Patient Safety-Informed Consent

Introduction: Patient safety is a fundamental concern for all health workers and requires trustworthy health care delivery. Patients must be involved in their care and decision-making. Informed consent is imperative with the recipient retaining the right to fully understand proposed treatment and its consequences, underwriting “Patient Autonomy”. Principles: Basic principles include “Autonomy” and Beneficence”, the patient’s right to decide treatment designed in their “best interests”. The sanctity of life is less relevant than autonomy. Informed Consent: Cardozo J stated that everyone of sound mind could decide what happens to his /her body. Informed Consent v Consent: Rogers v Whitaker defined “material risk” for informed consent and questioned the Bolam Principle regarding advice to the prospective patient. Capacity: Capacity is a legal concept relating to a person’s ability to make their own decisions. An individual’s ability to make certain decisions may be compromised and they may require a substitute decision-maker. Consent in Clinical Trials: Clinical trials require Human Research Ethics Committee approval and recognise lack of equipoise, between researcher and subject. Consent must avoid coercion and acknowledge alternative treatments. Advanced Care Directives: There must be respect for Advanced Care Directives, prepared by the patient when (s)he was competent, even if same results in negative outcomes, contrary to the sanctity of life. The directive can contain all the patient’s needs, values and preferences for future care and nominate a substitute decision-maker. An Advance Care Directive is a formal title for a Living Will Conclusions: Patients should be involved in decision-making with adequate information, recognising that informed decisions necessitate being adequately advised of “Material Risks”, and respects Autonomy and Beneficence.