Research Ethics

HREC Terms of Reference

The Hunter New England Human Research Ethics Committee operates in accordance with:
NSW Health Operations Manual: Human Research Ethics Committee.

HREC Standard Operating Procedures

The Hunter New England Human Research Ethics Committee is constituted according to the National Statement on Ethical Conduct in Human Research 2023, and its membership is maintained in excess of the minimum requirements of Section 5.1.30, which are as follows:

The Hunter New England Human Research Ethics Committee is constituted according to the National Statement on Ethical Conduct in Human Research 2023, and its membership is maintained in excess of the minimum requirements of Section 5.1.30, which are as follows:

• A chairperson
• Laywoman with no affiliation with the institution and drawn from the local community
• A layman with no affiliation with the institution and drawn from the local community
• At least two people with knowledge of, and current experience in the areas of research regularly considered by the Committee
• At least a person with knowledge of, and current experience in, the professional care, counselling or treatment of people
• A minister of religion or person of equivalent standing in the Community
• A lawyer.

For details of the Committee’s composition for a specific meeting email HNELHD-ResearchOffice@health.nsw.gov.au

The Clinical Trials Sub-Committee advises the Hunter New England Human Research Ethics Committee on methodological and pharmacological aspects of applications to conduct clinical trials and innovative therapy in the HNE Health.

Terms of Reference

Clinical Trials Sub-Committee Terms of Reference

Membership

• Clinical Pharmacologist
• Pharmacist with appropriate experience
• A Statistician experienced in the design of clinical trials
• Persons with research experience and/or expertise relevant to the areas of research reviewed by the Committee

Applications are due on the last working day of each month (except December as the Committee and its subcommittee do not meet in January). Late applications will not be accepted.

Please Note: It is mandatory for all NEW Single and Multi-Site Applications to be completed and submitted in REGIS.

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

Application Form – Human Research Ethics Application Form (HREA)

Ethics Review Pathway ‘Greater than low risk research’

• HREA (ETH) in REGIS (All new applications) - REGIS log in
• The Mandatory Checklist for New Ethics Submissions (DOCX 79.19KB) must be completed and uploaded as a new document in your HREA for all research/all review pathways
• HNELHD Research Office Ethics & Governance Review of Clinical Trial Research Fees Invoicing Authorisation Form must be completed and uploaded as a new document in your HREA for all Clinical Trials Research with Commercial/Non-Commercial External Sponsor.
• Guidance to Completing the Human Research Ethics Application
• REGIS QRG - Completing an Ethics Application

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.

Checklist: Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities 

• https://redcap.link/nonresearch_checklist

Case Reports

• Case Report Application Form
• Case Report Consent Template

For further information visit our Research Governance. 

All enquiries should be directed to the HNELHD-ResearchOffice@health.nsw.gov.au

• All New Ethics Applications must be submitted in REGIS.
• The Mandatory Checklist for New Ethics Submissions  (DOCX 79.19KB)must be completed and uploaded as a new document in your HREA for all research/all review pathways.
• HNELHD Research Office Ethics & Governance Review of Clinical Trial Research Fees Invoicing Authorisation Form must be completed and uploaded as a new document in your HREA for all Clinical Trials Research with Commercial/Non-Commercial External Sponsor

Full HREC review

• HREA (ETH) via REGIS (All new applications)
• QRG – Completing an ethics application
• Mandatory Checklist for New Ethics Submissions  (DOCX 79.19KB)(complete and upload as a new document in your HREA).
• HNELHD Research Office Ethics & Governance Review of Clinical Trial Research Fees Invoicing Authorisation Form (complete and uploaded as a new document in your HREA) -  for all Clinical Trials Research with Commercial/Non-Commercial External Sponsor

Expedited Review of Low and Negligible Risk (LNR) Research

• HREA (ETH) via REGIS (All new applications)
• QRG – Completing an ethics application
• Mandatory Checklist for New Ethics Submissions (DOCX 79.19KB) (complete and upload as a new document in your HREA).

Guidance to Completing the HREA

• Guidance to Completing the Human Research Ethics Application

Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities

• Checklist: Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities 

Clinical Case Reports

• HNELHD Clinical Case Report Application Form
• Case Report Consent Template

Access Request (See Research Governance)

Amendment form in REGIS

A Notification of an Amendment to a Research Study is to be completed in REGIS against your Ethics Application.

There are 4 amendment types:

1. General Amendment

Affecting the conduct, design or methodology of a trial and includes changes to:

• Information previously given in the HREA
• The Protocol
• The Information sheet(s) and consent form/s for participants
• Any other supporting documentation for the study

2. Request for an extension of HREC Approval

Approval to extend the project beyond the original period granted by the HREC
(NOTE: For requests of over 12 months you should contact the Research Office first, as a full re-submission may be required)

3. Addition of a Site

Update the study details of the additional site(s) and investigator(s)
(NSW sites will have a site application form generated in REGIS)

4. Change to CPI/PI
Notify the HREC of changes to the Coordinating Principal Investigator and/or Site Principal Investigator(s)

• QRG – Ethics Amendment – Completing & Submitting
• Ethics Amendment Submission Checklist (under development)

Suggested Protocol Templates for Clinical Trials

• SPIRIT
• TRANSCELERATE
• EQUATOR

Suggested Protocol Templates for Non Clinical Trials (including Biological Studies and Data Studies)

• Non Clinical Trial Protocol Template (DOCX 56.2KB)

Suggested PICF Templates

• CTIQ InFORMed Template (DOCX 150.18KB)
• InFORMed User Guide (PDF 899.49KB)
• HNE Complaint Statements for Participant Information Statements (PDF 780.68KB)

The National Statement on Ethical Conduct in Human Research 2023, which the Hunter New England Human Research Ethics Committee is obliged to adhere to, include the requirement that the Committee monitors the research protocols it has approved. In order for the Committee to fulfill this function, it requires:

• A report of the progress of the protocol to be submitted at 12 monthly intervals. The Annual Progress Report must be submitted in REGIS. The Coordinating Principal Investigator will receive upcoming and overdue reminders from REGIS.
• A final report be submitted at the completion of the protocol, that is, after data analysis has been completed and a final report compiled. The Final Report must be submitted in REGIS.

In REGIS against your Ethics Application via Milestones

Annual Progress Reports and Final Reports

• Milestone Report (Annual Report) in REGIS
• QRG – Submitting a Progress/Final Report

As of January 2018 the Hunter New England Local Health District has adopted the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods https://www.nhmrc.gov.au/guidelines-publications/eh59

In line with these guidelines the safety reporting requirements for the Hunter New England Research Ethics and Governance Office is as follows.

REGIS Safety Reporting Forms

• Significant Safety Issues (SSI's) in REGIS
• Serious Breach Notification (third party) in REGIS
• Reporting Local Safety Events to the Institution in REGIS
• Updated Investigator Brochures via a General Amendment in REGIS
• Annual Safety Reports in REGIS via a General Amendment or attached to the Annual Progress Report Milestone

QRG - Submitting a Clinical Trial Safety Report

• National Statement in Ethical Conduct in Humans Research 2023
• Lawlink NSW
• Payment of participants in research
• Peer review and Ethical Review
• Quality Assurance and Evaluation Activities

• The Health Records and information Privacy Act 2002 (NSW) (HRIP Act)
• Health Records and Information Privacy Regulation 2012 (NSW)
• Health Records and Information Privacy Statutory Guidelines on Research

The role of the AH&MRC Ethics Committee is to assess research proposals affecting the health and wellbeing of Aboriginal Peoples and Communities in NSW, and to monitor the collection of data on Aboriginal Health to ensure these activities will be conducted ethically. This role is endorsed by the NSW Health Department and embodied within the NSW Aboriginal Health Information Guidelines which guide all NSW Government Agencies responsible for the management of Aboriginal Health and health-related information.

• AH&MRC Ethics Committee
• Ethical conduct in research with Aboriginal and Torres Strait Island Peoples and communities: Guidelines for researchers and stakeholders
• Keeping Research on Track II
• Aboriginal Health Research; Research our Way; Wukul Yabang (PDF 957.69KB)
• Wukul Yabang (Aboriginal Health Research Community Panel) | HNE Health Intranet

• Australian Clinical Trials Alliance (ACTA) CALD project resources
• CALD Communities Health Advisory Group
• NSW Health Multicultural health policy
• Multicultural Health research services
• Clinical trial recruitment resources for CALD communities in NSW

• Australian clinical trial handbook - guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods.
• International scientific guideline: ICH guideline for good clinical practice - replaces 'Note for guidance on good clinical practice (CPMP/ICH/135/95)'.

• NSW Health and Medical Research - Ethics and Governance policies and guidelines
• Justice Health NSW research
• NSW Health Policy Distribution System (PDS) - all policy documents and guidelines applicable to the NSW Health system.
• Australian Paediatric Research Ethics and Governance Network (APREG) Guide for investigators and sponsors (PDF 273KB)