What is research?

Research vs. audit/quality assurance

The Department of Health HREC primarily reviews research, and not audit, quality assurance (QA) projects or project evaluations. "Research" is defined broadly in the National Statement (pp. 7-8) but allows some discretion for HRECs to decide which research warrants ethical review.

For the purposes of the Department of Health HREC, the following distinction is drawn between research and audit/QA. Audit/QA is essentially an evaluation of an existing practice that involves the delivery of services to people. The goal of audit/QA is to improve that service. Examples might include the evaluation of existing psychiatric services to young offenders, the evaluation of existing counseling services provided to victims of child abuse, evaluation of morbidity and mortality data from hospital services, and so on.

Research involves, amongst other things, evaluation of a new practice (e.g., the introduction and evaluation of a new psychiatric service to young offenders) or an existing practice that is not a service (e.g. evaluating the frequency of needle sharing amongst intravenous drug users, evaluating the use of natural therapies).

There are instances where it may be difficult to determine whether an activity is research or audit/QA. Such "borderline" projects may be primarily an evaluation of a service, but may include elements that could warrant ethical review.

Generally speaking, audit/QA does not require ethics review by an HREC if:

1. The evaluation does not breach confidentiality or privacy.
   
   AND
2. The evaluation is non-interventional. An example of a non-interventional evaluation is counting the number of recorded wound infections after surgery. An example of an interventional evaluation is performing right heart catheter studies to examine some cardiological practice.
   
   OR
   
   The evaluation is interventional but does not present ethical issues. An example is a brief questionnaire that does not ask questions that may adversely affect the well-being of participants (physically or psychologically), such as an anonymous patient satisfaction survey of inpatient stay administered as the patient is about to leave hospital.

Audit/QA that satisfies these criteria is "low risk audit/QA". Audit/QA that breaches confidentiality or privacy, or presents other ethical issues and which may or may not be interventional is "high risk audit/QA".

Researchers should make a judgement as to whether their project is research or audit/QA. If they judge it to be audit/QA, they should decide whether it is low risk or high risk. High-risk audit/QA may benefit from ethical review by the Department of Health HREC.

In 2003, the NHMRC published advice on the issue of ethical review of QA in health care. This advice includes questions to be considered in deciding whether an activity requires ethical review. Download the full text of the document "When does quality assurance in health care require independent ethical review?" from the NHMRC web site.

The DH HREC has used these questions as the basis of a checklist to assist investigators who believe their proposal is not research, but who are unsure whether their proposal should be reviewed by an HREC. Investigators should download and complete the checklist. If, as a result of this process, it is determined that an application for ethical review will be submitted to the DH HREC, the completed checklist should be included with the application.

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