An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably. In this document the term ‘quality assurance’ is used to include all of these terms.

QA commonly involve minimal risk, burden or inconvenience to participants, and, while some level of oversight is necessary, Human Research Ethics Committee (HREC) review processes are often not the optimal pathway for review of these activities.

Irrespective of whether an activity is QA, evaluation or research, the activity must be conducted in a way that is ethical. This should include consideration of whether the people involved will be exposed to any harm as a result of the activity. Those conducting the activity need to consider a range of issues including consent, privacy, relevant legislation, national/professional standards.

Taken from: NHMRC document Ethical Considerations in Quality Assurance and Evaluation Activities, March 2014

QA projects conducted by a Peninsula Health staff member accessing existing Peninsula Health data. To be eligible for review as a QA project, the project must meet the following criteria:

• 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 in point (e) of Ethical Considerations in Quality Assurance and Evaluation Activities) are present.

 Projects that do not meet the criteria above require formal ethics review.

Retrospective review of QA Applications cannot be completed.

Application Information

Below is a list of the documents required for submission. Incomplete applications will not be accepted for review.

All applications must:

• Contain documents which have a version number and date (no draft documents will be accepted)
• Comply with the submission instructions

Submission Requirements

QA applications are to be submitted through the Ethics Review Manager (ERM) Database.  First time users will need to create an ERM account before completing their application. 

Notification of Review Outcome

The outcome of the QA application review will be sent by the Office for Research through the ERM Database.  You will receive a notification in your ERM account work area. 

The project should not commence until a formal signed approval has been received.

Ongoing Management of QA Projects

Any changes to the project which may impinge on the ethical principles that guide human research must be reported to the Office for Research prior to implementation to determine if ethical review is required.

A brief final report and any abstracts accepted for publication or external presentation should be sent to the Office for Research via the ERM Database on completion of the project.