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Ethics submission process

Submit your ethics application through the Research Ethics and Governance Information System. The system has a two stage submission process:

  • Stage one - register your project
  • Stage two - complete your ethics submission application. Upload your supporting documentation and submit.

Find out more in the ethics submission process guide.

Once you have submitted your application you will receive an acknowledgement email. This email provides information about when your application will be reviewed and a reference number. You can also track the progress of your application in the system.

Site governance submission process

Submit your site governance application by emailing research.governance@act.gov.au.

Find out more about site governance submission requirements in the submission checklist.

Insurance

Insurance requirements for sponsored clinical trials

You must meet the following requirements:

  • Your insurance certificate must specifically name the Australian corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy
  • If your certificate is provided in the name of an overseas parent company it must name the Australian entity as a subsidiary
  • Your insurance certificate must include a valid coverage period for the policy
  • The insurer providing the cover must be approved by the Australian Prudential Regulation Authority and must have a minimum financial strength rating of A- or above
  • The insurance certificate must provide coverage of AUD$20 million for each and every occurrence and AUD$20 million in the annual aggregate against a class of insurance appropriate for the risk associated with the research.

These requirements do not apply to low risk ethics proposals. If you have questions email research_governance@act.gov.au or call 02 5124 5659.

Document naming and version control

All study documents must follow document naming guidelines contain appropriate version control and to assist with the review and approval process.

Amended documents must be submitted in tracked changes.

If you submit a documents without version control will be returned to you for updating prior to review.

Find out more in the document naming and version control guidelines.

Fees

A fee for service model is used to recover costs associated with the work undertaken by the Human Research Ethics and Committee and the Research Ethics and Governance Office.

These services include:

  • ethical, scientific and site governance review of new human research proposals
  • insurance vetting
  • contract and budget review
  • ongoing monitoring of approval research proposals.

You will be invoiced for fees when we receive your submission. You need to complete any requirements to secure a payment authority such as a purchase order number before submission.

Include evidence in your submission where a purchase number or goods receipted authorisation is required.

Fees are reviewed regularly and subject to change without notice. Find out more about clinical trial fees in the 2023-24 fee schedule.

Cross institutional projects

You must submit an application to the Human Research Ethics Committee or Low Risk Sub-Committee if you are a researcher or student researcher and your project includes staff, facilities or resources of:

  • ACT Health Directorate
  • Canberra Health Services
  • University of Canberra
  • Australian National University.

Applications will be reviewed first by the committee and subsequently submitted to the second institution for expedited review.

Participant information sheets (PIS) and consent forms should follow the national standard and include contact details for the Human Research Ethics Committee or Research Governance Office. Each site will incorporate its institutional PIS and consent form requirements through its site governance processes.

More details about the streamlined process are contained in the institutional agreements:

  • University of Canberra
  • Australian National University

Contact the Research Support Office of the relevant institution if you have any questions.

Contact

This page is managed by: ACT Health Directorate