Research Development Unit (RDU)

Research Policies and Procedures

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

 

Application Guidelines

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.

 

Consumer Involvement in Research

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 for how to involve consumers in the design, execution and analysis of your research, click here.

The White Coats Foundation aims to raise awareness about the role of clinical trials in advancing medical science and healthcare. To view their resources, click here: What is Consumer Led Research?

If you are interested in the development of research and clinical trials as a clinical trial consumer, please click here to find out more.

 

Research conducted by Students

All students who are not current Barwon Health staff wanting to be involved in a research project that involves contact with Barwon Health patients/samples and/or medical records, must complete the following forms:

• Research Placement Student Agreement (download here)
• Research Placement Student Induction Protocol (download here)

Once completed, these forms should be uploaded to ERM under the specific project/s they will be working on. 

The 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 [email protected]

 

Research Conduct Guidelines

Quick links

• Handling Complaints in Research
• Managing Conflicts of Interest
• Data Storage and Archiving
• Access to Health Records for Research Audit and Monitoring purposes (coming soon)
• Collaborative Research and Authorship
• Determining Co-Authorship for Biostatisticians
• Research Data and Records Management Policy
• Roles and Responsibilities in a Research Project

 

Research Safety Monitoring Guidelines

• Research Safety Monitoring, Reporting and Management Procedure

 

Research involving Radiation Guidelines

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.

 

Consent Guidelines

Quick links

• Plain Language Statement (PLS) Template for Surveys
• Victorian Patient Information and Consent Form (PICF) templates
• Waiver of Consent Checklist (updated June 2022)
• Waiver of Consent 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

1. 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.
2. 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.
3. Attach consent documents to Human Research Ethics Application (HREA) or Site Specific Assessment (SSA) in ERM
4. Submit your application in ERM
5. 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
[email protected]

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
[email protected]

Enquiries

If you have any questions about being a research participant, please contact

The Barwon Health Research Development Unit (RDU)
(03) 4215 3373
[email protected]

 

ERM Tools and Training

Ethics Review Manager (ERM) Quick links to Guides & Tools

• ERM login page
• Applicant User Guide to ERM
• Frequently Asked Questions
• How to Create a LARF and Submit Post Approval Items
• Signature Instructions
• Signature Training Slides
• Training Tools & Quick Tips
• Troubleshooting Guide
• How to transfer a project in ERM

 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 [email protected] 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. See instructions on 'How to Create a LARF and Submit Post Approval Items' at the top of this page.

 

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 [email protected]
• Coordinating Office for Clinical Trial Research: https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager , 0408 274 054, [email protected] 

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.

 

REDCap Tools and Training

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 [email protected] with questions or to arrange a time for a training session. Training sessions are also available through Intersect Training, and basic video tutorials are available here. Note: Google Chrome should be used when accessing REDCap for optimal functionality.

 NEW July 2022: 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.

 

Ethics Tools and Training

NHMRC clinical trials elearning modules 

The NHMRC modules use interactive learning, interviews with experts and knowledge reviews to provide an overview of the nature and importance of the clinical trials environment and approval process in Australia. 

The modules provide an introduction to the clinical trials environment, clinical research ethics and ethical review and research governance processes and are a component of the Government’s Expediting Clinical Trials Reforms initiative to maintain Australia’s position as a world leader in quality clinical research.

The modules are free, easy to use, and highly recommended for all staff involved in clinical research. Each module takes approximately 45 minutes.

1. Clinical Trials Environment in Australia: This module provides an overview of how clinical trials work in Australia
2. Ethical Issues related to Clinical Trials: This module looks at the ethical aspects of clinical trials and how to manage the process of an ethics review
3. Research Governance related to Clinical Trials: This module looks at the research governance process including all the checks and clearances that are necessary to start a research project

 

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.

 

Clinical Trials/ Clinical Research Tools and Training

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) - Victorian Clinical Trials Education Centre learning management system 

Barwon Health GROW learning management system for Good Clinical Practice training 

 

Related Links

National Statement on ethical conduct in Research 

Australian Code for the Responsible Conduct of Research 

NHMRC

International ICMJE recommendations and ethical standards in the conduct and reporting of research

Guardianship (Victoria)

Therapeutic Goods Administration

Medical Technology Association of Australia

Therapeutic Goods Administration

Medical Technology Association of Australia