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Is my research proposal exempt from ethical review?

Some proposals for human research (research proposal) may be exempt from ethical review. A research proposal may be exempt from ethical review if it is:

1. A Quality Assurance activity; or
2. Negligible risk

Quality Assurance

An activity where the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider (an individual, a service or an organisation) is a quality assurance (QA) study.

A research proposal may be exempt from ethical review if it is a QA study and if:

1. The activity is undertaken with the consent of the patients, carers, health care providers or institutions involved;
   or
   Is consistent with National Privacy Principle 2.1(a), which states: ‘An organisation must not use or disclose personal information about an individual for a purpose (the secondary purpose) other than the primary purpose of collection unless’ ... ‘both of the following apply:
   • the secondary purpose is related to the primary purpose of collection and, if the personal information is sensitive information, directly related to the primary purpose of collection;
   • the individual would reasonably expect the organisation to use or disclose the information for the secondary purpose’;
   and
2. It is an activity where participants, including patients, carers, health care providers or institutions are unlikely to suffer burden or harm (physical, mental, psychological, spiritual or social).

(Excerpts from NHMRC, When does quality assurance in health care require independent ethical review?, 2003)

Negligible risk

Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk (NHMRC, National Statement on Ethical Conduct in Human Research, 2007, 2.1.7)

A research proposal may be exempt from ethical review if the research:

1. is negligible risk research; and
2. involves the use of existing collections of data or records that contain only non-identifiable data about human beings. (NHMRC, National Statement on Ethical Conduct in Human Research, 2007, 5.1.22)

With advances in genetic knowledge and data linkage, human tissue samples should always be considered re-identifiable data (NHMRC, National Statement on Ethical Conduct in Human Research, 2007, 3.2 Tissue and Data).

If you believe that your research proposal may be exempt from ethical review, please contact the Human Ethics Office to obtain written confirmation prior to commencing your research.