Research Ethics and Governance

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

Authorised Prescriber Applications

A medical practitioner wishing become an authorised prescriber of an unapproved good, in line with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations) must submit an application to the HREC for review and approval prior to the submission of a separate application to the TGA.

Applications must be submitted with the following template forms:

• TGA Authorised Prescriber HREC Application Form
• Authorised Prescriber Patient Information Sheet
• Authorised Prescriber Consent Form
• Authorised Prescriber Consent Form (Guardian-POA)

Email ethics@act.gov.au to submit an authorised prescriber application.

ACT Health conducts concurrent ethical and site governance review processes, including insurance review by the ACT Insurance Authority (ACTIA). The following outline the steps required for ethics and site governance approval at ACT Health:

Ethics submission

Information on the requirements and the application submission process.
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Site Governance submission

Information on the requirements for site governance submissions.
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Document Naming and Version Control Guidelines

To assist with the review and approval process, all study documents must contain appropriate version control. Amended documents must be submitted in track changes. Documents submitted without version control will be returned to the researcher for updating before review.
View the guidelines

Inter-Departmental Support 

Projects that require inter-departmental support (ACT Pathology, CHS Pharmacy, CHS Imaging) must submit a fully agreed upon quote in support of a stage two HREC or site governance submission.

Please contact ACT Pathology research for further information on requesting pathology support pathologyresearch@act.gov.au

Use of Ionising Radiation in a Research Project

ACT Health requires that all research projects that include any level of ionising radiation exposure undergo a notification process to ensure participant safety.

For projects that include ionising radiation exposure that is not considered to be additional to that received as standard of care for the clinical management/care of the patient group at this site, please complete and submit this form to the Radiation Safety Officer for acknowledgment prior to submission to the Research Ethics and Governance Office.

For projects that include ionising radiation exposure that is considered to be additional to that received as standard of care, a full report from a Medical Physicist is required to be submitted to the reviewing HREC and/or site governance office.

For further information please contact the Medical Physics and Radiation Engineering Department on 5124 5623 or email CHS.DRPhysics@act.gov.au.

Research Ethics and Governance services include ethical, scientific and site governance review of new human research proposals. This includes insurance vetting, contract and budget review and ongoing monitoring of approved research proposals. To recover costs associated with this work, fees are charged for services provided.

Fees will be invoiced on receipt of submission. Please ensure that any requirements to secure a payment authority, such as a purchase order number, are completed BEFORE submission to the Research Ethics and Governance Office. Where a purchase order number or goods receipted authorisation is required please provide evidence of these with your submission. Fees are reviewed regularly and subject to change.

• 2023-24 Fee Schedule

Sponsors, via the local principal investigator, will be required to provide the Research Ethics and Governance Office (REGO) with an annual safety report that supports trial oversight, includes a clear summary of the evolving safety profile of the trial and evidence that the sponsor is conducting its own ongoing safety monitoring appropriately. Should there be any new safety information the sponsor will be required to provide an updated participant information and consent form.

• Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and REGO.
• Sponsors must provide REGO with reports of Data Safety and Monitoring Boards.

Principal Investigators (PIs) are obliged to review the safety information that is sent to them by the trial Sponsor and to act on all safety advice.  The PI has primary responsibility to ensure that all investigators are up to date on all aspects of the safety of their protocol.  Questions of product or protocol safety are relevant to the conduct of any clinical trial.  Therefore, it is incumbent upon the investigator that they should be aware of, and act on, the latest available safety information and that this information should be discussed with participants as part of the ongoing assurance that consent is informed and remains valid.

Serious Adverse Event Reporting

Serious adverse events (SAEs) occurring at Canberra Health Services sites, including Canberra Hospital, or involving trial participants enrolled through Canberra Health Services are to be reported to REGO using the report form below. 

•    Notification Form: Serious Adverse Event (SAE)
 

Consent Issues

Respect for human beings involves giving due scope to people’s capacity to make their own decisions. In the research context, this normally requires that participation ought to be the result of a choice made by participants.  This is commonly known as ‘the requirement for consent’. 

See the Consent page for detailed information.

Ethics Committee Submissions and Queries: ethics@act.gov.au

Site Governance Submissions and Queries: Research.Governance@act.gov.au

Phone Queries: Contact a REGO team member on 02 5124 3949 or 02 5124 5659.