​Research Ethics

The Hunter New England Human Research Ethics Committee is accredited to be a Lead Human Research Ethics Committee for the purpose of multicentre review in both clinical and general research. The Committee also reviews single site research within Hunter New England Health.

Types of review

There are three types of review for research and related activities in HNE Health:

  • Full HREC review
  • Expedited review of low and negligible research
  • Review of non-research activities that may result in external presentation/publication

Full HREC review

Research Projects that will require full review by the Hunter New England Human Research Ethics Committee (HNEHREC):

  • Interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities
  • Active concealment or planned deception of participants;
  • Exposure of illegal activities;
  • Research specifically targeting Aboriginal or Torres Strait Islander peoples; and
  • Research involving some vulnerable groups of participants

Low and Negligible Risk (LNR) Review

An expedited review process for research projects, which are considered to be low or negligible risk to participants.
The types of low and negligible risk research that may undergo expedited review include research where:

  • The threat to participants privacy and confidentiality is remote;
  • The project does not (or does not have the potential to) involve sensitive information about participants; and
  • The level of intrusiveness and disruption to participants is minimal.

Access request

All enquiries should be directed to Dr Nicole Gerrand on 4921 4950 or Nicole.gerrand@health.nsw.gov.au

Review of non-research activity

HNE Health encourages audits, evaluations and other types of reviews of its services.  A proportion of such activities are undertaken with the intention of presenting or publishing the results and journal editors or conference organisers will require some proof of review by the organisations Human Research Ethics Committee, prior to accepting the publication or presentation.

The process for the review of non-research activities is as follows:

  1.   Email a brief description of your project to the Manger Research Ethics and Governance to establish the level of review        required before the activity is undertaken.
  2. If advised complete the form Review of Non-research Activity and submit electronically.
  3. The form will be reviewed, signed and returned to you as proof the review has taken place.  Rarely, you may be advised      that, as a result of the review, another level of review is required.

Please Note: This is for a waiver of HREC review and applies to the Hunter New England Local Health District and Calvary Mater Newcastle staff only.

All enquiries should be directed to Dr Nicole Gerrand on 4921 4950 or Nicole.gerrand@health.nsw.gov.au

 

Submission requirements for Full HREC Review & LNR Review

​Multi-Site and Single-Site Applications

The Research Ethics and Governance Information System (REGIS) is the portal to help manage ethics and site governance in NSW and ACT Public Health Organisations (PHOs).​​

The following documents to be uploaded against the HREA in REGIS:

  • Clinical Trial Protocol
  • Investigator Drug Brochures, Device Manuals or Product Information, Patient Diaries
  • Information Statements  (If Multi-site, Masters should be submitted)
  • Consent Forms ( if Multi-site, Master Versions should be submitted)
  • Advertisement
  • Surveys, questionnaires, interview schedules as required (if <5 pages)

Please Note: For Governance Review - A Site Specific Assessment Form (SSA) must also be submitted for all research being conducted at a site within HNE Local Health District. See Research Governance.

 

National Mutual Acceptance (NMA)

As of 16 July 2018, six NMA jurisdictions are using three different application platforms.  

Where do I create and submit HREAs for NMA studies? 


 

While research applicants proposing studies under NMA will need to work within multiple platforms, the theory behind the process for creating those applications remains the same. Please see the following Links to the MoH website for more information: