Quality Assurance (QA) projects are an essential and integral part of health care delivery. The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research (2018) also apply to QA.
Staff conducting QA activity must consider a range of issues including consent, privacy, relevant legislation, professional standard, and whether ethical review is required.
Applicants should familiarise themselves with the following Acts, Codes or Guidelines:
- The Australian Code for the Responsible Conduct of Research 2018
- The National Statement on Ethical Conduct in Human Research 2018
- NHMRC Guidelines on Ethical Considerations in Quality Assurance and Evaluation Activities – March 2014
- Any other relevant Commonwealth, state, or territory legislation or guidance
- Principles of Research Integrity
- Data management and storage requirements (refer to MH guidelines)
- Publication and authorship (refer to MH guidelines)
Is my project quality assurance?
Click here to determine whether your project is considered QA or research.
COVID-19 Guidance for Research Studies including Clinical Trials
For updates on how COVID-19 impacts research (including review of QA applications) and updated requirements at Melbourne Health please visit our COVID-19 webpage.
For new Covid-19 related studies please also refer to information from the Co-ordinating Office for Clinical Research (DHHS) (visit the COVID-19 webpage and scroll down).
The OFR 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 study records as confirmation that your application has been noted by the OFR.
The study must be complete within 2 years of the date of the acknowledgement email.
- if there are any changes to the project a new QA project will need to be submitted
- if the study is to continue beyond 2 years, a new QA project will need to be submitted
- annual progress reports are not required for QA projects
Multi-site QA projects will receive acknowledgement covering ethics and governance review for the MH site only. Collaborating organisations may choose to accept the MH review or may require the application to be reviewed under its review process.
Sharing your improvements
To increase opportunities to share improvements across the organisation and avoid duplication of effort QA projects undertaken at The Royal Melbourne Hospital that have received review and acknowledgement from the HREC and Office for Research will be added to the new organisation-wide project register which will be shared via Workplace and the intranet. This will include the title, description and key contact of the project. You may also be contacted by the improvement team to provide an update of your project’s status for the register. If you have any concerns or wish to opt out please contact the improvement team via email at firstname.lastname@example.org.
The application process
It is the responsibility of the applicant to complete and submit all applicable documentation including obtaining statements of approval from HIS, pathology etc. and Head of Department and Divisional Director approval and declaration form.
The following steps will help you to complete your application for QA.
Ask your manager if you can do the study and if there is a departmental process that you need to also comply with in order to get approval to conduct the study.
Prepare a detailed protocol that includes information on all steps and processes that will be conducted for the project.
Researchers may elect to use the QA project protocol template.
Conduct a literature search and ask for advice from your colleagues to ensure that you have a robust protocol.
Include the following information:
- who has written the protocol
- who will be involved in the study and in what capacity
- clear aims
- clear and complete procedures
- what information/data will be collected
- how information will be collected and in what format (include templates of data collection forms/tools in the application)
- how data will be stored (i.e. on the MH server)
- who will have access to the data
- If any personal identifying data is collected, how will confidentiality be maintained, stored, protected etc.
Download and complete the QA Application Form.
Ensure that you complete the Declarations section of the application form. The designation requirements are outlined in the form.
Ensure that all other supporting documents are completed and are ready to be included in the application, such as:
- clear and detailed protocol (use the QA project protocol template)
- assessment tools
- data collection sheets.
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 cover note to questionnaire 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 HOD of each MH department used to conduct the project; OR
- provide email evidence of support for the project by the head of each department.
If your research involves access to paper Medical Records, complete a Health Information Services QA Form.
A Health Information Services QA Form is no longer required when accessing Medical Records via EMR/ECM.
Full details of the process, cost and conditions are outlined in the HIS form.
This form must be signed by the Health Information Services Manager, before the QA Application is submitted to the Office for Research.
The Office for Research will provide acknowledgement of QA projects for MH only.
If there is another site involved they will need to obtain their own QA approval. This may be the acceptance of the MH review.
An agreement is required when there is another organisation/s involved in the project. For example:
- when data will be shared (received or sent) with another site (including health services and universities) and/or
- when students are involved in the study
The agreement will outline the key details, e,g., the parties involved, arrangements for intellectual property, resources, funding and ownership of results, etc.
NOTE: If money will be received from, or paid to MH, by an external entity then the project does not meet the MH criteria of a QA project and must be submitted for ethics and governance review.
Complete a draft agreement:
Complete a draft agreement to be reviewed as part of the QA application:
- MACH Research Collaboration Agreement: For all collaborative projects. This includes interstate and overseas sites.
This template is required for MH lead projects (i.e. MH authored the protocol), however if the protocol was written by the collaborating partner, the template provided by that partner may be used.
Note: when the following terms are used, they should be taken to mean:
- “Research project” = “Quality assurance project”
- “Principal Investigator” or “Investigator” = “Project Lead”
For assistance refer to the MH Guide to completing the MACH agreement (with comments)
Review of the agreement:
Draft agreements must be submitted for review with the QA applications.
The Office for Research will manage the agreement review process and signing of the agreement should only occur once all parties involved (organisations) have agreed to the terms of the agreement.
The signing process:
The Office for Research will manage the MH signing process for the agreement once the review process has been completed.
Complete the Approval to Examine Records for the Purpose of Research form.
Any student who is involved in the examination of Melbourne Health medical records for the purposes of research is required to complete this form which must also be co-signed by the Principal Investigator.
In the circumstances where the Principal Investigator is not a Melbourne Health employee, a Melbourne Health Senior Medical Staff member is required to sign the form.
Please refer to point 7 to complete an agreement for these studies.
Ask your manager how to arrange Head of Department approval.
Submit all QA project documents for review and approval by the Head of Department.
The Head of Department will need to sign the ‘QA Head of Department Declaration’.
Submit all documentation to the Office for Research by email to QA Review.
This email should list all the documents submitted including the following:
- Completed and signed QA Application Form
- Project protocol
- Any other forms relevant to this application, such as:
- assessment tools
- data collection sheets
- statements of approval