Informed Consent Presentation PDF

Informed Consent Dr Brad Beira Mtech C, ICSSD, AHLF, BCom Law, LLM Introductions Orientation The presentation will address many of the Acts, Regulations, and legal obligations relating to the professional conduct and practice management. This includes all health care related leg...

Informed Consent Dr Brad Beira Mtech C, ICSSD, AHLF, BCom Law, LLM Introductions Orientation The presentation will address many of the Acts, Regulations, and legal obligations relating to the professional conduct and practice management. This includes all health care related legislation and regulations, OSHE, COID, POPI & PAIA, the Consumer Protection Act and Acts and laws governing contracts, therapeutic agreements and our duties and obligations in managing our practices. We discuss the key components of ethical conduct and consider how this relates to your professional behaviour within the context of your hospital environment, private practice, your communication and disclosures to patients, colleagues and other parties. Agenda The Therapeutic Landscape Medical Law and Professional Conduct The ‘Laws of the Land’ The Legal Landscape of Medical Practice Informed Consent, Disclosure, Record Keeping Telehealth, Social Media https://medpharm.ie/code-of-conduct-professional-principles-standards-and-ethics-for-pharmacists/ Ethical Practice Ethical practice relies on the balance we maintain as practitioners between our HEALTHCARE responsibilities to ourselves, our colleagues, LIFECYCLE and our patients, whereby we encourage their responsibilities to their own care and ensure our compliance with the rules and regulations that govern how we operate our practices while providing access to health services. Informed Adjective having or showing knowledge of a subject or situation: "an informed readership" Knowledgeable; enlightened; illuminated; literate (of a decision or judgement) based on an understanding of the facts of the situation: "she lacks the ability to make an informed decision" · "obtaining informed consent from research participants is central to ethical research practice" Consent Consent is the voluntary agreement or approval of what is done or proposed by another. Consent requires that the person giving consent has the age, mental capacity, knowledge, and understanding to make a decision, and is not under duress or coercion. Consent can be given to various actions, such as medical treatment, sexual activity, or marriage Medical Law Body of rules that relate directly to the care of health and is the concern of a complex group of professions dealing not only with patients and diseases, but also with healthy people and public health (provide access to health care, Section 9, 12, 27 & 36 – Bill of Rights) Body of rules relating to: The medical profession The relationship between doctor/patient/hospital Relationship between medical profession and other health care workers The doctor and health care legislation Duties and Obligations For human beings there are “natural duties”, namely un-acquired general duties simply because we are members of the human community. These are the natural duties to refrain from doing harm, to promote the good, or to be fair and just For health professionals there are “moral obligations”, namely general duties we acquire by being qualified and registered as healthcare professionals. These are the professional duties to provide health care, relieve pain, gain informed consent, respect confidentiality, and be truthful Professional obligations If a health care professional chooses to make known that he or she practises in a specific field, the health care professional assumes a legal and ethical responsibility for having acquired a level of professional competence within that field of expertise which must be demonstrable and acceptable to his or her peers. Principles of Medical Ethics - Professionalism All professions are characterized by four core elements: (1) a monopoly over the use of specialized knowledge; (2) in return for that monopoly that we enjoy, relative autonomy in practice and the responsibility of self-regulation; (3) altruistic service to individuals and society; and (4) responsibility for maintaining and expanding professional knowledge and skills. Professionalism describes the cognitive, moral, and collegial attributes of a professional. Ultimately, it is all the reasons that your mother is proud to say that you are a doctor and a surgeon Principles of Medical Ethics - HPCSA Being registered as a health care professional with the Health Professions Council of South Africa (HPCSA) confers on us the right and privilege to practise our professions. Correspondingly, practitioners have moral or ethical duties to others and society. These duties are generally in keeping with the principles of the South African Constitution (Act No. 108 of 1996) and the obligations imposed on health care practitioners by law HPCSA Booklet 1, 2 & 3 Principles of Medical Ethics The foundation of professional conduct in medicine is open, honest, respectful, and sensitive communication with patients, fellow healthcare providers, and other interested parties Ethical and Legal Issues in Neurology, Emily B. Rubin, in Handbook of Clinical Neurology, 2013 Pursuit of the just and equitable distribution of finite resources Commitment to improving quality of care U. Mini B. Swift MD, MPH, FACP,... Alden H. Harken MD, FACS, in Abernathy's Surgical Secrets (Seventh Edition), 2018 Principles of Medical Ethics Trust is integral to the practice of medicine. The code of professional conduct clarifies the relationship between the HC profession and the society it serves. This is often referred to as a social contract. For patients, the code of professional conduct crystallizes the commitment of the surgical community toward individual patients and their communities. Trust is built brick by brick. https://www.sciencedirect.com/sdfe/pdf/download/eid/3-s2.0-B9780323478731001078/first-page-pdf motives, methods, and actions shall at all times be above reproach and conducted with respect for human dignity Current Ethical Guidelines and a Theory of Ethics. Nicholas V. Passalacqua, Marin A. Pilloud, in Ethics and Professionalism in Forensic Anthropology, 2018 Unprofessional Conduct “improper or disgraceful or dishonourable or unworthy conduct or conduct which, when regard is had to the profession of a person who is registered in terms of this Act, is improper or disgraceful or dishonourable or unworthy” Allied Health Professionals Act - https://ahpcsa.co.za/wp-content/uploads/2015/10/The-Allied-Health-Professions-Act-63-of-1982-_as-amended.pdf ; Code of Ethics https://ahpcsa.co.za/wp-content/uploads/2015/10/39531_18-12_NationalGovernment-1.pdf Forty-three per cent of the findings of unprofessional conduct have been in the 'criminal/dishonesty' category Seven year overview (2007-2013) of ethical transgressions by registered healthcare professionals in South Africa Willem Hoffmann et al., South African Health Review Legislative Framework SA CONSTITUTION – CHPT 2, Bill of Rights HEALTH PROFESSIONS ACT, 1974 (ACT NO. 56 OF 1974) ETHICAL RULES OF CONDUCT FOR PRACTITIONERS REGISTERED UNDER THE HEALTH PROFESSIONS ACT, 1974 The Health Professions Council of South Africa, in consultation with the professional boards, has, under section 49 of the Health Professions Act, 1974 (Act No. 56 of 1974), made the rules in the Schedule. Legislation – Private Practice SA Constitution, 1996 & Bill of Rights [Chpt 2] National Health Act, 2003; Mental Health Act, 2002 Allied Health Professions Act, 1982 [AHPCSA] Health Professions Act, 1982 [HPCSA] Nursing Act, 2005 Pharmacy Act, 1974 Traditional Health Practitioners Act, 2007 Children’s Act, 2005; Older Persons Act, 2006; Legislation - Communication Protection of Personal Information Act, 2013 Promotion of Access to Information Act, 2000 [s53&61], Consumer Protection Act, 2008; Financial Intelligence Centre Act [FICA], 2001; Electronic Communications and Transmissions Act, 2002; Regulation of Interception of Communications and Provision of Communication-Related Information Act (RICA), 2003; The Protection of Personal Information Act outlaws the acquisition of data about an individual’s personal information [health or sex life] outside the healthcare setting, and by having access to patients’ social media profiles, health care practitioners may find themselves privy to personal patient information that has not been shared in the healthcare setting risk = Invasion of Privacy Legislation – Payment of fees Banks Act 1990 ; FAIS Act, 2002; Insurance Act, 2017 Medical Schemes Act, 1998 Council for Medical Schemes Levies Act , 2000 COID Act, 1993 Information on payment arrangements must be limited to statements relating to formal arrangements, e.g. "credit cards acceptable", “cash only”, etc. Reference may not be made to discounts or quantum of fees. [billing and collection of fees] Legislation – Employment law Occupational Health & Safety Act, 1993 Compensation for Occupational Injuries & Diseases Act, 1993 Labour Relations Act, 1995 Basic Conditions of Employment Act, 1997 Employment Equity Act, 1998 Promotion of Equality & Prevention of Unfair Discrimination Act, 2000 [certificates of indisposition / injury & incapacity / fitness to work] Additional Legislation Medicines and Related Substances Act, 1997 Schedules of the Medicines and Related Substances Act, 2020 SA Research Council Act, 1991 & SAHPRA Prevention and Treatment of Drug Dependency Act, 1992 Drug Safety Act, 2000 Inquests Act, 1959 Criminal Procedure Amendment Act, 1986 Correctional Services Act, 1998 Additional Legislation National Road Traffic Act, 1996 Domestic Violence Act, 1998 Promotion of Administrative Justice Act, 2000 Institute for Drug-Free Sport Act, 1997 SASCOC and related Acts and Regulations Additional Legislation Human Tissue Act, 2018 Choice on Termination of Pregnancy Act, 2006 Sterilisation Act, 1998 Births and Deaths Registration Act, 1992 Reflection Legal landscape SA Constitution, 1996 & Bill of Rights [Chpt 2] National Health Act, 2003 Mental Health Act, 2002 Allied Health Professions Act, 1982 [AHPCSA] Legislation Health Professions Act, 1982 [HPCSA] Nursing Act, 2005 Pharmacy Act, 1974 1 Traditional Health Criminal Action - Inquest Practitioners Act, 2007 Regulation Protection of Personal 6 2 Information Act, 2013 Promotion of Access to Information Act, 2000 [s53&61] Civil Action - Negligence Consumer Protection Act, 5 3 2008 Electronic Communications 4 Guidelines and Transmissions Act, 2002 Regulation of Interception of Communications and HPCSA / AHPCSA / SANC Provision of Communication- disciplinary action Related Information Act (RICA), 2003 Medical Schemes Act Childrens Act Medscape Malpractice Survey 31 Cold Black Letter of the Law Informed Consent SA Constitution CHPT 2 – Bill of Rights National Health Act Section 6 & 7 – legal requirements of consent HPCSA – Code of Ethics Booklet 1, 2, 3, 4, 5, 6, 9, 10, 16 Natural duties, and moral obligations, institutional duties and legal duties 34  Inform: tell someone about specific facts Defining Informed Consent Consent: agree to do something / allow someone to do something i.e. to allow someone to do something after being told particular facts Doctrine of volenti non fit injuria (to a willing person, injury is not done) A patient’s knowing choice about a 1. It must be recognised by law and not contra bonos mores; medical treatment or procedure 2. Given by a person capable in law (Intention & Understanding); made after a physician or other 3. Free and voluntary; healthcare provider discloses 4. Knowledge and awareness of nature and extent of harm/risk; whatever information a reasonably 5. Appreciated and understood the nature and extent of harm/risk; prudent provider in the medical 6. Consented to the harm or assumed the risk; community would give to a patient 7. Consent must be comprehensive extended to entire transaction and regarding the risks involved in the inclusive of consequences; proposed treatment or procedure 8. Clear and unequivocal; 9. Proceed the conduct in question; Blacks Law Dictionary 10.Manifest externally to qualify as a legal act; 11.Conduct must not exceed the consent given 35  Defining Informed National Health Act Consent Section 6 – User to have full knowledge (1) Every health care provider must inform the user of the user’s The Constitution a) health status except in circumstances where there is substantial evidence Key Bill of Rights phrases: that the disclosure of the user’s health status would be contrary to the best “Security in” & “Control of” interest of the user; d) right to refuse health services and explain the implications & risks … everyone has the right to 12 (1) (c) - ….to be free from all forms In terms of giving over information for informed consent: of violence from either public or Section 6 (2) – the healthcare provider must... inform the user … private sources; in a language that the user understands and in a manner which 12 (2)(b) –….bodily and considers the user’s level of literacy. psychological integrity which includes the right to security in and control of their body; 36  National Health Act 61 of 2003 – Section 7 Defining Informed Consent Section 7 (1) – consent of the user must be obtained unless a) The user is unable to give informed consent and consent is given by a person mandated in writing or authorised by law / court order; b) …Consent given by spouse or partner, parent, grandparent, an adult child or brother or sister of the user, in the specific order; c) ….Authorised in terms of any law or a court order; d) Failure to treat the user … Will result in a serious risk to public health; e) Any delay…may result in death or irreversible damage to his/her health 37  Stoffberg v Elliot 1923 Case Law “Any bodily interference with our restraint of a man’s person which is not justified in law,…,or consented to, is a wrong,…” Casteel v De Greef 1994 (locus classicus) Negligence vs Assault (injuria) “…the doctor’s duty to disclose a material risk must be seen in the contractual setting of an unimpeachable consent to the operation and its sequelae”; Richter and Another v Estate “… a physician’s failure to adequately inform a patient constitutes assault and Hammarin (1976) not negligence … Reference to Rogers v Whitaker – “….the doctor has a duty “If he fails to disclose the risks he may to warm a patient of a material risk inherent in a proposed treatment…this render himself liable to an action for duty is subject to therapeutic privilege”. assault, whereas if he discloses them he may well frighten the patient into Louwrens v Oldwage 2006 not having the operation…” Question was raised as to what degree of risk should be disclosed to a patient. Plaintiff must show that the McDonald v Wroe 2006 practitioner intentionally did not No informed consent – violation of plaintiff’s right to bodily integrity. obtain informed consent 38  Section 27A. A practitioner shall at all times Ethical Rules ….b) respect patient confidentiality, privacy, choices and dignity; ….d) provide adequate information about the patient’s diagnosis, treatment options and alternatives, costs associated with each such HPCSA – General Ethical Rules alternative and any options and alternatives … to enable the patient Booklet 2 – section 27A to exercise a choice in terms of treatment and informed decision- making pertaining to his or her health and that of others; Main responsibilities of health ….g) except in an emergency, obtain informed consent from a patient practitioners or, in the event that the patient is unable to provide consent for treatment himself or herself, from his or her next of kin ….. Respect Respect 4 Golden rules Respect Obtain consent from the person legally competent to give consent; Obtain an informed consent; Obtain a clear and unequivocal consent; Obtain a comprehensive consent Strauss 1990 39  Update on Informed Consent Montgomery v Lanarkshire, 2015  “a patient should be told whatever they want to know, not what the doctor thinks they should be told”  “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” BMJ 2017;357 40  Update on Informed Consent Shinal v Toms, 2017  a physician's duty to provide information to a patient sufficient to obtain her informed consent is non delegable  the landmark decision, potentially leaves HCP’s vulnerable to legal action if a physician delegates informed consent to another member of the patient’s care team 41 Summary Informed Consent If they have the maturity to do so, children aged 12 or above may consent to medical treatment on their own behalf and to surgical treatment with the assistance/ascent of a parent or guardian For consent to be valid, the person giving the consent must be given all relevant information, including the material risks and consequences of each option, including no treatment  Summary Informed Consent HIV testing without the patient's consent is illegal, except in circumscribed situations authorised by law When a patient loses decisional capacity, an advance directive made when he or she was still competent must be honoured, unless there are good reasons for believing that the patient has changed his or her mind  Medical Records AHPCSA – Maintaining a professional All descriptions of physical findings – e.g. swelling, bump, redness – need practice S3 D7, F 2(c) qualification such as ‘firm’, soft’, ‘spongy’ to add the necessary clarity and detail HPCSA – Guidelines on the keeping of medical records Booklet 9 ‘Cold words of the record’ is the only factual basis that the court has to ascertain the accuracy and detail of the examination and the resultant findings which informed the diagnostic opinion and subsequent treatment Health Record plan “any relevant record made by a health AM and another v MEC Health, Western Cape (2020) para 30 care practitioner at the time of or subsequent to a consultation and / or examination or the application of “If it’s not there, it wasn’t done” – Dr Goosen (as above) health management” *** remember *** Promotion of Access to Information Act 45 & Protection of Personal Information Act  A health record contains the information about the health of an identifiable individual recorded by a health care professional, either personally or at his Medical Records or her direction. (a) Personal particulars of the patient. (b) History of the patient's health conditions. Health Record (c) The time, date and concise information of every consultation. (d) The assessment of the patient’s condition. “any relevant record made by a (e) The proposed healthcare management of the patient. health care practitioner at the time (f) Details of referrals to other health professionals, if any of or subsequent to a consultation (g) The patient’s reaction to treatment, including adverse effects. and / or examination or the (h) Self-serving or disapproving comments should be avoided in patient application of health management” records. (i) Written proof of informed consent, where applicable. (j) Records must be retained for the period of time prescribed by relevant legislation that applies to the particular circumstance. (k) Accounting records must be kept separately from patient care records 46  Retaining Records Health records should be stored for a period of not less than six (6) years as from the date they became dormant. Health records should be stored in a safe place and if they are in electronic In the case of minors and those patients who are mentally incompetent, format, safeguarded by passwords. health care practitioners should keep the records for a longer period: Practitioners should satisfy themselves For minors under the age of 18 years health records should be kept until the that they understand the AHPCSA’s minor’s 21st birthday because legally minors have up to three years after guidelines with regard to the retention they reach the age of 18 years to bring a claim. of patient records on computer compact discs. This would apply equally for obstetric records. Health records kept in a provincial In terms of the Occupational Health and Safety Act (Act No. 85 of 1993) hospital or clinic shall only be health records must be kept for a period of 20 years after treatment. destroyed as authorised by the Deputy Director-General concerned. 47 Access to Records 11.1.1 A health care practitioner shall provide any person of age 12 years and older with a copy or abstract or direct access to his or her own records regarding medical treatment on request (Children’s Act (Act No. 38 of 2005)). 11.1.2 Where the patient is under the age of 16 years, the parent or legal guardian may make the application for access to the records, but such access should only be given on receipt of written authorization by the patient (Promotion of Access to Information Act (Act No. 2 of 2000)). 48 Access to Records 11.1.3 Information about termination of a pregnancy may not be divulged to any party, except the patient herself, regardless of the age of the patient (Choice on Termination of Pregnancy Act (Act No. 92 of 1996)). 11.1.4 No health care practitioner shall make information available to any third party without the written authorisation of the patient or a court order or where nondisclosure of the information would represent a serious threat to public health (National Health Act (Act 61 of 2003)). In terms of PAIA - Paul v MEC for Health, Eastern Cape Provincial Government and Others ; Mbobo v MEC for Health ,Eastern Cape Provincial Government and Others; Ncumani v MEC for Health, Eastern Cape Province and Others (5031/2018; 5108/2018; 5689/2018) ZAECMHC 18; 3 All SA 879 (ECM) (29 March 2019) 49 Social Media Social media describes the online tools and electronic platforms that people use to share content such as opinions, information, photos, videos and audio Social media includes social networks (e.g. Facebook, Twitter, WhatsApp and LinkedIn), content-sharing platforms (e.g. YouTube and Instagram), personal and professional blogs (including email, SMS, electronic journals as well as those published anonymously), internet discussion forums, and the comment sections of websites HPCSA – Booklets 16, S3.2 HPCSA regulations The utilization of any social media (not limited to social networks such as FACEBOOK) may take place within the provisions of the relevant laws and regulations, including, but not limited to, the laws and regulations applicable to the professions registered under the AHPCSA HPCSA Booklet 16 HPCSA regulations – Legislation to consider Section 36 of the Bill of Rights provides for the limitation of a right to the extent that the limitation is reasonable and justifiable in an open and democratic society, based on human dignity, equality and freedom, taking into account all relevant factors including among other things the nature of the right and the nature and extent of the limitation. CHPT 2, Constitution of SA The manner and extent of social media interaction also bears reflection within the paradigm of the Consumer Protection Act, 2008 (Act 68 of 2008). HPCSA Booklet 16 HPCSA regulations No practitioner may interact on social networks in any manner which might be construed as defamatory or might fall into the lesser category of contumelia, or insult, either to other individual practitioners, to the profession as a whole or to the HPCSA itself; these interactions infringe on the rights enjoyed by parties so affected Social media should never be used in a way that breaches any of the prescribed Code of Ethics, policies or regulations HPCSA Booklet 16 HPCSA regulations Interaction with any patient on any open web- or social media site accessible by the public or any other third party (other than the practitioner and consumer/patient) in a manner that is associated with the condition of that patient or constitutes medical advice is disallowed The ethical and legal duty to protect patient confidentiality applies equally on Internet as to other media. Practitioners who post online have an ethical obligation to declare any conflicts of interest HPCSA Regulations There are ethical obligations and responsibilities imposed on health practitioners regarding their relationships with their patients and each other: The HPCSA advises practitioners not to accept as friends, followers or any other means of interaction, any patient onto any personal social media profile. The HPCSA further advises that practitioners should be conscious of their online image and how it may impact on their professional standing or the professional standing of their profession SA Legal perspective “Social media sites and applications include Facebook, WhatsApp, Twitter, MySpace, LinkedIn, YouTube and Instagram.” A Legal Perspective on Social Media Use and Employment: Lessons for South African Educators (Vol 22) PER 7 (saflii.org) Consent to share data Health practitioners must obtain the written consent of the patient before publishing information (e.g. case histories and photographs) about them in media to which the public has access, whether or not the health care practitioner believes the patient can be identified by the data If the patient is a minor under the age of 12 years old, the health care practitioner will require the written consent of the patient’s parent or guardian and assent of the minor Health practitioners sharing information or data for the sake of diagnosis, treatment or education and training through social media must ensure that the recipient of the information is not able to identify the patient from the data disclosed HPCSA – Booklet 5, S2.2 & 16, S6.3-5 Disclaimers Health practitioners may engage fully in debates on health matters, however they must be aware that the laws regarding defamation, hate speech and copyright also extend to content shared via social media Health practitioners are advised to include disclaimers in their social media profiles, indicating that the views expressed therein are their own and not those of the health profession or the health establishment they represent This does not absolve the health care practitioner from the above rules Social Consultation What do you think? Do I need care? What should I do? NOT Telehealth Telehealth vs. social media Except in an emergency or life-threatening situation, if a patient is seeking health care advice over social media, the health care practitioner should politely request them to set up an appointment in- person If a patient persists in contacting the health practitioner, the practitioner should keep a log of all contacts and seek advice from the AHPCSA Providing health advice over social media to individuals with whom the health practitioner does not have a practitioner-patient relationship is discouraged and should be done with the outmost discretion HPCSA – Booklet 16 s7.7-9 Information vs. opinion “Spreading scientific information, not medical advice” – Prof. Tim Noakes If health advice is shared online, it must be evidence based , scientifically sound and generic and the recipient must be directed to consult with a health practitioner HPCSA – Booklet 16, S7.10 Interaction with any patient on any open web- or social media site accessible by the public or any other third party (other than the practitioner and consumer/patient) in a manner that is associated with the condition of that patient or constitutes medical advice is disallowed. Disclosure Health practitioners must ensure that the recipient of patient information via social media understands that such information is given to them in confidence, which they must respect Disclosure of information on social media must be kept to the minimum necessary in order to protect the rights of patients Health practitioners must be aware that there is always a risk that the information can be disseminated, even in so-called “invisible” groups National Health Act S14 [Confidentiality] & 15; HPCSA – S 5 Boundary setting Interaction between health practitioners and their patients on social media can blur the boundaries of the professional practitioner-patient relationship Health practitioners are advised not to interact with patients via social media platforms as a failure to maintain strictly professional relationships with patients could result in other ethical dilemmas HPCSA – Booklet 16 s7.1-3 Social Media Health practitioners may choose to share personal information about themselves with their patients during face-to-face consultations, but social media does not offer a similar level of control over the extent and type of content shared If the health practitioner performs a non-medical role in their community, maintaining appropriate professional boundaries may be difficult as they may receive requests on social media from patient’s they know in a nonprofessional capacity Health practitioners should consider the circumstances and implications before accepting these requests This does not absolve the health care practitioner from the above rules HPCSA booklet 16 Discussion and reflection [email protected] 072 975 2822