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HREC Applications
The HREC uses the Department of Human Services (DHS) Common Application Form. The form consists of a number of modules. All applicants must complete Module 1 - Core Application Form.
Applicants undertaking specific types of research must also complete the additional module/s relevant to their research. Each module includes guidelines for answering the questions. We recommend that applicants read the guidelines before completing the form.
Module 1 - Core Application
Guidelines Form | | | |
| | Participant Information and Consent Form
Guidelines Forms for use in clinical research projects Forms for use in non-clinical research projects | | | |
| | Module 2 - Projects Involving Drugs and Therapeutic Devices
Guidelines Form
Indemnity form
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Module 3 - Human Tissues
Guidelines
Form | | | |
| | Module 4 - Ionising Radiation
Guidelines Form
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| | Submitting an Application
The application forms can also be accessed directly from the DHS website at www.health.vic.gov.au/ethics/. The final application form must be typed and extra pages may be attached as appropriate. Incomplete applications will be returned. One (1) original and ten (10) copies should be sent to:
HREC Secretary
Monash Surgical Private Hospital
252-256 Clayton Road
Clayton VIC 3168 The Participant Information and Consent Form (PICF) must list the name and contact phone numbers, including after hours numbers of the Principal Researcher or appropriate persons. This is to ensure that in the event a participant has any concerns before commencing, during or after completion of the project, they can contact the appropriate person.
Researchers may be required to attend a meeting of the Ethics Committee to present the research project and answer questions, before approval can be given. Researchers are also required to submit to the Secretary, names and addresses of all patients involved in drug trials and projects involving the use of therapeutic devices.
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| | Amendments
An Amendment Request Form is required to be completed and submitted to the Ethics Committee if:
a) the experimental protocol has changed for continuing projects b) an extension is required for projects that are about to expire
Written approval must be obtained before the amendments are put into effect. It is the responsibility of the researcher to ensure that all project approvals are current. Amendments may be dealt with between meetings. However, depending on the type of request, it may need to be presented to the committee at the next meeting.
Amendment Request Form | | | |
| | Expedited Review & Approval
The HREC may undertake expedited review of research projects depending on the nature of the request and the urgency. Expedited review will be decided on an individual basis and provided there is minimal risk to the participants. In general, research applications that will not be accepted for expedited review are new research projects and drug trials.
A request for expedited review must be in writing and addressed to the Secretary of the HREC. The matter will then be forwarded to the Chairperson and a decision will be made subject to ratification by the full Ethics Committee and then the Board of Directors. Once a final decision is reached, the researcher will be formally notified.
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| | Annual Reporting of Project Progress
A condition of approval for all HREC approved research projects is that a progress report be submitted annually (or earlier if requested). A letter will be sent to the researcher towards the end of each calendar year requesting an update. At the completion of a project, the researcher is also required to provide a progress report.
NB – if a researcher fails to submit an annual progress report, approval for their project may be suspended by the HREC. Annual Progress Report Form - Quality Assurance Annual Progress Report Form - Research Project | | | |
| | Reporting of Serious Adverse Events
A condition of approval for all HREC approved research projects is that serious adverse events (SAE) experienced by research participants must be reported to the HREC immediately. Details of the incident whether the researcher believes it is related or not, must be included in the report. SAE Form | | | |
| | Quality Assurance vs Research
Under the National Statement on Ethical Conduct in Research Involving Humans, all research projects involving patients as participants must be submitted to a HREC for ethical review. Projects which may be considered Quality Assurance (QA) or Audit do not require a full ethics submission. An application form is still required for submission to the HREC to determine whether the study is research or QA. Provided that all questions are answered in the negative, a full ethics submission is not required. However, the researcher will still be issued with a formal approval. If any questions are answered in the positive, then the Module 1 – Core Application Form must be completed. Guidelines Form | | | |
