Quality Assurance projects are an essential and integral part of health care delivery that is encouraged by the RMH.
It is the aim of the Office for Research to encourage and facilitate the approval and conduct of Quality Assurance (QA) projects. QA projects are essentially an evaluation or monitoring of a current service or practice with the aim or improving that service or practice.
QA projects also include negligible risk research (NRR) aimed at identifying and/or quantifying the extent of a problem, practice or behaviour to gain knowledge that may then be used to improve a service or practice. Projects that seek to gain knowledge from monitoring and evaluating the introduction of a new practice/procedure may also fit the criteria of quality assurance.
The ethical principles of integrity, respect for persons, beneficence and justice apply to all QA and research projects as set out in the National Statement on Ethical Conduct in Human Research 2007 and the RMH Guidelines for Scientific Practice.
The QA/NRR Approval Process aims to expedite approval of low risk quality assurance projects and negligible risk research. However those projects that fall into the high risk category will need to be submitted for review by the Melbourne Health Human Research Ethics Committee (MH HREC).
Find out more about the ethical review process.
Quality assurance and negligible risk research review process
RMH and the MH HREC consider that most QA projects and NRR projects can be reviewed by the Office for Research with advice from the HREC.
QA and NRR projects that involve staff (as participants), patients, carers or relatives or their information or tissue must be submitted to the Office for Research for review.
The review will assess whether the project is QA or NRR that does or does not require HREC review and that it meets the requirements of all applicable legislation, codes of practice and RMH policy:
- Projects deemed as requiring HREC ethical review will need to follow the ethical review process.
- Projects deemed to not require ethical review will be approved as QA projects or NRR projects.
The MH HREC does not provide retrospective approval of research projects. Projects must be submitted to the Office for Research for review prior to commencing the study.
Find out more information about the NHMRC guidelines for QA projects.
Is my project quality assurance?
It is difficult to separate QA from research. For the purposes of simplicity you should answer the following questions about your project:
- 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?
If you answer yes to questions 1 to 3, your project may fit the definition of a low risk QA project.
Is my project negligible risk research?
NRR is research in which there is no foreseeable risk of harm or discomfort and any foreseeable risk is of inconvenience only. Additionally, NRR is defined as basic simple research that does not require an extensive scientific review.
Answer the following questions:
- Does the project aim to establish new knowledge about a disease by collection of information via surveys or interviews?
- Does the project aim to establish new knowledge about a disease by collection of information that has already been collected and is stored by RMH only, such as medical record review, database review?
If you answer yes to questions 1 and/or 2, your project may fit the definition of a negligible risk research.
For either QA or NRR please consider:
- Is it likely that the participants would expect the project to be reviewed by the HREC?
- Does the project involve 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)?
If you answer yes to questions 4, 5, or 6, your project may not be considered to be QA or NRR and will need to follow the ethical review process.
Once you know whether your project is QA or NRR, you can submit your project for review and approval.
The application process
There are nine steps to complete to apply for QA and NRR review. You only need to complete the steps applicable to your project.
2. Provide a project protocol
Submit a detailed project protocol and include all other documentation, such as:
- documents to be given to participants, such as letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
- assessment tools
- advertising materials
- data collection sheets
Researchers may elect to use the project protocol template for investigator initiated studies.
3. Complete Participant and Information Consent Form (if applicable)
4. Complete a Health Information Services QA form (if applicable)
If your research involves access to Medical Records, complete a Health Information Services QA Form.
This form must be signed by the director of Health Information Services before the QA and NRR application is submitted to the Office for Research
6. Draft a MoU (if applicable)
complete one of the following Research Agreements:
- MACH Research Collaboration Agreement: For all collaborative projects except where an Annexure A or MIA are used. Includes interstate and overseas sites.
- Annexure A: Master Collaboration Agreement 2015: For collaborative projects involving ONLY Melbourne Health and the University of Melbourne
Note: Researchers may use the template of the collaborating partner if the protocol was written by the collaborator.
8. Provide evidence of department head signoff
Provide email evidence that the relevant Head/s of Department sign off on the project.
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