Higher risk research and Riverland Academy of Clinical Excellence

'Higher risk research' includes research where there is a risk of harm and may also be a foreseeable burden (National Statement on Ethical Conduct in Human Research (2023)).

Project authorisation

Ethical review and governance (site specific assessment (SSA)) are two distinct processes. Approval of both is required before a project can begin. The Principal Investigator (PI) will be notified of approval via email from the Research Governance Officer (RGO). See the SA Health - Health and Medical Research website for more information.

Research ethics and governance applications for higher risk research projects must be submitted via the SA Health research governance and ethics management system (Research GEMS). The GEMS login page provides user guides with step-by-step instructions on how to navigate the Research GEMS system.

Ethics

Higher risk research projects are reviewed at full Human Research Ethics Committee (HREC) meetings. See the relevant HREC websites for meeting dates and submission deadlines.

Additional approval from the South Australian Aboriginal Health Research Ethics Committee (AHREC) is required for all research applications where the focus is on a topic or disease/health burden identified as being of specific concern to Aboriginal and/or Torres Strait Islander peoples. See the SA Health Research Ethics and Governance Policy for further details. Applications to AHREC are submitted directly to AHREC by email (i.e. outside of research GEMS).

Governance

Governance submissions (site specific assessments - SSAs) must be submitted via Research GEMS and are reviewed by the RGO on a rolling basis.

Registration of clinical trials

All clinical trials must be registered on the national platform prior to participant recruitment - Australian and New Zealand Clinical Trials Registry (ANZCTR).

Documents

NHMRC Participant Information Sheet/Consent Form Template

Links

Resources

Human Research Ethics Committees (HREC)