​​​​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 Health retains responsibility for authorising the commencement of research to be undertaken within their institutions through a separate research governance process.

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

The Hunter New England Research Ethics and Governance Office (REGO) is a soft launch site for REGIS which commences on 12 February 2018.  During soft launch, only new single site applications can be submitted through REGIS. That is, new ethics applications for research to be conducted at a single site, or only at sites within the HNELHD.  The corresponding governance applications for single site applications can also be submitted through REGIS.

The following advice is for new submissions during the implementation period:

Date​Advice to Researchers Re New Submissions

​From 12 February 2018

For the HNEHREC Meeting 21 March 2018 - (Submission due date 28 February 2018)

​For Single-Site Submissions (both LNR and Full HREC Review) we invite you to submit through REGIS and we will provide support as required

​From 1 March 2018

For the HNEHREC Meeting 18 April 2018 (Submission due date 30 March 2018)

​It will be mandatory that all Single-Site Submissions (both LNR and Full HREC Review) be submitted through REGIS

​Date TBA

​It will be mandatory for all new Mult-Site and Single-Site Submissions be submitted through REGIS

 

Please contact Dr Nicole Gerrand on 49214950 or Ms Lisa Woseen on 4921 4943 prior to using REGIS.  Advice may be provided over the phone or face-to-face training organised to assist you with the registration and the commencement of your first submission in REGIS.

 

TRANSITION FROM THE NATIONAL ETHICS APPLICATION FORM (NEAF) TO THE HUMAN RESEARCH ETHICS APPLICATION (HREA)

On 31 August 2017, the National Health and Medical Research Council's (NHMRC's) Human Research Ethics Application (HREA) replaced the National Ethics Application Form (NEAF) in Online Forms.

All new ethics applications regardless of study risk level should be generated on a HREA inside of Online Forms. (Please do not access the HREA from the NHMRC site). This change applies to all NMA jurisdictions, so that all multi-jurisdictional projects regardless of study risk level may be submitted on a HREA under NMA.

In-progress applications

NEAF, SSA, NSW LNR and NSW LNRSSA applications that have already been created/in progress in online forms prior to 31 August 2017 can still be submitted up until the 30 November 2017.

All new submissions for 2018 must be submitted on the new HREA.

WESTERN AUSTRALIA HEALTH JOINING NATIONAL MUTUAL ACCEPTANCE (NMA)

As of 31 August 2017, Western Australia joined the National Mutual Acceptance (NMA) scheme of single ethical review for health and medical research conducted in more than one participating jurisdiction's public health organisations (PHOs). States now participaing in National Mutual Acceptance (NMA) are Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia.

To add a Western Australia site to an existing project approved under NMA, an ethics amendment needs to be submitted to the original reviewing HREC requesting the approval of the additional site. For studies taking place in Western Australia, Western Australian Specific Module (WASM) must be completed in addition to the HREA. All other NMA procedures remain the same.

 

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@hnehealth.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@hnehealth.nsw.gov.au

 

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

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

 

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

Email: Debbie.Madden@hnehealth.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