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How to start a trial in Australia? * Ethics Approval

Human Research Ethics Committees (HRECs)

Irrespective of which regulatory route is followed, all clinical trials must be submitted to the Australian equivalent of an Independent Ethics Committee (IEC) – a Human Research Ethics Committee (HREC).

In line with the National Health and Medical Research Council (NHMRC) standards, numerous public and private health HRECs operate in Queensland to review clinical trial protocol submissions (National Ethics Application Form - NEAF). Please note, when submitting to a Queensland Health (QH) institution the application must be on a QH online NEAF.

Many HRECs work cooperatively with industry by utilising:

  • checklists that facilitate efficient preparation of ethics submissions 
  • template approval letters that comply with GCP 
  • a uniform fee structure across all HRECs and trial sites 
  • national indemnity and compensation guidelines.

The requirements of the NHMRC National Statement for HRECs exceed those of ICH GCP. The NHMRC is a Federal Government Committee that, amongst other duties, oversees HRECs in Australia. The NHMRC is independent of the TGA.

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Ethics approval timelines

Most HRECs require submission to be made 2-6 weeks prior to a planned meeting date. The submission must be comprised of, but not limited to the:

  • protocol 
  • Case Record Form (CRF) 
  • Investigational Drug Brochure (IDB) 
  • Patient Information Sheet (PIS) and 
  • Patient Informed Consent (PIC).

If all required documentation is not available at the time of submission a letter of explanation may be submitted and all missing documentation must be submitted at a later date but earlier than the HREC meeting date.

If the CTN scheme is being used it is common for the submission to be first passed to a HREC Research Committee, who perform a review of the science of a proposed study and then pass their recommendation on to the HREC. The HREC will commonly meet 4-6 weeks later to perform a traditional IEC review. At any time the review and approval process may be suspended whilst the committee seeks answers to questions put to the submitting investigator. A standard timeframe from submission to final approval is 12-16 weeks, dependent on the scheme used, complexity of the study, requirements for advertising and other key factors relating to the proposed trial.

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Informed consent

Sites are required to have their own informed consent forms that comply with:

  • their own specific template 
  • any HREC guidelines and 
  • ICH GCP.

Sites are likely to request changes to sample informed consent forms provided by overseas sponsors. Australian details on data protection, patient compensation, reimbursement and contact details for emergency safety issues, as well as independent advice, must be provided.

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Insurance, indemnity and compensation

Insurance is required to be held by the Australian sponsor throughout the study. Some Australian states have specific requirements regarding the level of insurance cover and some sites require a copy of the Sponsor’s certificate of insurance before commencing a trial. All clinical trial indemnity agreements between the Sponsor and the Institution in Australia must conform to the Medicines Australia standard as published in Guidelines for Compensation for Injury Resulting From Participation in a Company-sponsored Clinical Trial, a Form of Indemnity for Clinical Trials-Standard and a Form of Indemnity for Clinical Trials - HREC review only.

A standard Medicines Australia Form of Indemnity is often required by Australian HREC's and if used, should be signed off by the Sponsor for each site. Furthermore, some sites require that the form of indemnity is printed on Australian Company letterhead and that the Sponsor listed on this is an Australian legal entity.

Australian HRECs commonly expect appropriate insurance to be held by the Sponsor. Furthermore, specific excess levels may be required. Insurance should be maintained for the life of the clinical trial and a copy of documentation, supporting the coverage provided in the premium, held by the Sponsor may be required by an institution or HREC, updated yearly as required.

When considering a trial proposal a HREC needs to be satisfied that trial participants will be adequately compensated for the costs of any injury suffered as a result of participation in the clinical trial. HRECs verify compensation arrangements to ensure that they satisfactorily protect the interests of participants and the trial site. Terms of the available compensation should be explained to all prospective trial participants.

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Patient recruitment costs

It is typical for sponsor companies to reimburse patients for all out of pocket expenses associated with attending scheduled trial visits. This reimbursement must be clearly indicated in the patient information sheet.
Advertising and accelerated recruitment strategies are permitted if approved by the HREC. The costs of advertising are typically covered by the sponsor company.

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