HNE Research Office

About us

The HNE Research Office  is responsible for the oversight of all research involving humans that is undertaken in the Hunter New England Local Health District.  This involves providing Secretariat support to the Hunter New England Human Research Ethics Committee and ensuring all governance requirements have been met for research conducted in the Hunter New England Local Health District. 

The HNE Research  Office will:

  • Assist with the preparation of applications for human research ethics review 

  • Facilitate and co-ordinate the ethical review and approval of Research protocols

  • Ensure all research governance requirements are met and research protocols are authorised prior to commencement.

  • Hunter New England Local Health District (HNE Health) participates in the NSW Health System for Single Ethical and Scientific Review for Multicentre Research. This is for both research ethics approval and governance authorisation  

Hunter New England H​​​​​​​​​​ealth retains responsibility for authorising the commencement of research to be undertaken within their institutions through a separate research governance process.

 

2020 Christmas Closure – HNE Research Office

Closure Dates for Research Ethics and Governance submissions for 2020

The HNE Research Office will be closed from Friday 25 December 2020 to Friday 8 January 2021 (inclusive) with limited Research Ethics functions occurring from 21 December 2020 to 15 January 2021 (inclusive).

  • Closure date for submission of new LNR Applications to be processed for 2020 is 30 November 2020
  • Closure date for all REGIS Amendment applications to be processed for 2020 is 9 December 2020
  • Closure date for HNELHD Governance Submissions to be processed for 2020 is 9 December 2020

The decision for Submissions reviewed at the HNEHREC meeting held on 16 December 2020 will be sent prior to Christmas but responses to these decisions will not be approved until late January.  

New 2021 Ethics Submissions due date for the February 2021 HREC Meeting is 29 January 2021.

 

What's New​​​

 

COVID-19 Guidance for Research/Clinical Trials

The HNE Research Office has received COVID-19 guidance for research/clinical trials from 3 levels as follows: 

Local

Guidance for human research activities during COVID-19

This guidance advice is for those involved in human research initiatives.  It is based on the collective expertise of the Human Research Ethics Committees at the University of Newcastle and the Hunter New England Local Health District.

State

NSW Health – COVID-19 Guidance on Clinical Trials

This guidance has been provided to minimise the adverse health impacts on clinical trial participants as well as site, sponsor and vendor staff involved in clinical trials. Emphasis is placed on managing burden and disruption to health-related services in NSW at this critical time. 

National

COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors

This guidance provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields.

 

If you have any questions, please contact the HNE Research Office; 

HNELHD-HREC@health.nsw.gov.au or (02) 4921 4950.

 

Research Office Relocation

The HNE Research Office will be relocating to HMRI as of 9 March 2020.

Our contact numbers and email will remain the same.

New Postal Address

Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305

 

RESEARCH ETHICS AND GOVERNANCE INFORMATION SYSTEM (REGIS)

The Research Ethics and Governance Information System (REGIS) is a new online portal that is being introduced by the Office of Health and Medical Research (OHMR) to manage ethics and site governance of health and medical research projects in NSW and ACT public health organisations (PHOs).

  • It has replaced AU-RED and the Online Forms website as one system
  • It is accessible by PHOs and Researchers
  • It facilitates the creation, processing and storage of ethics and site-governance applications as well as post-approval/authorisation, progress reports, safety notifications and amendments
  • It incorporates the new ethics application form (HREA)

As at 1 December 2018 - It is mandatory for ALL NEW Single Site and Multi Site Applications to be completed and submitted through REGIS.

BEFORE commencing any new application for Ethics and Governance, you are advised to consult with the Research Office to which you are intending to submit your application for confirmation of local arrangements.

For the HNE Research Ethics & Governance Office, please contact Dr Nicole Gerrand on 49214950 or Ms Lisa Woseen on 49214943. 

​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? 

 
  • ​ACT​​ - Please contact ACT Health for advice on how to submit applications to ACT Health HREC.
  • NSW -​ Online Forms​ as of 1 December  2018 - REGIS

Where do I create and submit SSAs 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:

​​​INCREASE IN RESEARCH ETHICS AND GOVERNANCE FEES

When the NSW System for Single Ethical and Scientific Review of Multicentre research was introduced in 2007, the then Department of Health set a fee schedule for all Research Officers whose HREC's had been accredited to review multicentre research.  This fee schedule is outlined in clause 1-5 of the policy PD_2008-28 HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research. Revenue from these fees was to be used in accordance with clause of the policy which states:

Revenue raised through the application of this policy must be used by Public Health Organisations to support their HREC and their research governance functions (including salaries, administrative support and training).

To date the only fees levied within HNELHD have been in accordance with the afore mentioned policy directive, there has been no increase in these fees since 2007. 

The new fee structure is to be implemented from 1 July 2018 which will effectively mean the revenue will start being collected in August 2018.

More information on the new fee structure can be found on the HNE Research Ethics and Governance Website Fees Page http://www.hnehealth.nsw.gov.au/ethics/Pages/Fees.aspx

Complaints

Any person (including participants, researchers, staff, students, administrators) can make a complaint to the Hunter New England Research Ethics Committee about any aspect of a research study. Any other matter of ethical concern can also be bought to the Committee's attention and will be appropriately investigated.

All such complaints and concerns should be directed to the Hunter New England Local Heath District Research Office:

Dr Nicole Gerrand
Manager, Research Ethics & Governance
Hunter New England Human Research Ethics Committee
Level 3, Pod, HMRI,

Lot 1, Kookaburra Circuit,

New Lambton Heights NSW 2305

Telephone: 4921 4950

Email: HNELHD-HREC@health.nsw.gov.au

Should the Complaint relate to the review of an Application or any other of the Hunter New England Human Research Ethics Committee's activities, please contact:

Ms Jane Gray
Director of Partnerships, Innovatation and Research
 

Please see Participant Information Statement Template for the Complaint Statement on the Forms and Templates page

Location

HNE Research Office
Level 3, Pod, HMRI,

Lot 1, Kookaburra Circuit,

New Lambton Heights NSW 2305

Postal address

HNE Research Office
Level 3, Pod, HMRI,

Lot 1, Kookaburra Circuit,

New Lambton Heights NSW 2305

Contacts

Dr Nicole Gerrand
Research Ethics and Governance - Manager
Phone: 4921 4950

Email: Nicole.Gerrand@health.nsw.gov.au

 

Lisa Woseen
Research Ethics and Governance - Support Officer
Phone:  4921 4943

Email: Lisa.Woseen@health.nsw.gov.au

 

Debbie Madden
Research Ethics and Governance  - Administrative Officer
Phone: 4985 5929

Email: Debbie.Madden@health.nsw.gov.au 

 

Institution details for regulatory documents

Hunter New England Local Health District
Lookout Road
New Lambton NSW 2305 
ABN 63 598 010 203