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 low risk sub-committee will meet every two weeks, or as required, commencing Wednesday 16 January 2019.

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).

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

Submissions for all research, including multi-site research, seeking approval through the ACT Health HREC must be made via the REGIS platform from the end of December.  From this time, the HREC will be unable to accept submissions via any other format.

Applications that wish to be considered under the NMA agreement must clearly state the sites that will be covered by the application.  Sites can be added or removed at a later date.

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 site to an NMA approved multi-site study a Site Governance Application is required. Please ensure that the ACT Health 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 ACT Health.
  • Please note there are a number of study types excluded from the ACT Health HREC NMA process. See the NMA section for more details.
ACT Health Certified HREC Exemption Applications

This process is used to add ACT Health as a new site to a multi-site study that has been approved by an NMHRC Certified Lead HREC prior to 1 August 2016.

To add an ACT Health site to an NHMRC Certified HREC approved multi-site study a Site Governance Application is required. ACT Health has agreed to accept ethical and scientific approval from NHMRC certified HRECs without requiring additional duplicate review. Projects approved under the exemption rule are managed in the same as any NMA project.

Please note: The ACT Health Certified HREC Exemption process was introduced on 5 Jan 2016 and was designed to bring the benefits of NMA to ACT Health researchers. In line with its obligations under the National Statement chapter 5.3 (minimising duplication of ethical review) ACT Health HREC agreed to accept ethical responsibility for the conduct of these projects on the basis of the certified HREC review and approval. These arrangements were reviewed and approved by the legal unit and ACT Health insurer. Exemption applies to multisite projects excluded from NMA due to the 1 August 2016 start date agreed by NMA jurisdictions.

Page last updated on: 13 Nov 2018