The Royal Childrens Hospital (RCH) supports and encourages research, quality improvement & clinical audit activities involving children. All research conducted on the RCH campus must be approved by the RCH Human Research Ethics Committee (HREC) before it can commence.
The RCH HREC is constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007).
The RCH HRECs primary objectives are:
The RCH Ethics and Research Department is responsible for managing and facilitating the ethical review process for the campus. This involves co-ordinating scientific & ethical review of research. In addition, the department is responsible for research monitoring, research management including meeting legislative and regulatory requirements, policy development, the provision of researcher support and advice, and risk management.
The Royal Children's Hospital Campus combines research, education and clinical services to provide world-class healthcare to children. The Campus partners comprise The Royal Children's Hospital, the Murdoch Childrens Research Institute, The University of Melbourne Department of Paediatrics and The Royal Children's Hospital Foundation, the fundraising arm of the hospital. The Campus Research & Education website showcases some examples of the activities conducted on The Royal Children's Hospital Campus that highlight the strength of integrating research, patient interaction and training of hospital staff and the wider community to improve the treatment and care of children in hospital and beyond. These highlights are presented by the Campus Council, the Campus Research Committee and the Campus Education Committee to coincide with Campus Research and Education Week 2012.
Research Development & Ethics have developed some new guidelines and a documentation checklist to assist you with Site Specific Assessment (SSA) applications for multisite research via the streamlined ethical review process (SERP). SERP is the Victorian Government initiative to enable single ethics review of multi-site clinical trials applications. The aim of SERP is to provide a faster, more efficient process to conduct clinical trials at multiple sites.
When the RCH Campus is an "Accepting Site" rather than the "Reviewing Site" (or "Reviewing HREC") under the SERP process then researchers must seek governance approval from the Research Development and Ethics Office prior to commencement of a study. If you have any queries please see Site Specific Assessment Applications or contact Research Development and Ethics on (03) 9345 5044 or firstname.lastname@example.org
Research Development & Ethics recognize that for Low & Negligible Risk Research there are many questions in the NEAF & Victorian Specific Module (VSM) which are unnecessary and repetitive if the researchers have a well written and detailed protocol. As such, a new Low & Negligible Risk (LNR) Short Application Formhas been developed which is in effect an extension of the current application coversheet and includes the necessary questions from the NEAF and VSM. For all Low & Negligible Risk research, researchers can now complete this one short form (instead of the NEAF, VSM and Site Specific Assessment (SSA)Form) and submit to Research Development & Ethics office with a detailed Protocol attached. For greater-than-low risk research which requires review by the full HREC, the NEAF, VSM and SSA are still a necessary part of the review process. The Short Application Form: Negligible Risk Research & Clinical Audit will not be accepted after 1st September 2012; the new LNR form must be used.
Research Development & Ethics has an electronic review and approval process. ALL submissions must be made in electronic format to email@example.com; however in some cases 1 hard copy is still required for original signatures. The RDE website has been updated with this new information and it is essential you continue to use the most recent forms and instructions directly from the website. When submitting your electronic documents please ensure the files are named correctly, more information on document naming here.
In order to keep campus researchers up to date with the latest changes in multicentre ethical review, research policies & procedures, opportunities for research development & training and other relevant campus human research news, the new Research Development & Ethics office have started a quarterly newsletter.
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Telephone +61 3 9345 5522
50 Flemington Road Parkville
Victoria 3052 Australia