The Royal Adelaide Hospital has an obligation to ensure that research being conducted by staff or external researchers meets all ethical requirements in accordance with the relevant guidelines and standards, including the NHMRC’s National Statement on the Ethical Conduct of Human Research (2007).

Research ethics approval takes into consideration the legal, ethical organisational and cultural standards relevant to the research to be undertaken.

The Royal Adelaide Hospital Research Ethics Committee is appropriately constituted in accordance with the requirements of the NHMRC, and fulfils the requirements of the National Statement (section 5.2).

ASB1403_HI_090

RAH Research Ethics Committee

A/Prof Andrew Thornton

REC Chairman

Ms Heather O’Dea

REC Executive Officer

Contact Details

Email: Health.CALHNResearchEthics@sa.gov.au

Phone: +61 8 8222 4139

Level 4, Women’s Health Centre, Royal Adelaide Hospital North Terrace, ADELAIDE SA 5000

National Health and Medical Research Council (NHMRC)

The RAH REC 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).

 

 

Human Research Ethics Application (HREA)

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.

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

The National Health and Medical Research Council has 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). The Guidance will apply to all studies approved by a CALHN HREC.

For further information contact:

Email: Health.CALHNResearchEthics@sa.gov.au

Phone: +61 8 8222 4139

CALHN HREC documentation will be updated to reflect these changes in due course.

Guidelines for clinical trial monitoring and reporting at CALHN are available here.