The 'corpus' of knowledge is less well established in psychology and the brain sciences than in other disciplines relevant to medicine. Hence it will more often be the case in psychiatry that there is disagreement among experts about the likelycopyright. on November 22, 2021 by guest. Protected by http://jme.bmj.com/ J Med Ethics: first published as 10.1136/jme.19.2.85 on 1 June 1993. Downloaded from 86 Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers extent of any increase in knowledge from a given research project. NECESSITY: Psychopathology, unlike physical pathology, is a predominantly human phenomenon. Also, it is revealed mainly by self-report. Hence there is less scope in psychiatry than in other branches of medicine for using animals in research and thus for avoiding the necessity of working with patients. BENEFIT: Three main kinds of difficulty may arise in the assessment of the risks and benefits of research with psychiatric patients: i) Empirical: As already noted, there is rather less in the way of an established corpus of knowledge in psychiatry than in many other branches of medicine. The likely clinical usefulness of a research project and its inherent risks of harm may thus be difficult to assess with any confidence. For example, the difficulties of psychiatric diagnosis can make for uncertainties about the extent to which the results even of drug-treatment trials can be transferred to everyday clinical practice: and in psychotherapy research the very criteria by which outcome should be measured may be at issue (5). It should be added, though, that whatever the difficulties of predicting outcome, most psychiatric research, as against say the more esoteric areas of biochemistry, is at least directly concerned with patients and their difficulties. Thus, while the overall utility of a given psychiatric research project may be at issue, its clinical relevance will generally not be in doubt. ii) Evaluative: In addition to the empirical difficulties involved in assessing the likely benefits and harms arising from a psychiatric research project, there may be difficulties about what should count as a benefit or harm. These difficulties of evaluation may be of two kinds. They may be non-specific, ie, concerned with judgements simply of good and bad. There may be differences of view, for example, about what should count as a good or bad outcome, a benefit or a harm, in behaviour therapy. The question of what should count as 'desirable' behaviour is raised directly by the need for precise definition of goals in treatment of this kind (6); whereas, as Wing has pointed out, it is commonly neglected altogether in 'social' therapies (7). But evaluative difficulties may also be specific, ie, concerned with the specifically medical judgements of health and disease: is grief, for example, a disease to be 'cured' (8); or, more contentiously, homosexuality (9)? The proper scope of medical research may thus be at issue in psychiatry in ways, or to an extent, that it is not in other areas of medicine. iii) Conflicts of interest: The risks, as well as the benefits, of research in psychiatry may accrue to individuals other than the actual patient, thus giving rise to conflicts of interest. This is notoriously so in family therapy, for example. Such difficulties, though, are certainly not confined to psychiatric research. For instance, the work required for the development of pre-symptomatic genetic testing for inherited conditions such as Huntington's Chorea, can have highly unwelcome implications for members of the patient's family (10). CONSENT: Either or both of the elements of valid consent - that it be given freely and on the basis of appropriate information - may be problematic in psychiatric research. The difficulties involved in establishing that consent is given freely include: i) Covert pressures: Psychiatric patients are often especially vulnerable emotionally. The difficulties here have been examined empirically, though mainly in respect of treatment rather than research, by Lidz, Meisel et al (11). They found that while active coercion is generally avoided, there is a particular danger of covert (though mostly unintentional) pressures arising from the unequal power