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20 - The law relating to consent
- Edited by Sue Eckstein, King's College London
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- Book:
- Manual for Research Ethics Committees
- Published online:
- 08 January 2010
- Print publication:
- 20 February 2003, pp 89-95
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Summary
General principles: treatment
Consent and battery
In general, medical treatment may only be given lawfully to a patient with that patient's consent. A doctor who acts without a patient's consent risks criminal prosecution for assault or, more likely, being sued for damages in the tort of battery. A signed consent form is only evidence (not conclusive) that a patient has given consent to a treatment. It is the reality of the patient's consent which is the concern of the law (Chatterton v. Gerson [1981]).
Exceptionally, medical treatment may be given without consent where the patient is unable to consent, for example, where the patient is unconscious in an emergency or where the patient is permanently unable to consent through mental disability and the treatment is reasonably necessary in that patient's best medical interests (Re F (A Mental Patient: Sterilisation) [1990]).
A valid consent in law requires three elements:
(i) the patient must be competent to consent;
(ii) the consent must be based upon adequate information;
(iii) the consent must be voluntarily given.
Competence to consent
A patient will be competent to give consent if he or she is capable of understanding what is involved in the medical treatment, including the procedure itself, its consequences and the consequences of non-treatment.
An adult patient (i.e. has attained the age of 18) will usually be presumed to be competent to understand a medical procedure unless there is good reason to doubt it, for example, if he or she is mentally ill, mentally disabled or affected by external factors such as drugs, alcohol, extreme pain, panic or shock.
2 - Research ethics committees and the law
- Edited by Sue Eckstein, King's College London
-
- Book:
- Manual for Research Ethics Committees
- Published online:
- 08 January 2010
- Print publication:
- 20 February 2003, pp 15-17
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Summary
The legal framework for the regulation of medical research on human beings has not been set out in legislation. As a result, many developments have taken place through the publication of official circulars and guidance. For example, the current framework for the functions and operation of Research Ethics Committees is described in the Department of Health document Governance Arrangements for NHS Research Ethics Committees (July 2001). This document replaces the Department of Health circular HSG(91)5 which required District Health Authorities to set up local Research Ethics Committees (LRECs) in 1991, and circular HSG(97)23 which dealt with the establishment of Multi-centre Research Ethics Committees (MRECs) in 1997. (These documents apply to England and Wales, but there are equivalent documents for Scotland.) These official publications do not have the same legal force as legislation. Therefore, Research Ethics Committees do not have the legal status of a statutory body, with clearly defined legal powers and duties. Thus, any authority that an Ethics Committee wields is informal and extralegal. Such authority should not, however, be underestimated. Within the National Health Service, the Governance Arrangements for NHS Research Ethics Committees places a clear responsibility upon Health Authorities to set up, support and monitor NHS Local Research Ethics Committees, and the Department of Health's document, The Research Governance Framework for Health and Social Care (2001), states: ‘The Department of Health requires that all research involving patients, service users, care professionals or volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical standards.’