NSW Health early phase clinical trials HRECs Scheme- Expression of Interest is now open for appointment of NSW Health early phase clinical trials HRECs

Goal 

Rapid and high quality approval to commence early phase trials​

Framework

  • NSW Health 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 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 (30 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.

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

  1. The NSW Health early phase clinical trial HRECs will be selected through a three-step application and appointment process:
  2. 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 OHMR. The application needs to be approved by the Head of Organisation of the entity hosting the HREC.
  3. A selection panel will assess the applications and may invite HREC Chairs and their institution’s CE, or a delegate, for an interview. Selection panel will then provide advice to OHMR.
  4. Chief Health Officer appoints the early phase clinical trial HRECs.

 Indicative timeline

These dates are indicative and are subject to change without notice

  • 19 July 2018 - Expressions of Interest open
  • 19 July 2018 -  Online registration open for information session
  • 10 August 2018 - Information session 2:00 - 3:00pm
  • 28 September 2018 - Expression of Interest close
  • 4 October 2018 - Panel meeting to assess applications
  • 10 October 2018 - HREC Interviews
  • 26 October 2018 - Appointment of NSW health Early Phase HRECs

Application documents

Support resources

 More information

For further information, email earlyphasetrials@moh.health.nsw.gov.au

Page Updated: Wednesday 18 July 2018