Ethics and Research Governance
Human Research and Ethics Committee (HREC) approval of the registry protocol and related documentation must be obtained prior to the commencement of data collection at every site. Research must be approved by a HREC that is constituted according to the NHMRC National Statement on Ethical Conduct in Human Research (March 2007).
Every hospital must have relevant institutional approval prior to commencing data collection.
There are two (2) components to approval for all research projects. Both of these must be addressed in full before a project can be given approval to commence data collection:
- HREC approval (overarching ethical consideration)
- Research Governance approval (site-specific assessment relating to project viability)
The VCOR Project team will assist with compilation and coordination of HREC applications. This ensures that the HREC approval and ethical requirements remain consistent across all participating VCOR sites.
Some sites' HREC will acknowledge previous approval from a recognised HREC without having an application fully reviewed by a full HREC committee at a scheduled meeting. In these situations, a governance review is often still required.