RDU is here to help. If you are not sure where to start or have a question regarding your research project, email us at rdu@barwonhealth.org.au and a member of the RDU team will get back to you within 24 hours.
Complaints
If you have any complaints about any aspect of the project or the way it is being conducted please contact;
Consumer Liaison Officer
P.O. Box 281
University Hospital Geelong
Bellerine Street
Geelong VIC 3220
(03) 4215 1251
Consumer.LiaisonOfficer@barwonhealth.org.au
Quick links
- Research Policy
- Research Governance Framework
- Research Handbook
- Conflict of Interest in Research
- Research Related Complaints Procedure
- Investigation and management of Breaches of the Australian Code Procedure
- Clinical Trial Sponsorship Procedure
- Research Governance and Site Specific Assessment Process and Practice
- Research Safety Monitoring, Reporting and Management Procedure
The application process that meets your needs will vary depending on the level of risk and the sites involved in your research. Please visit the How to Prepare an Application page for an overview and to be guided through each step.
RDU recommends talking to your Manager and Head of Department early about your intended research project. This ensures any concerns they may have can be ironed out, and that you have their support when it comes to ethics and governance application time.
Barwon Health strongly encourages consumer involvement in research to ensure the research we conduct is responsive to the dynamic healthcare needs of our regional community, and is directly translated into improved outcomes for the community.
As outlined in the NHRMC Statement on Consumer and Community Involvement in Health and Medical Research (2016), meaningful consumer involvement in research provides significant benefits:
Benefits to the public include:
- Research being conducted that is relevant to community needs
- public awareness of, and support for, science and research, and
- more effective translation of research to deliver improved health outcomes.
Benefits to researchers and research institutions include:
- increased community relevance, through improved research priorities and projects informed by consumer and community perspectives and lived experiences
- public confidence in research through improved openness and transparency in the conduct of research
- public confidence in research through improved accountability and openness over the use of public money
- communities being better informed and having a greater understanding of research, and
- increased opportunities to continuously improve the quality of research.
While the importance of involving consumers in research is clear, it can be a difficult task for researchers to put into practice.
For tips and suggestions from Barwon Health for how to involve consumers in the design, execution and analysis of your research, click here.
Other resources include:
- The White Coats Foundation aims to raise awareness about the role of clinical trials in advancing medical science and healthcare. Click here to find out more or watch a video about Consumer led research here.
- If you are interested in the development of research and clinical trials as a clinical trial consumer, please click here to find out more.
- If you are interested in finding out about Consumer Advisors at Barwon Health, please click here to find out more.
- The Community and Research Network (CARN) is a network of health professionals, health consumers and researchers, seeking to share their expertise and experience to promote good health and wellbeing for the community of Geelong. Click here to find out more.
- The International Association for Public Participation (IAP2) promotes the values and leading practices associated with involving the public in decisions that impact their lives. Click here to find out more.
- The Health Consumers Centre is the peak health consumer body in Victoria based within the Institute for Health Transformation at Deakin University (formerly the Health Issues Centre). Click here to find out more.
All external researchers and students who are not current Barwon Health staff, wanting to be involved in a research project at Barwon Health, must complete one of the following 3 forms which are all available in our Library of Forms.
Please use the following document to determine which form to complete: Visiting Researcher – External Researcher Credentialing Process Overview.
Once you have determined which form is relevant to your needs, download and complete the appropriate form:
- Visiting Researcher – General Application Form
- Visiting Researcher – Student Induction Protocol & Placement Form for BH
- Visiting Researcher – Scientist Credentialing Application Form
Once completed, these forms should be uploaded to ERM under the specific project/s they will be working on or email directly to RDU@barwonhealth.org.au.
The external researcher or student should not work on the project until receiving acknowledgment by either the Barwon Health Human Research Ethics Committee (HREC) or the Research Governance Officer (RGO) at Barwon Health.
Any questions about this process please contact rdu@barwonhealth.org.au
Quick links
- Handling Complaints in Research
- Managing Conflicts of Interest
- Data Storage and Archiving
- Access to Health Records for Research Audit and Monitoring purposes
- Collaborative Research and Authorship
- Determining Co-Authorship for Biostatisticians
- Research Data and Records Management Policy
- Roles and Responsibilities in a Research Project
Quick links
- Research Involving Ionising Radiation
- Research Involving Radiation Exposure of Human Volunteers
- Barwon Health Radiation Management Plan
- HREC Radiation Notification Letter
- Medical Physics Risk Assessment Form
To find out how to submit your research involving radiation for ethics, governance and risk assessment review, please click here.
Quick links
- Victorian Patient Information and Consent Form (PICF) templates
- Writing a PICF in plain English
- Waiver of Consent checklist and application
- National Statement
- Consent in Research Involving Children: The ethical Issues. A Handbook for Human Research. Ethics Committees and Researchers
- Guidance for explaining your survey to potential participants
Why consent is required in research
One of the most important ethical rules governing research with humans is that participants must give their informed consent before taking part in a study, or an ethics committee must approve a request to waive the requirement for consent. The requirement to seek consent is both a legal duty to provide information about research risks and a moral duty to respect people by ensuring that they are making free and informed decisions.
A form of participant consent is required for all research, except for research involving the use of;
- existing data collected for clinical purposes, AND
- when the data is being analysed and stored in a de-identified format, AND
- when the data being collected is being used for research related to the clinical purpose, AND
- by researchers who have access to the data as part of routine clinical care.
How to complete consent requirements in your research project application
- Decide whether consent is needed. This will depend on the type of project. For help, contact RDU or refer to the Barwon Health Consent in Research Manual.
- Develop consent documents that are required for your research: Patient Information and Consent Forms (PICFs) and Plain Language Statements (PLS), waiver checklists and application forms (refer to quick links above). Please note: all Barwon Health PICFs must be written on a Barwon Health letterhead. Non Barwon Health employees, please request a template from your Clinical Trial Coordinator.
- Attach consent documents to Human Research Ethics Application (HREA) or Site Specific Assessment (SSA) in ERM
- Submit your application in ERM
- Submit amendments as required if consent requirements change during the project
Key Contacts
Barwon Health HREC Executive Officer/Local HREC Contact
Mr Richard Larsen
Research Ethics Officer
Research Development Unit (RDU)
(03) 4215 3371
rdu@barwonhealth.org.au
Complaints
If you have any complaints about any aspect of the project or the way it is being conducted please contact;
Consumer Liaison Officer
P.O. Box 281
University Hospital Geelong
Bellerine Street
Geelong VIC 3220
(03) 4215 1251
Consumer.LiaisonOfficer@barwonhealth.org.au
Enquiries
If you have any questions about being a research participant, please contact
The Barwon Health Research Development Unit (RDU)
(03) 4215 3373
rdu@barwonhealth.org.au
Before submitting your Human Research Ethics Application (HREA) or your Site Specific Authorisation (SSA) form to the research office, you will need to provide signatures in ERM.
Obtaining signatures in ERM can be tricky for researchers not familiar with the system. There are three options available in the ERM system for gathering signatures
For each team member (collaborator) who needs to sign your form, you can choose for them to sign the declaration section of the form using one of the following:
- Upload other evidence
- Wet ink sign after printing
- Electronic signature (in place of HREA ‘sign on screen’)
Instructions for each method:
1. Upload other evidence
- You can upload evidence of other team members agreement to the form declaration section (e.g. a PDF of an email)
2. Wet ink sign after printing
- You can have researchers/investigators sign this application after it is completed and printed (i.e. a ‘wet ink’ signature). If a wet ink signature will be used, please save this document by clicking on the “Print” icon in the upper left area of the screen, save it to the local drive, and print out this signature page for the wet ink signature. The page with the wet ink signature must be uploaded in the ERM application form.
3. Electronic signature (in place of HREA ‘sign on screen’)
- You can use the request signature button to have other team members complete their declaration within this application or if you are the one electronically signing, click the sign button to electronically sign.
Important notes:
- You must first identify all team members (collaborators) who will be providing other evidence or wet ink sign after printing.
- You will need to print and upload all supporting documents before requesting electronic signatures as this will lock the form. Once the form is locked you cannot upload or amend the form. You do have the option to unlock a form, but this removes all signatures that have been requested or received. If you unlock your form you will need to re-request all signatures.
- Remember to click submit on your form once all the signatures are attached as this does not happen automatically. To check if your project has been submitted please look at the Action Required and status on the front page:
Additional Resources:
The Victorian Department of Health has developed the following resources to help:
- General information for adding signatures to all forms in ERM: click here
- Specific information for adding signatures to HREA form in ERM: click here
- Specific information for adding signatures to SSA forms in ERM: click here
Ethics Review Manager (ERM) Quick links to Guides & Tools
- ERM login page
- Applicant User Guide to ERM
- Frequently Asked Questions
- Signature Instructions
- Signature Training Slides
- Training Tools & Quick Tips
- Troubleshooting Guide
What is ERM?
Ethics Review Manager (ERM) is a paperless information management system for completion, submission and storage of:
- Ethics applications
- Research governance/site specific assessment (SSA) applications
- Post approval (ethics) forms
- Post authorisation (research governance) forms
The communication features of ERM ensure that the entire life-cycle of a research project can be managed within the ERM system.
All submissions must be submitted via ERM (please do not submit items for review via email). All approval letters, authorisation letters, acknowledgements, requests and feedback are provided within ERM to ensure all study documentation and correspondence is stored in one place.
The Victorian Government Coordinating Office for Research, now ‘Clinical Trials and Research’ has a new ERM webpage that has extensive guidance on ERM for researchers, including a series of ERM video tutorials and quick tips. This is a great place to start if you are new to ERM.
I’m not sure if my project is on ERM. How can I find out?
Please contact the RDU at rdu@barwonhealth.org.au so we can do a search for you. If the project was initially submitted via Online Forms, the project has been migrated to ERM and we may need to organise for the project to be transferred to you.
What if my project isn’t on ERM and I need to submit an amendment, report or safety item?
A Legacy Application Replacement Form (LARF) should first be completed on ERM (consult the RDU first before completing). Once completed, a ‘sub-form’ can be created in order to submit the required post-approval item.
What should I do with my project in ERM if I leave Barwon Health?
It is important for projects to be transferred to another project collaborator when the current project owner leaves an organisation.
Click here for instructions for current project owners and new project owners regarding transferring the project.
Where can I find help with ERM?
All guides, instructions and tips on using ERM are available via the links above.
In addition, Clinical Trials and Research offers ERM training via Microsoft Teams throughout the year. Click here for more information and training session dates.
For technical assistance, please contact:
- Infonetica Helpdesk: (02) 9037 8404 or helpdesk@infonetica.net
- Coordinating Office for Clinical Trial Research: https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager , 0408 274 054, multisite.ethics@ecodev.vic.gov.au
Note: ERM no longer supports Internet Explorer and Old Microsoft Edge browsers. If you are currently using these browsers, we advise you to update to the new Microsoft Edge browser or Google Chrome.
What can REDCap be used for?
REDCap is a secure web platform for building and managing online databases and surveys. REDCap’s streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to various data collection strategies. REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.
Who can use REDCap?
Barwon Health’s REDCap system is open for all employees and can be used for research, quality improvement activities, and operational support. You can access REDCap here.
If you are not already a user of REDCap, please complete the REDCap user account application form.
External researchers are encouraged to use their own institution’s platform, however access can be arranged for collaborative projects (a Barwon Health sponsor is required to oversee external accounts. Contact the REDCap administrator for more information).
Where can I get help with REDCap?
The REDCap administrator can assist with basic training and troubleshooting. Please email redcap-admin@BarwonHealth.org.au with questions or to arrange a time for a training session. Training sessions are also available through Intersect Training.
Barwon Health staff can access a 15 minute REDCap training video within the GROW learning management system. Click here to view or search for REDCap in GROW.
National Institutes of Health (USA)
NIH online training course Introduction to the Responsible Conduct of Research.
The progress and excellence of NIH research is dependent on our vigilance in maintaining the highest quality of conduct in every aspect of science. The NIH has developed a set of general principles for the ethical conduct of research, these can be found in the Office of Intramural Research (OIR) Sourcebook. For those directly involved in the research activities of the NIH intramural research programs, it is important that they read, understand, and incorporate these guidelines into everyday practice.
This course describes these basic principles of good research ethics, through sections on scientific integrity, data acquisition and management, publication and authorship, peer review, mentor/trainee relationships, collaborative research, research involving human and animal subjects, and conflict of interest and commitment.
Praxis Australia
PRAXIS Australia is a not for profit, registered charity created in 2015. Their purpose is to enhance access to high quality, relevant and accessible education and training that can be used by individuals or organisations across the broader research and clinical trials eco-system in Australia and internationally. Praxis believes that education is the key to their broader purpose – to enhance the welfare of research participants and the quality and effectiveness of research.
View Praxis online learning and other resources here.
Barwon Health Clinical Trial Research Support Hub
Global Health Network – General Research Training, including ICH_GCP Good Clinical Practice training
Australian Clinical Trials Education Centre (A-CTEC) – Australian Clinical Trials Education Centre learning management system
Barwon Health GROW learning management system for Good Clinical Practice training
Page last updated: June 2, 2025