Low-risk Human Sciences
Human Sciences Subcommittee (TBD)
Please be advised that due to the changes to the National Statement on Ethical Conduct in Human Research (2018) and the new Research Data Management (RDM) Framework, the current HASS form in FoRA is no longer fit for purpose and will be disabled on the 1st of May 2022.
All Human Ethics applications would now need to be submitted using the HREA form in FoRA.
1) Ethics online form - Review Pathway
The online ethics application system includes a question about whether the research described in your application is "no more than low risk" or "more than low risk". The answer to this question will automatically send your application to the Faculty Subcommittee (no more than low risk) or the MQ Human Research Ethics Committee (more than low risk). That is, you are self-assessing the level of risk - no other human/officer reviews the application prior to it being forwarded to either the Faculty Subcommittee or the MQ HREC.
If you choose "no more than low risk", sending the application to the Faculty Subcommittee for review, but one of the reviewers thinks the application is more than low risk (as happens quite often), the application will then be sent back to you to change the answer to question 0.3 Filter Questions (question 1.3.5 in HASS form) so that the application can be forwarded to the MQ HREC - this costs you time in the review process.
So, if there is any likelihood, even if small, that your research will cause more than discomfort to your participants, please choose "more than low risk" so that the MQ HREC can review your application in a timely fashion.
2) Applicants are advised to consider the following when deciding the risk level of projects: Topic, Participants, Procedure and Questions.
Examples of More Than Low Risk Projects (this list is not exhaustive)
- Migrants and/or refugees being asked to recount any experiences of discrimination or challenges settling into life in Australia or about issues that prompted them to come to Australia.
- Surveys, interviews or focus groups asking participants about eating disorders, mental health issues, distressing topics, personal health matters, traumatic experiences, etc.
- Research involving members of the armed forces, including the police.
- People who are in a specific situation that makes them vulnerable and where they might be subject to a significant power imbalance, e.g. aged care home residents, the homeless, people with disabilities who are dependent on others for their care, etc.
- Research that directly or indirectly exposes any illegal activity, e.g. dangerous working conditions, fraud, drug-taking, child abuse, theft, etc.
- Research that uses a waiver of consent, e.g. to collect personal data about school or tertiary students, etc. or where no direct consent is being obtained from participants.
- Projects where participants might require access to mental health referral options after their participation, e.g. the research could trigger distressing memories, etc.
- The use of active deception or planned concealment: (National Statement 2.3.1.)
- Research on relationship issues or parenting styles where the focus of the research is to discover challenges and problems.
- Educational, psychological or physical interventions.
- Research in overseas countries where there is a risk to participants, e.g. through conflict, discrimination, jeopardising employment, social status, arrest, etc.
- Research in overseas country where the research topic is illegal in that country.
- Research using devices, e.g. functional MRI, MEG, transcranial simulation that could discover physical conditions that require follow-up by a health professional.
- Use of devices that could potentially trigger an adverse event, e.g. tDCS or tACS, that might require follow-up by a health professional.
- Research that involves viewing or reading disturbing or violent content.
- Projects that involve the DASS21 and other similar questionnaires that ask people questions about negative emotions.
Examples of no more than low risk research (this list is not exhaustive)
- Study aiming to determine whether cue utilisation moderates the allocation of resources during a simulated driving task.
- Research on investigating whether eye-movements can be related to reading comprehension during silent reading in order to create a new and more valid test of reading comprehension.
- Study investigating the development of children’s learning-oriented talk from infancy to age three from a multi-dimensional perspective.
- Research on investigating international students’ approaches to university writing assignments.
- Research using multiple case-study design to investigate how language identity of ELICOS students develops during study in Australia.
- Study aiming to investigate teachers’ beliefs and practices about oral corrective feedback (CF), students’ beliefs about CF and the change in teachers’ beliefs and practices about CF which can occur as a result of training and awareness raising activities (in Vietnam).
- Study investigating the effect that teacher-created computer-based video instruction (CBVI) using iPads in mathematics lessons has on students’ cognitive, behavioural and affective learning in the primary school classroom.
- Research aiming to generate de-identified data on parents' and educators' perspectives on play.
- Study examining the effects of challenge demands, hindrance demands and job resources on work engagement, employee innovation and job performance among bank workers.
Examples of Projects returned to change Q 0.3/Section 1.3.5 to ‘more than low risk’
To consider People (participants) – Collecting data via surveys or interviews is not considered ‘more than low risk’; however, the targeting participants are people with disability or refugees. These projects are considered ‘more than low risk’.
To consider Topic – Research involving mental health issues (as indicated in the project title) and the questionnaire containing questions that may cause distress (e.g. more than discomfort).
To consider Procedure/Questions
- While collecting data by using questionnaires/surveys is 'low risk', the survey contains items that assess Borderline Personality Disorder and there is a large battery of questions (300+) asking participants about negative relationship experiences.
- Collecting data using surveys/questionnaires is ‘low risk’ but projects using DASS 21 (the Depression, Anxiety and Stress Scales) are deemed ‘more than low risk’.
Review and Process (TBD)
- New Applications are sent to the Ethics subcommittee for review upon receipt.
- Timeframe - 1) 20-25 working day turnaround from allocation of an application to notification of outcome. 2) 5 working days to review responses to the subcommittee’s questions.
- Please indicate ‘Human Sciences’.
- When you submit an ethics application you may receive feedback from the subcommittee advising that changes must be made before it is approved. It is essential to include a word document (Responses word doc) and to show tracked/highlighted changes in all the revised documents (e.g. PICF).
- Please contact Ethics Secretariat (ethics.secretariat@mq.edu.au) if you have any questions or require assistance.
Post Approval (TBD)
1. Amendment Request - An amendment request is made when an Approved Application requires changes. An approved application needs to be unlocked by the Ethics Administrators to make any amendments. All proposed changes to the project and associated documents must be submitted to the subcommittee for review and approved before implementation. Timeframe: 7 - 10 working days.
1) Data transfer form - All active Human Research Ethics applications that were approved or submitted before 17 July 2018 are identified in the Human Ethics Management System as a "Data Transfer Form".
- Request for the form to be unlocked (per usual process).
- Indicate Amendment Request in section 1.1.0 Application Purpose.
- Section 1.1.7 review pathway - The approved project risk level must remain unchanged for the life cycle of the project.
- Revise the original application and relevant supporting document using tracked changes and save it as a PDF with tracked changes.
- Upload both the revised documents with tracked changes and the original application and relevant supporting documents.
- Sign and submit by Chief Investigators.
- Please see 'How to submit amendments PDF'.
2) Current online form
- Request for the form to be unlocked (per usual process).
- Indicate Amendment Request in section 1.1.0 Application Purpose.
- Update the information by editing the application form directly with the new information.
- Upload the revised documents with tracked changes or highlights (PDF).
- Sign and submit by Chief Investigators.
- Please see 'How to submit amendments PDF'.
2. Annual / Final Report – Ethics approval is valid for five (5) years, subject to the submission of annual reports. Please submit your reports on the anniversary of the approval for your protocol.
- Applicants will receive reminders when annual reports are due.
- Annual / Final Reports are submitted as sub-forms to an application form, in the Human Research Ethics Management System. Please see 'Sub-form PDF'.
- Sign and submit by Chief Investigators.
- Please note: Annual/final reports will be returned to Applicants
- -if Section 2.1.1 the period covered is incorrect.
- -if Section 2.1.5, Describe the location, security, and maintenance of your records now and in the future, is not completed correctly. Please check the current advice on data management, Interim Data Standards Advice (PDF), or via Human Ethics website.
3. Adverse Events - All adverse events, including unforeseen events, which might affect the continued ethical acceptability of the project, must be reported to the subcommittee within 72 hours.
- Unexpected Adverse Events are submitted as sub-forms to an application form, in the Human Research Ethics Management System. Please see 'Sub-form PDF'.
- Sign and submit by Chief Investigators.
4. Please contact Ethics Secretariat (ethics.secretariat@mq.edu.au) if you have any questions or require assistance.