Do I need Ethical Approval?
Do I need Ethical Approval?
All projects that are defined as a research project must obtain ethical approval by a Human Research Ethics Committee (HREC) or sub-committee and governance approval at each site (All Northern Health campuses are considered as one site) that the project will be conducted, prior to implementation. Human research is research conducted with or about people, their data or their tissue.
Most quality assurance projects do not require ethical approval provided that:
a) The evaluation does not breach confidentiality or privacy; AND
b) The evaluation is non-interventional; OR
c) The evaluation if interventional but carries negligible risk (e.g: an anonymous patient satisfaction survey or inpatient stay administered as the patient is about to leave hospital).
Ethical review is not necessary where:
- The data being collected and analysed is coincidental to standard operating procedures with standard equipment and/or protocols;
- The data is being collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained;
- The data being collected and analysed is not linked to individuals; and
- None of the triggers for consideration of ethical review listed below are present:
- Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations
- Secondary use of data - using data or analysis from QA or evaluation activities for another purpose
- Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations
- Testing of non-standard (innovative) protocols or equipment
- Comparison of cohorts
- Randomisation or the use of control groups or placebos
- Targeted analysis of data involving minority/vulnerable groups whose data is to be separated out of that data collected or analysed as part of the main QA/evaluation activity.
Where one or more of the triggers above apply, the guidance provided in the National Statement on Ethical Conduct in Human Research, 2007 (National Statement) should be followed.
If you intend to publish the outcomes of your Quality Assurance project, then journals generally request a letter indicating that the project has received ethical review. Northern Health also require projects to undergo review if Principal Investigators intend to present external to Northern Health.
Human Research Ethics Committees do not provide retrospective ethical approval as per the guidelines in the National Statement.
Contact the Quality department for information on registering a Quality Assurance project.
Human research projects can be classified as:
- Negligible risk
- Low risk
- High risk
A quality assurance project may fit into either of the above classifications.
HRECs reserve the right to determine the level of ethical review for all projects which they review. This may result in researchers being requested to re-submit an application for appropriate ethical review.