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NSW Early Phase Clinical Trials Framework

Key dates

  • 10-AUG

    Information session

  • 28-SEP

    Expressions of Interest close

  • 19-OCT

    HREC interviews

The Office for Health and Medical Research has developed a framework to support early phase clinical trials across NSW. Following broad support from the sector and endorsement by local health district and specialty network Chief Executives, the Framework has been approved by the Chief Health Officer.

More than 100 experts across the sector were involved in consultations to inform the design of the Framework.

Overview of the stages to develop and implement the Early Phase Clinical Trials Framework for NSW

Expressions of Interest

Expressions of interest for NSW Health’s early phase clinical trials HRECs  scheme are is now open for appointment of NSW Health’s early phase clinical trials HRECs. Expressions of interest close on 28 September 2018.

  • NSW Health Early Phase Clinical Trials HRECs Scheme Application Form

    DOC - 1 MB

Before you apply

Information Session

An information session will be held on Friday 10 August, 2-3pm.

Register here

Eligibility Criteria

  1. All private and public HRECs or organisations providing ethics review services within Australia are eligible to apply to be appointed by NSW Health as HREC to assess early phase trials conducted within NSW.
  2. HRECs applying must be certified under the NHMRC National Certification Scheme (for ethics review of Phase 1 clinical trial research).
  3. Public Health Organisation HRECs within National Mutual Acceptance (NMA) participating jurisdictions must be a Certified Reviewing HREC under the NMA scheme.
  4. All private and public HRECs, host institutions of a HREC or an organisation providing ethics review services is required to be/is responsible for ensuring that it is covered by adequate insurance for the purposes of conducting a review of early phase clinical trials. This insurance must also cover HREC members, including those who are not employed by the host institution.

Application Process

The NSW Health early phase clinical trial HRECs will be selected through a three-step application and appointment process:

  1. HRECs complete and submit an application form and this will involve a self-assessment against the eligibility and selection criteria noted in sections 8 and 9, along with any associated documents to the Office for Health and Medical Research. The application needs to be approved by the Head of Organisation of the entity hosting the HREC.
  2. A selection panel will assess the applications and may invite HREC Chairs and their institution’s Chief Executive, or a delegate, for an interview. Selection panel will then provide advice to the Office for Health and Medical Research
  3. Chief Health Officer appoints the early phase clinical trial HRECs.

Support Resources

Other reference material includes:

Australia’s National Statement on Ethical Conduct in Human Research (2007) (Updated May 2015) issued by NHMRC

National Mutual Acceptance of scientific and ethical review of multi-centre human research

More Information

If you require any further information, please direct your enquiries to earlyphasetrials@moh.health.nsw.gov.au

Frequently asked questions

How to apply?

Submit an electronic copy of the Expression of Interest and all relevant attachments (refer to Checklist) to earlyphasetrials@moh.health.nsw.gov.au

Applications need to be approved by the Head of Organisation of the entity the HREC.

How much funding will be available?

NSW Health early phase clinical trials HRECs will receive funding support through the Office for Health and Medical Research if the committee is within a University or public health organisations within NSW. Funds up to $50,000 as a one off payment in the first year will be available to support change management.

Funds up to $50,000 per annum will be available to support the HRECs plans to review early phase clinical trials.

Refer to the NSW Health Early Phase Clinical Trials HRECs Scheme Guideline: Section 7.1 OHMR Support

How should the funding be used?

Funds can be used for change management activities that will include but not be limited to:

  • appropriate change management activities to transition to the new operational arrangements to meet the timeline benchmarks
  • clear and transparent communication to stakeholders
  • appropriate changes to administrative processes and adherence to other relevant administrative protocols.

Funds available to support the HRECs plans to review early phase clinical trials will be used to:

  • pay for additional scientific review as required by HRECs. HRECs are to draw on the networks of experts, such as the list of expert technical reviewers and HREC members with the appropriate expertise (for all public entities)
  • support plans to achieve the rapid turnaround time of reviews (for public entities in NSW).

Refer to the NSW Health Early Phase Clinical Trials HRECs Scheme Guideline: Section 7.1 OHMR Support

What are the expectations of the Host Institution?

Applicants will need to present a business case supported by the Host Institution.  The business case outlined in the application should indicate the in-kind and funding support provided by the Host Institution. Through this, there is an expectation that the Host Institution will demonstrate its support for early phase clinical trial ethics assessment.

Refer to the NSW Health Early Phase Clinical Trials HRECs Scheme Guidelines: Section 9- Selection Criteria number 11

Who is on the Selection Panel?

Selection Panel members are treated as private and confidential. Selection Panel members are from the pillars and local health districts who have extensive NSW Health knowledge and understanding. Any conflicts of interest will be managed by the Office for Health and Medical Research.

Who is on the NSW Health list of early phase clinical trial expert technical reviewers?

The NSW Health list of early phase clinical trial expert technical reviewers will be created based on advice from the NSW Health Early Phase Clinical Trials HRECs at the first meeting.  The list will be living and updated as required when the HRECs meet at 6-monthly meetings.

What is the Risk Assessment Tool?

This tool is currently under development. It will be finalised with the appointed NSW Health Early Phase Clinical Trials HRECs. The tool may be used by the NSW Health early phase clinical trials HRECs when reviewing early phase clinical trial applications. This tool will be embedded in the HREC ethics review process.

How will NSW Health’s Office for Health and Medical Research assist the HRECs to get ready?

The Office for Health and Medical Research will provide additional support for capability development across the NSW Health Early Phase Clinical Trials HRECs, including:

  • initial support to develop capacity to review early phase trials (for public entities in NSW), including orientation tool, education and training
  • ongoing support for continuous professional development including education and training.

The Chairs of the NSW Health Early Phase Clinical Trials HRECs will advise teh Office on what capability development activities are required overtime.

Please clarify what is meant by the statement which appears on page 13 of the guideline “Provide safe and high quality scientific and ethics review of all applications within 30 working days benchmark (with the aim to work towards achieving 20 working days benchmark) as defined by days ‘on the clock6 from submission closing date to initial review decision and all amendments within 10 working days. and please clarify what ‘review’ means.

This statement should be amended to clarify that the review decision is referring to the final review decision. Provide safe and high quality scientific and ethics review of all applications within 30 working days benchmark (with the aim to work towards achieving 20 working days benchmark) as defined by days ‘on the clock6 from submission closing date to final review decision and all amendments within 10 working days.”

The benchmarks are referring to the final full review decision. The term “review” refers to the full review of valid applications resulting in a final HREC decision (i.e. when the HREC formally notifies the applicant of the final decision.)

  • 30 ‘working days’ benchmark is equivalent to approximately 42 ‘calendar days’.
  • 20 ‘working days’ benchmark is equivalent to approximately 28 ‘calendar days’.

The use of the language “days on the clock” is confusing as AURED operates on calendar days not working days so there is a mismatch in terminology used between early and later phase trials? Note that NSW Health’s current mandated research office metrics are measured in ‘calendar days’.

Equivalent ‘calendar days’ will be updated in the NSW Health Early Phase Clinical Trials HRECs Scheme Guidelines and the operational phase to allow consistency.

  • 30 ‘working days’ benchmark is equivalent to approximately 42 ‘calendar days’.
  • 20 ‘working days’ benchmark is equivalent to approximately 28 ‘calendar days’.

There are often delays in the governance process. Are there any plans to streamline this with regard to early phase trials?

The Quality Recognition Scheme is currently under development for sites and investigators conducting early phase clinical trials under the Quality Recognition Scheme. Once this scheme is operational (with reference to the Framework, page 28), there will be a guarantee of a site specific approval review time within an agreed short timeframe of receipt of applications for trials within the quality recognised sites (10 working days).

If I understand correctly, a private HREC may become a specialist Early Phase HREC. Will the NSW Health policy be changed to allow public health organisations to accept the HREC approval of a non-National Mutual Acceptance HREC?

The provisions of the NSW Health Early Phase Clinical Trial HRECs Scheme will be incorporated into NSW Health policy.

If it is mandatory for Phase 1 trials being conducted in the NSW public health sector to be reviewed by a specialist NSW Early Phase HREC where does that leave trials reviewed by an interstate lead HREC under National Mutual Acceptance?

This scheme allows for the continued acceptance of ethical approval from interstate HRECs under the National Mutual Acceptance scheme. The National Mutual Acceptance scheme allows multi-site early phase trials to commence in NSW having been reviewed by an National Health and Medical Research Council certified HREC from a participating jurisdiction. This means that a specialist early phase review would not be required for multi-centre studies, where the lead site is outside of NSW. The interstate-HREC must be certified under the NHMRC National Certification Scheme for phase 1 and also be a certified reviewing HREC under the National Mututal Acceptance scheme.

How will applications be allocated to the appointed HRECs? Is that where the research team approaches an ethics committee or is there other venue by which a project or application will be designed, if you like, to work particular committee?

This operational detail will be worked through with the appointed NSW Health Early Phase Clinical Trials HRECs with the Office for Health and Medical Research as operational processes are designed.

Would there be the possibility of being able – a committee being able to decline a particular application or cap the numbers of applications they receive?

This operational detail will be worked through with the appointed NSW Health Early Phase Clinical Trials HRECs with the Office for Health and Medical Research as operational processes are designed.

In the application form, page 14, question 9, there is reference to 30-day post-approval reports. This responsibility currently lies with RGO. Is there expectation for this for appointed HRECs?

This responsibility will still be part of Research Governance Office. Please ignore the 30-day post approval requirement in the application form; there is no need to address this. Applications should include description of processes in place for the monitoring of approved clinical trial research projects with respect to HREC responsibilities as per the National Statement.

If an ethics committee (decides to apply or not) but might have members that might be interested in becoming involved in the specialist technical reviewers. Would that be open to them?

Yes, anyone who is suitably qualified and meets the criteria of being an expert reviewer could be invited on to the Office for Health and Medical Research’s list of Early Phase Clinical Trial Expert Technical Reviewers.

What fees will be paid to the expert technical reviewers? Is this going to be set by the Office for Health and Medical Research?

Funds will be provided by the Office for Health and Medical Research to support the HRECs’ plans to review early phase clinical trials. These funds will be used to pay for additional scientific review including expert technical reviewers. The fee structure will be set up by the Office.

Currently the implementation of REGIS is in progress across NSW and ACT and it has been slower and more cumbersome than anticipated. Has the Office for Health and Medical Research considered delaying the Early Phase HREC expression of interest until REGIS is appropriately implemented?

The expression of interest process will not be delayed. However, there will be a transition period from the time of appointment to the actual expectation of when the appointed HRECs should start business work as the NSW Health Early Phase Clinical Trial HRECs. The operational detail will be worked through with the appointed NSW Health Early Phase Clinical Trial HRECs and the Office.

About the Framework

The framework contains the design of two practical schemes to make NSW a centre of excellence in clinical trials, through the provision of a high quality and efficient environment to conduct early phase trials, with the ultimate aim of improving health outcomes for NSW residents.

The Framework is designed to:

  • strengthen the capability in NSW to become a centre of excellence for early phase trials
  • support and enable opportunities for residents and the research community across the
  • State to engage in national and international early phase trials
  • reduce the administrative burden in the approval and conduct of early phase trials
  • ensure alignment with best practice internationally and nationally.

Framework benefits

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.

Updated 3 months ago