Understanding your Letter of Approval
Your letter of approval will contain various details specific to your study. These are listed below with a brief description.
Study title: The title of your study as submitted in your ethics application. You should quote this title as reference in all communications with the Ethics Office subsequent to receiving approval.
Project number: The unique reference number for your study.
Approval date: This is the date that formal approval was granted. No activities involving participants can be conducted prior to this date.
First Annual Report Due: Typically one year after your approval date. HREC approval is valid for four years, which is conditional upon you submitting annual report forms.
Authorised Personnel: All personnel that are approved to be working on the study will be listed. If any other personnel wish to be involved you will need to submit a formal request to add the person/s to your study using the 'Change in personnel ONLY' form in IRMA.
Documents Approved: This lists documents such as the participant information statement, consent forms, surveys, interview questions and other instruments approved for use in your study. Please make sure the version that you are using corresponds to the version that was uploaded and approved as listed in your letter of approval or in subsequent modifications.
Conditions of Approval
Your letter of approval stipulates various conditions of approval. There are two types of conditions.
- Special Conditions of Approval
- Conditions of Approval
Your letter of approval may stipulate Special Conditions of Approval that are specific to your study.
This could include provision of certified translated documents, site/agency/organisational approvals, provision of specific feedback to participants etc. Please read the condition carefully.
In some instances (eg. certified translations) you will be required to forward documents to the Ethics Office (refer to Responding to Special Conditions of Approval. In this instance, the Ethics Office will send you reminders if it has not received a response to the special condition within two months of the issue of your letter of approval. In other cases you may not be required to respond to the Ethics Office, however you must ensure that you retain any documentation that verifies compliance with the Special Condition of Approval. For instance, if you are required to obtain site approvals, these written approvals must be obtained prior to the start of your study at the relevant sites and you must retain this written approval with your study records so that you can demonstrate compliance with your ethics approval should the need arise (eg. in an audit).
Please note that special conditions of approval may also be included on any letters of approval regarding modifications to your study that you request subsequent to receiving initial approval.
Responding to Special Conditions of Approval
If your letter of approval (for your study or subsequent modifications) specifies Special Conditions of Approval you may be required to provide a response to the Ethics Office regarding this special condition. The requirement to respond will be stipulated within the condition and can be done through IRMA.
- Login to IRMA
- Click on 'Researcher Profile' at the top right
- Navigate to the 'Human Ethics' tab
- Click on the 'Create' button
- Select the form titled 'Compliance with Special Conditions of Approval'
- Link to your project
- Outline the special conditions you are addressing on the coversheet
- Upload relevant documents under the 'Documents' tab
- Press the 'Submit' button in the coversheet tab to submit your form
- Approve the form under the 'My Approvals' tab
2. Condition/s of Approval
This section lists general conditions of approval that are relevant to all researchers and all research projects. Please read this section carefully and make sure you are familiar with the requirements stated, particularly regarding submission of annual reports, reporting of serious and unexpected events, reporting of unforeseen events that may affect continued ethical acceptability of the project, and obtaining approval for any changes to your study.
Failure to adhere to any of these conditions will constitute non-compliance with your ethics approval and may result in withdrawal of approval for your study. (Please note that special conditions of approval may also be included on any letters of approval regarding modifications to your study that you request subsequent to receiving initial approval).
Chief Investigator/Supervisor's responsibilities
Regardless of how many people are involved in a study, the Chief Investigator (as specified in your ethics application) has ultimate responsibility for the conduct of the study.
The Chief Investigator has a list of specific responsibilities in relation to ethics approval, which are outlined in the corresponding section of the conditions.
In the case of studies being undertaken by students (eg. Honours, Masters, PhD) the Chief Investigator is the student's supervisor.