Checklist to determine if your project is Quality Improvement, negligible, low or high risk research

NH QA-Audit application form

At Northern Health, all Quality Improvement/ Assurance, Clinical Audits, and Negligible Risk projects where there is an intention to publish or otherwise present the data beyond the hospital staff members, should be submitted to the Office of Research for review and approval before the commencement of the project.

Quality Improvement/ Assurance & Audits

Quality Improvement (QI) is an organised process that evaluates, assesses and seeks to improve health service delivery to improve patient and population outcomes and health service efficiency. It is also known as Quality Assurance. QI activities often involve the collection, use and disclosure of health, personal and sensitive information for the purpose of funding, management, planning, monitoring, improvement or evaluation of health services.

Common QI activities include sentinel event monitoring, incident monitoring, root cause analysis, medical record review, and clinical audit. QI activities may include activities involving staff, patients or members of the community.

An audit does not involve the collection of new raw data (other than information that would ordinarily be collected as part of patient management) from a patient either in person, through a survey/questionnaire nor can it be instigated by an external person.

Most quality improvement activities do not require ethical approval, however, quality improvement activities that use methodologies that infringe on patients confidentiality or privacy will be required to undergo ethical review.

Negligible Risk Research

Ethics committee review may not be necessary, and projects may be eligible for an exemption from full HREC review, where the research involves only:

  • Negligible risk – ‘Research is negligible risk where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk’; and
  • The use of existing collections of data that contain only non-identifiable data about humans; or
  • Aims to establish new knowledge by use of non-sensitive, identifiable information that has already been collected as a routine part of the practice, including
    • Data collected as part of patient management via a survey/questionnaire in person or stored in medical records
    • Data collected as part of staff management e.g. for training or compliance; or
  • Aims to establish new knowledge through the use of non-sensitive identifiable information that will be collected as a matter of routine business, including:
    • Data collected as part of patient management via a survey/questionnaire in person or stored in medical records
    • Data collected as part of staff management e.g. for training or compliance.

Ethics Considerations

The NHMRC guideline states that where one or more of the triggers below apply, ethical review should be sought:

  • It is a departure from standard care (eg testing of non-standard protocols or equipment)
  • It involves direct contact with patients or staff members (eg a survey)
  • It involves allocation to different treatment options
  • It involves the gathering of data about a patient beyond what is routinely collected
  • Access to health information extends beyond those who are part of the clinical team
  • It is a targeted analysis of data involving minority or vulnerable groups
  • The data collected may identify individuals
  • Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations
  • Randomisation or the use of control groups or placebos
  • Secondary use of data, for example, using data or analysis from an existing QI or evaluation activities for other purposes

Submitting QI/Audit application

If you think your project is QI/ Audit or negligible risk research, and therefore exempt from HREC review, please complete the checklist and the application form (at the top of this page) and submit to ethics@nh.org.au for review.

We strongly recommend you to follow the SQUIRE guidelines when designing the project protocol and completing the application form. If you have any queries, please do not hesitate to contact the Office of Research ethics@nh.org.au or your departmental Research Lead. Please note that incomplete applications will not be reviewed and will be returned to the investigator.

Please ensure that you register the QI project with RiskmanQ.