Australia has human research regulations to ensure research has scientific merit, is ethically acceptable and is well supported to succeed by the responsible institution – ultimately protecting the rights of the participant. So what does that mean practically?
A well-considered research protocol takes time to draft, often with many contributors to ensure robustness. The research team may also need to develop Investigator Brochures (IB), Data Monitoring Committees (DMC) and participant facing documents, alongside a Human Research Ethics Application (HREA).
Once these documents are prepared, the Human Research Ethics Committee (HREC) reviews, and considers the proposal against the National Statement. This is to ensure the research has merit and integrity, justice, beneficence and respect. Along with HREC review, there is also Site Specific Assessment (SSA) or Research Governance Office (RGO) review.
While the HREC considers the science and merit of a research proposal, the RGO review focuses on the resources available to support the research. This includes :
- The sites equipment to support the protocol requirements
- The personnel available at the site to run the trial, including their expertise
- The potential participant pool available to meet the recruitment target
- The sites capacity to support the study financially if there is a budget deficit.
An SSA is often being prepared and drafted around the same time as the HREC submission as there are many moving parts to an RGO submission. This can include budget and contract negotiations, Head of Department approvals, inter-departmental or third-party provider quotes for services related to delivering the protocol.
While these things take time, the result is a research protocol that is scientifically robust, well supported and set up for success.
The Australian research space is supported by education opportunities for researchers and research support staff. These opportunities include training modules, webinars and seminars on A-CTEC and the ACTA website. Have you checked out these resources yet?
ACTA: Teletrials – ACTA – Australian Clinical Trials Alliance
A-CTEC: please note, these resources are non-exclusive and accessible only with a A-CTEC log-in
- Role Competency Frameworks: ACTEC: Role Competency Frameworks | ACTEC
- Trial Essentials for Research Support Team: Course: Trials Essentials for Research Support Team (ICH E6 R2 GCP included) | ACTEC
- Research Ethics and Governance Process Research Ethics and Governance Process | ACTEC
- *The regulatory Environment of Clinical Trials: The regulatory environment of clinical trials – Research Support Staff | ACTEC
- *Ethics and Governance Application Process: The regulatory environment of clinical trials – Research Support Staff | ACTEC
*these courses are included as part of the trial essentials package.
