Central Adelaide Local Health Network Human Research Ethics Committee
Central Adelaide Local Health Network (CALHN) previously supported two human research ethics committees (HRECs): Royal Adelaide Hospital REC and TQEH/LHM/MH HREC.
As of 1 January 2018, the two HRECs are merged into one committee known as the Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC). The CALHN HREC will retain responsibility for monitoring all projects previously approved by the RAH REC and TQEH/LMH/MH HREC.
HREC Chair: Mr Ian Tindall
HREC Executive Officer
Phone: +61 8 8222 6841
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Please note all submissions to the CALHN HREC must be made via email to Health.CALHNResearchEthics@sa.gov.au. Hard copy submissions will not be accepted.
National Health and Medical Research Council (NHMRC)
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.
National Mutual Acceptance
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 Monitoring and Reporting Tables – based on the 2009 NHMRC Position Statement
Human Research Ethics Application (HREA) and the Research Governance and Ethics Management System (Research GEMS)
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 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.
Please note: Online Forms will cease operations on 31 October 2020 and will be replaced by the Research Governance and Ethics Management System (Research GEMS). Researchers using Online Forms are advised to complete submissions in this system prior to 31 October 2020, as ‘in flight’ applications will not be automatically migrated into Research GEMS.
Further information about Research GEMS is available here.
CALHN HREC documentation will be updated to include GEMS information in due course.
Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods
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.
Reports to the CALHN HREC must be made on the appropriate form available under the Forms tab below.
For further information contact:
Phone: +61 8 7117 2218
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.
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
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.
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
- 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)
- 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