Research Ethics and Governance

The Research Ethics and Governance Office (REGO) is responsible for the coordination and management of concurrent ethical and site governance review processes for ACT Health.

Research Ethics and Governance Office

COVID-19 Updates

The Research Ethics and Governance Office (REGO) is working with local and national counterparts to ensure consistent and responsible management of research during the COVID-19 pandemic. Please review the following advice and if you have queries contact ethics@act.gov.au. We will respond to your query as soon as we are able.

Clinical trial sponsors are advised to liaise with principle investigators and site coordinators in the first instance. REGO has provided advice and guidance to PIs and SCs on the management of trials during this time.

HREC processes have been addressed and business continuity plans are in place to ensure appropriate oversight of research.

REGO processes have been amended to support efficient and responsible management including:

  • Paper documents will not be accepted. All document transfer is to be electronic via email or other digital means. Signatures to and from REGO and HREC are to be digital and will be provided via email correspondence.
  • REGO will not support wet-ink signatures on triplicate copies of legal documents. REGO will facilitate single copy endorsement from relevant signatories by means of electronic signing and digital transfer. All signatory documents are to be scanned in their true form and emailed to ethics@act.gov.au
  • COVID-19 matters will be prioritised. Researchers and sponsors are advised to expect delays in processing non-COVID-19 matters. REGO will work to provide responses as soon as the team is able.

ACT Health updates on COVID-19

National position from the Clinical Trials Project Reference Group

We will continue to update this page as the situation evolves.

Please contact REGO on ethics@act.gov.au for further information.

The Research Ethics and Governance Office (REGO) is responsible for the coordination and management of concurrent ethical and site governance review processes for ACT Health. This includes scientific and ethical review of new research proposals, site governance review and ongoing monitoring.

Ethical and scientific review is provided by the ACT Health Human Research Ethics Committee (HREC). The HREC is constituted and operates in accordance with National Statement on Ethical Conduct in Human Research (National Statement; NS)

As of 1 July 2019 REGO and HREC no longer provide ‘wet ink’ signatures or hard copy letters. All correspondence is distributed via email. Where appropriate letterhead will be provided as PDF with electronic signature. 

Research Pathways

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. 
Click to read more

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. 
Click to read more

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.
Click to read more

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

Submission Requirements

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.
Read more... 

Site Governance submission

Information on the requirements for site governance submissions.
Read more...

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.

Fees

Research Ethics and Governance services include ethical, scientific and site governance review of new human research proposals. This includes insurance vetting 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. A full list of ethics and governance fees is below.

The Fee Schedule – contains a list of fees and charges.  Fees are reviewed regularly and subject to change.

Pharmacy and Pathology

The Pharmacy and Pathology Departments charges a range of fees for services provided to clinical trials. Fees are reviewed regularly and subject to change. In any given year fees will increase as of 1 July.

Project Reports to HREC

As a condition of approval, every research project is required to provide formal reports to the Human Research Ethics Committee.  These reports are generally required on an annual basis, but may be more frequent.  A final report is required to be submitted for all projects, including student projects.

The following are templates for the required reports.

Safety Reporting for Clinical Trials

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) – Canberra Health Services sites
 

Consent Guidelines

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.

Contact Us

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

Site Governance Submissions and Queries: research.goverance@act.gov.au

Phone Queries: Sarah Flood, 02 5124 3949

Unit Head: Augie Marchesi, 02 5124 7968

Page last updated on: 17 Aug 2020