Overview and introduction
The NSW Ministry of Health in conjunction with the corresponding government health agencies in Queensland, South Australia, Australian Capital Territory (ACT) and Victoria (the ‘participating jurisdictions’) agreed to implement a scheme of National Mutual Acceptance (NMA) of single ethical review of multi-centre clinical trials conducted in each participating jurisdiction’s public health organisations.
In December 2015, the scope of NMA was expanded beyond clinical trials to all human research. Under the expansion, researchers and sponsors proposing to conduct a human research project at Public Health Organisation (PHO) sites in more than one participating jurisdiction may submit the study to one Certified Reviewing Human Research Ethics Committee (HREC). These HRECs have been certified by the National Health and Medical Research Council (NHMRC). Under NMA, participating organisations in the participating states and territories will then accept the scientific and ethical review of those Certified Reviewing HRECs.
The aim of this initiative is to reduce duplication of ethical and scientific review and to inform the development of a national system of single ethical review.
Under the mutual acceptance initiative, each proposal for a multi-centre study (using a NEAF) conducted across the participating states will be ethically and scientifically reviewed once by a Public Health Organisation Human Research Ethics Committee (HREC) that has been certified by the National Health and Medical Research Council (NHMRC) to review clinical trials.
Public Health Organisations will continue to undertake a site-specific assessment (SSA) of all research projects that are to be conducted at institutions under their control, in compliance with the relevant jurisdictional standard operating procedures. A separate SSA application must be made for each site at which the research project is to be conducted.
Effective 23rd April 2013 the National Health and Medical Research Council (NHMRC) has granted certification of single ethical review for multi-centre research to South Western Sydney Local Health District Human Research Ethics Committee.
Currently, New South Wales, Queensland, South Australia, Victoria, Australian Capital Territory and Western Australia participate in NMA. For contact details, please visit the following website: http://www.health.nsw.gov.au/ethics/Documents/nma-contact-info.pdf
For information on types of human research projects excluded from single ethical and scientific review under NMA please download the National Mutual Acceptance Factsheet.
Information for Investigators
The National Mutual Acceptance Factsheet and National Mutual Acceptance Brochure are intended to provide information in an easy-to-use format for research offices to distribute to their research communities.
NMA and REGIS
Please follow the Quick Reference Guide for REGIS to ensure you are able to complete a SSA on REGIS for a project with lead HREC approval outside of NSW - https://regis.health.nsw.gov.au/media/1333/qrg-resapp-nma-guide-v1.pdf