Research Ethics and Governance Office (REGO)

About us

The Research Ethics and Governance 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 Research Ethics and Governance 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.

 

Christmas Closure

The Research Ethics and Governance Office (REGO) will close on the 20 December 2019 and re-open on the 20 January 2020. 

Please see below closure dates for submissions to the Research Ethics and Governance Office for processing prior to the Christmas closure period:

All New Applications for submission to the December 2019 HREC Meeting

by 29 November 2019​

​All New Low & Negligible Risk Applications

by 29 November 2019

​HNELHD Governance Submissions for authorisation prior to closure

​by 30 November 2019

​All Amendments & Extensions of Ethics Approval

​by 13 December 2019

 Any submissions made after these dates will not be reviewed until after 20 January 2020, our apologies for any inconvenience.

Please Note: The HNEHREC  does not meet in January. The first meeting for the HNEHREC will be held on 19 February 2020. The submission close date for this meeting is 31 January 2020.

 

What's New​​​

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 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 Ethics and Governance Office:

Dr Nicole Gerrand
Manager, Research Ethics and Governance Office
Hunter New England Human Research Ethics Committee
Hunter New England Local Health District
Locked Bag 1
New Lambton 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

Research Ethics and Governance Office
The Lodge, Rankin Park Campus
Lookout Road,
New Lambton NSW 2305

Postal address

Research Ethics and Governance Office
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305

Contacts

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

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

 

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

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

 

Debbie Madden
Research Ethics and Governance Office - 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