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

NH QA-Audit application form

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.

A QI/ Audit activity may require ethical review when:

  • 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

Please ensure that you register the QI project with RiskmanQ.