributions in psychiatric research

This paper describes the application of Gaussian mixture distributions to biological marker research in psychiatry. Mixtures of univariate and multivariate normal distributions can be used to determine if diagnostically similar psychiatric patients belong to biologically distinct subpopulations. The resulting biological subtypes may be important in understanding the etiology of psychiatric disorders. The general model and estimation procedure are described (EM algorithm; Dempster, Laird and Rubin 1977). The method is illustrated using two examples of biological data: (1) red cell membranes and monoamine oxidase activity data in normal individuals having no family history of psychiatric illness, the first-degree relatives of bipolar depressed patients and a heterogeneous patient population; and (2) smooth pursuit eye movements that classify relatives of schizophrenics, nonschizophrenics and normal controls into biologically distinct populations.     

Ethical guidelines in psychiatric research

Capacity to consent is a basic prerequisite for participation of patients as probands in research. However, mental illness often impairs this competence. Therefore, in psychiatric research, the first obligation is to assess a mentally ill patient’s competence to consent. This is not a simple task. Informed consent should be viewed not only as a legal must, but also as a chance to build up a trusting patient–psychiatrist relationship. This is called for by respect for the autonomy and dignity of the patient. Specifically, competence to consent is related to the specific intervention; the validity of a consent requires that the patient understands the intervention-related medical information, comprehends its significance and consequences, and can appreciate its meaning for himself. Research with patients who lack this competence to consent validly meets a major problem: an uncovered need for research in frequent major psychiatric disorders exists, but a substantial number of patients with these illnesses cannot consent validly. Several guidelines for dealing with this problem will be discussed. Mentally ill patients who are willing to participate in needed research are a rare resource. This must be protected by the virtue of the clinical researcher who has to take great pains over the strict adherence to ethical guidelines.

     

Statistical power in psychiatric research

Statistical power is neglected in much psychiatric research, with the consequence that many studies do not provide a reasonable chance of detecting differences between groups if they exist in the population. This paper attempts to improve current practice by providing an introduction to the essential quantities required for performing a power analysis (sample size, effect size, type 1 and type 2 error rates). We provide simplified tables for estimating the sample size required to detect a specified size of effect with a type 1 error rate of alpha and a type 2 error rate of beta, and for estimating the power provided by a given sample size for detecting a specified size of effect with a type 1 error rate of alpha. We show how to modify these tables to perform power analyses for multiple comparisons in univariate and some multivariate designs. Power analyses for each of these types of design are illustrated by examples.     

Using meta-analysis in psychiatric research

Meta-analysis is a technique for summarizing the results of many studies which can allow reviewers in a particular field to arrive at a synthesis of the various findings in a more objective manner than relying on expert opinion and combine the results of these studies to arrive at an overall estimate of the magnitude of the effect of a treatment, to determine if the evidence favours its effectiveness. The technique consists of determining an effect size or odds ratio for each study and combining them, taking into account the fact that studies with large samples should exert more influence than those with small samples. However, the procedure is not mechanical. The reviewer must make a series of decisions regarding the studies to be included or excluded, the weight to place on the methodological rigour of the trials, the results from each study to be used, how to handle differences in the magnitude of the results across studies, how to derive the best overall estimate of the effect across studies, and how to determine the precision of that estimate. Each of these decisions can affect both the quality of the review and the nature of the findings.