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FAQ: Multi-centre research (general)
FAQ: Multi-centre research (general)
What is NSW Health’s system of single ethical and scientific review of multi-centre research and how does it work?Can researchers opt out of the system?Does the system apply outside of NSW Health?Are there any exceptions to the single review principle?How does a HREC become a lead HREC?Are there different types of lead HREC?Which HRECs are lead HRECs?Can I submit my research project to any lead HREC?Will a lead HREC automatically accept a multi-centre research application?Can a multi-centre research application be submitted to more than one lead HREC?Can an application be withdrawn from one lead HREC and submitted to another?Is there an appeal mechanism if the lead HREC does not approve the application?What is the 60-day clock and what are the consequences if this is exceeded?What happens to multi-centre research projects approved by a NSW Health HREC prior to implementation of the single ethical review system?Will the single ethical review system be evaluated?
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 conducted within the NSW public health system is scientifically and ethically reviewed once only. Lead HRECs are accredited to conduct a single ethical and scientific review of multi-centre research on behalf of all sites within the NSW public health system at which a research project is to be conducted, thereby eliminating the need for each local HREC to conduct its own review. Public health organisations retain responsibility for authorising the commencement of research within their institutions. As such, public health organisations are required to undertake a site-specific assessment of each research project, thereby allowing the organisation to consider whether it has the capacity to conduct the research at that site. This site-specific assessment considers such matters as staff, resources and patient availability. The site-specific assessment and ethical review may occur in parallel, however the decision to authorise or not authorise the conduct of a research project is only made by the public health organisation when the lead HREC has granted approval and the site-specific assessment has been satisfactorily completed.
Can researchers opt out of the system?
No. All multi-centre research projects conducted within the NSW public health system must be reviewed under the single ethical review system by a lead HREC.
Does the system apply outside of NSW Health?
No. The single ethical review system is provided only for the benefit of public health organisations within the NSW public health system.
Are there any exceptions to the single review principle?
Yes.
- Research projects involving persons in custody in NSW must be submitted to the HREC of NSW Justice Health, even if the project has been reviewed by a lead HREC.
- Research projects coming within section 6.4 of the NSW Aboriginal Health Information Guidelines (currently under review) must be considered for review by the HREC of the Aboriginal Health and Medical Research Council, even if the project has been reviewed by a lead HREC.
- Research projects requiring access to statewide data collections owned or managed by NSW Health must be reviewed by the NSW Population & Health Services Research Ethics Committee (a HREC jointly convened by NSW Department of Health and the Cancer Institute NSW). This HREC is a lead HREC so although research projects must be reviewed by this committee, further review by another lead HREC is not required.
How does a HREC become a lead HREC?
HRECs must be nominated for accreditation by the 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 convened by the Chief Health Officer of NSW. All HRECs that meet the accreditation standards are accredited as lead HRECs. The accreditation standards can be accessed at:
Are there different types of lead HREC?
Yes. A 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, a few HRECs operate in specialised therapeutic areas. For example, the Cancer Institute NSW Clinical Research Ethics Committee will accept cancer related research only.
Which HRECs are lead HRECs?
Details of lead HRECs are maintained on the NSW Department of Health website and can be accessed at:
Can I submit my research project to any lead HREC?
Applications can be submitted to any NSW Health lead HREC, provided that the HREC is accredited in the research area of the project. For example, clinical trials must be submitted to a lead HREC accredited in clinical trials/interventional clinical research. In addition, If the lead HREC operates within a specialised therapeutic area, only research in that therapeutic area may be lodged with that HREC. Where possible, the application should be submitted to a lead HREC associated with one or more of the sites at which the research is to be conducted.
Will a lead HREC automatically accept a multi-centre research application?
HRECs can cap the number of multi-centre research protocols they review at each meeting. If your application arrives after the cap for the next meeting has been met, the HREC will inform you that your application can be held over to the following meeting, or that you can apply to another lead HREC. Lead HRECs may also decline to accept a multi-centre application if they are not accredited to review multi-centre research proposals in a particular area of research. For example, a lead HREC accredited to review general research only, may not review multi-centre research applications for clinical trials. In addition, any HREC within NSW Health can advise an investigator that it does not have the appropriate expertise to review a particular project and suggest another, more appropriate HREC. Co-ordinating investigators are therefore encouraged to contact the Executive Officer of the lead HREC before submitting an application.
Can a multi-centre research application be submitted to more than one lead HREC?
No.
Can an application be withdrawn from one lead HREC and submitted to another?
Only where there are extenuating circumstances (for example, if the original lead HREC has reached its meeting capacity for the review of multi-centre applications). Where an application is re-submitted to a different lead HREC, all documentation associated with the initial ethical review must be provided to accompany the re-submission. HRECs can identify whether a project has been withdrawn from another lead HREC, and will consider an application for a re-submitted project to be incomplete unless this previous documentation is provided.
Is there an appeal mechanism if the lead HREC does not approve the application?
Yes. All lead HRECs have a documented complaints procedure, which can be followed if a research project is rejected. In the event that the matter is not resolved through the complaints procedure, the Department will co-ordinate an appeal panel. The appeal panel will hear arguments from both sides, and remit the application back to the lead HREC with recommendations. However, the appeal panel cannot substitute its decision for that of the lead HREC. Once the lead HREC has re-considered the matter after the appeal panel process, their decision will be final. The project may not be submitted to another lead HREC for a second opinion.
What is the 60-day clock and what are the consequences if this is exceeded?
The 60-day clock is a quality assurance mechanism. Lead HRECs are expected to be able to give a final ethical opinion within 60 calendar days of the closing date for the meeting at which the project is first considered. The 60-day period excludes any time in which the HREC is awaiting further information from the co-ordinating investigator. Progress in meeting the 60-day clock is tracked through the Australian Research Ethics Database (AU RED). The purpose of the 60-day clock is to allow lead HRECs and the Department to monitor a committee's efficiency and timeliness in processing HREC applications. If a lead HREC consistently fails to meet the 60-day time frame, this will be considered as part of their ongoing accreditation. In respect to individual applications, there are no consequences if the 60-day period is exceeded. An investigator cannot assume or demand an approval after the 60 days has expired.
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 original ethical approval. Where the research project is to be extended to an additional site, an ethics application may be submitted to the HREC associated with the site or to a lead HREC. Where the research project is to be extended to more than one additional site, an ethics application must be submitted to a lead HREC.
Will the single ethical review system be evaluated?
Yes. A formal evaluation of the system by an independent consultant will commence in early 2009.
Where can I get more information/advice?
Detailed information about the single ethical review system is available in the NSW Health policy 'Research - Model for Single Ethical & Scientific Review of Multi-Centre Research', which can be accessed at:
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