The National Statement on Ethical Conduct in Human Research (National Statement) requires registered HRECs to monitor all approved projects including by the submission of a completed Annual Progress Report. The University takes its responsibilities in this regard very seriously. To help ensure compliance, and given the very large number of research projects requiring ethical clearance, the University has implemented a number of automatic checks and procedures. All investigators are expected to familiarise themselves with these procedures.

 

The Annual Progress Report form is available on the University of Queensland’s web site. The form requires Researchers to answer questions in relation to the human participants involved with their project.

 

In 2017, the University progressed to anniversary reporting for human ethics approvals. The return date for the completed form to the Office of Research Ethics is by the last day of the month of the anniversary of the approval date of your project and can be found on the bottom of the project's approval form. A final report is also required at the completion of a project. If you did not submit an annual report in 2017 or if your ethical approval expired at the end of 2017, please do so by COB Friday 9 February 2018 in order be in compliance with the requirements of the National Statement.

 

Where no response is recorded in the Office of Research Ethics a final reminder will be sent to the Chief Investigator. Failure by the Researcher to comply with the completion of the Annual Progress Report by either the anniversary month, or the follow-up reminder, may result in the approving Committee suspending research on the project in question or not considering additional projects or amendments from the investigator/s until the compliance requirements are met.

 

Suspension is not a disciplinary proceeding. It means that the University must temporarily stop the project until it can be sure that it is able to properly monitor the project as required by the NHMRC.  Suspension means that all work on the named project must stop pending submission of completed Annual Progress Reports.

 

As part of the ethical monitoring process at the University of Queensland a Researcher should anticipate at any time the possibility of a random audit by the approving Committee.  All current projects have the possibility of being selected for a random audit.
 
Audits are selected by member's consensus at a meeting, from a randomly selected set of current projects.  The audit confirms that the project is being conducted in accordance to its approval by asking questions of the research team, inspecting all consent documents and records and being guided through any physical experiments associated with the project.  Particular attention is paid to involvement of any collectivities that may be deemed to be 'vulnerable' by the nature of their age, mental and/or physical ability, confinement and/or race, religion or birth.
 
The Chairperson (or nominee) will advise the Researcher of the outcome of the audit. Official written advice is sent shortly after.  The Chairperson (or nominee) has the authority to immediately suspend continued work on the project should the audit show that the project is not complying with its original approval. Suspension will hold until the full membership of the approving committee has met and discussed the project and/or circumstances under question.  The auditor will provide a report which is tabled at the next meeting of the full committee with a copy being held on the project file.

UQ’s HRECs have approved the use and wording of the University's Ethical Clearance Paragraph for inclusion in all Participant Information Sheets to be given to participants of research projects.

The University's Ethical Clearance Paragraph provides an avenue for the participants to contact an officer of the University who is not connected with the project, namely the Ethics Coordinators, to discuss any concerns that may arise from their participation in the research.

This avenue of complaint is ideally recommended after the participant has discussed the issue/s with the Researcher/s, or where the participant wishes to address particular concerns with regard to the researchers themselves.

If negotiations through the Ethics Coordinator do not resolve the issue the matter is referred to the Chairperson of the approving Committee for further advice.

The Ethics Coordinator and the Chairperson have the authority to contact any professional assistance available to them within, or external to, the University of Queensland to assist in the resolution of the complaint.

Any legal matters are referred to the University's Legal Officer for advice.

The University's Insurance Manager may also need to be made aware of the matter.

The full membership of the approving Committee is made aware of any such matters at the next meeting.

Details of matters of a serious nature, that are sufficient to suspend the project, produce legal and/or insurance concerns are also made known to the Chairperson of one of UQ’s HRECs.

In addition to the above, a person wishing to make a complaint or an allegation of breach of The Australian Code For The Responsible Conduct of Research or research misconduct should refer to the Policy and Procedures Library (4.20.05).

The following paragraph is to be incorporated into all Participant Information Sheets given to participants in human research:

"This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research. Whilst you are free to discuss your participation in this study with project staff (contactable on .......................), if you would like to speak to an officer of the University not involved in the study, you may contact the Ethics Coordinators on +617 3365 3924 / +617 3443 1656 or email humanethics@research.uq.edu.au."