Rationale
Consent is an essential requirement for the initiation, continuation, and termination of medical treatment or medical research. In some circumstances, verbal consent is sufficient whereas in others (e.g., certain investigations, surgical procedures) written consent is necessary.
Key Objectives
Given the necessity for patient consent, the candidate will be able to take the necessary steps to obtain valid legal and ethical consent for the proposed action, taking into account issues related to decision-making capacity, information sharing, the form of consent, limitations, and exceptions to the requirement of consent.
Enabling Objectives
Given the need to obtain consent, the candidate will
- determine a patient’s capacity to consent (e.g., cognitive impairment, coercion);
- know the process of obtaining consent where there is a lack of capacity (e.g., substitute decision-maker, court order);
- identify the information that must be gathered to ensure informed consent has been obtained;
- differentiate the circumstances in which implied consent is acceptable;
- identify issues related to written and verbal consent including appropriate documentation;
- identify exceptions to the requirement for consent (e.g., mandatory reporting, risk of harm to others); and
- describe the limitations and scope of the consent obtained in the situation (e.g., procedural limitation, duration of consent).
