3. Ethics Committee (EC)/Institutional Review Board (IRB)
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3. Ethics Committee (EC)/Institutional Review Board (IRB)
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3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.
Applications to the HREC should be made electronically via the attached link: https://hrea.gov.au/
Your application must include:
- a cover letter stating the meeting at which the review is sought
- a completed HREA or Victorian Low & Negligible Risk (LNR VIC)
- a completed Victorian specific Module (not required with LNR VIC)
- any other relevant attachments, such as protocol, survey instruments, copies of questions, data variables sought from databases, recruitment materials, plain language statements of the project, consent forms
- a curriculum vitae. Researchers are asked to please provide no more than a brief two-page CV of the lead investigator and the primary person doing the work of the project (if not the lead investigator).
Checklist - Determining Review Pathway
3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.
The benchmark for receipt of an ethical decision is 60 days from receipt of a valid ethics application. The length of time from submission of a research application to the researcher receiving a decision depends on a number of factors including:
- Completeness of the submission;
- Quality of the submission (including the quality of the research protocol, quality of the HREA and other documentation, correct adherence to policies regarding accessing, maintaining, and storing data and/or tissue, etc.);
- Time taken by researchers to respond to HREC concerns and requests.
3.3 Does EC/IRB have any fast-track or expedited review process?
Yes, Some institutions offer a fast-track process whereby they offer expedited service with review and approval within 30 days. This is provided at an additional cost. An example is presented below. https://www.svhm.org.au/research/industry/research-valet
3.4 Does EC/IRB to be registered and/or accredited/approved by RA/CA?
Institutions need to register their HREC with NHMRC. Organizations can register their HREC(s) by completing the registration form and uploading documentation that demonstrates that their HREC(s) meets the requirements of the National Statement: HREC registration form
Additional documentation required is as follows:
3.5 How frequently does EC/IRB meet? Please describe their schedule.
This varies depending on the institution. Most HRECs meet at least monthly, however, some now meet every two weeks. Most HRECs do not meet in January as this is the main summer holiday period in Australia.
3.6 Is any additional approval from EC/IRB needed e.g. scientific committee, subject matter expert committee, etc.?
No, subsequent to EC approval application to the TGA for approval can be made. For gene therapy products, approval is also required from the OGTR.
3.7 Please describe the process of EC/IRB submission for clinical trial approval.
The process and timings vary slightly from institution to institution but typically the process is as follows:
- Sponsor submits an online HREC application at least 14 days prior to the HREC meeting (HRECs publish a meeting calendar and deadlines for submission)
https://monashhealth.org/research/resources/human-research-ethics-and-site-authorisation/human-research-ethics-application/ (link to calendar and submission deadlines for 2022 and 2023)
- HREC meets and reviews the application
- If the application is considered acceptable then approval is granted
- If the HREC has further data requests or questions about the application these are communicated back to the sponsor within 7 days
- The sponsor must then submit their response within the timetable for the next HREC meeting
- The follow-up information is reviewed by the HREC at the next meeting and a decision is made.
It is typical for applications to receive at least one round of questions from the HREC.
3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)
National Statement on Ethical Conduct in Human Research states that institutions that individually or jointly establish ethics committees (ECs) (Human Research Ethics Committees (HRECs) in Australia) should allocate adequate funds to prevent charging fees for ethics reviews in amounts that would discourage research that the institution has an obligation to support.
The fees for HREC review vary from institution to institution. Some institutions run their HREC as a commercial operation, whilst others run it as part of a public hospital. Fees typically range from AUD 4,000 – 10,000. Additional charges may apply in order to receive an expedited service as per the example provided previously.
3.9 Does EC/IRB accept checks or payment can be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?
The payment method varies by institution. Payments are typically made electronically.
3.10 Is there any guidance tool available for making electronic applications? If yes, please provide the link and/or step-by-step instructions.
Guidance on making an HREC application is provided in the HREA Guide.
https://www.nhmrc.gov.au/file/17369/download?token=6gbyPn4q
3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?
It depends on the type of study and/or materials. Where electronic systems are being proposed, screenshots in English would typically be expected.
3.12 Does EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?
A template for the Informed Consent Form is available from the NHMRC.
3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirement?
Guidelines on the standard practice for compensation of clinical trial participants are provided by Medicines Australia.
https://www.medicinesaustralia.com.au/policy/clinical-trials/indemnity-compensation-guidelines/
3.14 Are there any specific local safety reporting requirements on clinical studies?
See Section 2.5.
3.15 Does EC/IRB require any periodic study reporting?
Annual Report
Sponsor must provide the HREC with an annual safety report including a clear summary of the evolving trial safety profile. The annual safety report should generally include:
- A brief description and analysis of new and relevant findings
- For investigational products (IPs) not on the Australian Register of Therapeutic Goods, a brief analysis of the safety profile of the IP and its implications for participants
- A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
- A description of any measures taken or proposed to minimize risks
A Development Safety Update Report (DSUR) or other similar documents may also serve as the annual safety report.
Final Study Report
The Sponsor should make the final report available to the TGA upon request.
Trials conducted under the Clinical Trial Approval (CTA) scheme are required to notify the TGA of the trial completion.
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