For guidance on which HREC to consult at your study phase, see the quick reference guide.
What is the definition of an early phase clinical trial (EPCT) in regard to the EPCT Human Research Ethics Committees (HRECs) Scheme?
Early phase clinical trials include all clinical trial phases up to but not including Phase II. It can also include studies with any Phase I component.
What are the key changes of this scheme?
NSW Health is excluding all adult EPCT from the National Mutual Acceptance (NMA) model. All adult EPCT applications proposed to be conducted in a NSW public health organisation (PHO) site, must be submitted to Bellberry HRECs for ethics review.
Paediatric EPCTs with a NSW PHO lead site is required to be submitted to Sydney Children’s Health Network (SCHN) HREC for ethics review.
Are paediatric EPCTs in NSW exempted from NMA model?
No, for multi-centred paediatric EPCTs, if an HREC hosted in a specialist paediatric tertiary hospital outside NSW has approved a paediatric EPCT, NSW PHO sites will continue to accept interstate HRECs’ approval in these instances.
What is the age group within the scope of Bellberry HRECs for EPCTs?
- Trials involving adults equal to and greater than the age of 18 years; or
- Combined paediatric and adult trials involving young people and adults equal to and greater than 16 years.
What is the age group within the scope of SCHN HREC for EPCTs?
- Trials involving only children and young people under the age of 18; and
- Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25.
Will Bellberry be acceptable as a lead HREC for NSW PHOs’ for non-early phase clinical trials?
No, the expression of interest (EOI) that Bellberry responded to and were successful, was specifically for reviewing EPCTs. There is currently no plan to expand Bellberry’s commission to non-EPCTs.
Is Bellberry recognised in the NMA scheme?
- Do other jurisdictions recognise Bellberry approvals for multi-centre trials with centres in their states?
- Will multiple HREC approvals be required? For example, if I set up a Phase I trial in NSW and obtain HREC approval from Bellberry, can my colleague in Victoria use that approval or does they need to go to another NMA HREC?
All private (and many university) sites in NSW and other jurisdictions currently accept Bellberry approvals. This scheme expands the acceptance of Bellberry approvals to EPCTs in NSW public health organisations (PHOs) as well. We welcome PHOs in other jurisdictions to accept a Bellberry-approved EPCT, but this is up to the individual jurisdictions. This scheme does not establish Bellberry as an NMA HREC.
For combined Phase I/II trials where the Phase I component of the trial is complete, does the request for ethics review of the Phase II component need to be submitted to the NSW Health EPCT HRECs?
No. For combined Phase I/II trials where the Phase I component of the trial is complete, Phase II ethics review applications do not have to be submitted to NSW Health EPCT HRECs. They can be submitted through the normal state-based single ethical review system or NMA scheme.
For guidance on which HREC to consult at your study phase, see the quick reference guide.