Human Research Ethics 

The HREC (TQEH/LMH/MH) is constituted and functions in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007)

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants.

The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia.

Researchers are encouraged to read the National Statement prior to submitting their application for review.

Researchers are also encouraged to use the NHMRC Standardised Participant Information Consent Forms available here.

Australian State and Territory Departments of Health have signed a Memorandum of Understanding for mutual acceptance of scientific and ethical review of multi-centre human research projects undertaken in Public Health Organisations. Currently New South Wales, Queensland, South Australia and Victoria are
participating in National Mutual Acceptance (NMA).

Further information is available below:

National Mutual Acceptance Brochure

National Mutual Acceptance Fact Sheet

2016 NHMRC Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods – The Guidance

National Mutual Acceptance Standard Principles for Operation

National Mutual Acceptance Monitoring and Reporting Tables – based on the 2009 NHMRC Position Statement

As part of the initiative to streamline ethics approval, NHMRC has developed the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF).

The HREA replaces the NEAF in Online Forms for all new applications created for a full HREC review process. Any NEAF created before 1 September 2017 can still be completed and submitted and SSA forms can still be created and attached.

The HREA should be used for a full research ethics submission to a Human Research Ethics Committee at a South Australian public health organisation. The HREA must be used for any multi-jurisdiction research application where ethical approval is being sought under the National Mutual Acceptance Scheme.

A fact sheet for using the HREA via Online Forms is available here.

Further information from the NHMRC about the HREA is available here and a HREA User Guide is available here.

CALHN HREC documentation will be updated to include HREA information in due course.

In 2016 National Health and Medical Research Council (NHMRC) released new guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance) to replace the 2009 Australian Health Ethics Committee Position Statement of the same name (the Position Statement). 

In 2018 the NHMRC released new guidance on Reporting of Serious Breaches of Good Clinical Practice or the Protocol for Trials Involving Therapeutic Goods.

CALHN Research Services has prepared a guideline document for researchers and sponsors detailing CALHN’s submission requirements under these new guidances.

CALHN Clinical Trial Safety Monitoring and Serious Breach Reporting Guideline

Reports to the CALHN HREC must be made on the appropriate form available under the Forms tab below.

For further information contact:

Email: Health.CALHNResearchEthics@sa.gov.au

Phone: +61 8 7117 2218

CALHN HREC Meeting and Submission dates 2019

CALHN HREC Meeting and Submission dates 2020

CALHN HREC Member Composition 2019

CALHN HREC Member Composition 2018

CALHN HREC Terms of Reference

CALHN HREC Consolidated Standard Operating Procedures

SA Health Research Ethics Policy

SA Health Research Ethics and Governance Fee Schedule

SA Health Research Ethics and Governance Fees – Information for Applicants

Submission

CALHN Required Submission Documents

CALHN HREC Drug and Device Studies Checklist

SA Health Research Ethics and Governance Fees Schedule

Complaints

The CALHN HREC is committed to fulfilling Section 5.6 of The National Statement on Ethical Conduct in Human Research  and ensuring that research is conducted according to the Australian Code for the Responsible Conduct of Research by ensuring all complaints are handled appropriately. All complaints must be handled promptly with due sensitivity and in recognition of principles of natural justice.

Receiving complaints

Research participants, their families and other concerned parties have the right to communicate their concerns about any aspect of the services provided and are encouraged  to do so. To facilitate this process the HREC will ensure that all Information Sheets for research participants contain the contact information for the HREC Executive Officer.

The HREC may receive the complaint in any form: in person, by telephone, by email or in writing. If the complaint is not received in writing the complainant will be encouraged to document the complaint in a letter or email to the Chairperson of the CALHN HREC but, although desirable, this is not essential for the complaint to be investigated. Notes are taken by the person receiving the complaint (usually the Executive Officer) and a confidential memorandum is written to the Chairperson of CALHN HREC. The complainant may be identified or anonymous.

If the complainant is identified a letter acknowledging the receipt of the complaint will be sent to the complainant irrespective of the nature of the complaint. This letter will be sent within 5 working days of receiving the complaint.

Details of the complaint are recorded in the HREC Complaints Database by the Executive Officer in the first instance and then updated by the Chairperson or other delegated person in due course.

CALHN HREC Executive Officer:

Tel. +61 8 8222 6841

Health.CALHNResearchEthics@sa.gov.au

HREC New Submission Covering Letter Template

CALHN Amendment Request Form

CALHN Annual Progress Report Form

CALHN Final Report Form

CALHN Safety Event Report Form

CALHN Deviation Report Form

CALHN Serious Breach Report Form (Sponsor)

CALHN Suspected Breach Report Form (Third Party)

Invoicing and Fee Form – Ethics and Governance  – Please note this fee form should only be used for CALHN HREC and CALHN Research Governance fees. The NALHN Research Governance fee form is available here.

EPA Notification Form

National Health and Medical Research Council (NHMRC)

• NHMRC National Statement on Ethical Conduct in Research Involving Humans
• NHMRC and Australian Health Ethics Committee
• NHMRC National Approach to Single Ethical Review
• NHMRC Challenging Ethical Issues in Contemporary Research on Human Beings
• NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities

Regulatory Bodies

• Therapeutic Goods Administration (TGA) – Australia
• TGA Research Ethics Committees and the TGA legislation
• TGA Accessing Unapproved Products
• Food and Drug Administration (FDA) – USA
• European Medicines Agency (EMA) – Europe

South Australian and Australian Government publications

• SA Health Research Ethics Website
• Mental Health Act 2009 (SA)
• Guardianship and Administration Act 1993 (SA)
• Good Clinical Practice (GCP) for Researchers
• Privacy Act 1988 (Cth) and Australian Privacy Principles
• Code of Practice for the Exposure of Humans of Ionizing Radiation for Research Purposes 2005 (Cth)

Global Documents

• World Medical Association – Declaration of Helsinki
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• International Conference on Harmonisation of Statistical Principles for Clinical Trials

Clinical Trial Registration Websites

• Australian New Zealand Clinical Trials Registry
• clinicaltrials.gov
• EU Clinical Trials Register