Quality assurance (QA) projects are an essential and integral part of improving the quality of healthcare service and delivery.
Sometimes it's difficult to determine whether a project is QA.
An activity where the purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity.
These include situations where:
- The data being collected and analysed is coincidental to standard operating procedures with standard equipment and/or protocols;
- The data being collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained;
- The data being collected and analysed is not linked to individuals unless identifiers have been removed or replaced by a code.
Below are a series of questions to help determine whether your project fits the criteria for quality assurance.
The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research 2025 also apply to quality assurance.
QA oversight by the Office for Research is conducted for RMH-governed sites only. The interpretation of the National Statement by the Office for Research is for RMH only.
The study team conducting QA activities must consider a range of issues, including:
- Consent
- Privacy
- Relevant legislation (State and Federal)
- Professional standards
Is my project QA?
Prior to registering the QA project with the RMH Office for Research, the investigator must consider the following questions.
You must be able to answer 'YES' to the below statements for your project to be considered QA:
- The collection of information about participants is not beyond that which is collected routinely
- The information being collected and analysed is specifically for the purpose of maintaining standards or identifying areas of improvement of RMH health service delivery to our patients and community
- The activity is being undertaken by a RMH paid staff member or student enrolled in a Higher Degree
- The activity will not impact the reputation and/or privacy of researchers and/or the organisation
- The activity will not infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence, and respect)
- The activity does not involve targeted data analysis of research participants who may experience increased risk (see Section 4 of the National Statement on Ethical Conduct in Human Research)
- The activity proposed does not significantly deviate from standard practice
- The activity does not aim to generate new generalisable knowledge - that is, by testing a hypothesis, collecting, or using data about patients beyond that collected routinely, tissue and/or blood samples from patients, carers, or their relatives. The collection of non-routine data is permitted where it does not cause additional harm or inconvenience and is undertaken solely to improve service delivery, for example, a feedback survey.
- Money will not be received from, or paid to the RMH, by an external entity (individual small grants which may be used to fund QA research may be accepted).
- The activity does not involve collaboration with a commercial entity.
- The activity does not involve linkage of participant information with other sources or organisations.
- The activity does not involve participant information being exported offsite or shared with external institutions for the purposes of a research project.
- The activity does not involve prospective comparison of cohorts, the use of control groups or placebos.
Is my project actually research?
If you answered 'NO' to any of the above statements, your project is likely considered to be research and not quality assurance, and you will need to submit an application as a standard research project via the ethics review pathway (Refer to Submit an ethics application for review).
The RMH Office for Research reserves the right to request a standard research ethics application where required.
Register your Quality Assurance project with the Office for Research
| Section | Mandatory | As applicable |
| Section 1: All components in this section are mandatory and must be completed | ✓ | – |
| Section 2: Each component to be completed where applicable to your project | – | ✓ |
| Section 3: Submission | ✓ | – |
Section 1: Mandatory components
Provide a current copy of the Principal Investigator's Curriculum Vitae (CV) if one has not been submitted to the Office for Research in the previous three years. Email the CV to research@mh.org.au.
Investigators who do not have a CV on hand may complete and submit an Investigator Curriculum Vitae form instead. For the purposes of QA, you can disregard the "clinical trials" sections and any other research-only fields in the form.
Royal Melbourne Hospital has recently updated the method of payment for submission fees. All fees will now be via RMH invoice or internal journal transfer.
Section 2: Complete these components as they apply to your project
Complete a QA participant information sheet if your project will include any participants to whom you wish to provide information about your project, but from whom you are not required to obtain written consent.
This statement can be provided to participants separately or it may be inserted as a cover note to questionnaires or surveys.
Note: If you are gaining written consent, your project does not meet the requirements for QA review.
Where multiple departments are involved in the project, you may either:
- Submit a signed Statement of Approval form signed by the head of each RMH service or department used to conduct the project, or
- Provide email evidence of support for the project by the head of each department
Departmental requirements
In addition to submitting SoAs, the following departments require additional information. Please complete all as they apply to your project.
Pathology
Visit the Pathology Clinical Trials web page for instructions
Health Information Services (HIS)
If your research involves access to paper Medical Records, complete a HIS Statement of Approval for QA.
The HIS Statement of Approval for QA needs to be signed by the HIS Manager before submitting your application to the Office for Research. This form is no longer required if you are accessing electronic medical records via EPIC.
Health Intelligence / EMR
If you require assistance obtaining data extracts from EPIC and/or Health Intelligence, log a request via IT Service Now portal and provide details of the data extract. Include the allocated ticket number from Service Now in your QA submission.
An agreement is required when there is another organisation involved in the project. The agreement captures the written agreement between parties around intellectual property, resources in the conduct of the project. Examples when this would apply include:
- Data sharing with any organisation outside of the RMH
- Additional personnel
- Involvement of student researchers
- Collaborative QA projects
Note: Where funding is to be exchanged, the project does not meet the criteria of a QA project and must be submitted for ethics and governance review as a standard application.
Process for Agreement Reviews
QA projects requiring an agreement need to contact the Office for Research at research@mh.org.au to obtain the appropriate agreement template.
Where the QA project lead organisation is not RMH, the collaborators preferred agreement may be used. Agreement will need to be reviewed by the RMH legal team and therefore review may take longer. Within the agreement, when the following terms are used, they will be taken to mean:
- “Research project” = “Quality assurance project”
- “Principal Investigator” or “Investigator” = “Project Lead”
Agreements will be reviewed as part of the application process. Any queries and recommended changes will be sent to the QA project main contact.
Once agreed, the agreement should be sent to the other parties for review and agreement before execution.
The QA Project Lead should organise execution of the agreement with a fully executed copy provided to the Office for Research.
QA acknowledgement
- The Office for Research will provide acknowledgement of QA projects for RMH only
- Collaborating organisations may choose to accept the RMH review or may require the application to be reviewed under its own review process
Does your project involve students? They may need an honorary appointment!
- Where a student is accessing RMH medical records, it is a requirement that they hold an honorary appointment with the RMH.
- If the student does not currently hold an honorary appointment, contact the relevant clinical head of department to ensure one is organised for them.
- In instances where are student only has access to non-identifiable information, an honorary appointment is not required.
Section 3: Submission process
Submit all documentation to the Office for Research by email to ethics@mh.org.au.
The email should list all the documents contained within, including the following:
- Completed and signed QA Application Form
- Project protocol
- Assessment tools
- Data collection sheets
- Statements of approval
- Agreement
- Fee form
- and any other forms relevant to the application
Will I be given a QA project number?
Yes, however the Office for Research will assign a project number for your QA application after receiving your submission. This number will be emailed to you within five business days.
QA acknowledgement
The Office for Research will acknowledge the QA project via email and provide you with an application reference number and confirmation of the study period. Retain the approval information in your project records as confirmation that your application has been noted by the Office.
The project must be complete within two years of the date of the acknowledgement email.
NOTE:
- If the project is to continue beyond two years, a new QA project will need to be submitted
- Annual progress reports are not required for QA projects
QA projects will receive acknowledgement covering ethics exemption and governance review for RMH only.