​​​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.

Application Closing Dates for 2017

The HNELHD Research Ethics and Governance Office will be closed from 18 December 2017 to 15 January 2018.

In order for applications to be reviewed prior to the closure, they must be submitted by the following dates:

  • Variation Applciations - by 11 December 2017
  • Low & Neglible Risk Applications -  by 30 November 2017

What's New

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 will not be affected, and can still be submitted until further notice.

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.

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) has been chosen as a soft launch site for REGIS, meaning that it will be one of the first sites to be using REGIS.

As part of the soft launch, the estimated timeline dates for REGIS implementation for the HNELHD is 1 December 2017. However, this date may be subject to change. Please keep this date in mind if you are intending to submit an application in the upcoming months.

For the commencement of researcher submission of applications into REGIS as part of the soft launch, it will only apply to HNE single site applications. All multi-site studies or studies involving sites outside of HNELHD will continue to use HREA in online forms.

We will update HNELHD researchers and our website as we receive more information on when REGIS will be implemented for our site. Please check our website in the upcoming months for updates on this transition and available training for researchers.

For more information about REGIS and to receive updates from their website directly, please register your email at the REGIS website: https://regis.health.nsw.gov.au/

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