Theories in health care and research: Theories of consent

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Abstract
Real consent Positivism distinguishes factual concepts defined through dichotomies: informed/ignorant, competent/incompetent, free choice/coercion. Medicine, psychology, analytical philosophy, 2 3 and law 4 5 tend to assume positivist concepts of consent. The appropriate information, including percentage risks, for obtaining informed consent is treated almost as a “thing” which doctors give to patients. It is assessed by checking how patients recall and recount standard details of the information they have been given. Positivist surveys dominate research about consent; mainly they measure information given. The essence of consent (patients' thoughts, feelings, and values as they evaluate information and make and express their decision) is far harder to observe or record—and too subjective and elusive to count as hard data. Problems in real consent are attributed to patients' and doctors' limited knowledge and communication skills, and are addressed by efforts to improve knowledge and skill. Social pressures, and great anxiety and distress, are assumed to inhibit patients' ability to make independent, rational choices, and so should be reduced or avoided if possible. The respect for informed consent within a positivist framework brings important benefits. It encourages health professionals to be accountable and to know and explain clearly what they plan to do, and why. Basic information standards are agreed (see box) and are achieved partly through research, audit, and professional education, which also improve health care. Respect for patients' consent or refusal expresses precious ideals of respect for their physical and mental integrity. It defends them from unwanted interventions and from deception or coercion during treatment and research. Yet positivist theories set such high standards that many people are classified as too ignorant, too dependent, or too emotional to be competent. In an all or nothing approach, consent is seldom discussed in relation to good practice with supposed “incompetents.”6 Sharp dichotomies are unhelpful in assessing borderline cases, though in these the need for helpful theories of consent and competence is greatest. Because real consent is unrealistic for many ordinary people, clinicians and researchers feel cynical, irritated, or despondent about consent. Types of consent Informed consent involves knowing about7: The nature and purpose of the intervention Intended effects and unintended side effects Risks, harms, and hoped-for benefits Any reasonable alternatives Voluntary consent involves: Freedom from “force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion”8 Knowing about the right to refuse or withdraw, without prejudicing further health care The right to ask questions and to negotiate aspects of treatment coerced perhaps by disease, but not by other people Consent to research involves knowing about: The research purpose, questions, aims and methods Relevant terms like “randomise” The treatment, if any, which the research investigates Benefits, risks, harms, or costs to research subjects Hoped-for benefits to other groups such as future patients Confidentiality, indemnity, sponsors, ethical approval The research team and a named contact (Some of these details can be explained in leaflets and discussed with those who ask about them) Competent consent: Involves the person being able to make and stand by an informed, freely made decision. Adults can decide as they please, but a minor, in the opinion of the treating doctor,9 must have “sufficient understanding and intelligence to understand fully what is proposed,” be “capable of making a reasonable assessment of the advantages and disadvantages of the proposed treatment,” and have “sufficient discretion … to make a wise choice in his or her own interests.”10