Sometimes it's difficult to determine whether a project is quality assurance or research. Below are a series of questions to help determine whether your project fits the criteria for QA review.

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 RMH staff conducting QA activity must consider a range of issues, including:

  • Consent
  • Privacy
  • Relevant legislation
  • Professional standard
  • Whether ethical review is required

Is my project quality assurance?

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 intends to gather new medical, health or sensitive information
  • The project proposes activity that significantly deviates from standard practice
  • 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 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 RMH, by an external entity
  • The project involves collaboration with a commercial entity

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.

Submit an ethics application for review