The
following has been adapted from information provided by the Department
of Human Services Human Research Ethics Committee.
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 counselling
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).
Audit/QA
does not require Ethics
Committee review if:
The
evaluation does not breach confidentiality or privacy
AND
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.
It
is advised that audit or QA that breaches confidentiality or privacy, or
presents other ethical issues and which may or may not be interventional,
be presented for ethical review by the Ethics Committee.
The National Health & Medical Research Council has recently published a
more detailed document addressing this issue. “When does quality
assurance in health care required independent ethical review?” can be
found
at
http://www.nhmrc.gov.au/publications/synopses/e46syn.htm