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Clinical audits

  • What is the difference between quality assurance, evaluation and research?

    Quality assurance, evaluation and research can exist on a continuum. Your project might begin as one type of activity and evolve into another type of activity over time. For this reason, the boundaries between quality assurance, evaluation and research can be fluid.

    Quality assurance and evaluation usually involve minimal risk, burden or inconvenience to participants. For this reason, while some level of oversight is necessary, Human Research Ethics Committee (HREC) review processes are often not the optimal pathway for review of these activities. As per NMHRC guidance, these types of projects can undergo ethical review via an alternate pathway, or in some cases, be exempt from ethical review. As such, these applications should undergo organisational review at the department level, with the involvement of the Quality Unit where needed. 

    What really matters is that: 

    • participants in quality assurance and evaluation projects are afforded appropriate protections and respect 
    • quality assurance and evaluation is undertaken to generate outcomes that are used to assess and/or improve service provision
    • those who undertake quality assurance and evaluation adhere to relevant ethical principles and state, territory and Commonwealth legislation
    • organisations provide guidance and oversight to ensure activities are conducted ethically, including a pathway to address concerns. 

     As long as the relevant department has the ability to assess the above issues, there is no need to seek ethical review from the relevant HREC or research office. However, in some cases the department is not capable of such a review, or the project contains sensitive issues. In this case, you should make an application for a quality assurance review to the relevant research office. Once they have considered and resolved any ethical issues, they will grant you an exemption of approval to commence your project. 

    Definitions

    Negligible Risk

    The NHMRC National Statement on Ethical Conduct in Human Research (2007)(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

    The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014),state that these studies’ “primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation.” 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

    Application form

    The following application form and 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. Negligible risk type research – to apply for HREC approval via an expedited pathway
    2. Quality Assurance activity – the Research Office will review and provide Organisational Approval (i.e. an exemption of HREC approval).

    You should not use the application form if:

    • it is activity which is greater than negligible risk e.g.  vulnerable groups are involved
    • sensitive questions are being asked, or participation which involves more than inconvenience
    • the activity potentially infringes the privacy or professional reputation of participants, or organisations
    • identifiable data will be accessed by staff who do not have rightful clinical access and/or consent was not obtained to use this data for research
    • there is 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
    • it is a project that will last for more than two years
    • the study is multi-site.

    In the above cases, you will need to complete a submission for research ethics approval.

    Please note:

    • The application form is for use in Victoria only. If data from other organisations will also be used as part of the project, i.e. multi-site, consider if 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.
    • 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; amendments must be submitted as a new application.
    • If the projects requires support from other departments including but not limited to access to a dataset outside the department, access to a research dataset, and/or services from another department, please obtain sign-off from the appropriate Head of Department, data custodian or Principal Investigator via the Supporting Department Declaration (SDD) form.

    Please contact the REG Office for guidance if you are unsure whether this application process best suits your study.

    Submission process

    If your project meets the criteria for quality assurance or evaluation, please see the below checklist. The documents in this checklist must be all submitted through the ERM portal, using the Quality Assurance (QA) VIC form. Note that the application form is now embedded within the ERM QA form. This means you do not have to fill out the application form separately to ERM .

    When you submit your ERM application, please attach the below, protocol and other, supplementary project related documentation, if applicable.

     Document Number of copies
    Protocol One electronic copy

    Head of Department Declaration

    Principal Investigator Signature

    Associate Investigator Signature

    One electronic copy each

    Using these forms are an alternative way to obtain signatures if cannot be signed via ERM.

    Other project related documentation (If applicable):

    One electronic copy each 

    FAQs

    Do I need to do a pre-registration form?

    A pre-registration form is NOT required for Quality Assurance/Negligible Risk applications. 

    Quality Assurance or Research?

    If you are unsure whether your project is QA or research please complete the Quality Improvement or Research? Survey that has been developed as a screening tool. 

    Even if my project is quality improvement (QI), I want to publish my results so I need ethics approval. 

    Ethics approval is not required to publish the results from the QA activity. The completed Quality Improvement or Research? Survey signed by your Head of Department should be provided to the journal as evidence of organisational approval if required.

    However, if the primary purpose is to publish your findings, then you should reconsider whether the project is actually research. In many cases publishable findings are new generalizable knowledge, and therefore research. 

    Collection, Use and Disclosure of Health Information 

    Identifiable (including potentially identifiable) health information cannot be transferred outside of the RCH without consent from participants e.g. must remain within the RCH server, cannot be transferred onto RedCap or other MCRI/UoM applications. This is a requirement of the Health Records Act (Vic) 2001 and the Privacy Act (1998).