Ethics Submission

Requirements for Ethics Submission

Prior to all submissions to the ACT Health Human Research Ethics Committee (HREC) please ensure all study personnel are familiar with the following:

Requirements for Ethics Submission:

The meeting dates for applications for full HREC consideration are here:

The ACT Health HREC membership is available here:

The meeting dates for applications for Low Risk Sub-Committee consideration are here:

Application Submission Process

All applications will be evaluated via appropriate HREC review.  All ethics considerations are made in accordance with guidance provided through the National Statement on Ethical Conduct in Human Research, ICH-GCP, and Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. Research involving Aboriginal and Torres Strait Islander people and communities should also seek guidance from the AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS).

Protocol Templates

Example protocol templates are provided, however these may be varied as required:

The following are additional application process details based on the type of ethics application.

Single Site Study Applications

Submissions for all single site research seeking approval through the ACT Health HREC must be made via the REGIS platform. Applications are to be made using the HREA form and need to be accompanied by a separate protocol document and any supporting documentation.

Approval for single site studies will not be included in National Mutual Acceptance (NMA) scientific and ethical review of multi-centre human research.  Researchers can make a multi-site NMA application at a later date.

Multi-Site Study Applications

All submissions for review by ACT Health HREC, including low risk research and multi-site research, must be made via the REGIS platform. 

The HREC does not accept submissions via any other format or platform.

National Mutual Acceptance Applications for Multi-Site Studies

This process is for multi-site projects which were or are to be approved on or after 1 August 2016.

  • ACT Health Lead Site Ethics and Governance applications will be evaluated via the standard HREC and Governance reviews. As the lead HREC ACT Health HREC will accept ethical responsibility for the conduct of the project at all study sites. Please note as a Lead site the Coordinating Principal Investigator and Study Coordinator will be responsible for the research conduct, administrative coordination and study safety reporting requirements at all sites. If you intend to submit a Lead Site application, please contact the Research Ethics and Governance Office for additional information.
  • To add an ACT Health or Canberra Health Services site to an NMA approved multi-site study, a Site Governance Application is required. Please ensure that the appropriate site has been added as an approved site by the Lead HREC prior to your Governance Application. The lead HREC will accept ethical responsibility for the conduct of the project at all named/approved sites.
    For further information please see the clinical trials section.
  • Please note there are a number of study types excluded from the ACT Health HREC NMA process. See the NMA section for more details.
Page last updated on: 11 Oct 2023