FAQ: Mutual acceptance of ethical and scientific review of interstate multi-centre clinical trials
What is the Interstate Mutual Acceptance initiative? | Are there any exclusions from the Interstate Mutual Acceptance initiative? | Can clinical trials involving delayed consent or a waiver of consent be reviewed under the Interstate Mutual Acceptance initiative? | Are observational studies included in the Interstate Mutual Acceptance initiative? | Are paediatric clinical trials included in the Interstate Mutual Acceptance initiative? | Does the Interstate Mutual Acceptance initiative apply only to commercially sponsored trials? | Who is responsible for providing indemnity under the Interstate Mutual Acceptance initiative? | My clinical trial was approved by a participating certified Human Research Ethics Committee (HREC) in Queensland/Victoria prior to the Interstate Mutual Acceptance initiative commencing in NSW. I now want to add some NSW sites. Does the original approval cover the NSW sites as well? | Can an approval provided by a participating NSW Health Human Research Ethics Committee (HREC) prior to 1 February 2012 be used by sites in Queensland and Victoria? | Can NSW sites be added to a clinical trial approved as a single site study in Victoria? | Can private sites participate in clinical trials approved under the Interstate Mutual Acceptance initiative? | Which application form(s) should I complete? | Does the Victorian Specific Module need to be completed for all participating Victorian sites? | The Victorian Specific Module appears to require similar information to the NEAF. What is the purpose of completing this Module and who reviews it? | Where do I submit my application?What is the Interstate Mutual Acceptance initiative?
The NSW Ministry of Health and Queensland and Victorian Departments of Health have signed a Memorandum of Understanding to introduce mutual acceptance of ethical and scientific review of multi-centre clinical trials undertaken in Public Health Organisations across the three jurisdictions. 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 Interstate Mutual Acceptance initiative, each proposal for a multi-centre clinical trial conducted across the three participating jurisdictions will be ethically and scientifically reviewed once by a Public Health Organisation Human Research Ethics Committee that has been certified by the National Health and Medical Research Council (NHMRC) to review clinical trials.
For the purposes of the initiative, clinical trial is defined as:
‘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.’
Are there any exclusions from the Interstate Mutual Acceptance initiative?
Yes. The Memorandum of Understanding covers clinical trials only. Other types of research projects (including clinical research) are excluded from the initiative.
In addition, the following clinical trials are excluded from the initiative:
- Clinical trials involving persons in custody or staff of the jurisdictional Justice Health departments;
Within NSW, all human research projects involving persons in custody and/or staff of NSW Justice Health must be reviewed by the NSW Justice Health HREC. Investigators intending to submit applications relating to clinical trials involving persons in custody or staff of the jurisdictional Justice Health departments in Queensland or Victoria should check the requirements within those jurisdictions.
- Clinical trials specifically affecting the health and wellbeing of Aboriginal people and communities;
Within NSW, 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.
Investigators intending to submit applications relating to clinical trials affecting the health and wellbeing of Aboriginal people and communities in Queensland or Victoria should check the requirements within those jurisdictions.
- Clinical trials requiring access to statewide data collections;
Within NSW, 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. Investigators intending to submit applications relating to clinical trials involving access to statewide data collections in Queensland or Victoria should check the requirements within those jurisdictions.
- Clinical trials involving persons unable to provide consent; and
Within NSW, multi-centre clinical trials involving persons unable to provide consent should be reviewed by a HREC that is accredited as a lead HREC in the category of clinical trials/interventional clinical research.
Under the Guardianship Act 1987 (NSW), a person unable to consent may not participate in a clinical trial unless the trial has been approved by the Guardianship Tribunal. In reviewing such a trial, the Guardianship Tribunal will decide whether consent can be granted by the person responsible or should be granted by the Tribunal. The Guardianship Tribunal will not deal with an application for approval of a clinical trial until: it receives proof that the relevant ethics committees have approved the clinical trial; and all the centres conducting the clinical trial have provided the Tribunal with the patient information sheets and consent forms for the clinical trial. Further information is available from the Guardianship Tribunal.
Investigators intending to submit applications relating to clinical trials involving persons unable to provide consent in Queensland or Victoria should check the requirements within those jurisdictions.
- Clinical trials involving access to coronial material.
Within NSW, multi-centre clinical trials involving access to coronial material should be reviewed by a HREC that is accredited as a lead HREC in the category of clinical trials/interventional clinical research. Investigators intending to submit applications relating to clinical trials involving access to coronial material in Queensland or Victoria should check the requirements within those jurisdictions.
Can clinical trials involving delayed consent or a waiver of consent be reviewed under the Interstate Mutual Acceptance initiative?
No. Clinical trials involving delayed consent or a waiver of consent are excluded from the initiative as they fall within the exclusion category ‘Clinical trials involving persons unable to provide consent’.
Are observational studies included in the Interstate Mutual Acceptance initiative?
Yes. Observational studies related to clinical trials are included in the initiative.
Are paediatric clinical trials included in the Interstate Mutual Acceptance initiative?
Yes. The exclusion category ‘Clinical trials involving persons unable to provide consent’ relates to studies in which adults are unable to provide consent.
Does the Interstate Mutual Acceptance initiative apply only to commercially sponsored trials?
No. The initiative covers all clinical trials, including investigator-initiated and collaborative group sponsored trials, unless they fall into one of the exclusion categories.
Who is responsible for providing indemnity under the Interstate Mutual Acceptance initiative?
Each jurisdiction will ensure that it’s certified Human Research Ethics Committees (HRECs are indemnified for their decisions in reviewing multi-centre clinical trials. For commercially sponsored clinical trials, the sponsor will continue to provide indemnity to the certified HREC.
My clinical trial was approved by a participating certified Human Research Ethics Committee (HREC) in Queensland/Victoria prior to the Interstate Mutual Acceptance initiative commencing in NSW. I now want to add some NSW sites. Does the original approval cover the NSW sites as well?
No. The Memorandum of Understanding between the three jurisdictions does not apply to retrospective approvals. Public Health Organisations in NSW cannot accept approvals from certified HRECs in Queensland or Victoria prior to the initiative commencing in NSW on 1 February 2012.
For clinical trials reviewed by a certified HREC in Queensland or Victoria on or after 24 October 2011 and before 1 February 2012, investigators seeking to extend the trial to sites in NSW will need to submit a separate application for ethical and scientific review of the trial for the NSW sites. The application may be submitted to the original reviewing HREC or any other HREC participating in the Interstate Mutual Acceptance initiative.
Can an approval provided by a participating NSW Health Human Research Ethics Committee (HREC) prior to 1 February 2012 be used by sites in Queensland and Victoria?
No. The Memorandum of Understanding between the three jurisdictions does not apply to retrospective approvals. Public Health Organisations in Queensland and Victoria cannot accept approvals from participating NSW Health HRECs prior to the initiative commencing in NSW on 1 February 2012.
For clinical trials reviewed by a certified HREC in NSW prior to 1 February 2012, investigators seeking to extend the trial to sites in Queensland and/or Victoria will need to submit a separate application for ethical and scientific review of the trial for the Queensland and/or Victorian sites. The application may be submitted to the original reviewing HREC or any other HREC participating in the Interstate Mutual Acceptance initiative.
Can NSW sites be added to a clinical trial approved as a single site study in Victoria?
Yes. NSW sites can be added to clinical trials that qualify for inclusion in the Interstate Mutual Acceptance initiative and are currently approved as single-site studies in Victoria. Investigators seeking to add NSW sites to a study of this type should contact the reviewing Victorian HREC for advice. Further information is available from the Victorian Department of Health website at: http://docs.health.vic.gov.au/docs/doc/Retrospective-entry-to-streamlined-system.
Can private sites participate in clinical trials approved under the Interstate Mutual Acceptance initiative?
Private sites can be included as accepting sites under the initiative, in accordance with the practice of each jurisdiction.
In order to accept the ethical review decision of a NSW Health certified HREC, a private organisation must enter into a Memorandum of Understanding with the NSW Public Health Organisation hosting that HREC, in accordance with Policy Directive PD2008_046 Human Research Ethics Committees: Ethical Review for External Entities.
Investigators from private sites wishing to submit to a Queensland/Victorian HREC should contact the relevant jurisdiction for advice. More information is contained within the document HREC RGO and Organisations Jan 2012.
Which application form(s) should I complete?
Applications for ethical and scientific review must be submitted on a National Ethics Application Form (NEAF), which must be completed using the Online Forms website.
For clinical trials that involve one or more sites located in Victoria, the Victorian Specific Module must also be completed. This is the case, even if the reviewing HREC is located within NSW or Queensland.
In addition, all applications must be accompanied by a completed Research Project Ethics Checklist.
Does the Victorian Specific Module need to be completed for all participating Victorian sites?
No. Only one Victorian Specific Module needs to be completed. However, if the study involves using ionising radiation, then Section 4: Use of Ionising Radiation must be completed for each Victorian site. This is necessary as radiation dose measurements will differ at each site for the same treatment due to radiation machines delivering different doses.
The Victorian Specific Module appears to require similar information to the NEAF. What is the purpose of completing this Module and who reviews it?
The Victorian Specific Module addresses Victorian legislative requirements regarding research on humans that are not specifically addressed in the NEAF. The HREC must review the Module.
Where do I submit my application?
Only Human Research Ethics Committees (HRECs) certified by the National Health and Medical Research Council (NHMRC) to review clinical trials will accept applications for ethical and scientific review of clinical trials under the Interstate Mutual Acceptance initiative. Details of participating certified HRECs can be accessed at:
The submission process depends on the jurisdiction to which the application is being submitted:
- In NSW, selection of the certified HREC is at the discretion of the applicant;
- In Queensland, applications are allocated by the Central Coordinating Service; and
- In Victoria applications are allocated by the Central Allocation System.