Determining your type of project (quality assurance vs research)

What is a Quality Assurance, Audit or Service Evaluation project?

An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a quality assurance (QA) activity (e.g. an audit of practice against current standards).

Terms such as “peer review”, “quality assurance”, “quality improvement”, “quality activities”, “quality studies” and “audit” are often used interchangeably and are considered part of a QA program, as is a project undertaken to understand the service provided (service evaluation).

Undertaking a QA project does not require HREC approval and formal exemption from the requirement of full ethical review may be granted by the HREC Chairperson. This may occur when the project is recognised as not being research in accordance with the definition of research on page 6 of the National Statement.

Other types of projects which may be granted exemption from the requirement of full ethical review can include:

  • Presentations at conferences
  • Case studies to be published (many case studies are not research and form part of clinical care and clinical training).  Where multiple case studies are presented they may constitute a case series, a form of research.
  • Exempt research (refer to page 70 of the National Statement)

What is research

The definition of research is outlined on page 6 of the National Statement.

Research projects are reviewed according to their level of risk (for more information see National Statement Chapter 2.1 Risk and Benefit, from page 12 ).

Low risk and negligible risk research

The National Statement defines low risk and negligible risk research as follows

  • “The expression low risk research describes research in which the only foreseeable risk is one of discomfort.” (National Statement, Page 13)
  • “The expression negligible risk research describes research in which there is no foreseeable risk of harm of harm or discomfort.” (National Statement, Page 13)

Low or negligible risk research may be reviewed between monthly meetings by a sub-committee of the HREC, except where a waiver of consent is required or an opt-out consent process is used (see below).

Research that requires full Committee review at a monthly meeting includes the following:

  • Greater than low risk research
  • Low or negligible risk research that is not seeking participant consent (National Statement Sections 2.3.9-11 and Privacy Act Section 95, 95A and 95AA)
  • Low or negligible risk research that uses an opt-out consent process (National Statement Sections 2.3.6-8)
  • Research that includes any of the following:
    • Interventions and therapies, including clinical and non-clinical trials, and innovations (National Statement Chapter 3.3)
    • Human genetics (National Statement Chapter 3.5)
    • Women who are pregnant and the human fetus (National Statement Chapter 4.1)
    • People highly dependent on medical care who may be unable to give consent (National Statement Chapter 4.4)
    • People with a cognitive impairment, an intellectual disability, or a mental illness (National Statement Chapter 4.5)
    • Aboriginal and Torres Strait Islander Peoples, and some categories of research (National Statement Chapter 4.7)
    • People who may be involved in illegal activities (National Statement Chapter 4.6)