HoMER newsletter…
HaRMonisation of Multi-CEntRE EtHiCal REviEw
T
he objective of the Harmonisation of
no. 6 July 2009
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.
Current happenings
Progress of state and territory systems
States and Territories are continuing to develop and implement streamlined ethical review and have provided the following update on their activities: New South Wales – Training for researchers on NEAF and site specific assessment in NSW is being developed with the aim of improving the quality of applications and turnaround times for approvals. The training will require participants to complete on-line learning modules, a case study and attend a face to face session. An evaluation of the NSW single ethical review system has been conducted. The evaluation report (due early August) will form the basis for ongoing development of the system in NSW. Queensland – Has fully implemented their AU-RED system as a tool for tracking ethical reviews carried out by Queensland Human Research Ethics Committees (HRECs). Queensland now has a database of more than 10,000 records of multi-centre and single centre research projects.
Professor Colin Thompson will conduct a workshop for HREC members in August 2009. Regular Queensland Health meetings continue with stakeholder network groups (HREC Chairs, HREC Coordinators, Research Governance Officers and the clinical trial coordinator network groups). South Australia – Is developing a proposal for a state based pilot program of single ethical review involving cancer clinical trials. Western Australia – The Department of Health Western Australia facilitates gatherings of WA HREC Chairs and representatives on a regular basis. The following topics were discussed at the last forum held on 4 June 2009 in relation to HoMER:
• HoMER consultation document • accreditation consultation document • subgroup membership • specific state legislation and administrative requirements.
welcome to the sixth HoMER newsletter. in this issue we report on the progress of states and territories towards streamlining the ethical review of multi-centre research. we also discuss the progress of our public consultation initiatives and current HoMER subgroup activities.
HREC representatives were encouraged to participate in HoMER via consultation documents, subgroup memberships and surveys. Australian Capital Territory – Currently establishing a central research governance office within ACT Health.
HoMER newsletter…
Victoria – Is continuing to progress streamlining of ethics review, with staff of the new Coordinating Office for Human Research Ethics to commence on 6 July 2009. Northern Territory – Finalising research portfolio arrangements within the Northern Territory Department of Health and Families. and insurance matters within multi-centre research proposals using a single ethical review. Once finalised, the FAQs sheet will be available on the NHMRC website and jurisdictional websites to provide guidance to institutions participating in the national approach.
Upcoming activities
Jurisdictional Group
The Jurisdictional Group will meet in Sydney on 22 July 2009 to discuss the model for the national approach to single ethical review of multi-centre research that will be presented to the Australian Health Ministers’ Advisory Council later this year.
Activities since our last newsletter
accreditation subgroup
The consultation on the proposed national accreditation scheme closed 5 June 2009. The Accreditation subgroup met three times to consider the feedback of 50 stakeholders. The recommendations of the Accreditation subgroup on the structure and operation of the proposed scheme are being given further consideration by the HoMER Reference Group and the HoMER Jurisdictional Group.
standardisation of forms subgroup
The HoMER Standardisation of Forms subgroup has agreed on the list of forms that will benefit from standardisation under single ethical review. A draft consent form for research participants as well as a draft participant information sheet is currently being developed.
atsi subgroup
An Aboriginal and Torres Strait Islander Peoples Research subgroup met in early July. The subgroup will assist the NHMRC in addressing the impact of national single ethical review on current institutional and jurisdictional arrangements for ethical review of multi-centre research involving Aboriginal and Torres Strait Islander Peoples.
Research Governance subgroup
The HoMER Research Governance subgroup has met twice. The subgroup will help to develop guidance for stakeholders participating in multi-centre research.
Further information
The development of a national approach to single ethical review will impact the ethical and scientific review of multi-centre health research across Australia. If you would like to register interest in receiving further updates, send your contact details to homer@ nhmrc.gov.au or contact: Research Integrity Section NHMRC GPO Box 1421 Canberra ACT 2601 T: (02) 6217 9213 F: (02) 6217 9035 Further information on the HoMER project may be found at: http://www.nhmrc.gov.au/health_ ethics/homer/index.htm
survey of multi-centre review approaches by HRECs
NHMRC registered HRECs have been invited to participate in a survey seeking information on their experience with the ethical review of multi-centre health and medical research. The closing date for the survey is Monday 13 July 2009.
Monitoring subgroup
The HoMER Monitoring subgroup is discussing ‘monitoring’ in single ethical review of multicentre research and how to ensure that the requirements of the National Statement on Ethical Conduct in Human Research and The Australian Code for the Responsible Conduct of Research are integrated into proposed guidance materials.
indemnity and insurance subgroup
The HoMER Indemnity and Insurance subgroup is developing a FAQs sheet related to indemnity