Category: <span>Blog</span>

CALL FOR PAPERS AND WEBSITE LAUNCH!

It is a pleasure to invite you to join us at the 2016 AEN Conference to be held in Adelaide’s rapidly growing research hub. The conference is brought to you as a result of the collaboration of Bellberry, PRAXIS Australia and the Australian Research Management Society (ARMS), in conjunction with our sponsor, the University of South Australia.

We encourage you to visit the conference website to find out how to submit your abstract and to learn more about the various conference themes.

http://themeetingpeople.com.au/aen2016/

The AEN 2016 Conference will seek to explore in detail how the research and research ethics communities in Australia can prepare for innovation by better understanding what kinds of challenges this era of innovation brings our way, how we can utilise innovation to improve processes, and importantly to identify and address the ethical implications of those innovations.

Registration and session information coming soon, including an announcement of exciting key note speakers.

conference team contact
Ms Lesley Woods
AEN 2016 Conference Secretariat
PO Box 764
MITCHAM SA 5062, Australia
Telephone: +61 (02) 8177 2215
Email: reg@themeetingpeople.com.au

Thurs 7 April – The Science Exchange, Adelaide

Committee F’s inaugural meeting will be taking place next week with Prof Annette Braunack-Mayer as the newly appointed Chair.

Annette is a Professor of Health Ethics in the School of Public Health at the University of Adelaide and she was the Head of School until October last year. Her area of research is public health ethics and policy, with a particular focus on vaccination, obesity and chronic disease prevention. She has for many years been an ethicist in a medical setting and she also chairs the Ethics Health Advisory Council for the South Australian Department of Health and Ageing and sits on their HREC. Her mix of expertise in the clinical setting, population health and qualitative methods is a great addition to the Chair team. Annette has worked with agencies supporting both PBAC and MSAC, so has a deep understanding of the lifecycle of the clinical work.

We are delighted to welcome Annette to the Bellberry team.

Bellberry is delighted to announce that its 6th Human Research Ethics Committee has been registered ahead of an inaugural meeting in March 16.

In preparation ahead of the formal launch, the Bellberry team have been busy with the recruitment and selection process. We are pleased to introduce Annette Braunack-Mayer as the new chair for Committee F. Annette is a Professor of Health Ethics; her area of research is applied ethics and qualitative methods. We are delighted to welcome Annette to the Bellberry team.

The 6th committee adds further capacity to the Bellberry ethics review process. With Bellberry holding at least one HREC meeting every week, we are able to provide researchers with a 2-week lead time from submission to review.

7-10 October 2015, Sydney

The theme of this year’s meeting is Better Evidence, Better Health and it aims to bring together a broad range of local and international experts in the design and conduct of clinical trials, clinical data and registry custodianship, healthcare funding, policy and regulation, healthcare service delivery, health information technology and patient advocacy to:

• Review international experiences and achievements in developing self-improving healthcare systems;
• Bring focus to the health and economic value of integrating clinical research within routine care delivery;
• Consider the current environment for generating and applying high-quality evidence within the Australian healthcare system and identify key issues and strategies for accelerating progress;
• Explore cutting-edge advances in clinical research methodology that can improve the quality and efficiency of research efforts; and
• Foster the development of new collaborations and funding partnerships to enhance clinical research capacity both locally and internationally.

Bellberry will again be attending this event and hosting a stand so please come along and find out who we are and what we do or just to say hello!

From 1 July 2015 the Clinical Trials Notification (CTN) Scheme transitioned from a paper based form to an online format. The paper-based notification form is now no longer available as there are some differences in the required information for the online form.

As a reminder any paper based forms the TGA receive after 1st July 2015 will need to be submitted online via the TGA Business Services website

Bellberry have prepared a Guidance document for Bellberry applications. This is available on the Investigators pages under Policies, SOPs, Guidance. Please contact us if you have any queries.

Bellberry@bellberry.com.au

Last Friday 7 August Bellberry staff again wore jeans in support of national Jeans for Gene’s day. Jeans for Genes (Australia) was born in 1994 to support research into genetic diseases, birth defects and cancers at Children’s Medical Research Institute (CMRI).

Jeans for Genes Day is held on the first Friday in August each year and continues to be a major fund-raiser of CMRI. On this day, people are asked to wear their jeans and donate money to support research at CMRI. All money raised by Jeans for Genes goes directly to CMRI to ensure valuable research into conditions like epilepsy, cancer and birth defects can continue. Over $200,000 has already been raised by this years event!

Bellberry staff enjoyed a jeans inspired morning tea which included Operation Manager Trina O’Donnell’s wonderful jeans cake (below). Thanks everyone for your support!

Bellberry are delighted to announce the launch of the PRAXIS Australia website at http://www.praxisaustralia.com.au/

PRAXIS Australia Ltd promotes the understanding and practice of ethical human research in Australia and internationally, to enhance the welfare of research participants and the quality and effectiveness of research.

Over the next few weeks PRAXIS will expand their online services with resources and a communication forum that promotes the exchange of ideas and facilitates discussion around matters of interest to the research ethics and research communities.

Please visit the PRAXIS site to register for courses, subscribe for updates or simply ask a question about PRAXIS services or other tailored training needs.

Bellberry is a Member Organisation of PRAXIS and fully support this initiative.

e: info@praxisaustralia.com.au

International Clinical Trials Day is held on 20 May each year to commemorate the day that James Lind began his trials into the causes of scurvy.

Lind’s experiments in 1747 were run under very different conditions to today. Serving as a surgeon on the HMS Salisbury, his trial consisted of just 12 men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons. The trial only lasted six days but, within that time, there was a noticeable improvement in the group eating the fruit, providing Lind with evidence of the link between citrus fruits and scurvy.

Clinical trials have come a long way since Lind’s discovery. Each year on May 20 we pause to remember his work and acknowledge the major improvements in health outcomes that have come since thanks to clinicians who are dedicated to finding answers to important clinical questions and members of the community who participate in clinical trials.

Bellberry commemorated this day with a ‘Clinical Trials’ themed morning tea which included edible delights such as brain pate, heart jelly and petri dish white chocolate mousse all provided by our talented Operations Manager Trina O’Donnell.

Happy International Clinical Trial Day!

Bellberry are pleased to welcome Hon John Hill and Prof Ian Frazer AC to the Board of Bellberry Ltd.

John Hill is perhaps best known for his recent and long-term appointment as health minister for South Australia. John is a teacher by profession, but entered politics in 1997. With the Rann Government election in 2002 he joined the State Cabinet, and held a variety of ministerial appointments for the following 11 years including Health, Aging and the Arts. Since retiring from Parliament in 2014, John has continued to support his areas of interest: Health, Aging and the Arts.

Professor Ian Frazer AC was trained as a renal physician and clinical immunologist in Edinburgh Scotland, and immigrated to Australia in 1985. In 1991, along with Chinese colleague, Dr Jian Zhou, he developed the virus-like particle technology which has become the basis of vaccines to prevent cervical cancer. Dr Frazer was founder CEO and Director of Research of the newly created Translational Research Institute in Brisbane, Australia. He now pursues research on skin cancer and on immunotherapy for cancer as head of the cancer immunotherapy program at TRI.

Both John and Ian have joined the board of Bellberry because of their passion for medical research and the positive outcomes that can be gained for our communities. They support the work of Bellberry, as an Independent Not For Profit working in this space.

Bellberry is delighted to announce the appointment of Dr Barry Chatterton as Chair of Bellberry Ltd HREC D.

Dr Chatterton is a highly qualified physician, with a specialisation in nuclear medicine. He brings a wealth of experience from both the public and private sectors. Dr Chatterton is also an experienced HREC Chair having been involved as Deputy Chair of the RAH HREC for many years.

Dr Chatterton graduated from the University of Adelaide in 1971 with a Bachelor of Medicine, Bachelor of Surgery (MBBS). He gained his MRACP in 1974 and went on to train in Nuclear Medicine at the Royal Adelaide Hospital from 1975 – 1977 and was made a Member of the Australasian College of Physicians (FRACP) in 1978 upon achieving his Nuclear Medicine qualifications.

Dr Chatterton joined Dr Jones & Partners in 2002 and consults in general and cardiac Nuclear Medicine, PET, Bone Densitometry, Ocular ultrasound and Oncology. He was also a Senior Director at the Royal Adelaide Hospital until his recent retirement after 42 years. Dr Chatterton has special interests in radiopharmaceutical development and oncology and is author or co-author on over 130 publications.

Clinical Trends and New Approaches

Wed 6 May, The Royal Australasian College of Surgeons, Melbourne

Simon Windsor and Trina O’Donnell attended this event held at the Royal Australasian College of Surgeons in May. Simon presented a session to over 200 people at this popular workshop which is organised by Victoria Health.

The workshop addressed current issues and use of electronic approaches. There were sessions on participant consent including e-consent, personalised medicine and developments in investigator initiated projects, industry related topics including online monitoring and social media surveillance

Simon presented a session on the National PICF Project, A Participant-focused Approach. The session was very well received and many thought provoking questions were raised.

All presentations from this workshop will be available to view on the Victoria Health website.

Thurs 30 April – The Science Exchange, Adelaide

Around 45 people with several members from interstate attended this interesting and informative event. The two topics presented were ‘Ethical and regulatory challenges generated by surgical innovation’ and ‘Procedures and Devices.’

The event was very well received and a range of interesting questions were raised. Our Education evenings are part of our ongoing commitment to the continuing professional development of our HREC members. We believe that on-going education is a fundamental requirement in the delivery of a high quality ethics review service to the human research community.

Bellberry wishes to thank our excellent speakers and everyone else who attended for their input and discussion. We look forward to the next event.

ARCS Scientific Congress, Sydney

5-7 May 2015

This year ARCS are running a combined congress for those working in the development of medicines and medical technologies including clinical research, regulatory affairs, quality/GMP, medical devices, reimbursement, pharmacovigilance, medical information, medical affairs, and workplace management.

This year Bellberry are delighted to be presenting at two sessions. Our Project Officer Simon Windsor will be speaking on Tues May 5 at the Improving Investigational Site Operations session. Simon will be presenting information about the National PICF Project and providing pilot data from the project.

On Wed May 6 Melanie Gentgall will be talking at the Trends in Clinical Research Governance session which will be chaired by Bellberry CEO Kylie Sproston.

We will also have our usual booth at the conference so please feel free to come along for further information on Bellberry and our ethics Committee’s or just to say hello! We look forward to meeting new friends and catching up with old acquaintances.

Natasha Johns started at Bellberry in April and has joined forces with long term Bellberry employee Chris Weinert to form Bellberry’s new executive assistant frontline team!

Natasha who is originally from SA, has recently returned after living in QLD for four years. She has been an executive assistant for 5 years and has held previous roles at the Department of Transport and Main Roads in QLD.

Chris and Natasha are located at the Bellberry reception and will be the first people you speak to when calling the main Bellberry number. Chris and Natasha are job sharing this role and will be able to assist you with a wide range of questions and queries including how to submit a study for review, Committee meeting dates, document requirements and much more!

Please do not hesitate to contact the team on 08 83613222