Quality Assurance projects are an essential and integral part of health care delivery that is encouraged by Melbourne Health. It is the aim of the Office for Research (OfR) to encourage and facilitate the approval and conduct of Quality Assurance (QA) projects.
The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research (2007) also apply to QA. Those conducting QA activity must consider a range of issues including consent, privacy, relevant legislation, professional standard, and whether ethical review is required. The reviewers delegated to appraise application will also determine whether an application meets the criteria for QA, and can be reviewed as part of the low risk QA submission process. Applications that do not meet these criteria may be or redirected to the ethical review process.
Evidence of ethical consideration is required prior to the publication of all QA activity (as well as research activity). Melbourne Health does not provide retrospective approval. Projects must be submitted for review prior to commencing.
The QA application process aims to expedite the approval of QA projects. Projects that present a greater than low risk should be submitted for ethical (and governance) review. For example projects that involve any of the following will need ethical review:
- may cause more than discomfort;
- will involve vulnerable groups of participants;
- intend to gather new medical, health or sensitive information; or
- propose activity that significantly deviates from standard practice
If you are unsure please seek advice from the OfR.
The quality assurance review process
RMH and the MH Human Research Ethics Committee (HREC) delegates the review of QA, out of session, to reviewers with specialised knowledge, and an understanding of the ethical and governance framework, and guidelines which govern health service activity. This is in line with the National Health and Medical Research Council (NHMRC) Guidelines on Ethical Considerations in Quality Assurance and Evaluation Activities (March 2014), and the National Statement on Ethical Conduct in Human Research (2007, updated March 2014), paragraphs 5.1.18-5.1.23.
The review will assess whether the project meets the criteria for QA, whether it can be approved as a low risk QA project, whether the project is ethically acceptable, and has scientific merit, meets the required codes of practice, legislation and RMH policy. Projects that are deemed to be research activity or constitute a ‘greater than low’ risk will be directed to submit via the ethical review process.
Projects which aim to generate new generalizable knowledge, by testing a hypothesis, collect or use data, tissue and / or blood samples from patients, carers, or their relatives, and require written consent are unlikely to meet the criteria for QA.
Is my project quality assurance?
It is sometimes difficult to separate QA activity from research. For the purposes of simplicity you should answer the following questions about your project:
- Does the project aim to use the outcomes to improve delivery of health care?
- Does the project seek to identify and or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
- Does the project seek to evaluate current health practices or to monitor the introduction of a new practice?
If you answer yes to these questions your project may meet the criteria for QA.
However QA projects that present a greater than low risk, e.g., that may cause more than discomfort; will involve vulnerable groups of participants; intend to gather new medical, health or sensitive information; or propose activity that significantly deviates from standard practice; or requires written consent from participants, then ethical review is required should be submitted for ethical (and governance) review. If you are unsure please seek advice from the OfR.
Further some QA conducting a survey or questionnaire with hospital/health service staff, with implied consent, i.e, consent which is implied via the return of the survey or questionnaire may also meet the criteria for QA. However if you answer yes to the following questions, your project may not be deemed QA and you will need to submit an ethics application.
- Is it likely that a reasonable person would expect the project to be reviewed by the HREC?
- Does the project involve more risk than just inconvenience (physical, psychological and information/privacy risks)?
- Could this project infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence and respect)?
- Will there be any patients, carers, or relatives involved as participants?
- Is written consent from the participants required?
Is my project actually research?
Research is activity which is designed to generate new knowledge, which is generalizable, by testing a hypothesis. Research activity is processed via the ethical and governance review processes, and reviewed by the HREC. If you answer yes to either of the following questions your project is considered to be research and you will need to submit an ethics application.
- Does the project aim to establish knowledge about a disease by collection of information, where written consent is required from participants?
- Does the project aim to establish new knowledge about a disease by collection of information that has already been collected and is stored by RMH only, such as medical record review, database review?
The application process
There following steps will help you to complete your application for QA.
Submit a detailed project protocol and include all other documentation, such as:
- documents to be given to participants, such as letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
- assessment tools
- advertising materials
- data collection sheets
Researchers may elect to use the QA project protocol template.
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.
If you are gaining written consent your project may not meet the requirements for QA review. If you are uncertain please contact the Office for Research.
Where multiple departments are involved in the project, you may either:
- submit a signed Statement of Approval form for 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 Medical Records, complete a Health Information Services QA Form. This includes viewing medical record notes on ECM (for which there is no charge), paper records and any records retrieval. 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 OfR.
In accordance with the Australian Code for the Responsible Conduct of Research, all projects involving Melbourne Health and at least one other institution requires a written agreement. This is required even if there is no funding provided for the project.
The agreement will outline the key details, e,g., the parties involved, arrangements for intellectual property, resources, funding and ownership of results, etc.
Complete one of the following agreements:
- MACH Research Collaboration Agreement: For all collaborative projects except where an Annexure A is used. This includes interstate and overseas sites. This template is preferred, however if the protocol was written by the collaborating partner, the template provided by that partner may be used.
- Annexure A: Master Collaboration Agreement: For collaborative projects involving only Melbourne Health and the University of Melbourne
Note: Agreement templates have been designed for research projects, however they can be used for QA projects. When the following terms are used, they should be taken to mean:
- “Research project” = “Quality assurance project”
- “Principal Investigator” or “Investigator” = “Project Lead”
Complete the QA Fee Payment Form.
All QA project submissions attract a $100 fee for processing the application. This charge represents only a partial recovery of the total cost of processing applications including the review of the initial submission though to the management of the project over its lifetime.
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
- Fee payment form
- Project protocol
- Any other forms relevant to this application