After you have submitted
Who approves it?
The University’s Human Research Ethics Committee (HREC) approves human ethics applications. There are two HRECs currently functioning at the University of Sydney. Each Committee meets once every four weeks and there is therefore a meeting of the HREC each fortnight.
The University also has five subcommittees which review low risk applications. These are discipline-specific or divisional committees in the fields of Business, Psychology, the Conservatorium of Music, Humanities and Health. You do not need to assess whether your application is low risk, this will be done by the Ethics Office once you have completed the application form in IRMA.
How are applications assessed?
Applications are assessed on the basis of compliance with the National Statement on Ethical Conduct in Human Research. The Committee considers the four ethical principles outlined in the statement (Research Merit & Integrity, Justice, Beneficence and Respect). To assess these principles the Committee will look at issues such as the recruitment and consent processes, the strength of the methodology, any privacy considerations, whether the potential risks of the study are outweighed by the potential benefits, how risk will be minimised and managed and other matters related to the ethical nature of the study.
How long does it take?
Generally, researchers are notified of the outcome from a committee meeting within 10 working days of a meeting date.
How will I be notified?
Researchers are notified of the outcome via email. The email is sent to the Chief Investigator with a copy to all named researchers.
What does the outcome Category mean?
Category A – there are no outstanding ethical or administrative issues and the application is approved.
Category A with conditions – there are no outstanding ethical issues however there are some specific conditions of approval the researchers must comply with. These may require you to submit material to the ethics office.
Category B Office – there are no objections to the study however some reasonably straightforward amendments/clarifications are required. These are reviewed by nominated ethics office staff.
Category B Chair – there are no objections to the study however some amendments/clarifications that require more detailed consideration are required. These are reviewed by chair of the committee that reviewed the application.
Category C – the committee was unable to make an assessment and there are major amendments/clarifications required which are significant enough in quality or quantity to require reconsideration by the full committee. Your response will be reviewed by the same committee at the next available meeting round (refer to submission deadlines).
Category D – this application was not approved due to significant ethical, methodological or administrative issues. The applicant is invited to discuss the matter directly with the chair of the committee and submit a new application.
Escalated – the application has been escalated for review by another person or committee.
If I am asked to make changes how long will this take?
Sometimes researchers will be asked to make amendments/clarifications to their applications before they are granted approval. This may require submitting a response to be reviewed at another full committee meeting, or it may require submitting a response to be reviewed by the Chair or the Ethics Office. In all instances, these processes take additional time and researchers should allow for this when planning their research schedules.
If your application is reviewed by one Committee and you are requested to make major amendments/clarifications and submit these for a full Committee meeting, your response must be reviewed by the same Committee that originally considered the application. Please refer to the submission deadlines to ensure you submit your response in time for the relevant meeting deadline. As with your initial application, you should receive an outcome from the meeting within 10 days of the meeting date.
Your study may be approved at
- a full HREC meeting; or
- a low risk subcommittee meeting; or
- if you have been asked to make changes, your application will be approved once these changes/amendments/clarifications have been addressed.
Once your study has been approved you will receive a final letter of approval, which you must retain as part of your study records. Make sure you are aware of the details of your approval, including any conditions, responsibilities and reporting deadlines, which are explained in Understanding the Letter of Approval.
You can access your approval letter in your project file in IRMA.