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Approval process

Do I Need Ethics Approval? |

Audit versus Research | Research not involving drugs and not industry sponsored 

Research commercially or industry sponsored |Research involving drugs but not industry funded

 

Do I Need Ethics Approval?

Approval from the Human Research Ethics Committee is required if your project involves research on humans . This includes questionnaires, medical record reviews and the use of databases.

Research versus Audit and Quality Assurance

Quality Assurance or audit activities are an evaluation of existing practices involving the delivery of services. However, HREC approval for quality assurance and audit activities may be required if:

• The results are to be published and subjects are identifiable, either directly or through identifiers linked to the subjects’ response
• The privacy of the participants is compromised
• Any other ethical concerns are raised
• The project involves the collection of health information for the purposes of management, funding or monitoring of a health service, where the information is identified (or potentially identifiable) and consent will not be obtained, where the Privacy Principles set out in Section 95A of the Commonwealth Privacy Act 1988 apply.

 

If you are unsure whether your proposal is a research or Quality Assurance project or if HREC approval is required, please refer to the new National Health & Medical Research Council (NHMRC) recommendations “When does quality assurance in health care require independent ethical review?”, the “Quality Assurance and Ethical Review” checklist prepared by the Princess Alexandra Hospital Clinical Services Evaluation Unit, and information from the Victorian DHS HREC.

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You intend to submit an application and your research does not involve drugs and is not industry sponsored

All applications to the Human Research Ethics Committee must include the following:

• 1 original and 17 copies must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier, patient consent form and all advertising / marketing material that is to be given to patients· (please ensure that you as the submitter also keep 1 copy of everything for your records – required for auditing and monitoring)
• 1 copy of the Summary Submission Form
• 1 original signed Site Specific Assessment Form
• 1 copy of Checklist

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You intend to submit an application and your research study is commercially or industry sponsored

All applications to the Human Research Ethics Committee must include the following:

• 1 original and 17 copies must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier , patient consent form and all advertising / marketing material that is to be given to patients
• 1 copy of the Summary Submission Form
• 1 original signed Site Specific Assessment Form
• 1 copy of Checklist

 

Please ensure that you as the submitter also keep one copy of everything for your records as a requirement for auditing and monitoring.

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You intend to submit an application and your research study involves the use of drugs but is not industry funded

All applications to the Human Research Ethics Committee must include the following:

• 1 original and 17 must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier, patient consent form and all advertising / marketing material that is to be given to patients
• 1 copy of the Summary Submission Form
• 1 original signed Site Specific Assessment Form
• 1 copy of Checklist

 

Please ensure that you as the submitter also keep 1 copy of everything for your records – required for auditing and monitoring.

 

In addition to the above you must submit the following:

• Any information that will be given to patients eg quality of life forms must also be submitted
• TGA Clinical Trial Exemption (CTX) and Clinical Trial Notification (CTN) scheme must be specified and requirements must be met. The CTN form must be signed by the Principal Investigator before submission which is countersigned by the Clinical CEO upon approval.
• Indicate indemnity arrangements – QH, University, other. If University subcontract arrangements required
• Contracts/clinical trial agreements

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