For the purposes of simplicity you should answer the following questions about your project:
1. Is this project undertaken for a valid purpose and does it aim to use the outcomes to improve delivery of health care?
2. Does this project seek to identify and or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
3. Does this project seek to evaluate current health practices or to monitor the introduction of a new practice?
4. Could this project infringe on ethical principles that guide human research?
If you answer yes to questions 1 to 3 your project may fit the definition of a low risk QA project. To seek approval for a QA project, you need to complete the QA Application Form and if applicable, complete the QA Participant Information and Consent Form. QA projects are reviewed by one member of the WH Low Risk Ethics Panel.
If you answered yes to question 4 your project may warrant ethical review and need to be submitted to the WH Low Risk Ethics Panel as a research project. The following table may assist you in determining whether your project falls in the QA, low risk or high risk catergory, if unsure contact the Office for Research to clarify.
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|
QUALITY ASSURANCE |
LOW RISK RESEARCH |
HIGH RISK RESEARCH |
|
Study Design |
Retrospective medical audit of current practice |
Prospective study comparing "standard of care" Impact on patients? If review will identify issues that will require patients to be contacted/ treatment amended |
Prospective study comparing "standard of care" vs intervention |
|
Questionnaire based research |
Questionnaires/survey of treatment group |
Patients group - survey of patients outside "usual care" |
|
|
Data Storage |
12mths |
5 years |
5 years/ Clinical Trial 15 years |
|
Consent |
Consent or waiver of consent |
Consent or waiver of consent (data use related to purpose of collection) Participants able to consent for themselves |
Patients unable to consent for themself or waiver of consent (data use not related to purpose of collection) |
|
Data identifiability |
Data re-identifiable or non-identifiable |
Collect and use identifiable data |
Collect, use and release of identifiable data. Databases. Tissues and Genetics Samples |
|
Intervention & Impact risk to participants |
Minimal or none |
Minimal |
Participants - high impact, unable to consent and/or "vulnerable" group e.g. Children; Pregnant women; People with a cognitive impairment, an intellectual disability or a mental illness |