Human ethics
The University of Newcastle is committed to the highest standard of ethical practice in research involving or impacting on humans.
All human research projects conducted at the University, or by staff and students of the University, require ethical oversight.
The University of Newcastle's Human Research Ethics Committee (HREC) has responsibility for reviewing the ethical acceptability of human research and ensuring compliance with regulatory and legislative requirements, as well as University policies relating to human research.
The principal point of reference for the HREC is the NHMRC's National Statement on Ethical Conduct in Human Research. The primary purpose of the National Statement is the protection of the welfare and rights of participants in research. It is binding on all institutions and organisations that receive research funding from the Australian government.
Review process
The University uses a risk assessment review model for human research requiring ethics approval. Applications are reviewed for ethics approval using one of three assessment levels based on the risk that the research poses to participants. Two of the levels provide for expedited review of applications. This has streamlined the process for researchers and resulted in a reduction in processing time for the majority of applications.
Research Ethics Advisors (REAs) are located in Faculties to assist researchers to design ethically acceptable human research and assist them through the ethics approval process. REAs are the first 'port-of-call' for researchers requiring assistance or advice on human research ethics matters.
Research Information Management Systems (RIMS)
Applications for ethical clearance must be submitted to the Committee via the Research Information Management Systems (RIMS). All staff (including Conjoint appointments) and HDR candidates can apply for access to RIMS in order to submit and manage their applications.
Undergraduate and postgraduate coursework students who require assistance in accessing RIMS should contact a Human Ethics Officer. Researchers without a University of Newcastle computer account can contact a Human Ethics Officer for alternate submission procedures.
Resources
General links
- RIMS login
- Hunter New England Health Human Research Ethics Committee
- Guardianship Tribunal of NSW
- NSW Department of Education & Communities - State Education Research Approvals Process (SERAP) guideline
- Therapeutic Goods Administration (TGA)
NHMRC/ARC/Universities Australia
- NHMRC National Statement on Ethical Conduct in Human Research (2007) (updated 2018)
- NHMRC Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders
- World Medical Association, Declaration of Helsinki (2008)
- NHMRC Australian Code for the Responsible Conduct of Research 2018
Privacy
- NSW Health Records and Information Privacy (HRIP) Act 2002
- NHMRC Guidelines under Section 95 of the Privacy Act 1988
- NHMRC Guidelines approved under Section 95A of the Privacy Act 1988
Clinical trials
- Australian New Zealand Clinical Trials Registry (ANZCTR)
- Note for Guidance on Good Clinical Practice CPMP/ICH/135/95 - Annotated with TGA comments
- Human Research Ethics Committees and the Therapeutic Goods Legislation (PDF 248 KB)