The University’s Research Code of Conduct 2019 (the Code) sets out the University’s expectations in terms of responsible research practice and research integrity.

As part of this, ethics approval is necessary for a range of research activities. This includes research conducted with or about people or animals, or with their biological materials (tissue or cadavers). It also includes information or data about people (even if they don’t know they are the subjects of your research). You are expected to take responsibility for ensuring that you have the necessary ethics approval for any research projects you are involved in.

Discuss the need for ethics approval with your supervisor early in your candidature, as they’ll usually need to be listed as the chief investigator (CI) on any ethics application required for your project. This is because the CI must be a University staff member for risk management, insurance, and legal reasons. Although they’ll be listed as the CI, all investigators, including you and any other students conducting research under the protocol, must be listed as investigators, and have responsibilities in regard to ethics. Your supervisor should provide guidance on the preparation of an ethics application if approval of a new protocol is needed.

You should also carefully check the conditions of your scholarship, as they may require ethics approval for your research.

If your research involves human participants, you’ll need to submit an application for ethics approval for consideration by one of the Human Research Ethics Committees. If your research involves animal subjects, you’ll need to apply for ethics approval from one of the Animal Ethics Committees.

If you’re unsure whether approval is required, contact the Human Ethics or Animal Ethics teams at the University for guidance. They can also provide you with advice on preparing your application.

If you plan to conduct research as part of a pre-existing project, you should be sure your name is added to any pre-existing approvals. Don’t assume that this has been done. If you plan to conduct research using data or primary materials collected by others as part of a separate project, you should discuss the issue of ethics approvals with your supervisor. You should never assume that your research is covered – always make sure you have ethics approval.

Advice on all aspects of ethics approvals can also be obtained at any time during your candidature from research integrity and ethics or from one of the faculty research integrity advisors.

External approvals

Sometimes a project will only need ethics approval from the University. In other instances, such as where research is being carried out at a hospital or other institution, you may need ethics approval from the University as well as from the human ethics, animal ethics or biosafety committees of the institutions or bodies where you are doing your research.

All external institutions with ethics oversight have their own processes and administrative requirements for seeking ethics approval. Enquiries should be made directly to the relevant institutions.

Discuss the need to go through any separate external ethics approval processes with your supervisor early in your candidature. Make sure that you submit your applications to the various bodies in a timely manner and in the most appropriate order.

Depending on the external institutions involved, it may be that the University will accept ethics approval from an external committee but you need to check with the University’s research integrity and ethics. Don’t assume you are covered – always be prepared to seek approval from University ethics committees in addition to any external committees.

Clinical trials

Ethics approval and clinical trial approval are separate. For advice on whether your research constitutes a clinical trial, and all aspects of the clinical trial approval process, contact the University’s Clinical Trials Support Office.

The ethics approval process

Applications are completed online through the Integrated Research Management Application (IRMA). Once the declarations have been completed by all listed investigators and the application has been approved by your nominated faculty approver, the ethics office will review your completed application, prior to forwarding it on to the relevant committee meeting for review.

Applications are considered by the committee on a first-submitted basis. As the committees have a cap on the number of applications they’ll consider at each meeting, your application may be carried forward for consideration at the next available meeting. You may also be contacted by a member of staff or committee member seeking additional information before the meeting.

Once your application has been discussed at the ethics committee meeting, you’ll receive an email advising you of the outcome within 10 working days of the meeting. The ethics committee may:

1. approve your application
2. ask you to address questions or concerns raised by the committee
3. decide not to approve the application.

If approval is granted it will be for 4 years, conditional on you submitting annual reports.

If approval isn’t granted, you’ll be offered the opportunity to discuss the reasons for any decision not to approve your application. You may be invited to make amendments, or where there are serious issues, to prepare and submit a new application. If you’re asked to make amendments, you’ll need to allow additional time for your response to be reviewed.

If you don’t agree with the rejection of your application, you can lodge an appeal. As the appeals process for the two committees varies, you should contact either the Human Ethics or the Animal Ethics teams at the University to discuss any appeal.

Give yourself sufficient time

Ethics applications require explanations of the theoretical basis for your research and your methodology as well as significant documentation which means they take time to prepare. The process of gaining approval can also be time-consuming. It’s not unusual to have your application deferred to the next available committee, or to have to address questions or concerns raised by the committee, sometimes multiple times. All of this can impact on your research schedule. If you experience a substantial delay in obtaining ethics approval at any time during your candidature, this may be grounds to seek an extension of candidature.

Online workshops

Research integrity and ethics provides online training modules for research involving humans or animals. If your faculty doesn’t automatically enroll you, you should do so yourself.

Working with children, and criminal record checks

If your research involves direct contact with children, the University’s Working with Children Policy 2014 requires you to have a Working with Children Check clearance. More information on working with children in NSW.

For requirements for a criminal record check, consult your faculty.

Concerns about research ethics

If you have concerns about the ethical conduct of research at the University and want to make a complaint, contact:

Research integrity
Research Integrity Team
research.integrity@sydney.edu.au
02 8627 0200

Human ethics
Human Ethics Manager
human.ethics@sydney.edu.au
02 9036 9161

Animal ethics (not directly involving animal welfare)
Animal Ethics Manager
animal.ethics@sydney.edu.au
02 8627 8174

Animal welfare concerns
Animal Welfare Veterinarian
resint.veterinarian@sydney.edu.au
02 8627 5223 or 02 8627 6608 or 0481 008 721

Policies

• Higher Degree by Research Supervision Policy 2020
• Research Code of Conduct 2019
• Working with Children Policy 2014

Australian Research Integrity Committee

If you’re unhappy with the University’s response to a complaint which you have made, and your complaint was related to research funded by the Australian Research Council (ARC) or the National Health and Medical Research Council (NHMRC), you can request a review from the Australian Research Integrity Committee (ARIC).

The Australian Code for the Responsible Conduct of Research has more information about research integrity.

Further assistance

Contact us for advice regarding ethics and conducting research or if you’re considering submitting a complaint.

Disclaimer

This information is current as at November 2020 and is intended as a guide to the law as it applies to people who live in or are affected by the law as it applies in NSW. It does not constitute legal advice.