Clinical Audit, Quality Assurance Activity or Negligible Risk Research Projects.
The following definitions apply and should help you to determine the level of risk of your intended activity.
Negligible Risk Research (NRR)
The NHMRC National Statement on Ethical Conduct in Human Research (2007 updated 2018) (Chapter 2.1), defines negligible risk as "when there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible 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
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 NRR project?
Download Checklist here
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 below has been provided to assist researchers to choose the correct submission pathway for their Project.
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LEVEL OF RISK CHECKLIST
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Is it
an activity which is greater than negligible risk e.g. Vulnerable groups are
involved?
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Yes
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No
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Are
sensitive questions being asked?
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Yes
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No
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Does
participation involve more than inconvenience?
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Yes
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No
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Does
the activity potentially infringe the privacy or professional reputation of
participants, or organisations?
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Yes
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No
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Will
identifiable data be accessed by staff who do not have rightful clinical
access and/or consent was not obtained to use this data for research?
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Yes
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No
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Is
there a reasonable expectation that the project findings arising from the
project may be clinically relevant to the individual participants e.g. the
disclosure of genetic testing/results?
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Yes
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No
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Is it
a project that will last for more than two years?
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Yes
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No
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Is it
a multi-site study?
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Yes
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No
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If you answer YES to any of the questions above the intended project is NOT APPLICABLE for submission via the QA/NRR submission pathway.
In each of these cases, a standard research submission for research ethics approval is required. See more information here to determine the review pathway suitable for your project.
If you answered NO to all of the questions above the intended project IS APPLICABLE for submission via the QA/NRR submission pathway.
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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/NRR submission pathway. These templates provide the level of information required by both the Office for Research and the LREP to review these types of applications.
Before you start please determine the category of your intended activity and then select the relevant WH protocol template to be used.
PROTOCOLS FOR CLINICAL AUDIT QUALITY ASSURANCE, EVALUATION OR NEGLIGIBLE RISK RESEARCH CATEGORIES:
A. CLINICAL AUDIT | B. QUALITY ASSURANCE, AND EVALUATION | C. NEGLIGIBLE RISK |
- 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 NRR protocol template (right hand side download) | The research involves the potential for no more than negligible risk, for example: - Use of anonymous existing clinical data with no foreseeable risk; or
- Use of existing research data for which consent has been provided for the secondary use; or
- Project using surveys or basic short interviews
Complete the
WH QA NRR 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 form pathway on Ethical Review Manager (ERM). Complete the correct protocol template and then submit via the ERM Portal
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3. Application Processing Pathway
The following pathway has been developed to expedite the approval of negligible risk type research or provide the oversight 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. Negligible Risk Type Research – to apply for ethics approval from the Western Health Low Risk Ethic Panel (LREP) via an expedited pathway (reviewed out of session).
If you would like advice regarding the process for submission of a QA/NRR 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.
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4. SUBMISSION PROCESS
All submissions for these types of activities at Western Health are now made via the ERM website portal by completion of the QA VIC Form and including other relevant documentation that is requested.
PLEASE NOTE:
- The QA form is for use in single site Victorian projects only. If data from other Organisations will also be used as part of the project, i.e. multi-site, consider whether this is the most appropriate form to be used. If other sites are conducting the same project, this from will need to be submitted to each participating site. WH is an accepting site for QA/NRR activities that have been approved by a certified HREC and where the approval lists WH as a site. In these instances, a Research Governance submission should be submitted. Do not submit a new QA/NRR application via ERM. More information can be found here.
- This application facilitates an expedited review and acknowledgment process. Once approved, a formal letter of approval (for Negligible Risk research) or exemption (for Quality Assurance & Clinical Audits) 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 this pathway must be completed within 2 years and a final report and self-audit form must be submitted at the end.
PLEASE FOLLOW THESE SUBMISSION INSTRUCTIONS
1.
| QA local Reference number | Email [email protected] with the following information to receive a QA reference number: - Project title
- Principal Investigator name
- Contact person – name, email & telephone
You will receive a QA local reference number to be quoted within your documents when you submit. |
| 2. | Protocol | Please attach the applicable protocol: A: The WH Clinical Audit Protocol template or B & C: WH Negligible Risk/QA/QI/ protocol template === Useful Assessment Tool (no need to submit for ethics review) 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 Manager, Alan Kong [email protected].
Please also note that if your project is audited, this document may be requested for review as a supporting document. |
| 3. | QA VIC Form | This QA VIC Form is to be completed on the Ethical Review Manager (ERM) Portal. Please ensure to upload all documents onto ERM. Signatures: - Digitally signed by all investigators
- Digitally signed by Head of Department
- Digitally signed by Supporting Head of Department of additional services/departments
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 |
| 4. | Curriculum Vitae | Curriculum Vitae using the WH CV template from all investigators with signatures indicating that they have read and understood the WH Research Code of Conduct (2023). A revised CV and declaration is required every 2 years |
| 5. | International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) Training Certificate | It is mandatory for the Principal investigators to have completed GCP Training, please provide a copy of their completion certificate. It is also recommended that all investigators undertaking research complete GCP Training. GCP Training must be valid and completed within the last 3 years. |
| 6. | Other documents (if applicable) | Submit the following if applicable to your project activity: - Information Letters (Letter of Invitation) or PICF
- Advertising materials e.g. posters, web content
- Survey/Questionnaire or interview guide/script
- Database template (from 01 July 2020 all data must be stored on the Western Health REDCap database platform)
- MOU Agreement - If the QA project involves an external parties, a Memorandum of Understanding (MOU) may be required.
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| 7. | Application Fee | All projects incur a review fee. Please see our fee schedule here. |
| 8. | Submission | 1. Submission to be made through ERM Portal When you submit your ERM application, please attach ALL documents above to the form online. Please ensure you name the file correctly. It should be uploaded using the document name, version and date that appear on the opened file. Do NOT use the date of upload as the document date. see more detail below regarding Mandatory Electronic File Name convention 2. Send a Submission notification Email Please notify ethics of your formal application via Email: [email protected] with your QA local reference number & ERM ID reference in the subject title. DO NOT attach documents to the email, documents should be submitted through ERM as stated above. IMPORTANT: Submissions will not be processed unless the notification email has been received by the [email protected] email.
3. Mandatory Electronic file name convention: To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name. Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender. Convention: [QA Reference/ERM Project ID] [Document Name] [version number] [Date DDMMMYY] E.g. QA2020.123 QA Application Checklist 01Jan19; 41234 Protocol v1 01Jan19; 41234 Data Collection Sheet v1 01Dec18. CV's GCP & Codes (where applicable) to be named as - [first name][last name]WH CV DDMMMYY
- [first name][last name] GCP DDMMMYY
- [first name][last name]WH Code DDMMMYY
PLEASE NOTE: Applications that do not have documents named correctly will be deemed invalid and sent back to the researcher for resubmission. QA submissions can be made at any time independent of the Low Risk Ethics Panel Submission Dates.
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What can you expect once you have submitted a Clinical Audit/QA or NRR Application for review at Western Health?
- An email from the Office for Research (within 5 days of ERM submission) notifying you that the application has been received.
- The application will then be reviewed by the Office for Research and if applicable by a member of the Low Risk Ethics Panel. The reviewer may take 2 weeks to review the application.
- An email advising you of the review outcome. It will indicate whether the project has been approved unconditionally or if there are any revisions or additional information required.
- Researchers are given 2 weeks to provide their response should revisions or clarifications be required.
- Researcher responses to review comments will then be reviewed by the Office for Research and if appropriate/necessary forwarded to the reviewer for further comment or clarification
- Researchers will be notified by email of their project Approval and will be provided with a formal Approval letter for their records.
Please note the following:
The submission will be deemed invalid and the application will be rejected and a revision and resubmission will be required if the submitted documents DO NOT follow the mandatory naming convention, the ERM application is NOT signed by ALL investigators and Head/Supporting Heads of Departments, or the incorrect WH protocol template has been completed for the proposed activity to be undertaken during the project.
If there are any further requirements you will be advised via email and asked to make the required revisions and update your submission on ERM.
If requested; upon receipt of a satisfactory resubmission or revision; the application will then be reviewed by the Office for Research and if applicable by a member of the Low Risk Ethics Panel. The reviewer may take 2 weeks to review the application.
