Applications for Ethical Clearance involving humans

Clearance must be sought from the Committee BEFORE the research is undertaken.

Applicants should familiarise themselves with the National Statement on Ethical Conduct in Human Research before completing the request for clearance. This introductory document contains some additional information.

There are two (2) methods of applying for ethical clearance: Low Risk Review (for projects involving negligible or low risk, as defined by the National Statement), or completion of the full National Ethics Application Form (NEAF) - for projects involving greater than low risk. This flowchart summarises the process. Researchers are advised to proceed to the low risk form and complete the checklist to determine the level of risk. If the checklist indicates that your project is NOT eligible to be considered as low risk, you will be required to complete a full NEAF application. A sample Low Risk form has been provided for your assistance, and you are most welcome to contact the Secretary on 0749 23 2603, or ethics@cqu.edu.au, if you have any queries.

Low Risk Process

If the checklist indicates that your project IS eligible to be considered as low risk, then you should complete the rest of the form, and lodge it, together with the supporting documentation, with the secretary of the committee. Applications may be forwarded at any time, as they are not required to be assessed by the full HREC. The application will be assessed by two committee members, with their recommendation being forwarded to the Chair for consideration. The outcome will be communicated to the researcher within 15 working days of the receipt of the application.

Full Application Process

Applications which do not meet the criteria for Low Risk must be submitted on the National Ethics Application Form (NEAF), an online application process that covers all requirements of current regulations. The form is completed online (www.neaf.gov.au) and then saved as a PDF file. This file can then be printed, signed and posted to CQUniversity's Ethics and Compliance Officer, or may be emailed, provided that the signature page is sent in hard copy.

Applicants are encouraged to download the:

to assist them with the process. Regular tutorial sessions are offered on the Rockhampton campus (and other campuses as required) where researchers and students can obtain individual support with their applications.

Applicants for ethical clearance are recommended to submit their request for ethical clearance at least two (2) months prior to the date on which they will be commencing their project. An email will be sent to the applicant to confirm receipt of the application and allocation of the application number. Electronic Applications are sufficient, provided that the signed declaration page is sent by mail, or scanned and emailed prior to the date of the meeting at which the application is being considered.

Expedited Review

If expedited review is requested, a memo from the applicant justifying the request for executive approval needs to accompany the application. Expedited review is only available in exceptional circumstances, where unforeseen circumstances outside of the control of the researcher arise, requiring the prompt collection of data. The notification of the outcome of the expedited review is approximately ten (10) working days after the receipt of application.
Important Note: Only minimal risk research will be reviewed executively where appropriate justification for such a review is given by the applicant.

Meetings

CQUAEC meets six times per year and the meeting dates and submission deadlines are available on the meetings website.

Modifications

All requests for changes to approved projects must be submitted to the CQUHREC on the modification request form. Minor amendments may be approved by the Executive subcommittee of the CQUHREC. All minor amendments approved by the Executive on behalf of the CQUHREC must be ratified by the full committee at the next meeting.

Important Note: Extensions or amendments cannot be granted retrospectively. Should you need an extension but not apply for this before the end-date of the approval then a full new application for approval must be submitted to the Secretary for the Committee to consider.

Reporting

The National Statement requires that institutions ensure that the conduct of all research approved by a human research ethics committee is monitored.

CQUHREC requires an annual report to be submitted for approved projects of longer than twelve (12) months' duration and final report on the completion of the data collection period. Researchers who fail to submit an appropriate annual report when requested may have their ethical clearance revoked and / or the ethical clearances of other projects suspended.