2021 Conventions and Consent

1. 1) Universal Declaration of Human Rights 1948 2) Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research Involving Human Subjects, 1964 (and amended in 1975, 1983, 1989, 1996 and 2000) 3) International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences 1982 (and amended in 1993 and 2000) United Nations Convention on the Prevention and Punishment of the Crime of Genocide 1948 4) International Covenant on Civil and Political Rights 1966 5) United Nations International Covenant on Economic, Social and Cultural Rights 1966 United Nations Convention on the Rights of the Child 1989 6) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine of the Council of Europe 1997 7) Universal Declaration on the Human Genome and Human Rights 1997/98 8) The International Declaration on Human Genetic Data 2003 9) Universal Declaration on Bioethics and Human Rights 2005 10) NHS Green Book Chapter 2 **************************************************************************************************************** 1) Universal Declaration of Human Rights 1948 (30 Articles) Article 1 All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood. Article 4 No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms. Article 5 No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment Article 9 No one shall be subjected to arbitrary arrest, detentionor exile. Article 16 (3) The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.

2. Article 19 Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers. Article 21 (3) The will of the people shall be the basis of the authority of government; this will shall be expressed in periodic and genuine elections which shall be by universal and equal suffrage and shall be held by secret vote or by equivalent free voting procedures. Article 26 (3) Parents have a prior right to choose the kind of education that shall be given to their children. 2) World Medical Association – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, June, 1964 General Principles 3. The Declaration of Geneva of the WMAbinds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declaresthat, “A physician shall act in the patient’s best interest when providing medical care.” 4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty. 6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. 7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. 8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. Privacy and Confidentiality 24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

3. Informed Consent 25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees. 26. In medical research involving human subjectscapable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. Unproven Interventions in Clinical Practice 37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. 3) International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1966 (updated in 2002) The first international instrument on the ethics of medical research, the Nuremberg Code, was promulgated in 1947 as a consequence of the trial of physicians (the Doctors’ Trial) who had conducted atrocious experiments on unconsenting prisoners and detainees during the Second World War. The Universal Declaration of Human Rights was adopted by the General Assembly of the United Nations in 1948. To give the Declaration legal as well as moral force, the General Assembly adopted in 1966 the International Covenant on Civil and Political Rights. Article 7 of the Covenant states: ‘‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consentto medical or scientific experimentation’’.

4. The Declaration of Helsinki (2), issued by the World Medical Association in 1964, is the fundamental international document in the field of ethics in biomedical research and has influenced the formulation of international, regional and national legislation and codes of conduct. • It is through this statement that society expresses the fundamental human value that is held to govern all research involving human subjects—the protection of the rights and welfare of all human subjects of scientific experimentation. • All research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and justice. • Respect for persons incorporates at least two fundamental ethical considerations, namely: • respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination • b)Beneficence refers to the ethical obligation to maximize benefit and to minimize harm. This principle gives rise to norms requiring that the risks of research be reasonable in the light of the expected benefits, that the research design be sound, and that the investigators be competent both to conduct the research and to safeguard the welfare of the research subjects. Beneficence further proscribes the deliberate infliction of harm on persons; this aspect of beneficence is sometimes expressed as a separate principle, non-maleficence (do no harm or ‘non prenumnocere’). • Exceptionally, a physician may undertake the compassionate use of an investigational therapy before obtaining the approval or clearance of an ethical review committee, provided three criteria are met: • 1. a patient needs emergency treatment, • 2. there is some evidence of possible effectiveness of the investigational treatment, and, • 3. there is no other treatment available that is known to be equally effective or superior. • Informed consent should be obtained according to the legal requirements and cultural standards of the community in which the intervention is carried out. • Commentary on Guideline 4 (page 33) • General considerations. • Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation. Informed consent is based on the principle that competent individuals are entitled to choose freely whetherto participate in research. Informed consent protects the individual’sfreedom of choice and respects the individual’s autonomy.

5. Each individual must be given as much time as is needed to reach a decision, including time for consultation with family members or others. Adequate time and resources should be set aside for informed-consent procedures. 4/5The International Covenant on Civil and Political Rights (ICCPR) (53 Articles) Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966, entry into force 23 March 1976, in accordance with Article 49 PART I - Article 1 1. All peoples have the right of self-determination. By virtue of that right they freely determine their political status and freely pursue their economic, social and cultural development. Article 4 1. In time of public emergency which threatens the life of the nation and the existence of which is officially proclaimed, the States Parties to the present Covenant may take measures derogating from their obligations under the present Covenant to the extent strictly required by the exigencies of the situation, provided that such measures are not inconsistent with their other obligations under international law and do not involve discrimination solely on the ground of race, colour, sex, language, religion or social origin Article 6 1. Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life. 3. When deprivation of life constitutes the crime of genocide, it is understood that nothing in this article shall authorize any State Party to the present Covenant to derogate in any way from any obligation assumed under the provisions of the Convention on the Prevention and Punishment of the Crime of Genocide. PART II - Article 7 No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation. Article 8 1. No one shall be held in slavery; slavery and the slave-trade in all their forms shall be prohibited. 2. No one shall be held in servitude

6. Article 9 • 1.Everyone has the right to liberty and security of person. No one shall be subjected to arbitrary arrest or detention. No one shall be deprived of his libertyexcept on such grounds and in accordance with such procedure as are established by law. • 2.Anyone who is arrested shall be informed, at the time of arrest, of the reasons for his arrestand shall be promptly informed of any charges against him. • 4. Anyone who is deprived of his liberty by arrest or detention shall be entitled to take proceedings before a court, in order that that court may decide without delay on the lawfulness of his detention and order his release if the detention is not lawful. • 5. Anyonewho has been the victim of unlawful arrest or detention shall have an enforceable right to compensation. • Article 11 • No one shall be imprisoned merely on the ground of inability to fulfil a contractual obligation. • Article 12 • 3. The above-mentioned rights shall not be subject to any restrictions except those which are provided by law, are necessary to protect national security, public order (ordre public), public healthor morals or the rights and freedoms of others, and are consistent with the other rights recognized in the present Covenant. • Article 14 • 2. Everyone charged with a criminal offence shall have the right to be presumed innocent until proved guilty according to law. (See point 3(a) through (g)) • Article 18 • 1. Everyoneshall have the right to freedom of thought, conscience and religion. This right shall include freedom to have or to adopt a religion or belief of his choice, and freedom, either individually or in community with others and in public or private, to manifest his religion or belief in worship, observance, practice and teaching. • 3. Freedom to manifest one's religion or beliefsmay be subject only to such limitations as are prescribed by law and are necessary to protect public safety, order, health, or morals or the fundamental rights and freedoms of others. • Article 20 • Any propaganda for war shall be prohibited by law. • 2. Any advocacy of national, racial or religious hatred that constitutes incitement to discrimination, hostilityor violence shall be prohibited by law.

7. Article 23 1. The family is the natural and fundamental group unit of societyand is entitled to protection by society and the State.

8. 6) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997, Council of Europe Chapter II –Consent; Article 5 General rule An interventionin the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. Article 9 – Previously expressed wishes The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account. Chapter III – Private life and right to information Article 10 – Private life and right to information 1. Everyone has the right to respect for private life in relation to information about his or her health. Article 16 – Protection of persons undergoing research v the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time. Chapter VI – Organ and tissue removal from living donors for transplantation purposes Article 19 – General rule 2 The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body. Article 21 – Prohibition of financial gain The human body and its parts shall not, as such, give rise to financial gain. Chapter VIII – Infringements of the provisions of the Convention Article 24 – Compensation for undue damage The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.

9. 7) Universal Declaration on the Human Genome and Human Rights 1997/98 (25 Articles) (Adopted on the report of Commission III at the 26th plenary meeting, on 11 November 1997) Solemnly recalling its attachment to the universal principles of human rights, affirmed in particular in the Universal Declaration of Human Rights of 10 December 1948 and in the two International United Nations Covenants on Economic, Social and Cultural Rights and on Civil and Political Rightsof 16 December 1966 Proclaims the principles that follow and adopts the present Declaration. A. Human dignity and the human genome Article 1 The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity. Article 2 (a) Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics. (b) That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity. Article 4 The human genome in its natural state shall not give rise to financial gains. B. Rights of the persons concerned Article 5 (a) Research, treatment or diagnosis affecting an individual’s genome shall be undertaken only after rigorous and prior assessment of the potential risks and benefits pertaining thereto and in accordance with any other requirement of national law. (b) In all cases, the prior, free and informed consent of the person concerned shall be obtained. If the latter is not in a position to consent, consent or authorization shall be obtained in the manner prescribed by law, guided by the person’s best interest. Article 6 No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity.

10. Article 7 Genetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose must be held confidential in the conditions set by law. Article 8 Every individual shall have the right, according to international and national law, to just reparation for any damage sustained as a direct and determining result of an intervention affecting his or her genome 8) The International Declaration on Human Genetic Data 2003 (27 Articles) (Resolution adopted on the report of Commission III at the 20th plenary meeting, on 16 October 2003) The General Conference Recalling the Universal Declaration of Human Rights of 10 December 1948, the two United Nations International Covenants on Economic, Social and Cultural Rightsand on Civil and Political Rights of 16 December 1966. Recalling more particularly the Universal Declaration on the Human Genome and Human Rightswhich it adopted, unanimously and by acclamation, on 11 November 1997 A. General provisions Article 2 – Use of terms For the purposes of this Declaration, the terms used have the following meanings: (i) Human genetic data: Information about heritable characteristics of individuals obtained by analysis of nucleic acids or by other scientific analysis; (ii) Human proteomic data: Information pertaining to an individual’s proteins including their expression, modification and interaction; (iii) Consent: Any freely given specific, informed and express agreement of an individual to his or her genetic data being collected, processed, used and stored; Article 3 – Person’s identity Each individual has a characteristic genetic make-up. Nevertheless, a person’s identity should not be reduced to genetic characteristics, since it involves complex educational, environmental and personal factors and emotional, social, spiritualand cultural bondswith others and implies a dimension of freedom. Article 6 Procedures (d) It is ethically imperative that clear, balanced, adequate and appropriate information shall be provided to the person whose prior, free, informed and express consent is sought. Such information shall, alongside with providing other necessary details, specify the purpose for which human genetic data and human proteomic data are being derived from biological samples, and are used and stored. This information should indicate, if necessary, risks and consequences.

11. This information should also indicate that the person concerned can withdraw his or her consent, without coercion, and this should entail neither a disadvantage nor a penalty for the person concerned. • B. Collection • Article 8 – Consent • (a) Prior, free, informed and express consent, without inducement by financial or other personal gain, should be obtained for the collection of human genetic data, human proteomic data or biological samples, whether through invasive or non-invasive procedures, and for their subsequent processing, use and storage, whether carried out by public or private institutions. Limitations on this principle of consent should only be prescribed for compelling reasons by domestic law consistent with the international law of human rights. • Article 9 – Withdrawal of consent • When human genetic data, human proteomic data or biological samples are collected for medical and scientific research purposes, consent may be withdrawn by the person concernedunless such data are irretrievably unlinked to an identifiable person. In accordance with the provisions of Article 6(d), withdrawal of consent should entail neithera disadvantage nor a penalty for the person concerned. • (b) When a person withdraws consent, the person’s genetic data, proteomic data and biological samples should no longer be usedunless they are irretrievably unlinked to the person concerned. • C. Processing • Article 13 – Access • No one should be denied access to his or her own genetic data or proteomic data unless such data are irretrievably unlinked to that person as the identifiable source or unless domestic law limits such access in the interest of public health, public order or national security.

12. 9) Universal Declaration on Bioethics and Human Rights 2005 (28 Articles) Recalling the Universal Declaration of Human Rights of 10 December 1948, the Universal Declaration on the Human Genome and Human Rights adopted by the General Conference of UNESCO on 11 November 1997 and the International Declaration on Human Genetic Dataadopted by the General Conference of UNESCO on 16 October 2003, noting the United Nations International Covenant on Economic, Social and Cultural Rightsand the International Covenant on Civil and Political Rightsof 16 December 1966, Also noting international and regional instruments in the field of bioethics, including the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine of the Council of Europe, which was adopted in 1997 and other texts in the field of bioethics, such as the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research Involving Human Subjects, adopted in 1964 and amended in 1975, 1983, 1989, 1996 and 2000 and the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences, adopted in 1982 and amended in 1993 and 2002. General provisions Principles Within the scope of this Declaration, in decisions or practices taken or carried out by those to whom it is addressed the following principles are to be respected. Article 3 – Human dignity and human rights 1. Human dignity, human rights and fundamental freedoms are to be fully respected. 2. The interests and welfare of the individual should have priority over the sole interest of science or society. Article 4 – Benefit and harm In applying and advancing scientific knowledge, medical practice and associated technologies, direct and indirect benefits to patients, research participantsand other affected individuals should be maximized and any possible harm to such individuals should be minimized. Article 5 – Autonomy and individual responsibility The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests. Article 6 – Consent 1. Any preventive, diagnostic and therapeutic medical interventionis only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

13. 2. Scientific researchshould only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law. Article 9 – Privacy and confidentiality The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law. Article 10 – Equality, justice and equity The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably. Article 11 – Non-discrimination and non-stigmatization No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms. Article 16 – Protecting future generations The impact of life sciences on future generations, including on their genetic constitution, should be given due regard. ANNEX II Statements on the interpretation of specific provisions of the Universal Declaration on Bioethics and Human Rights United Kingdom of Great Britain and Northern Ireland The United Kingdom has carefully considered its position with regard to this Declaration. We feel that the revised text following the June meeting of experts represents an outcome with which we are content. The United Kingdom’s interpretation, consistent with international and domestic law, with regard to the Articles 7(b) and 9 of the current draft, is the following: First, Article 7(b), the United Kingdom interprets this as research involving those without capacity to consent should be carried out for his and/or her potential health benefit as research is about innovation and uncertainty.

14. Second, Article 9, we interpret that information not to be used or disclosed for purposes other than those for which it was collected or consented to, relates to confidential personal information. For the United Kingdom, confidential personal information should not be used or disclosed in a form that may identify the person concerned but there are separate issues in the use of anonymized and non-confidential information. Resolution 2361 (2021) Parliamentary Assembly Council of Europe Vaccination

15. https://www.gov.uk/government/organisations/health-and-social-care-information-centrehttps://www.gov.uk/government/organisations/health-and-social-care-information-centre https://en.wikipedia.org/wiki/NHS_Digital - Formed April 01, 2013 - NHS Digital is the trading name of the Health and Social Care Information Centre

16. 10) NHS Green Book Chapter 2 1Consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by a clinician. Consent from a patient is needed regardless of the procedure, whether it's a physical examination, organ donation or something else.

20. The principle of consent is an important part of medical ethics and international human rights law. Defining consent For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The meaning of these terms are: voluntary – the decision to either consentor not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family informed – the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead capacity – the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision If an adult has the capacity to make a voluntary and informed decision to consent to or refuse a particular treatment, their decision must be respected. How consentis given Consent can be given: verbally– for example, a person sayingthey're happy to have an X-ray in writing – for example, signing a consent formfor surgery • 1https://www.nhs.uk/conditions/consent-to-treatment/ - Next review due: 29 March 2022

21. General Medical Council - Consent: patients and doctors making decisions together, 2008 (Guidance) 14. If, after discussion, a patient still does not want to know in detail about their condition or the treatment, you should respect their wishes, as far as possible. But you must still give them the information they need in order to give their consent to a proposed investigation or treatment. This is likely to include what the investigation or treatment aims to achieve and what it will involve, for example: whether the procedure is invasive; what level of pain or discomfort they might experience, and what can be done to minimise it; anything they should do to prepare for the investigation or treatment; and if it involves any serious risks. Expressions of consent 44. Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded. 45 Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their blood pressure taken. 47. In cases that involve higher risk, it is important that you get the patient’s written consent. This is so that everyone involved understands what was explained and agreed. 48. By law you must get written consent for certain treatments, such as fertility treatment

24. General Medical Council - Good medical Practice, 2013 16. In providing clinical care you must: prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatmentserve the patient’s needs9 b) provide effective treatments based on the best available evidence e) respect the patient’s right to seek a second opinion 17. You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research. Communicate effectively 31. You must listen to patients, take account of their views, and respond honestly to their questions. 32. You must give patients the information they want or need to know in a way they can understand. 52. You must explain to patients if you have a conscientious objection to a particular procedure. You must tell them about their right to see another doctor and make sure they have enough information to exercise that right. In providing this information you must not imply or express disapproval of the patient’s lifestyle, choices or beliefs. 55. You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should: a put matters right (if that is possible) b offer an apology c explain fully and promptly what has happened and the likely short-term and long-term effects. 62. You should end a professional relationship with a patient only when the breakdown of trust between you and the patient means you cannot provide good clinical care to the patient. 64. If someone you have contact with in your professional role asks for your registered name and/or GMC reference number, you must give this information to them. 65. You must make sure that your conduct justifies your patients’ trust in you and the public’s trust in the profession.

25. Resolution 2361 (2021) Parliamentary Assembly Council of Europe Vaccination The Future of Informed Consent in British Common Law European Journal a/Health Law 6: 235-248, 1999. 1. Informed Consent as a Doctrine in Common Law Jurisdictions Medical and surgical procedures constitute prima facie assaults unless authorised by the patient's consent1A patient is unlikely to give consent for an operation to be performed without reasonable care. The term must be seen in the context of the operation of the common law. Its judicial application is a way of balancing the physician's legal duty to provide information with the patient's right to make an autonomous choice. Perhaps the most fitting definition of the doctrine is in Harnish v Children’s Hospital Medical Center: , ... aphysician owes to his patient the duty to disclose in a reasonable manner all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient whether to undergo a proposed procedure4 In Canterbury v Spence it was held that ‘True consent to what happens to one's self is the informed exercise of a choice, and that entails the opportunity to evaluate knowledgeably the options available and the risks attendant upon each5

26. Risk Chester v Afshar [2004] UKHL 41 Pt 2 - The duty to warn patients about risk “A surgeon owes a general duty to a patient to warn him or her in general terms of possible serious risks involved in the procedure. The only qualification is that there may be wholly exceptional cases where objectively in the best interests of the patient the surgeon may be excused from giving a warning…In modern law medical paternalism no longer rules and a patient has a prima facie right to be informedby a surgeon of a small, but well-established, risk of serious injuryas a result of surgery.” Refusal of treatment Re C (Adult, refusal of treatment) [1994] 1 All ER 819 Patients who have capacity (that is, who can understand, believe, retainand weigh the necessary information) can make their own decisions to refuse treatment, even if those decisions appear irrational to the doctor or may place the patient’s health or their life at risk. Capacity to refuse treatment Re MB (Adult, medical treatment) [1997] 38 BMLR 175 CA An individual’s capacity to make particular decisions may fluctuateor be temporarily affected by factors such as pain, fear, confusion or the effects of medication Right of a patient who has capacity to refuse life-prolonging treatment Re B (Adult, refusal of medical treatment) [2002] 2 All ER 449 A competent patient has the right to refuse treatment and their refusal must be respected, even if it will result in their death. The right of a competent pregnant woman to refuse treatment even if that refusal may result in harm to her or her unborn child/Application of the Mental Health Act 1983. St George’s Healthcare NHS Trust v S; R v Collins and others, ex parte S [1998] 3 All ER 673 A competent pregnant woman can refuse treatment even if that refusal may result in harm to her or her unborn child. Patients cannot lawfully be detained and compulsorily treated for a physical condition under the terms of the Mental Health Act.