Quality assurance

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

All QA applications must be submitted via the Ethical Review Manager (ERM) platform.

All QA projects must be complete within two years of the date of approval in ERM. If the study is to continue beyond two years, a new QA project will need to be submitted.

Submitting for quality assurance

The Women’s endorses quality assurance activity that complies with the:

• National Statement on Ethical Conduct in Human Research and the
• National Health and Medical Research Council requirements for Ethical Considerations in Quality Assurance and Evaluation Activities.

QA registration and length of project

The Research Office will acknowledge the QA project via ERM following assessment against QA criteria.

The study must be complete within two years of the date of approval in ERM.

If the study is to continue beyond two years, a new QA project will need to be submitted

Annual progress reports are not required for QA projects.

QA projects will receive approval for the Royal Women's Hospital only.

Who needs governance authorisation for QA projects from the Women's?

All QA project require governance authorisation before the project can commence at the Women’s.

Research Governance/QA review

All QA projects receive approval by the Research Advisory Committee before they are progressed to the Research Governance Committee (for consideration and authorisation).

More information: Committees & meeting dates

When can I submit my Research Governance/Site Specific Assessment for review?

Research governance: QA projects may be submitted to the Research Office at any time.

For Research Advisory Committee meeting deadlines, visit Committees & meeting dates.

Is my project quality assurance?

Sometimes it's difficult to determine whether a project is quality assurance or research. 

The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research 2018 also apply to QA.

The Women's staff conducting QA activity must consider a range of issues, including:

• consent
• privacy
• relevant legislation
• professional standard
• whether ethical review is required.

Answer a series of questions to help determine whether your project fits the criteria for QA review.

For your project to be considered QA you must be able to answer ‘Yes’ to part 1 and 'No' to part 2.

Part 1

You must be able to answer YES to these statements for your project to be considered QA.

• Does the project aim to use the outcomes to improve delivery of health care?
• Does the project seek to identify and/or quantify problems within, or impediments to, good healthcare delivery and to identify ways of improving those problems?
• Does the project seek to evaluate current health practices or to monitor the introduction of a new practice?

Part 2

You must also be able to answer NO to these statements for your project to be considered QA.

• The project may cause more than discomfort.
• The project involves more risk than just inconvenience (physical, psychological and information/privacy risks).
• Could this project infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence and respect)?
• Written consent from the participants required.
• The project could impact the reputation and/or privacy of researchers and/or the organisation.
• The project involves targeted data analysis of minority or vulnerable groups.
• The project involves secondary use of data - use of using data/analysis from QA activities for another purpose.
• The project aims to generate new generalisable knowledge - that is, by testing a hypothesis, collect or use data, tissue and/or blood samples from patients, carers, or their relatives, and require written consent.
• The project intends to gather new medical, health or sensitive information.
• The project proposes activity that significantly deviates from standard practice.
• The project involves comparison of cohorts, randomisation or the use of control groups or placebos.
• A person would reasonably expect the project to be reviewed by the HREC.
• Money will be received from, or paid to the Women's, by an external entity.
• The project involves collaboration with a commercial entity.
• The project will last more than two years.
• The project collects data that will be transferred to an external organisation.

Is my project actually research?

If you answered 'No' to the part 1 statements and/or 'Yes' to the part 2 statements, your project is considered to be research and you will need to submit an ethics application.

---