Quality assurance

Quality assurance (QA) projects are an essential and integral part of improving the quality of healthcare service and delivery.

Sometimes it’s difficult to determine whether a project is QA.

An activity where the purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity.

These include situations 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 unless identifiers have been removed or replaced by a code.

Below are a series of questions to help determine whether your project fits the criteria for quality assurance.

The ethical principles of integrity, justice, beneficence and respect as set out in the National Statement on Ethical Conduct in Human Research 2025 (the National Statement) also apply to quality assurance. 

The Women’s provides QA oversight and approval for Women’s-governed sites only, and its interpretation of the National Statement is intended for the Women’s only.

The project team conducting QA activities must consider a range of issues, including:

• Consent
• Privacy
• Relevant legislation (state and Commonwealth)
• Professional standards

Is my project QA?

Prior to submitting the QA project to the Women’s via the Ethical Review Manager (ERM) website, the Project Lead must consider the following questions.

You must be able to answer ‘YES’ to the below statements for your project to be considered QA.

• The collection of information about participants is not beyond that which is collected routinely.
• The information being collected and analysed is specifically for the purpose of maintaining standards or identifying areas of improvement of the Women’s health service delivery to our patients and community.
• The activity is being undertaken by a Women’s paid staff member.
• The activity will not impact the reputation and/or privacy of researchers and/or the organisation.
• The activity will not infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence, and respect).
• The activity does not involve targeted data analysis of research participants who may experience increased risk (see Section 4 of the National Statement on Ethical Conduct in Human Research 2025).
• The activity proposed does not significantly deviate from standard practice.
• The activity does not aim to generate new generalisable knowledge, that is, by testing a hypothesis, collecting or using data about patients beyond that collected routinely, tissue and/or blood samples from patients, carers, or their relatives. The collection of non-routine data is permitted where it does not cause additional harm or inconvenience and is undertaken solely to improve service delivery, for example, a feedback survey.
• Money will not be received from, or paid to the Women’s, by an external entity (individual small grants which may be used to fund QA activities may be accepted).
• The activity does not involve collaboration with a commercial entity.
• The activity does not involve linkage of participant information with other sources or organisations.
• The activity does not involve participant information being exported offsite or shared with external institutions for the purposes of a research project.
• The activity does not involve prospective comparison of cohorts, the use of control groups or placebos.

Is my project actually research?

If you answered ‘NO’ to any of the above statements, your project is likely to be considered research and not quality assurance, and you will need to submit your research project for ethics review by a Certified Reviewing HREC under the National Mutual Acceptance (NMA) scheme.

The Women’s Research Office recommends submission to the Royal Melbourne Hospital (RMH) HREC for most research projects undertaken at the Women’s. Research in a particular specialty area should be submitted to the appropriate Certified Reviewing HREC; e.g., for cancer research, submission to Peter MacCallum Cancer Centre HREC, or for newborn research, submission to the Royal Children’s Hospital HREC.

The Women’s Research Office reserves the right to request ethics review where required.

Submit your QA project to the Women's

QA projects at the Women’s are reviewed by the Research Advisory Committee (RAC). For RAC submission deadlines and meeting dates, visit Committees and Meeting Dates.

All QA projects must be submitted via the Ethical Review Manager (ERM) website, using the Quality Assurance (QA) VIC Form.

Before submitting your application in ERM, ensure the following documents are uploaded under the Supporting Documents section:

• QA project description/protocol (e.g. QA protocol template (Word, 220 KB))
• Curriculum vitae (CV) (e.g. Curriculum vitae template (Word, 99 KB)) for each member of the project team
• Good Clinical Practice (GCP) certificate for each member of the project team
• Epic EMR Pre-Submission Survey
• Clinical Informatics Assessment
• Signed approval (if electronic signatures are not being obtained using the ERM function) from the following required signatories:
  • Project Lead (labelled Principal Investigator in the ERM Form)
  • Head of Department for each department conducting the project
  • Head of Department for each department supporting the project (e.g. Health Information Services (HIS) for retrieval of paper records

Evidence of approval may be uploaded either as a scanned wet-ink signature or a PDF copy of an email from the relevant signatory confirming their approval.

• Participant Information Sheets, surveys, questionnaires (where relevant)

Approval

Following review of the QA project by the RAC and once all queries have been resolved, the Research Office will issue an approval letter.

• The QA project may commence once approval has been granted.
• Approval by the RAC applies to the Women’s only.
• Approval is valid for two years from the date of the approval letter.
• Projects must be completed within the approved two-year period. If a project will continue beyond two years, a new QA project will need to be submitted.
• Annual progress reports are not required for QA projects.

Amendments to QA projects

The Research Office will acknowledge minor amendments to approved QA projects. Minor amendments may include the addition of personnel or an administrative change.

If a proposed amendment is considered substantial, the Research Office may advise that a new QA project will need to be submitted.

To discuss a proposed amendment to your QA project, please contact the Research Office at Research.Governance@thewomens.org.au.