Agenda | After the Meeting | Approval of Research Protocols
Investigator Responsibilities | Conditions of Approval | Monitoring
Clinical Pharmacological Review | Radiation Safety | Biosafety Committee
Upon receipt of the application, the Secretariat reviews all the documentation to ensure all documentation has been submitted and the content is adequate.
If you have any correspondence that you would like the HREC to consider, please ensure that it arrives by the submission due date. The agenda is prepared and sent out with all relevant papers to the HREC members seven working days in advance of meetings.
At the meeting decisions are generally reached through consensus. Investigators are permitted to attend by invitation. The Chair speaks to tabled business. The pharmacist or other members of the sub-committee speaks to serious adverse events.
The HREC will communicate to the Principal Investigator in writing on its deliberations and conclusions. You will receive these comments approximately 10 working days after the meeting. Please note occasionally delays may occur as the minutes of the meeting are reviewed and approved by the Chair prior to mail out of any correspondence.
Your application will either be ‘approved’, ‘not approved’ or ‘approved pending a response’ to the HREC’s comments or amendments to your application. Please note that in most instances you will be asked to respond to the HREC’s comments and that applications are rarely approved at the first meeting.
Please forward your response promptly to the Ethics Secretariat for efficient processing of your application. Alternatively, the HREC may want to review your response at the next meeting. The Ethics Secretariat can give you advice on the status of your application.
No research project may commence without written approval.
An Approval Letter will be issued by the Clinical CEO upon the recommendation of the HREC.
Approval of projects is normally valid for the duration of the project, subject to provision of requested reports and satisfactory discharge of obligations.
In accordance with the NHMRC Australian Code for the Responsible Code of Research please note that as a condition of approval, the investigator must report anything which may warrant review of the projects HREC approval including:
Any information given to patient eg Quality of Life forms, patient cards, instructions
It is a further condition of approval that if a project is discontinued before the expected date of completion that the HREC be informed in writing citing reasons for the termination.
Investigators are required to submit to the Ethics Secretariat a progress report, due on the anniversary of approval, or at regular intervals as determined by the HREC. A progress report will be requested at least annually. A final report is required at the completion of the project, or if the research is discontinued before the expected date of completion.
If a project is a National Institutes of Health (NIH) funded the original must be submitted yearly 1 month prior to the original submission date to ensure approval to continue will arrive in a timely manner. The NIH may terminate your participation if this is not completed in a timely manner. Federalwide Assurance (FWA) approval number and site.
The Human Research Ethics Committee has the responsibility of monitoring all research that it has approved in accordance with the National Statement on Ethical Conduct Human Research (2007). Part of the monitoring process includes the review of progress reports.
Based on information received in the progress report, the Human Research Ethics Committee may elect to undertake random inspection of the research site, data and signed consent forms, or interview research participants.
Projects involving drugs may require to be reviewed at the request by the Chair or the HREC by a clinical pharmacologist.
All projects using x-rays, MRI, radioactive isotopes, radio waves, microwaves, magnetic fields, short waves, lasers, ultrasound etc may need to be approved by the PAH Radiation Safety Committee following review by the Chair, HREC.
If you are undertaking research and development in genetic technology are required to be accredited by the Gene Technology Regulator and maintain a properly constituted Institutional Biosafety Committee (IBC). PAH is Accredited but uses the UQ IBC. The UQ IBC monitors all dealings with GMOs within PAH, and certifies facilities in accordance with the Office of Gene Technology Regulators Accreditation Guidelines.
All researchers wishing to deal with GMOs need to obtain approval to undertake their work from the Regulator, through the IBC. All dealings must be submitted to the UQ IBC, on the prescribed form for the particular type of dealing. The IBC who will review the application and provide advice and assistance to proponents. Dealings are defined in The Act to include conducting experiments, breeding, storage, disposal and culturing GMOs (http://www.ogtr.gov.au).
Further Information
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Jane Easson |
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Phone: |
(07) 3365-1857 |
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Fax: |
(07) 3365-1577 |
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E-mail: |
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Rosie Godwin |
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Phone: |
(07) 3346-9489 |
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E-mail: |
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