The following pages provide information specific to the different types of research pathways:
Clinical Trials
Before undertaking any clinical research, the researcher and research unit must complete a feasibility assessment through the Clinical Trials Committee.
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National Mutual Acceptance (NMA) Scheme
National Mutual Acceptance Scheme (NMA) is designed to reduce the administrative burden of research by providing one scientific and ethical approval for all sites in the participating jurisdictions.
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Other Human Research
Research in which the risk for participants is more serious than discomfort is not low risk and will need to be reviewed by the Human Research Ethics Committee before commencing. Click to read more
Low Risk Research
The expression ‘low risk research’ is described in the National Statement as research in which the only foreseeable risk is one of discomfort.
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Quality Assurance/Improvement Projects
Quality Improvement activities are an essential aspect of improving the delivery of person-centred, safe, and efficient healthcare within the Australian Capital Territory. Click to read more
Case Study
Case studies are an important part of clinical observation and advancing medical and scientific knowledge, especially of rare diseases or conditions. Case studies do not usually require ethical review/approval however, if unsure, please contact REGO for advice.
Case studies do require consent of the patient, their parent, guardian or next of kin as appropriate. Click here for a generic consent form that may be used or amended as needed.
Research Ethics Approval Pathways
The ACT Health Human Research Ethics Committee (HREC) is responsible for ensuring that researchers submitting proposals for its review and approval are aware of their ethical and legal responsibilities. As a condition of approval, every research project is required to provide formal reports to the Human Research Ethics Committee. Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and the HREC.
Sponsors must provide the HREC with reports of Data Safety and Monitoring Boards. Click to read more