When is ethics approval required?Any research involving humans, or requiring access to personal information, will require approval from a Human Research Ethics Committee. The design, review and conduct of research must be ethically acceptable and in accordance with relevant standards and guidelines in the National Statement on Ethical Conduct in Human Research 2007 (updated May 2015). as issued by the National Health and Medical Research Council.
When is ethics approval required from the Department of Health Human Research Ethics Committee?Ethics approval is only required when your project falls within the Department of Health Human Research Ethics Committee's Terms of Reference. If you are in doubt as to whether your project requires ethics approval by the Committee, you may submit a written outline of the project proposal to the Committee Secretariat.
This information will then be forwarded to the Chair of the Committee for consideration. The Chair will determine whether the Committee's ethics approval is required.
My project has already received approval from another Human Research Ethics Committee. Will I also be required to seek approval from the Department Health Human Research Ethics Committee?Project proposals that have approval from another Human Research Ethics Committee will not generally require additional approval from the Department of Health Human Research Ethics Committee. This is on the condition that the approving Human Research Ethics Committee is registered with the National Health and Medical Research Council and operates in accordance with standards and guidelines in the National Statement on Ethical Conduct in Human Research 2007 (updated May 2015). The exception to this rule is the departmental referral mechanism, where a data custodian or senior executive of the department can refer project proposals to the Department of Health Human Research Ethics Committee for review. This would happen at the time of your request for release of health data.
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My project has already received approval from another Human Research Ethics Committee and the Department of Health Human Research Ethics Committee. How will the change in treatment of projects affect the status of my existing approval with the Department of Health Human Research Ethics Committee? Will there be any changes to reporting requirements?There is no change to the status of project proposals already approved by the Department of Health Human Research Ethics Committee. Researchers will still be required to submit annual progress reports for the duration of ethics approval granted by the Committee. There is also a requirement that the Department of Health Human Research Ethics Committee be notified of any protocol variations that are lodged with an appropriate lead Human Research Ethics Committee.
Is there a fee involved in making a submission to the Department of Health Human Research Ethics Committee?There is no application fee for projects submitted to the Committee.
The Chair of the Department of Health Human Research Ethics Committee has determined that my project requires ethics approval. What factors do I need to consider when preparing my application?Applicants are encouraged to review the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research 2007 (updated May 2015) which sets out the ethical principles and values for research conduct.
For projects which involve Indigenous people, it is recommended that applicants examine the NHMRC’s Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003) report.
Can I use the National Ethics Application Form or is there a preference for the Department of Health Human Research Ethics Committee's application form?The Committee's application form is preferred but it is willing to accept research applications using the National Ethics Application Form.
Can you provide more information on the level of detail required in the project budget?A high level summary of the project’s financial position should be provided to the Committee. This summary will need to cover the entire duration of the project.
The Committee will consider whether the funding proposal is appropriate. Information is required on a breakdown of project costs by salaries, administrative costs, participant reimbursement and estimated indirect costs. Examples of indirect costs include travel, conference costs, recruitment incentives and equipment.
We are unable to obtain all the necessary signatures before the submission closing date. Who do I notify and can I still submit an application form?An application will not be considered by the Committee without the necessary signatures.
However, an application without signatures will be accepted on the submission closing date conditional upon:
- Signatures being received prior to the Committee meeting. Scanned copies of all relevant signatures must be sent to the Committee Secretariat.
- Provision of a covering letter from the Principal/Senior Researcher to the Chair of the Committee explaining the nature of the delay and a proposed course of action for obtaining any outstanding signatures.
My application is being considered at the next Department of Health Human Research Ethics Committee meeting. What outcomes can arise from the meeting?The following outcomes apply to applications considered by the Committee:
- The application is approved by the Committee.
- The application does not receive Committee approval and further information is required for consideration out-of-session. The Principal/Senior Researcher is required to provide further clarification on issues raised by the Committee. Once a satisfactory response is received, final approval will be granted.
- The application does not receive Committee approval and significant further information is required to be considered at the next Committee meeting. The Principal/Senior Researcher may be required to make changes to the project proposal or address issues raised by the Committee. When reconsidered, the project will either be granted approval or be progressed out-of-session.
How long will it be before I can expect a response on outcomes from the meeting?The Principal/Senior Researcher will be advised of the Committee’s decision within 7–10 working days of the Committee meeting.
No information will be available before that time.