Institutions with certified ethical review processes

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1 Harmonisation of Multi-Centre Ethical Review The objective of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative is to enable the recognition of a single ethical and scientific review of multi-centre health and medical research within and/or across Australian jurisdictions. Welcome to the fifteenth, Special Edition HoMER newsletter. With the festive season upon us, the HoMER team is pleased to announce the institutions whose ethical review processes have been certified under the HoMER initiative. We would also like to thank everyone who has assisted and contributed to the HoMER initiative in 2010 and to let you know of some HoMER Christmas reading, in the form of a Research Governance Discussion paper, now available online. Happy Holidays! #15, Special Edition December 2010 Special Edition Institutions Certified under the HoMER Initiative Institutions with certified ethical review processes As part of Harmonisation of Multicentre Ethical Review (HoMER) project, the ethical review processes of institutions are being certified in a phased approach, to ensure that they can facilitate single ethical review and that they meet the requirements of the National Statement on Ethical Conduct in Human Research (2007). NHMRC is currently finalising the first phase of certification under the HoMER project and has assessed and certified the ethical review processes of the institutions listed below. The register, including detail of the certified categories of institutions, is available on the NHMRC website at: ethics/homer/index.htm Prior to submitting a research application to any of these institutions, please contact the relevant institution regarding their readiness to conduct single ethical review of multi-centre research studies and the processes to be followed. These will vary at both institutional and jurisdictional levels. Researchers are reminded that ethical approval does not constitute site authorisation to conduct the research. Final authorisation is undertaken through a jurisdiction or institution s research governance process. Advice received from an HREC undertaking single ethical review will not replace the need for local decision-making on matters of research governance. Final authorisation will occur through institutional or jurisdictional research governance processes. Please note that for all public health services within Queensland, submission of all multi-centre studies for ethical review must be submitted via the state allocation system, and for all public health services within Victoria, applications for ethical review of multi-centre clinical trials must be submitted via the Central Allocation System (CAS). The processes of the following institutions have been certified: New South Wales The Cancer Council NSW The Cancer Council NSW Human Cancer Institute NSW Cancer Institute NSW Clinical Cancer Institute NSW Population and Health Services Research HoMER NEWSLETTER SPECIAL EDITION DECEMBER

2 Charles Sturt University Charles Sturt University Ethics in Human Research Committee The Children s Hospital at Westmead The Royal Alexandra Hospital for Children Human Hunter New England Area Health Service Hunter New England Human Research South Eastern Sydney Illawarra Area Health Service South Eastern Sydney Illawarra Area Health Service Northern Hospital Network Human St Vincent s Hospital Sydney Ltd St Vincent s Hospital Human Research Sydney South West Area Health Service Royal Prince Alfred Hospital Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone) University of New South Wales University of New South Wales Committee A University of New South Wales Committee B University of Wollongong and South Eastern Sydney Illawarra Area Health Service University of Wollongong and South Eastern Sydney Illawarra Area Health Service Medical Human Northern Territory Northern Territory Department of Health and Families and Menzies School of Health Research Human of Northern Territory Department of Health and Families and Menzies School of Health Research Queensland* Children s Health Services District, Royal Children s Hospital, Brisbane Children s Health Services District Human Research Toowoomba and Darling Downs Health Services District Toowoomba and Darling Downs Health Services District Human Gold Coast Health Service Gold Coast Health Service District Human Prince Charles Hospital, Metro North Health Service District The Prince Charles Hospital Human Research Metro South Health Service District Metro South Health Service District Human Queensland Health Office of Health and Medical Research Queensland Health Office of Health and Medical Research Human Queensland Institute of Medical Research Queensland Institute of Medical Research Human Royal Brisbane and Women s Hospital Health Service District Royal Brisbane and Women s Hospital Human Townsville Health Service District The Townsville Health Service District Institutional * For all public health services within Queensland submission of all multi-centre studies for ethical review must be submitted via the Queensland Health Central Coordinating Service. South Australia Bellberry Limited Bellberry Limited Human A Bellberry Limited Human B Bellberry Limited Human C HoMER NEWSLETTER SPECIAL EDITION DECEMBER

3 Victoria** Austin Health Austin Health Human Cabrini Hospital Cabrini Human Melbourne Health Melbourne Health Human Royal Children s Hospital Royal Children s Hospital Human Research Ethics Committee Southern Health Southern Health Human A Southern Health Human B ** For all public health services within Victoria applications for ethical review of multi-centre clinical trials must be submitted via the Central Allocation System (CAS). Western Australia Fremantle Hospital and Health Service South Metropolitan Area Health Service Human Sir Charles Gairdner Group Sir Charles Gairdner Group Human Research St John of God Hospital Group St John of God Health Care Additional institutions are also in the process of obtaining certification and will be added to the list as they are confirmed Certification Rounds Schedule Institutions interested in nominating for certification under the HoMER initiative may submit completed nomination forms in either of the two certification assessment rounds commencing in 2011 January round Nominations for this round will be accepted from Monday 3 January to Friday 18 February Assessment visits for this round will be conducted from Monday 21 February to Friday 24 June July round Nominations for this round will be accepted from Monday 4 July to Friday 19 August Assessment visits for this round will be conducted from Monday 22 August to Friday 25 November How to apply To apply for certification please download the nomination documents (go to ethics/homer/certification_scheme_handbook.php) and your completed self assessment, nomination form, declaration form and checklist, along with mandatory supporting documentation, to homer@nhmrc.gov.au with HoMER Certification Nomination in the subject line. Please note: Currently NHMRC and the Indigenous Research subgroup are developing a framework for Harmonisation of Multi-centre Ethical Review for the category of Aboriginal and Torres Strait Islander Peoples health research. Until the framework is finalised NHMRC will not be certifying institutions in this category. Further consideration of nominations in this category will be considered at a future date. HoMER NEWSLETTER SPECIAL EDITION DECEMBER

4 Institutions interested in accepting single ethical review of multicentre research The Australian Health Ministers Advisory Council (AHMAC) requested in 2006 that the National Health and Medical Research Council (NHMRC) facilitate the development and implementation of a national system where the single ethical review of a Human Research (HREC) would be recognised by institutions participating in a collaborative research project across Australian jurisdictions. As part of the Harmonisation of Multi-centre Ethical Research (HoMER) initiative, a number of institutions nationwide have had their processes for single ethical review certified and a phased implementation of the HoMER tools is planned for By having a single ethical review outcome accepted by collaborating institutions, protection of human participants will be maintained while delays due to the practice of seeking multiple ethical reviews will be mitigated and timelines for research start-up and results shortened. NHMRC is now seeking formal notification from institutions that are willing to consider the acceptance of the outcome of a single ethical review that is carried out by one of the certified HRECs. A list of institutions with certified processes, and a list of institutions willing to accept single ethical review, will be published on the NHMRC website and on the HoMER web portal once it is established. The NHMRC recognises that many factors will impact upon the acceptance of a single ethical review and the development of this list is not intended to define such acceptance at this time but instead will serve to assist in ongoing development of meeting the requirements of accepting institutions. If your institution is agreeable to consider accepting the outcome of reviews conducted by certified HRECs, a form can be found on the NHMRC at: au/health_ethics/homer/homer_news.htm. Research Governance Release of the HoMER Standardised Forms The documents have been approved through the Standardisation of Forms (SoF) Subgroup and HoMER Reference Group and were publicly released on 15 December 2010 on the NHMRC website: nhmrc.gov.au/health_ethics/homer/homer_tools.htm. The participant information and consent forms (PICFs) and HREC template letters went to public consultation from 28 May to 2 July this year. They also went to the Australian Health (AHEC) for feedback and received advice from the Human Genetics Advisory Committee Secretariat. The HoMER team again expresses their sincere thanks to the SoF subgroup members for their contribution in the development of these important guidance documents. HoMER in the New Year HoMER activities scheduled and anticipated in 2011 include: January Initial meeting of the Education Subgroup to address needs of stakeholders under the HoMER initiative. Jurisdictional Subgroup teleconference to discuss implementation planning. Indigenous Subgroup Teleconference to progress the development of the Indigenous Framework required under certification. Monitoring Subgroup Teleconference to progress a guidance document toward public consultation. More information on the progress of these groups will be available in our first newsletter in the New Year. The discussion paper Understanding Research Governance of Multi-centre Human Research, 2010 was released for public consultation on Monday 13 December 2010, and can be found at: homer/homer_consult.htm. The public consultation will close on 25 February HoMER NEWSLETTER SPECIAL EDITION DECEMBER

5 Merry Christmas We would like to take this opportunity to thank all of our stakeholders for the continuing tireless efforts throughout the year. Your valuable assistance has helped us to achieve some significant milestones. On behalf of the Research Integrity team we would like to wish everyone a very happy holiday season and a safe and prosperous new year. Further information If you would like to receive further updates about the national approach for single ethical review, please send your contact details to: homer@nhmrc.gov.au or contact: Research Integrity Section NHMRC GPO Box 1421 Canberra ACT 2601 T: (02) , F: (02) Further information on the HoMER project can be found at: gov.au/health_ethics/homer/index.htm HoMER NEWSLETTER SPECIAL EDITION DECEMBER