Expertise
Life Sciences
Informed Consent
Informed consent requirements arise in the conduct of clinical trials and other clinical research. Informed consent issues are wide ranging and include matters such as:
- Compliance with Canadian requirements
- Requirements for research use of genetic samples, including future research uses and withdrawal of consent
- Requirements under the Medical Devices Regulations for the use of identifiable pathology samples in clinical investigations of in vitro diagnostic devices
- Access to patient records or pathology samples for non-treatment purposes as a follow-up to treatment use of a drug
- Applicability of the Helsinki Declaration, particularly its provisions on the use of placebos in clinical trials and access to investigational drugs on completion of a trial
- Requirements for emergency medical treatment under the Health Care Consent Act, including treatment use of investigational drugs under the special access program
- Requirements for research in an emergency scenario involving patients incapable of providing consent under the Ontario Health Care Consent Act, the common law, and applicable research-related policies and guidelines
- Consent in contexts involving actual or potential conflicts of interest
