It can be difficult at times to determine whether a project is quality assurance or research. Below are a series of questions to help clarify whether you need to apply for quality assurance acknowledgement or research ethics approval.
Is my project quality assurance?
For your project to be considered QA you must be able to answer:
- ‘YES’ to these statements:
- does the project aim to use the outcomes to improve delivery of health care?
- does the project seek to identify and/or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
- does the project seek to evaluate current health practices or to monitor the introduction of a new practice?
- ‘NO’ to these statements:
- the project may cause more than discomfort
- the project involves more risk than just inconvenience (physical, psychological and information/privacy risks)
- could this project infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence and respect)
- written consent from the participants required
- the project could impact the reputation and/or privacy of researchers and/or the organisation
- the project involves targeted data analysis of minority or vulnerable groups
- the project involves secondary use of data - use of using data/ analysis from QA activities for another purpose
- the project intends to gather new medical, health or sensitive information
- the project proposes activity that significantly deviates from standard practice
- the project aims to generate new generalisable knowledge i.e. by testing a hypothesis, collect or use data, tissue and / or blood samples from patients, carers, or their relatives, and require written consent
- the project involves comparison of cohorts, randomisation or the use of control groups or placebos
- a person would reasonably expect the project to be reviewed by the HREC
- money will be received from, or paid to MH, by an external entity
- the project involves collaboration with an commercial entity
Is my project actually research?
If you answered 'No' and/or 'Yes' respectively to points 1 and 2 above, your project is considered to be research and you will need to submit an ethics application.
QA study files - documentation requirements
All documentation relating to a QA project must be kept in a study file for 12 months from completion of the study. Documentation includes:
- QA application documents (copy of all application documents)
- email correspondence (including the acknowledgement application)
- study data
However if you intend to publish the results, documentation must be kept for 5 years post publication or 5 years from the decision not to publish.