Levels of Ethical Review Public LER F1.1.1 Quality assurance checklist Preamble This checklist has been designed to assist in identifying when a proposed QA activity entails ethical ‘risks’. If any of the answers to the questions on the checklist are ‘Yes’ then it is likely full review from an HREC may be required. If all of the answers to the questions are ‘No’ then it is likely the activity is for QA or clinical audit purposes. Question Y/N Does my activity require ethical review? Consider the National Statement on Ethical conduct in Human Research 2007 (National Statement) definition of research: Is the activity required to undergo ethical review as defined in the National Statement (5.1.6b)? Is the activity more than low or negligible risk as defined in the National Statement (2.1.6 and 2.1.7)? The activity does not fit the description as defined in the National Statement (5.1.22) to be exempt from ethical review. What is the reason/s for conducting the activity? Consider the application of the values and principles in the National Statement. The process should not be a mechanical application but should weigh up the risks and benefits and burdens to the participants as per the National Statement 2.1. Is the activity being conducted for reasons other than the sole purpose of assessing a service for internal purpose only? Does the proposed activity require consent to be sought from potential participants as per the National Statement 2.2? Does the project involve direct contact with patients, consumers, or members of the public? Does the project pose additional risks or burdens to the participant beyond their routine role or care (e.g., a patient to attend an extra appointment, complete a questionnaire that is not part of routine)? Does the use of the data/sample comply with Commonwealth Privacy Principles? Consider the National Privacy Principles (see s95A guidelines) Consider the Information Privacy Principles (see s95 guidelines) Is the data to be collected of a sensitive nature or application? Is the purpose of the activity not ‘directly related’ to the patient’s disease, illness and or management? Will the data be used or available in such a way that may identify individuals? Will access to personal information extend beyond those who are members of the clinical care team or to others who normally do not have access to the patient’s record, or to other data sets? Will the project involve data on rare conditions or a small community? Will data be selected or identified by; Aboriginal or Torres Strait Islander peoples or ethnic, religious or minority groups? Will data be collected beyond that which is normally collected in routinely? Last review: 19/11/2021, next review: 7/10/2023 Page 1 of 2 Levels of Ethical Review Public LER F1.1.1 Quality assurance checklist Question Y/N Other considerations Will the project use ‘new’ interventions, protocols or devices? Will the project involve allocation of patients to groups to enable comparisons? Will the project involve genetic testing/tests? Will the project potentially infringe the rights, privacy or professional reputation of carers, health professionals or institutions? Does the project involve the use of a placebo? Publication Is the project likely to generate data that may lead to publication? Last review: 19/11/2021, next review: 7/10/2023 Page 2 of 2