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Guidelines and Policies

Clinical Trial Research Agreements for Use in NSW Public Health Organisations NSW
NSW Health
This policy directive sets out the Clinical Trial Research Agreements approved for use.

Clinical Trials – Insurance and Indemnity NSW
NSW Health

Guardianship Tribunal Information – Clinical Trials [PDF]    NSW
NSW Guardianship Tribunal
In cases where a person has impaired decision making, the Guardianship tribunal can consent to a person’s participation in a clinical trial and their receipt of treatment during that trial.

Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials
NSW Health

The Ethics of Clinical Research
Stanford Encyclopaedia of Philosophy

Legislation

Note for guidance on good clinical practice International
TGA
An internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. Annotated by the TGA.

Papers, Reports and Books

Equipoise and the Ethics of Clinical Research
(1987) New England Journal of Medicine 317(3) 141-145
Author: Benjamin Freedman
Argues for an alternative concept of equipoise whereby justification for a clinical trial requires genuine uncertainty in the clinical community (rather than, as traditionally required, uncertainty held by the investigator themself) about the preferred treatment.

Multimedia

Ethics of Clinical Research
Dr. Ruth Faden, James L. Stambaugh, Jr.
Lecture Series

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