Prior to research being undertaken a Human Research Ethics Committee (HREC) must approve the research proposal. The role of the HREC is to ensure clinical trials comply with guidelines as set by the National Health and Medical Research Council (NHMRC). Specially, to ensure that “all kinds of research involving or impacting on humans conform to the highest standards of ethical practice and academic integrity.”
All trials undertaken by RDC, except cosmetic trials, are approved by a HREC. This process involves submitting the research protocol to HREC for review. The HREC will return the proposal asking questions and/or requiring amendments if necessary. This process repeats itself until the HREC is satisfied the research protocol adheres to the strict guidelines set by NHMRC. This process is very robust and can take many months before a research proposal is approved. Once approved, recruitment for the clinical trial can begin. If any research protocol deviations occur, approval for such changed must be first approved by the same HREC.
To read more about HREC and the process of ethics approval click HERE.