Quality Improvement/Quality Assurance Registration & Authorisation Process

Quality Improvement (QI) is an organised process that evaluates, assesses and seeks to improve an aspect of Monash Health’s health service delivery to our patients and community. It is also referred to 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 and members of the community.

The National Health and Medical Research Council document NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities(March 2014) advises that regardless of whether an activity is called research or QI, those conducting the activity must consider whether the people involved will be exposed to any risk, burden, inconvenience or possible breach of their privacy. Further, attempts to distinguish between whether an activity is research or QI can be unhelpful because one form of activity may evolve into another activity over time. QI would normally involve minimal risk, burden or inconvenience to participants, and, while oversight is necessary, Human Research Ethics Committee (HREC) review may not be the appropriate level of oversight. Therefore, institutions are advised to develop policies around oversight of QI.

Monash Health staff undertaking QI activities are advised to follow the Decision Consideration Guideline, to assess whether the activity would meet QI criteria at Monash Health or whether the activity would be deemed to be a research activity requiring ethical review.

Upon completing the decision guide, if the staff member is of the view that the activity is QI, the staff member would complete the following steps:

1. Submit the online Decision Guide.

2. Email to research_qa@monashhealth.org the completed QA Form.

3. The registration and QA Form will be reviewed by the HREC Manager and an email will be sent to the first named investigator within 3 working days.

 Click here for Decision Guide Considerations

References:

The National Statement on Ethical Conduct in Human Research

https://www.nhmrc.gov.au/guidelines-publications/e72

NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities (NHMRC 2014)

NHMRC ethical considerations in quality assurance

University of California, San Francisco, Office of Ethics and Compliance, Human Research Protection Program

http://irb.ucsf.edu/quality-improvement-qi-and-quality-assurance-qa

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