What is NSW Health's system of single ethical and scientific review of multi-centre research and how does it work?
In 2007 a system of single ethical and scientific review of multi-centre research was implemented with the aim that every research project that takes place in the NSW public health system is ethically and scientifically reviewed once only. Lead HRECs are accredited to carry out a single ethical and scientific review of multi-centre research on behalf of all sites within the NSW public health system, thereby eliminating the need for multiple reviews.
Can investigators opt out of the system?
No. All multi-centre research projects that take place in the NSW public health system must be reviewed under the single ethical and scientific review system by a lead HREC.
Does the system apply outside of NSW Health?
No. The NSW Health system of single ethical and scientific review is provided only for the benefit of NSW Public Health Organisations.
Are there any exceptions to the single review principle?
Yes. The following types of research project have specific review requirements:
Research projects involving persons in custody or staff of NSW Justice Health
All human research projects involving persons in custody in NSW and/or staff of NSW Justice Health must be reviewed by the NSW Justice Health HREC.
Research projects specifically affecting the health and wellbeing of Aboriginal people and communities
Approval from the Aboriginal Health and Medical Research Council Ethics Committee is required where a research project involves research in, or concerning, NSW and any one of the following applies:
- The experience of Aboriginal people is an explicit focus of all or part of the research
- Data collection is explicitly directed at Aboriginal people
- Aboriginal peoples, as a group, are to be examined in the results
- The information has an impact on one or more Aboriginal communities or
- Aboriginal health funds are a source of funding.
Clinical trials requiring access to state-wide data collections
All human research projects requiring access (including linkage) to statewide data collections owned or managed by NSW Health or the Cancer Institute NSW must be reviewed by the NSW Population and Health Services Research Ethics Committee.
How does an HREC become a lead HREC?
HRECs must be nominated for accreditation by the NSW Public Health Organisation’s Chief Executive, with the support of the HREC Chair. Applications for accreditation are assessed against a set of accreditation standards by a selection panel. All HRECs that meet the accreditation standards are accredited as lead HRECs by the Secretary of NSW Ministry of Health.
Are there different types of lead HREC?
Yes. An HREC may be accredited as a lead HREC in one or both of the following categories:
- clinical trials/interventional clinical research; and
- general research (which includes epidemiological research, population health research, health services research, qualitative research, clinical research of a non-interventional nature and other general categories of research).
In addition, some HRECs operate in specialised therapeutic areas. For example, the Cancer Institute NSW Clinical Research Ethics Committee will review cancer related research only.
Which HRECs are lead HRECs?
Details of lead HRECs are maintained on the NSW Health website.
What happens to multi-centre research projects approved by a NSW Health HREC prior to implementation of the single ethical review system?
Research projects previously approved by a NSW Health HREC continue to operate in accordance with previous HREC arrangements. For example, amendment requests continue to require approval by each HREC which provided the original ethical approval.