The National Approach
After much negotiation, the National Approach to single ethical review of multi-centre research is here. As of 1 November 2013, National Mutual Acceptance of single ethical review of multi-centre research conducted in public health organisations commenced.
All jurisdictions support National Mutual Acceptance, participation in the scheme by individual States/Territories will be phased with commencement once four jurisdictions have signed an agreement. Currently the Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participants in NMA and other jurisdictions may join in the future. Investigators, trial coordinators, sponsors and Contract Research Organisation (CROs) should check with the relevant Health websites as listed in the Fact Sheet to confirm the status of participation in National Mutual Acceptance.
- Enable Public Health Organisations of participating jurisdictions to accept a single ethical and scientific review of multi-centre clinical trials; and
- Inform the ongoing development of the national system of single ethical and scientific review of multi-centre research.
Under the National Mutual Acceptance agreement a multi-centre clinical trial will be reviewed for ethical and scientific merit once only. There will be exceptions in the case of First Time in Human (FTIH), Phase 0 and Phase 1 trials in Australian Capital Territory, Northern Territory and South Australia which will require review within that jurisdiction. Other exemptions apply in each jurisdiction.
Scope of clinical trial research
Interventional research involving a drug/device trial, radiation therapy, surgery, treatment or diagnostic procedure and studies associated with ongoing activities relating to trials that have been conducted. This may include observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.
This includes commercially sponsored, Collaborative Groups and Investigator Initiated clinical trial research.
Reviewing Human Research Ethics Committees (HREC)
The single ethical and scientific review of a multi-centre clinical trial is to be conducted by an appropriate NHMRC Certified HREC in a participating jurisdiction.
For more information please refer to the following documents:
- National Mutual Acceptance e-Bulletin (PDF)
- National Mutual Acceptance Fact Sheet (PDF)
- National Mutual Acceptance Brochure (PDF)
The National Mutual Acceptance (NMA) Working Group has proposed that system-generated electronic signatures are acceptable from systems such as Ethics Review Manager (ERM) or REGIS. These systems rely on, system-generated emails and correspondence which have user signature authentication i.e. users must log in with their username and password.
This policy position is to support researchers who are asked by Sponsors for “wet ink” signatures and have to explain that they are not required for submissions, approvals, etc. in ERM or REGIS. Ideally, we can streamline processes and reduce paper with this policy statement.
Some Queensland Health Research Offices no longer issue documents with wet ink signatures as they are working in a digital environment. In these instances, the email and attached documents are considered the approval.