The article argues that a functional approach is ethically better than a categorical approach in deciding whether involuntarily admitted patients have the capacity to give informed consent to participation in research. Congruent with current South African laws, a functional approach requires that a patient's capacity to give informed consent to participation in research should be assessed clinically rather than assumed by virtue of his/her belonging to a category of legal admission status. Concerns about protection against exploitation may cause a categorical approach to appear attractive, but these concerns can be addressed deliberately through a functional approach without attracting the infringements of rights and entitlements of patients that are brought about by a categorical approach.
Researchers in psychiatry, sponsors of psychiatric research and research ethics committees are confronted with an ethical question, viz. whether patients admitted involuntarily to a psychiatric hospital can give informed consent to participate in research. Some studies resort to an exclusion criterion that precludes these patients from participation in research. This article compares two approaches, and I argue that a functional approach is ethically preferable to a categorical approach to this question. A categorical approach predicates that people should be considered incapable by virtue of their belonging to a certain category, for example, being involuntarily admitted to a psychiatric hospital. In contrast, a functional approach requires that incapacity should not be assumed by virtue of a patient's belonging to any one category (e.g. the category of having been involuntarily committed to hospitalisation), but instead it allows that a patient may be incapable of deciding about hospitalisation yet be capable of making other decisions such as giving informed consent to participate in research.
A functional approach requires that a patient's capacity to give informed consent to participation in research should be assessed clinically rather than be assumed by virtue of his/her belonging to any one category. Accordingly, the clinician needs to assess whether a mental disorder prevents the patient from: (i) understanding what he or she is consenting to; (ii) choosing decisively for or against participation; (iii) communicating his/ her choice; or (iv) accepting the need for an intervention. (1) It is therefore possible that a mental disorder could prevent a patient from accepting the need for hospitalisation, in which case he or she would be incapable of consenting to hospitalisation. Yet the same patient could at the same time be capable of giving informed consent to treatment with medication when a mental disorder does not prevent him/her from accepting the need for it, all other things being equal.
A functional approach to incapacity due to mental disorder has gained considerable support locally and abroad. South Africa's recently promulgated Mental Health Care Act (2) follows suit, requiring that one 'may intrude only as little as possible to give effect to the appropriate care, treatment and rehabilitation' (section 8(3)).
In the previous Mental Health Act of 1973 (3) voluntary or involuntary status was a categorical status of admission that served as a framework within which treatments were provided. In contrast, the current Mental Health Care Act does not take the admission status as a framework. For example, patients may also be treated involuntarily while they are outpatients. Voluntary or involuntary status is now taken as a functional status indicative of the patient's capacity to decide about specific interventions for appropriate care, treatment and rehabilitation--interventions that may or may not be about admission to a hospital, depending on the particular needs/situation of the individual patient. Thus, admission status is not the categorical factor by virtue of which a patient is rendered capable or incapable of giving informed consent. …