Clinical Audit, Quality Assurance Activity or Minimal Risk Research Projects
The following definitions apply and should help you to determine the level of risk of your intended activity.
Minimal* Risk Research (MRR)
The NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates) (Chapter 2.1), defines Minimal Risk Research as " No risk of harm or discomfort; potential for minor burden or inconvenience”. “Neither burden nor inconvenience should be considered a type of harm or discomfort and therefore should not be viewed as a risk.”
For example:
- Use of existing de-identified clinical data with no foreseeable risk to the participants;
- Use of existing research data for which consent has been provided for the secondary use; or
- Project using surveys or basic short interviews;
- And examples of burden and inconvenience may include the time that will need to be given up to participate in the research, filling in forms and costs related to travel.
*Previously known as Negligible Risk Research- name changed by NHMRC in 2023 with launch of the new National Statement on Ethical Conduct in Human Research (2023 and updates)
Quality Assurance (QA), Clinical Audit and Evaluation Activity
The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014), state that the primary purpose of these studies' "is to monitor or improve the quality of service delivered by an individual or an organisation." Audits form part of standard hospital monitoring processes and are not research. Furthermore, evaluation is a term that generally encompasses the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity for example
- clinical audits;
- quality improvement activity; or
- health service delivery evaluation
Irrespective of whether an activity is called research or QA or evaluation, those conducting the activity must consider whether the people involved (e.g. participants, staff or the community) will be exposed to any risk, burden, inconvenience or possible breach of their privacy.
An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as 'peer review', 'quality assurance', 'quality improvement', 'quality activities', 'quality studies' and 'audit' are often used interchangeably. We use the term 'quality assurance' to include all of these terms.
1. Is my intended project actually a QA or MRR project?
Investigators are advised to check that the intended project does NOT include any activities that would increase the risk profile of the project and accordingly escalate it to a higher level of ethical review. The checklist at the link below has been provided to assist researchers to determine if the expedited QA/MRR submission pathway is the correct submission pathway for their intended Project.
QA MRR Level of Risk Checklist.docx
A standard research ethics submission for ethics approval is required if the intended project does
not meet the criteria for QA/MRR Submission Pathway. See more information
here to determine the correct ethical review submission pathway suitable for your project.
You can also contact the Office for Research to discuss the correct submission pathway for your intended project.
2. Which protocol do I use for my project?
Western Health have mandatory protocol templates that have been developed specifically to be used for submission of projects via the QA/MRR submission pathway. These templates provide the level of information required by the Office for Research to review these types of applications.
Before you start please determine the category of your intended activity and then select the most relevant WH protocol template to use.
CATEGORIES:
A. CLINICAL AUDIT | B. QUALITY ASSURANCE, AND EVALUATION | C. MINIMAL RISK RESEARCH |
- A retrospective/prospective medical record review; which,
- Relates specifically to reviewing/measuring against current standards, systems or processes of care with the aim of improving outcomes for patients or improving service delivery; and
- Designed and conducted to produce information to inform delivery of best care; and
- Data is accessed, collected and used by a suitably qualified WH employee who in the course of employment would normally have access to such information/medical records; and
- Data collected is re-identifiable or non- identifiable data and not of a sensitive nature; and
- Data accessed is being used for a purpose related to that of its original collection; and
- Data collected is not beyond that which is collected in routine clinical care; and
- Has been instigated by Western Health; and
- It is NOT a research project but nonetheless intended for publication or presentation at a conference.
Complete the Clinical Audit Protocol template (right hand side download) | The proposed access is directly related to a quality/evaluation activity e.g. training or health service delivery evaluation, where the proposed investigators: - Have "rightful" access i.e. for clinical data as a treating clinician, head of department or junior medical staff under direct supervision from either of these persons, or for research data the Principal Investigator; AND
- Are using non-identifiable data only; OR
- For use of research data the extended consent provided by the participant covers the secondary use of the data.
Complete the
WH QA MRR protocol template (right hand side download) | The project involves the potential for no more than minor burden or inconvenience, for example: Complete the
WH QA MRR protocol template (right hand side download) |
If the proposed project meets one of the above categories it will be eligible for submission via the Quality Assurance pathway, select QA VIC Form on Ethical Review Manager (ERM). Complete the correct protocol template and then submit your application via the ERM Portal
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3. Application Processing Pathway
The following pathway has been developed to expedite the Approval for Minimal Risk Research and the Organisational Oversight Approval for quality and evaluation activity as described above.
1. Quality Assurance, Clinical Audit and Evaluation Activity – The Office for Research will review and provide an organisational oversight approval (i.e. a notification that the activity meets the criteria for exemption of ethics review)
2. Minimal Risk Research – The application will be reviewed by the Western Health Office for Research via an expedited pathway.
The Office for Research will review the application against the tenets of the NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014) and the NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates) to identify any ethical issues and provide approval only when all issues (if any) have been satisfactorily addressed.
If you would like advice regarding the process for submission of a QA/MRR Applications, or would like guidance to complete the documents, please contact Mrs. Kerrie Russell (03) 8395 8074 at the Office for Research or email to [email protected]
It is best that you make contact with the Office for Research prior to submission if you are not sure of the process or are new to Research and QA submissions.
Please ensure you are familiar with the WH Research Code of Conduct (2023) and the WH Standard Operating Procedures - Good Clinical Practice (WH SOP-GCP) for research. The WH Office for Research may conduct an audit at any time.
QA Applications can be submitted at any time as their review is independent to that of Low-Risk Ethics Applications.
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4. SUBMISSION PROCESS
All submissions for the above activity types at Western Health are now made via the ERM website portal by completion of the QA VIC Form and must include all relevant documentation.
PLEASE NOTE:
The QA form is for use in single site Victorian projects only. If other sites are conducting the same project, this form will need to be submitted to each participating site.
However, if the project is a multisite QA/MRR activity that has been approved by a certified HREC, and Western Health is listed as a site then a Research Governance submission is required to be submitted to Western Health Office for Research. Do not submit a new QA/MRR application via ERM please contact the Office for Research for further information on the governance submission process for QA/MRR. More information can be found here.
The QA/MRR application facilitates an expedited review and acknowledgment process by the Office for Research. A formal letter of ethics approval (for Minimal Risk research) or an Organisational Approval letter (for Quality Assurance & Clinical Audits) noting the project meets the criteria for exemption from HREC review will be issued to the Principal Investigator.
Projects submitted via this pathway cannot be amended once approved; protocol amendments must be submitted as a new application. Only minor administrative changes such as change of personnel, or database fields or typographical edits may be made and will be processed and acknowledged by the Office for Research on a case-by-case basis.
All Projects approved via the QA/MRR pathway must be completed within 2 years and at the completion of the project a final report and self-audit form must be submitted.
PLEASE FOLLOW THESE INSTRUCTIONS FOR SUCCESSFUL SUBMISSION OF YOUR APPLICATION
QA local Reference number
| Email [email protected] with the following information to receive a QA reference number from the Office for Research:- Project title
- Principal Investigator name
- Contact person – name, email & telephone
The subject line of the email should state: "QA reference number request". The QA reference number that is issued must be quoted on the ERM QA Application form (at insert local reference number if known) and it should also be inserted in the footers of project documents.
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Mandatory WH Electronic file name convention must be followed in naming of all documents.
| See more detail below regarding Mandatory Electronic File Name Convention: ERM generates the letters of approval so it is important that documents are named correctly so they are accurately reflected on the Approval Letters. Researchers will be asked to revise incorrectly named documents and this additional step unduly lengthens the review processing timeframe, therefore, researchers MUST check they have named documents correctly before submission. Convention [QA Reference/ERM Project ID] [Document Name] [version number] [Date DDMMMYY] E.g., QA2024.123_41234 QA PICF_v1_01Jan24. QA2024.123_41234 Protocol v1 01Jan24. QA2024.123_41234 Data Collection Sheet v1 01Dec18. For CV's GCP & Codes (where applicable) naming format to be: - [first name] [last name] WH CV DDMMYY
- [first name] [last name] GCP DDMMYY
- [first name] [last name] WH Code DDMMYY
e.g., John Smith WH CV_01Jan24; John Smith GCP_01Jan24 PLEASE NOTE: The processing time will increase for Applications that do not have documents named correctly. The Researcher will be required to upload correctly named documents before the project can be approved. Please remember to upload documents to ERM using the actual document name, version and date that appear on the opened file and DO NOT use the date of upload as the document date.
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Write your Protocol
| Please utilise the applicable protocol: A: The WH Clinical Audit Protocol template or B & C: WH Minimal Risk/QA/Evaluation protocol template DO NOT submit the QA/MRR Level of Risk Checklist – this is a guidance tool. Privacy & Data Management We are all responsible for the protection and handling of private personal information at Western Health. The WH Office for Research highly recommends that a Privacy Impact Assessment (PIA) is performed and completed during the development and planning of your project and protocol to identify potential privacy risks and to implement mitigation strategies to comply with the Privacy & Data Protection Act 2014 (PDP Act 2014) before a project commences.
Please see the Office of the Victorian Information Commission (OVIC) website for the PIA and guidelines.
Please note that this form does not need to be submitted to the Office for Research. For guidance and review of data management plans, contact the WH Corporate Records Management. The current contact there is [email protected]
Please also note that if your project is audited, this document (the PIA) may be requested for review as a supporting document.
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QA VIC Form
| This QA VIC Form is to be completed on the Ethical Review Manager (ERM) Portal. Please upload all documents onto the application in ERM. Signatures can be requested on ERM and the application must be signed electronically by: - all named investigators
- Head of Department
- Supporting Head of Department of additional services/departments involved or impacted
NOTE: all investigators or named department heads will need to create an account or already have an ERM account to electronically sign. You will find instructions in the HELP section of the ERM website that will advise how to ensure that the form is signed by all parties. ERM User Guide and Tools - DHHS Website
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Curriculum Vitae
| Include a signed Curriculum Vitae (CV) using the WH CV template for all investigators. All investigators must have read and understood the WH Research Code of Conduct (2023) and the WH template provides a declaration statement to that effect. If a Full CV is submitted it must be signed and a signed WH Research Code of Conduct (2023) must also be submitted. A revised WH CV and declaration is required every 2 years.
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International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) Training Certificate
| Include evidence of current GCP certification for each Investigator with the submission. It is mandatory for all named Investigators, including students to have completed GCP Training. GCP Training is valid for 3 years.
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Database Template
| For projects involving prospective or retrospective Data Collection onto a Database a template of the database in pdf format must be provided for review. From 01 July 2020 all data for QA projects must be stored on the Western Health REDCap database platform. (once set up – a pdf of the data instruments can be downloaded for inclusion with your submission)
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Other documents (if applicable)
| Submit the following documents only if applicable to your project activity:- Information Letters (Letter of Invitation) or Participant Information and Consent Form (PICF) If PICF used, please use the QA PICF Template
- Advertising materials e.g., posters, web content
- Survey/Questionnaire or interview guide/script
- Master re-identifier excel spreadsheet with field headers e.g., UR number, Study ID number and Date of Admission (Blank Template)
- Research Agreement - If the QA project involves an external party, a research agreement) will be required. Please click here for more information regarding agreement requirements.
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Application Fee
| All QA projects incur a review fee. Please see our fee schedule here. Please upload a completed GST Compliant Tax invoice and if payment made by credit card or EFT- include the remittance or receipt of payment
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What can you expect once you have submitted a Clinical Audit/QA or MRR Application for review at Western Health?
- The submitted application will undergo an initial review by the Office for Research (within 5 business days of ERM submission) and an email will be generated from ERM and sent to you notifying you of any further requirements. The status of the application on ERM will be “Information Requested”.
- If the initial Office for Research application review is completed and there are no further requirements the application will then be reviewed by a second member of the Office for Research team and you will see the status of the application will be “Assigned to Reviewer” on ERM.
- Once this review is done, you will receive either Approval (with the status of application changed to “APPROVED” on ERM and a letter of approval generated and sent to you) or if there are any matters for clarification or other further requirements a request for information letter will be generated and sent to you. (The status of the application will change to “Information requested”)
- If Information is requested, you are encouraged to be prompt with your response so we can provide a timely review of your reply and get the project approved for you. We allow two weeks for your response and you will only receive one reminder if the response is not received within 2 weeks.
- Applications will be withdrawn by the Office for Research if the Principal Investigator and applicant do not provide a response by the due date and do not communicate the reason for the delay or request an extension for their response.
- Where there has been no communication with the Office for Research for more than 1 month the Office for Research will automatically withdraw the application and if the Investigators wish to proceed a new submission and a new review fee will be required.
POST APPROVAL
- Only minor administrative changes such as change of personnel, or database fields or typographical edits may be made and will be processed and acknowledged by the Office for Research on a case-by-case basis.
- To submit one of the applicable changes outlined above, please select the correspond action tab within the application and explain the change request in the email that is generated. You will also need to upload the requisite documentation to support the change. An email generated via ERM by a member of the Office for Research team will be sent and will acknowledge receipt of the correspondence.
- All Projects approved via the QA/MRR pathway must be completed within 2 years and at the completion of the project a final report and self-audit form must be submitted.
- Please refer to the QA post approval submission documents available in the form’s library
a. WH QA Change of Personnel Form
b. WH QA Amendment Form
c. WH QA Final Report Form
