Audits, QA & Negligible risk applications
- Negligible Risk/QA Single-Site Application Guide
- Negligible Risk/QA Multi-Site Governance Submission Guide
- Evaluation vs. Audit Tips
- Privacy - Research and Audit Requests for Medical Records
- Authorisation and Document Requirements for New Single-Site Applications (please see the Guidelines and advice webpage)
Applying for a Barwon Health Reference Number
All applications submitted to Barwon Health for review are required to generate a reference number via the Barwon Health Research Reference Number Generator (please open with Google Chrome).
Please ensure that the Barwon Health reference number is quoted at the time of your submission.
All projects including Quality Assurance (QA), quality improvement, or audit activities, where there is an intention to publish or otherwise present the data beyond the hospital staff, must be submitted to the REGI Unit for review.
The National Statement on Ethical Conduct in Human Research (NS), Section 5.1, states that research that involves no more than low risk research (including QA and negligible risk research) 'must be reviewed by people who are familiar with the NS and have an understanding of the ethical issues that can arise; and have due regard to privacy regulations (laws) and is reviewed to ensure that it does not require review by the Human Research Ethics Committee (HREC).
Quality Assurance or research?
Quality Assurance projects, audits and service redesign projects (QA projects), often involve an investigation, evaluation or monitoring of a current service or practice with the aim of improving that service or practice. QA projects are an integral part of evidence based health care delivery. It is the REGI Unit's role to facilitate the oversight and conduct of QA projects.
So when is ethics review necessary? There is sometimes uncertainty about what level of oversight QA and evaluation activities require, and confusion about whether a project is research or an evaluation or QA.
Attempts to clearly separate QA from research are not always helpful. The activity must be conducted in a way that is ethical, irrespective of whether it is QA, evaluation, or research. This should include consideration of whether the people involved are at risk of any physical, emotional, financial, or social harms, and consideration of issues including consent, privacy, relevant legislation, and whether ethical review is required.
The NS advises that for many QA type projects, oversight of the activity is required, but ethical review is not necessary.
The REGI Unit has one review process for all projects that involve no more than negligible risk, and does not distinguish between QA projects, audits, service redesign projects, and other negligible risk projects, for the purpose of ethics oversight.
This negligible risk research approval process aims to expedite approval of negligible risk quality assurance projects and negligible risk research. Projects that are accepted as negligible risk may be exempt from HREC review, however those projects that fall into the greater than low risk category will need to be submitted for review by the Barwon Health Human Research Ethics Committee (BH HREC).
Many negligible risk projects can be exempted from full HREC review. At Barwon Health, all negligible risk projects (including QA and audits) where there is an intention to publish, or otherwise present the data beyond the hospital staff, should be submitted to the REGI Unit for review.
Projects submitted to the REGI Unit will be assessed to determine whether or not the project:
- Qualifies for an exemption from HREC review; and
- Meets the requirements of all applicable legislation, codes of practice and Barwon Health policy.
Projects that are accepted as exempt from HREC review will be approved out of session and ratified by the Barwon Health HREC.
Any project that is not exempt must be submitted for committee review.
Which projects are exempt from BH HREC review?
Ethics committee review may not be necessary, and projects may be eligible for an exemption from full HREC review, where the research involves only:
- Negligible risk - 'Research is negligible risk where 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'; and
- The use of existing collections of data that contain only non-identifiable data about humans - 'Non-identifiable data is data that has never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known they are about the same data subject, although the person's identity remains unknown'; or
- Aims to establish new knowledge by use of non-sensitive, identifiable information that has already been collected as a routine part of practice, including:
- Data collected as part of a patient management via a survey/questionnaire in person or stored in medical records or databases
- Data collected as part of staff management e.g. for training or compliance; or
- Aims to establish new knowledge through the use of non-sensitive identifiable information that will be collected as a matter of routine business, including:
- Data collected as part of patient management via a survey/questionnaire in person or stored in medical records or databases
- Data collected as part of staff management e.g. for training or compliance; and
- Are conducted by Barwon Health staff or students or affiliates under the supervision of senior Barwon Health staff and not instigated by an external person who is not affiliated with Barwon Health.
Which projects are not exempt from BH HREC review?
The NHMRC's advice, outlined below, states that where one or more of the triggers below apply, ethical review should be sought:
- Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations
- Secondary use of data - using data or analysis from QA or evaluation activities for another purpose
- Gathering information about the participant beyond that which is collected routinely (information may include bio-specimens or additional investigations)
- Testing of non-standard (innovative) protocols or equipment
- Comparison of cohorts
- Randomisation or the use of control groups or placebos
- Targeted analysis of data involving minority/vulnerable groups.
Where ethical review by a HREC is not required, the REGI Unit provides a statement which affirms that an alternative approach to ethical review was considered to be appropriate for the specific QA/evaluation activity. Increasingly reputable journals require this type of statement to accept a negligible risk project for publication.
How to apply for exemption from HREC review
If you think your research is negligible risk, and therefore exempt from HREC review, please view the negligible risk application guide, found at the top of this page, and follow the steps in order to apply.
Please note: All researchers are expected to have read the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research, and to conduct research according to these guidelines.
Last Modified: Thursday, 25 July 2019