ACT Health and clinical trials

Researchers based at Canberra Hospital

A researcher based at the Canberra Hospital who is also affiliated to the Australian National University (ANU) will need to obtain ethics clearance both from the ACT Health Ethics Committee as the primary HREC as per an MOU between the institutions. ACT Health HREC has agreements in place with the ANU HREC to facilitate streamlined ethical approval processes for research projects that are defined as “cross-institutional”.

If you are a researcher that requires ethics clearance from both HRECs, you should:

1. Submit your protocol with ACT Health Ethics Committee
2. Once ACT Health HREC approval has been granted, please submit a HREA form via REMS and indicate that you have received prior approval where prompted. Upload any relevant approval/application documentation with your HREA form and submit for expedited ANU review

Clinical trials

If you are a researcher (from any college) conducting a clinical trial involving a drug or device, it will need to be assessed and supported by the ACT Health Clinical Trials Committee before being assessed by the ACT Health Ethics Committee and the ANU HREC. Please submit your application to the ANU HREC after obtaining clearance from the ACT Health Ethics Committee. You will also need to provide a copy of your protocol (with attachments) to the Insurance Office. Please contact the Insurance Office on extension 54257 or email insurance.office@anu.edu.au for further information.

If you are conducting a clinical trial not involving a drug or device within the ACT Health system, it will need to be assessed by the ACT Health Ethics Committee. Once clearance is received by the ACT Health Ethics Committee for the clinical trial, please submit your application to the ANU HREC.

Drugs or devices not already approved by the Therapeutic Goods Administration will also need to be reported to the TGA under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.

If you are conducting a clinical trial that does not involve a drug or device and is not conducted within the ACT Health system, please submit your application directly to the ANU HREC.