Home > Research > Resources for Researchers > Human Research Ethics Applications and Site Authorisation > Quality Assurance and Negligible Risk Projects
Quality Assurance and Negligible Risk Projects
Registration of Quality Assurance
Step 1 – Prior to completion of a Quality Assurance Application, the investigator must consider the following questions.
| Decision Guide Considerations | Y/N/NA |
| The collection of information about participants is not beyond that which is collected routinely. Information may include bio specimens or additional investigations. | |
| The data being collected and analysed is expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained. | |
| The activity is being undertaken by a Monash Health staff member. If the activity is being undertaken by a student on placement with Monash Health, the student would be viewed as a staff member for this activity. | |
| There is no risk or burden to participants beyond those routinely experienced in the environment where the activity is being conducted. Risks include not only physical risks, but also psychological, spiritual and social harm or distress (e.g. stigmatisation or discrimination) and may involve people associated with participants. Burdens may include intrusiveness, discomfort, inconvenience or embarrassment, e.g. persistent phone calls, additional hospital visits or lengthy questionnaires. | |
| The data being collected and analysed is not linked to individuals. | |
| There is no secondary use of data. Ie. The data or analysis from this activity, will not be used for another purpose. | |
| Data will be stored for at least 7 years following the activity in accordance with the Victorian Health Privacy Principles. | |
| Data will be accessed by a Monash Health employee who would normally have access to this data through either their employment or in the case of a student, during the course of their placement with Monash Health. | |
| The confidentiality of participants will be maintained in any publication arising from the activity. The identity of an individual will be maintained by not revealing details or characteristics which would have the potential to reveal the participant’s identity. | |
| Data will not be obtained from other sources or organisations. Eg. Medicare, Health Insurance Company, another health service. | |
| The activity does not involve targeted analysis of data involving minority/vulnerable groups, whose data is to be separated out of that data collected or analysed as part of the main QI activity. | |
| The activity does not involve testing of a non-standard protocol or equipment. | |
| The activity does not involve a comparison of cohorts. | |
| The activity does not involve randomisation or the use of control groups or placebos. | |
| The activity is seeking consent from participants to engage in interviews, focus groups or other procedures related to the activity, if applicable. | |
| The activity is not supported by a competitive research grant. Ie. NHMRC Project Grant, ARC Grant etc. | |
| The activity is not seeking to establish a registry/databank |
If the answer to each question is yes, then the investigator would proceed with completion of a Quality Assurance/Negligible Risk Research Application.
If the answer to a question/s is no and the investigator is of the view that the project is Quality Assurance/Negligible Risk Research, then the investigator is advised to send a copy of the project description and a rationale for why they think this is Quality Assurance/Negligible Risk Research to research_qa@monashhealth.org. The Research Support Services team will then review with the Chair of the Human Research Ethics Committee and advise within 3 working days if a Quality Assurance/Negligible Risk Application may proceed or if an application to the Human Research Ethics Committee is required.
Step 2 – if the data collection is substantive and requires the support of:
- Health Information Services;
- Business Intelligence;
- EMR & Informatics;
- Diagnostic Imaging;
- Pathology
Then, the Investigator will need to seek written approval from the supporting area prior to commencing on an application. This will need to be detailed in the QA application, specifying the name and position of the person approving and the date approval was granted.
Step 3 – Monash Health Employee completes the Victorian Quality Assurance (QA) Application Form online at: https://au.forms.ethicalreviewmanager.com/Account/Login
The Application Form is online and will request:
- the names of the team,
- Head of Department Approval of the team conducting the activity. Eg. If it is a QA/Negligible Risk Research project in Pharmacy then the Head of Pharmacy will need to provide approval.
- A project plan/protocol.
The project plan/protocol must contain:
- Background and rationale
- Aims and objectives
- Methodology for collection of data and who will be collecting the data
- Recruitment details (if prospective data collection)
- Privacy, storage and disposal of data
- Data source, use and statistical analysis
- Risks and ethical issues (including mitigation and management and data governance arrangements)
- Dissemination of research (e.g. publication)
A project plan template is available via the Forms Library.
Step 4 – Following completion of the Quality Assurance (QA) Application Form, Monash Health employee sends a courtesy email to research_qa@monashhealth.org advising:
- ERM Reference Number
- Project Title
Step 5 – The Quality Assurance (QA) Application Form will be reviewed by the Research Support Services team and if required, the Chair of the Human Research Ethics Committee.
An email will be sent to the first named investigator within 3 working days. If the study is deemed to be QA/Negligible Risk Research and exempt from Human Research Ethics Review, a letter will be attached to the email, which may be used for verification purposes with journal editors/conference organisers if there is an intention to publish the results. The outcome will also be recorded on the Ethical Review Manager website.
If the activity is deemed to require human research ethics review, this advice will be communicated within 3 working days.