Research Ethics, Governance & Integrity (REGI) Unit

Important Updates 

  • New Barwon Health Research Reference Number Generator: The REGI Unit has implemented a new system for generating reference numbers for Barwon Health research projects. The old system will no longer be accessible via Improvement Activity Support. The Generator is based on the REDCap platform and can be accessed by both internal and external researchers. In order to streamline applications, additional questions relevant to each research project have been added to the online form. Follow this link to access the Barwon Health Research Reference Number Generator (please open with Google Chrome).
  • New Guidance for Safety Monitoring and Reporting in Clinical Trials: The NHMRC has issued new guidance on safety monitoring and reporting in clinical trials. This guidance will replace the existing 2009 Australian Human Ethics Committee Position Statement: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods. The new guidance reflects international best practice and was developed with input from researchers, human research ethics committees, the State and Territory jurisdictions and industry.
  • Launch of National Scientific Committees Pilot: The NHMRC, with the assistance of Bellberry Limited, has established two National Scientific Committees as part of a pilot project to provide expert advice to investigators and HRECs on complex genetic studies and clinical trials involving medical devices. The National Scientific Committees will provide a scientific opinion on research proposals as requested by HRECs or investigators (researchers or trial sponsors). While NHMRC supervised the development of the Committees and the appointment of members; the not-for-profit, private ethics review organisation Bellberry Limited, will undertake the day-to-day management. Bellberry Limited already hosts a number of HRECs. Sponsors and researchers can now request a review of their proposal online and this service is at no cost to users. Further information on the pilot program is now available.
  • Authorship: The Research Directorate strongly recommends that research teams discuss, negotiate and document authorship from the beginning, and throughout a project. The REGI Unit provides and encourages the use of an Authorship Record Form Template to document proposed authorship - this form can be lodged with the REGI Unit. The following guidelines are useful in determining warrant for authorship and acknowledgements:

Guidelines on Collaborative Research Authorship (found on the Guidelines and advice webpage)

The International Committees Medical Journal Editors (ICMJ) Guidelines

  • Submission via Online Forms: The REGI Unit is required by the Department of Health to process all governance applications via AuRED, which is linked to Online Forms. To fulfil our obligations, REGI requires that all Streamlined Ethical Review Process (SERP) projects be submitted for BH governance review via Online Forms e-submissions. Please call the REGI Unit or Online Forms Helpdesk for assistance with e-submissions and Online Forms. New SERP applications for governance review that are received via email cannot be processed.
  • Document Naming: In keeping with centralised document conventions and best practice guidelines, and to assist with a timely review of applications, the REGI Unit requires all documents to be named according to the Document Naming Guidelines found on the Guidelines and advice webpage - documents not named according to these guidelines will be sent back to the sender for re-naming and re-submission.

Welcome to the home page of the Barwon Health Research Ethics, Governance & Integrity (REGI) Unit.

Barwon Health has a vibrant research culture and enviable track record in research achievements. This research activity is supported by the REGI Unit, located in Kitchener House. The REGI Unit is an organisational unit of the Research Directorate and manages the many aspects of research compliance, research ethics applications and review processes.

The REGI team has a strong background in research ethics and management and can provide support and advice on research design, data management and analysis, and ethics applications. They also offer training for less experienced researchers.

All Barwon Health staff and associates interested in research are encouraged to drop in to meet the REGI team and get some tips for negotiating research ethics and governance.

The REGI Unit's role is to ensure that:

  • Barwon Health achieves research excellence and maintains the highest standards of research integrity and research conduct
  • Barwon Health research complies with national and international research ethics and governance guidelines and laws and exemplifies best practice

The REGI Unit works to achieve these aims by:

  • Providing support, advice and training to experienced and novice researchers on research design, data management and analysis, ethics applications and research dissemination
  • Providing support for research oversight to regional partners and collaborators
  • Coordinating all aspects of research oversight and compliance for research carried out under the auspices of Barwon Health
  • Coordinating and convening the Barwon Health Human Research Ethics Committee (HREC) and its associated sub-committee, the Research Review Committee
  • Reviewing and managing insurance, indemnity and contract documentation associated with clinical trials
  • Coordinating the Barwon Health Research Week activities
  • Producing the Research Report for the Barwon Health annual report
  • Producing the quarterly Barwon Health Research Newsletter

All correspondence and enquiries for REGI , RGO, and HREC, should be forwarded to REGI@barwonhealth.org.au.

 

Traditional Owners

We, Barwon Health, acknowledge the Traditional Owners of the land, the Wadawurrung people of the Kulin Nation. We pay our respects to the Elders both past and present.