Applying for human research ethics approval

Please refer to the National Statement on Ethical Conduct in Human Research while completing your application.

There are two different types of application forms used to apply for human research ethics approval, each depending on the level of risk to participants and researchers.

1. Expedited Review Application Form — used for negligible and low risk research. If you are unsure of the risk level of your research, please complete section A of this form for guidance.

2. Human Research Ethics Application (HREA) — used for greater than low risk research. This form must be reviewed and signed off by the Head of School (or their delegate) in the same manner as the Expedited application is. As the HREA does not include the Head of School declaration, please download the declaration here and attach it to your application.

The HREA has been developed by the governing body (NHMRC) for Human Research Ethics Committees in Australia. The first time you access the HREA (external website), you will need to register as a new user. For technical support on the HREA system, please contact HREA Help on 02 6217 9902 or help@hrea.gov.au. Please refer to the user guides for further assistance.

Reciprocal Approval - If your project is already approved by a registered NHMRC Human Research Ethics Committee, you may be eligible to undertake the reciprocal approval process. To see if your project is eligible click on the hyperlinked heading.

Once the forms are completed, they can be submitted via email to humanethics@une.edu.au.

For application submission and meeting dates, please refer to this webpage. Please note that any variation request, progress report or final report submitted for a greater than low risk research project, approval will need to be reviewed by the full Committee which meets monthly.

Please note, the application process can take between 6-8 weeks.

After your research is underway

During the course of your research, you may have the need to amend your project approval. You will also need to report to the HREC in relation to your ethics approval by providing 12 monthly Progress Reports and a Final Report at the conclusion of your data collection.

Please note, if your project lapses you may apply for an extension of time within 6 weeks of the project end date. No research may be conducted during the lapsed period. If an extension of time is not submitted within the 6 week period, a new application will need to be submitted.

Variation Form

Variation Form: A Variation Form can be used to request an amendment to your project such as an extension of time, adding or removing personnel or changes to your project protocols. Please note, researchers cannot conduct any research on the project if the approval has lapsed.

Progress Report

Progress Report: A Progress Report is required to be submitted for every 12 months that a project is active. Submission of Progress Reports assist the institution in fulfilling requirements of monitoring approved research under Chapter 5.5 of the National Statement.

Final Report/Project Abandonment Form

Final Report: Please complete a Final Report once the data collection phase of the project has been completed. This form can also be used for projects that have been abandoned or not commenced. Researchers cannot conduct any research on the project if the project approval has lapsed.

Complaints

Institutions may receive complaints about researchers or the conduct of research, or about the conduct of a Human Research Ethics Committee (HREC) or other ethical review bodies. Complaints can be made by participants, researchers, staff of institutions, or others. All complaints will be handled promptly and sensitively.

For all complaints:

If a resolution cannot be reached through internal processes, the complaint may be referred to an external agency or person upon mutual agreement by the parties concerned.
Following determination of a complaint about HREC process, the HREC should review the relevant procedures and re-evaluate any decisions in light of the reviewed process.
Researchers should be assured that submitting complaints about the merit of a HREC decision can be done confidentially and will in no way impact the any future ethics applications.

Complaints about the conduct of HREC or HREC members

Complaints against the Human Research Ethics review process or the Human Research Ethics Committee can be submitted in writing via email to the Human Research Ethics Secretary. The submission should include details for the grounds of the complaint and the name and contact details of the complainant. Anonymous complaints will not be accepted. Any complaint received will be treated as confidential in order to best protect the complainant, respondent and members of the Human Research Ethics Committee.
Complaints will be sent to the Chair of the HREC for review. The HREC Chair and Secretary will review and investigate the complaint and work to propose a resolution. The Chair may call a sub-committee of HRE members to assist in investigating and resolving the complaint where appropriate. Any persons assessing the complaint will be required to declare any potential or actual conflicts of interest prior to review.
As part of the review process, the Chair, or Secretary on their behalf, may contact the complainant to request further information or clarify any issues. The Chair will determine if the complaint has merit. Having determined the complaint has merit, if the complaint is against a Committee member(s), the Chair will seek the members written response to the complaint.
The Chair will make a recommendation based on the evidence provided. The Secretary will notify the complainant of the HREC determination of the matter in writing.
The Secretary will invite the complainant to provide a written response to the recommendation within 10 business days.
If a resolution cannot be reached through internal processes, the complaint may be referred to an external agency or person upon mutual agreement by the parties concerned.
Recommendations from persons external to HREC or UNE can be made to the Chair, however, the resolution of the complaint lies with the HREC and this responsibility cannot be overridden. The HREC is an independent decision-making body established by UNE Council.
Following determination of a complaint about HREC process, the HREC will review the relevant procedures and re-evaluate any decisions and/or procedures in light of the reviewed process.
Complainants should be assured that submitting complaints against the HREC or about the merit of a HREC decision or process can be done confidentially and will in no way impact the any future ethics applications.
Any complaints handled under this procedure will be consistent with the Guiding Principles outlined in the UNE Complaints Guideline and the Principles outlined in the UNE Code of Conduct.

Appeals against the rejection of an application

Where the HREC has rejected an application, the Principal Investigator can:

Submit a new application taking into consideration the feedback provided by the HREC or;
Lodge and appeal with the Chair specifying the grounds of the appeal in writing via email to the Research Ethics Office.
The Chair will investigate the appeal and its validity and recommend to the HREC an appropriate course of action. The Research Ethics Officer will notify the complainant of the determination and most appropriate course of action.

Appeals against approval of an application

The appellant may submit an appeal in writing via email to the Research Ethics Officer outlining the ethical or scientific issues or the perceived inconsistencies in the decision-making process.
The appeal along with any other relevant documentation will be reviewed and investigated by the by Chair.
The Chair will investigate the appeal and its validity and recommend to the HREC an appropriate course of action. The Research Ethics Officer will notify the complainant of the determination and most appropriate course of action.

Complaints about the conduct of an approved research project

The complaint must be submitted in writing via email to the Research Ethics Officer. The complaint should include the approval number or title of the project in question.
The complaint along with any other relevant documentation will be reviewed and investigated by the by Chair.
If the complaint relates to research conduct, it will be referred to the UNE Research Integrity Office to be dealt with under the UNE Procedures for Investigating Research Conduct Breaches or Related Complaints. The Research Integrity Office will inform the Chair of progress is assessing the complaint.
The Chair will investigate the appeal and its validity and recommend to the HREC an appropriate course of action. The Research Ethics Officer will notify the complainant of the determination and most appropriate course of action.