Informed Consent as a Mandatory Protocol in Medical and Dental Procedures: A Narrative Review of Its Ethical, Legal and Practical Foundations
Author
Dr. Althaaf Khan,
Abstract
Background: Informed consent is a cornerstone of contemporary clinical practice, yet in routine medical and dental care it is often reduced to a signature on a form rather than a meaningful exchange between clinician and patient. Objective: To review the ethical, legal and empirical basis for treating informed consent as a mandatory, structured protocol in medical and dental procedures, with particular reference to South Africa, and to propose a minimum operational framework. Methods: A narrative review was undertaken of international ethical instruments, statutes, judicial decisions and peer-reviewed literature addressing informed consent, with emphasis on the movement from professional-based to patient-centred standards of disclosure. Results and Discussion: Ethical doctrine grounded in respect for autonomy, and legal doctrine grounded in bodily integrity, have converged across major jurisdictions on a requirement that patients be told of material risks and reasonable alternatives. South African law, through the Constitution, the National Health Act and the guidance of the Health Professions Council of South Africa, imposes comparable duties. Empirical studies consistently show that patient comprehension and recall of consent information are limited, and that form-focused consent does not guarantee understanding. Interventions such as enhanced forms, extended discussion and the teach-back method improve comprehension. Dentistry raises particular concerns because treatment is frequently elective, irreversible, staged and privately funded. Conclusion: Informed consent should be regarded as a mandatory clinical process, proportionate to risk, supported by documentation but not reducible to it. A six-stage protocol is proposed to assist practitioners in meeting ethical and legal obligations while strengthening trust and shared decision-making.
Keywords
informed consent; patient autonomy; shared decision-making; dentistry; medical law; South Africa
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References
- Faden RR, Beauchamp TL. A history and theory of informed consent. New York: Oxford University Press; 1986.
- Beauchamp TL, Childress JF. Principles of biomedical ethics. 8th ed. New York: Oxford University Press; 2019.
- Katz J. The silent world of doctor and patient. New York: Free Press; 1984.
- Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(9):855-62.
- Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533-40.
- Montgomery v Lanarkshire Health Board [2015] UKSC 11.
- Schloendorff v Society of New York Hospital, 211 NY 125, 105 NE 92 (1914).
- Stoffberg v Elliott 1912 CPD 148.
- Salgo v Leland Stanford Jr University Board of Trustees, 154 Cal App 2d 560, 317 P 2d 170 (1957).
- Nuremberg Code. In: Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2. Washington, DC: US Government Printing Office; 1949. p. 181-2.
- World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-4.
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: US Department of Health, Education, and Welfare; 1979.
- World Medical Association. WMA Declaration of Lisbon on the rights of the patient. Ferney-Voltaire: World Medical Association; 1981 (amended 2015).
- Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
- Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871 (HL).
- Canterbury v Spence, 464 F 2d 772 (DC Cir 1972).
- Rogers v Whitaker (1992) 175 CLR 479 (HCA).
- Castell v De Greef 1994 (4) SA 408 (C).
- Broude v McIntosh 1998 (3) SA 69 (SCA).
- National Health Act 61 of 2003 (South Africa).
- Chester v Afshar [2004] UKHL 41.
- Constitution of the Republic of South Africa, 1996.
- Esterhuizen v Administrator Transvaal 1957 (3) SA 710 (T).
- Children's Act 38 of 2005 (South Africa).
- Health Professions Council of South Africa. Guidelines for good practice in the health care professions. Booklet 4: Seeking patients' informed consent: the ethical considerations. Pretoria: HPCSA; 2016.
- Dhai A, McQuoid-Mason D, editors. Bioethics, human rights and health law: principles and practice. Cape Town: Juta; 2011.
- Protection of Personal Information Act 4 of 2013 (South Africa).
- Appelbaum PS, Lidz CW, Meisel A. Informed consent: legal theory and clinical practice. New York: Oxford University Press; 1987.
- Appelbaum PS. Assessment of patients' competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40.
- Bester J, Cole CM, Kodish E. The limits of informed consent for an overwhelmed patient: clinicians' role in protecting patients and preventing overwhelm. AMA J Ethics. 2016;18(9):869-80.
- General Dental Council. Standards for the dental team. London: General Dental Council; 2013.
- Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014;84(4):207-10.
- Tam NT, Huy NT, Thoa LTB, Long NP, Trang NTH, Hirayama K, et al. Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186-98H.
- Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011;31(1):151-73.
- Schillinger D, Piette J, Grumbach K, Wang F, Wilson C, Daher C, et al. Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med. 2003;163(1):83-90.
- Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361-7.
- Spatz ES, Krumholz HM, Moulton BW. The new era of informed consent: getting to a reasonable-patient standard through shared decision making. JAMA. 2016;315(19):2063-4.
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