Education, Training & Support

The REGI Unit supports the training and education of Barwon Health researchers in research ethics, research design and methods, and ethics applications. We are available for one on one and small group education, training, and advice sessions during business hours. Please contact regi@barwonhealth.org.au to book a suitable time.


Academic Skills Program: A free 10 session training program introducing essential research skills

Barwon Health staff and students are invited to attend a new research training program developed by the Research Directorate and Library. Commencing March 2017, the program will offer ten sessions focused on topics identified through staff feedback and survey responses. Participants can attend any or all of the fortnightly, one hour, lunchtime sessions.

Round 2 of the training program will commence on 3 August 2017 - please click here to view the dates for Round 2 at University Hospital, Geelong, and to register.


Statistical Support: Data science consulting and training

Whether you have data and you're not sure what to do with it, you have an idea in mind but you're not sure how, or indeed what data to collect; or you wish to upskill a data analytics team, interadata is here to help.

interadata has the data science knowledge and training experience to take your project to the next level.

For more information and contact details, visit the interadata website (https://interadata.io/).


Education and training about clinical trials

Good Clinical Practice (GCP) Training

The principles of GCP have their own origin in the World Medical Association's Declaration of Helsinki. The Declaration of Helsinki was a response to the atrocities revealed during the Nuremburg trials conducted after World War II. The authors of this declaration sought to ensure that human participants involved in clinical research would, in future, have their rights, safety, and well-being placed above all other considerations in clinical research. The documents has been revised several times since it was first published in 1964.

The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the 'Good Clinical Practice' (GCP) guidelines, although the guidelines apply to clinical research rather than clinical practice. The GCP guidelines details the involved parties' responsibilities, requirements for trial documentation, protocol amendments, reporting lines for adverse events, and provision of medical care for trial participants.

The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context.

 GCP Requirements for Principal Investigators of clinical trials

In keeping with best practice, it is a Barwon Health requirement that Principal Investigators on all clinical trials must hold current GCP certification.

GCP Training

The REGI Unit recommends GCP training courses offered by ARCS Australia.

Course overview:

Applied GCP training for investigational sites and sponsor representatives (Certificate 1, 2 and 3) can be undertaken at the researcher's own pace and takes approximately 10 hours to complete. The training is principally focused on best practice in clinical trials research, but is sufficiently broad in scope so as to benefit all clinical researchers. Upon completion of the program, researchers should have a good understanding of Australian regulations for clinical research and ICH-GCP, as well as a clear understanding of roles and responsibilities of all stakeholders in clinical research. Certificates of completion are issued and are valid for two years.

National Health and Medical Research Council clinical trial training modules

The REGI Unit also recommends the new National Health and Medical Research Council (NHMRC) eLearning Modules which are particularly relevant to early career researchers and clinical trial coordinators.

These 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 are relevant to researchers, coordinators, educators and supervisors, and anyone interested in finding out more about how clinical trials are conducted.

These modules provide an introduction to the clinical trials environment, clinical research ethics and ethical review, as well as research governance processes. They are also 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 learning objectives of the module are:

  • To understand how clinical trials take place in Australia
  • To understand and promote responsible research practices
  • To ensure quality research outcomes
  • To ensure participant safety is maintained at all times.

Each module takes approximately 45 minutes.


Education and training about research ethics and integrity

Invitation to attend a Barwon Health Human Research Ethics Committee meeting

The Barwon Health Human Research Ethics Committee (BH HREC) is pleased to invite researchers from within Barwon Health to observe a HREC meeting. Any interested researchers who are either planning on or have submitted ethics applications for review by the HREC are encouraged to attend. The REGI Unit believes that observing a HREC meeting could improve understanding of the research ethics processes and the role and objective of the HREC and may help researchers to improve their HREC applications. Committee dates are available on the Committees, meetings and dates webpage. Please contact the REGI Unit if you would like to attend.

Courses available through Deakin University

Researchers affiliated with Deakin University are encouraged to access the training available through Deakin University. The REGI Unit is able to organise access to some courses for non-Deakin Barwon Health staff. Deakin Research Integrity provides online or live induction and training in the following areas:

Human ethics training is compulsory for all Deakin University staff and students submitting an ethics application for the first time at Deakin (either DUHREC or to a Faculty HEAG). Regardless of whether the training is undertaken in person or online, it is necessary to complete the online quiz available on the D2L site.

Additional information is available on Deakin's Human Research Ethics homepage.

Courses available through the University of Wollongong

The University of Wollongong offers free online human research ethics courses designed for researchers and members of Human Research Ethics Committees.

These courses comprise of:

  • An Introduction Module that offers basic knowledge of the historical and international contexts of contemporary human research ethics in Australia - this is designed for those with no prior involvement in human research ethics
  • Modules 2 to 5, where each focuses on one of the four basic principles of the National Statement (Module 2 - Research Merit and Integrity, Module 3 - Justice, Module 4 - Beneficence, Module 5 - Respect)

The REGI Unit recommends these modules to increase understanding of the principles and values that underpin ethical research conduct and familiarity with using the National Statement in human research ethics work.

Courses available through the Office of Research Integrity

The Office of Research Integrity (ORI) within the US Department of Health and Human Services, oversees and directs Public Health Service (PHS) research integrity activities and provides access to many training and education resources for research teams and supervisors.

The Research Clinic

The Research Clinic Video Image

 

 

 

 

 

The ORI and the Office for Human Research Protections (OHRP) present The Research Clinic. This interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each 'playable' character.

The characters

In this simulation, you get to become a principal investigator, a clinical research coordinator, a research assistant, and an institutional review board (IRB) chair and make decisions that affects the outcome of the story:

 

Dr Richard Sowers, a principal investigator (PI), a busy oncologist who must strike a balance between doing what he thinks is best for his patients and his research;

 

 

Jan Klein, RN, a clinical research coordinator, an overworked nurse who works for a PI who pressures her to falsify data and violate study protocols;

 

 

Megan Boyle, a research assistant who has difficulties obtaining informed consent and following research protocols;

 

 

Marcy Rosenberg, an IRB Chair, who is tasked with ensuring that research subjects and the integrity of the research enterprise are protected while dealing with a culture resistant change.

 

Researchers are also encouraged to view one or more of the below training videos:

REGI Education seminars

Coming soon...

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.