The Australian Defence Human Research Ethics Committee (ADHREC) requires your agreement to the following conditions in order to secure its endorsement of your project:
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1 You must quote your ADHREC number and title of your protocol in all correspondence. “INSERT PROTOCOL NUMBER AND TITLE.” |
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2 If you do not commence data collection within twelve months of this approval, the protocol will need to be resubmitted. |
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3 The approval of your protocol is for a period of three years. If your research is to continue beyond the three-year approval time, an extension is to be sought in writing. |
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4 You are required to submit six-monthly progress reports, the first of which is due “INSERT DUE DATE”. |
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5 The Committee requires confirmation that your project has begun, or notification that it has been delayed or abandoned. |
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6 The Committee requires that a copy of the ADHREC Guidelines for Volunteers be given to every participant when they are recruited for the protocol. |
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7 Committee approval must be sought before any modifications to the protocol are instituted. |
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8 The Committee must be informed of any deviations from the approved protocol and immediately informed of any protocol deviations with real or potential ethical implications. |
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9 The Committee must be informed immediately of unforeseen event that might affect the continued ethical acceptability of this project. |
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10 The Committee must be informed immediately of any untoward effects with respect to the medical, personal or administrative management of participants, or which may have ethical and / or publicity implications. |
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11 ADHREC gives it ethical approval subject to your explicit agreement to an intention to publish. Publication should be in a refereed journal or other source open to public audit. It would be appropriate to include in your submission for publication the phrase “Ethical clearance for this project was provided by the Australian Defence Human Research Ethics Committee”. Should a security classification make publish in an open source inappropriate, ADHREC is to be notified in writing. |
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12 ADHREC requires a comprehensive Final Report which details the conduct of the project and its findings. This report is to be submitted as soon as possible after the project has finished. |
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13 The ADHREC Secretariat requires that you provide notification of any change in your contact details. Point of Contact is the Executive Secretary at ADHREC@defence.gov.au. For Clinical Trials Only |
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14 ADHREC requires that the nominal roll of participants, for the purpose of future tracing, is to be kept for the requisite time by you, according to the NHMRC National Statement on Ethical Conduct in Human Research. |
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15 The Committee must be informed of any ‘adverse events’ and immediately informed of any ‘serious adverse events’ (SAE) which are considered by the Principal Investigator (PI) to be possibly drug related within 72 hours of their occurrence. |
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16 You must retain records of your volunteers’ details, any who withdraw, the reasons for that withdrawal (if known) and provide such on request. |
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