title: The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place.
abstract: In Australia, human research ethics committees approve clinical trials of drugs in accordance with federal regulations. Federal guidelines allow for the possible conduct of clinical trials in all populations. Within the State of New South Wales, persons unable to consent because of disability are subject to State legislation which, until 1998, regarded drug trials as Special Medical Treatment requiring consent of the Guardianship Tribunal. That consent could only be given if an anticipated individual benefit could be proved. As no such guarantee could be given prior to conduct of a clinical trial, it being unethical to trial an active substance against a placebo if potential individual benefit is already proven for the active substance, a conundrum resulted whereby the Tribunal could not give the required approval. Many argued that the New South Wales law resulted in some experimental medications, such as those being available to minimise tissue damage following stroke, or those being specifically developed for those with late stage dementia, not being made available to their target populations. Amendments were made to remove reference to clinical drug trials as Special Medical Treatment, and a new system established whereby such trials could proceed, including the use of a placebo, with the approval of an ethics committee and the Tribunal.
authors.affiliation: Centre for Health Law, Ethics and Policy, University of Newcastle, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Cooper
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003704:Dementia / Q000188:drug therapy; D004363:Drug Utilization / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D017041:Ethics Committees; D004992:Ethics, Medical; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D009517:New South Wales; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*; D020521:Stroke / Q000188:drug therapy
chemical_list: D015507:Drugs, Investigational