Early Phase Clinical Trials HREC Scheme

About Bellberry Limited

Bellberry Limited is a national, independent not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia. The organisation currently hosts eight HRECs. It has extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for early phase clinical trials. For more information visit the Bellberry Limited website.

Age group scope

• Trials involving adults equal to and greater than the age of 18 years
• Combined paediatric and adult trials involving young people and adults equal to and greater than 16 years.

Contact details

For further clarification regarding applications or submissions contact:

Jerneen Williams, Early Phase Clinical Trial Manager

Phone: (08) 8361 3222

Email: JerneenWilliams@bellberry.com.au

About the Sydney Children's Hospital Network HREC

The Sydney Children’s Hospital Network Human Research Ethics Committee is responsible for ensuring the ethical and scientific acceptability of research conducted at sites within the Network and other paediatric specific research referred to it by any public health organisation from NSW, ACT, VIC, QLD and SA. It has extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for paediatrics early phase clinical trials.

For more information visit the Sydney Children’s Hospital Network HREC webpage.

Age group scope

• Trials involving only children and young people under the age of 18
• Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25.

Contact details

For further clarification regarding applications or submissions contact:

Melinda Giles, EPCTs Research Ethics Officer

Phone: (02) 9845 3105

Email: Melinda.Giles@health.nsw.gov.au

What is the definition of an early phase clinical trial (EPCT) that encompasses with respect to the NSW Health Early Phase Clinical Trial (EPCT) HRECs Scheme?

Early Phase Clinical Trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

When will these NSW Health EPCT HRECs be operational?

From 29th April 2019, all EPCT HREC applications should be submitted to one of the two NSW Health EPCT HRECs for review and approval before it can be accepted by a NSW PHO site, unless under current arrangements of the Scheme involving paediatrics EPCTs.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

What are the key changes as a result of this Scheme been operational?

NSW Health is excluding all Adult EPCT from the National Mutual Acceptance Model. All new adult EPCT applications proposed to be conducted in a NSW PHO site, must be submitted to Bellberry HRECs for ethics review.

Paediatrics EPCTs with a NSW PHO lead site are required to be submitted to SCHN HREC for ethics review.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

Are Paediatrics EPCTs in NSW exempted from National Mutual Acceptance 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.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

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 paediatrics and adult trials involving young people and adults equal to and greater than 16 years.
Refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” for more information.

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.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

What happens to all EPCT applications submitted PRIOR to 29 April 2019?

These applications will not be affected by this Scheme. Ethics review and approval will be accepted by a NSW PHO site for EPCT applications submitted PRIOR to 29 April 2019

Will Bellberry be acceptable as a lead HREC for NSW PHO’s for NON-early phase clinical trials?

No. The EOI, to which Bellberry responded and were successful, was specifically for reviewing early phase clinical trials (EPCTs). There is currently no plan to expand Bellberry’s commission to non-EPCTs.

Where does Bellberry sit at present in the National Mutual Acceptance scheme? Do/will other jurisdictions recognise Bellberry approvals for multicentre trials with centres in their states? Or will multiple HREC approvals be required? For example, if I set up a Phase 1 trial in NSW and obtain HREC approval from Bellberry, can my colleague in Victoria use that approval or does s/he 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 has already been completed, does the request for ethics review of the Phase II component need to be submitted to the NSW Health Early Phase Clinical Trials HRECs?

No. For combined Phase I/II trials where the Phase I component of the trial has already been completed, Phase II ethics review applications do not have to be submitted to NSW Health Early Phase Clinical Trials HRECs. They can be submitted through the normal state-based single ethical review system or National Mutual Acceptance Scheme.

Goal one

Rapid and high quality approval to commence early phase trials.

How the Early Phase Clinical Trial Framework supports the goal

NSW Health appointed specialist early phase clinical trials Human Research Ethics Committees.

Expression of Interest open to all National Health and Medical Research Council certified Human Research Ethics Committees. Up to five early phase specialised Human Research Ethics Committees will be appointed for NSW.

Human Research Ethics Committees supported by the Office for Health and Medical Research for scientific review, and professional development.

Governance: Office for Health and Medical Research, National Health and Medical Research Committee.

Benefits

• Host institutions and sponsors have assurance of quality and ethical trial thereby mitigating risk.
• Guaranteed Human Research Ethics Committee review time (20 days) and frequent committee meetings.
• Consistency in what is required from applicants and decision making.
• Specialised review of pre-clinical data.
• Human Research Ethics Committee continuous improvement.
• Recognises National Mutual Acceptance.

Goal two

High quality operational conduct of early phase trials.

How the Early Phase Clinical Trial Framework supports the goal

Voluntary quality recognition scheme for early phase clinical trial sites and investigators in NSW.

Sites/units and investigators apply for quality recognition if they published meet standards. A central office will provide coordination and support capacity building of sites/units.

Sites/units will either receive quality recognition or be supported if they are working towards it.

Governance: Office for Health and Medical Research, Expert Oversight Committee.

Benefits

• Host institutions and sponsors have assurance of quality conduct including clinical governance thereby mitigating risk.
• Scheme promotes continuous improvement.
• Guaranteed site specific Authorisation review time (10 days).
• Sites/units have access to common standard operating procedures and capacity building.
• Investigators are appropriately qualified and/or are supported.