Ethics Committees
Irrespective of which regulatory route is followed, all clinical trials must be submitted to the Australian equivalent of an Independent Ethics Committee. In Australia these are called Human Research Ethics Committees (HREC).
The federal overseer of HRECs in Australia is the National Health and Medical Research Council (NHMRC) a body which is independent of the regulator, Therapeutic Goods Administration (TGA). In line with the NHMRC standards, numerous public and private health HRECs operate in Queensland to review clinical trial protocol submissions. They work cooperatively with industry by using:
- 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, and
- national indemnity and compensation guidelines.
The requirements of the NHMRC for HRECs exceed those of ICH GCP.
Ethics approval timelines
Most HRECs require submission to be made ~2-3 weeks prior to a planned meeting date. The submission must be comprised of, but not limited to the:
- Protocol,
- Investigational Brochure (IB),
- Patient Information Sheet (PIS) and
- Patient Informed Consent (PIC)
- Form of Indemnity
- Evidence of Clinical trial Insurance (CTI)
- Completed CTN form or evidence of CTX approval
- Draft Clinical Trial Research Agreement.
If all required documentation is not available at the time of submission a letter of explanation may on occasion be submitted and all missing documentation 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 Sub-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 2-4 weeks later to perform a traditional ethical review. At any time the review and approval process may be suspended while the committee seeks answers to questions put to the submitting investigator. A standard timeframe from submission to final approval is 5-8 weeks, dependent on the scheme used, complexity of the study, requirements for advertising and other key factors relating to the proposed trial. However, these timelines are often reduced when working with specialist units such as phase I facilities, due to experience, expertise and support of such groups.
Following HREC approval, the project is passed to the Institution’s Governance Office for review and approval of the CTI, Indemnity, Clinical Trial Research Agreement, and signature of CTN form.
Mutual Recognition between Australian HRECs
Australia has undergone a period of review with respect to the efficiency of multicentre HREC review with the exciting result being introduction of state by state Mutual recognition of one lead HREC review by other hospital HRECs in the same state. At this time such recognition is limited to the states of Queensland (QLD), New South Wales (NSW) and Victoria (VIC) though other states are working on similar state based implementation.
Furthermore, it is anticipated over the early part of 2012 that the three aforementioned major states will commence mutual recognition inter-state as well as intra-state.
Informed consent
Sites are required to have their own informed consent forms that comply with their own specific institutional standards and formats, any HREC guidelines and of course ICH GCP. As such 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.