FAQ: Does my study/project need ethical approval?
What types of research require ethical review? | Does student research require ethical review? | Do pilot studies require ethical review? | Do quality improvement projects require ethical review? | What is the difference between full HREC review and expedited HREC review? | Can I apply for expedited HREC review?What types of research require ethical review?
All human research that takes place in NSW Public Health Organisations must be reviewed and approved in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007). This includes, but is not limited to:
• Clinical research;
• Clinical trials;
• Epidemiological research;
• Health services research;
• Population health research; and
• Qualitative research.
Does student research require ethical review?
Yes. Student research involving humans that takes place in NSW Public Health Organisations is subject to the same ethical and scientific review processes as other research.
Do pilot studies require ethical review?
Yes. Pilot studies involving humans that take place in NSW Public Health Organisations are subject to the same ethical and scientific review processes as other research.
Do quality improvement projects require ethical review?
This depends on whether or not the quality improvement project poses any ethical risks to participants. The NSW Health Guideline GL2007_020 Human Research Ethics Committees - Quality Improvement & Ethical Review: A Practice Guide for NSW provides advice on determining when quality improvement activities require ethical review. The guideline can be accessed at: www.health.nsw.gov.au/policies/gl/2007/GL2007_020.html.
Individuals engaged in quality improvement projects should consult each NSW Public Health Organisation involved in the project in order to identify the process adopted by that Public Health Organisation for the ethical review of such projects.
What is the difference between full HREC review and expedited HREC review?
HRECs established by NSW Public Health Organisations provide full and expedited ethical and scientific review. Full HREC review must be undertaken for all human research that involves more than low risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007). Expedited HREC review can be conducted for human research that only involves low or negligible risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007).
Can I apply for expedited HREC review?
Only human research that involves low or negligible risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007), is eligible for expedited HREC review. You should consult the NSW Health HREC associated with the site(s) at which you propose to conduct the research to determine if your project can be classified as low or negligible risk research before making an application.