Category: <span>Company News</span>

We were delighted to welcome two new HREC Officers (HO’s) to the team recently. Pam Sim and Sav Perera joined us in June. Both Pam and Sav have studied in the science area and are a welcome addition to our growing HO team.

We are also excited to welcome Helen Daykin and Jo Carino to the team. Helen will be providing administration support to our EPCT team. She brings a wealth of knowledge and experience from within the clinical trials sector, having managed the Adelaide Cancer Centre for many years.  Jo Carino joined the Quality team this month as Quality Team Leader. Jo holds a Bachelor of Science (Honours in Chemistry) and has worked with Mayne Pharma for over 25 years.

Elsewhere in the team, HREC Officer Phoebe Manuel has been seconded to work with the Quality team until January 2022 and Tess Penglis has moved from the Quality team to a new Training Officer position within the Corporate Services team. Our many congratulations to both Phoebe and Tess on their new roles.

Many congratulations to all staff on their new roles.

Not-For-Profit and philanthropic leaders have been recognised and celebrated for their service to the community in this year’s Queen’s Birthday Honours List. Charity, humanitarian and philanthropic leaders shone through for their continued tireless work for the community despite the challenges they have faced.

Bellberry is delighted to share that two of our HREC members have been recognised on the 2021 Birthday Honours List and awarded Member (AM) in the general division in the Order of Australia.

Emeritus Professor James Toouli has been recognised for significant service to tertiary medical education, notably to gastroenterology. Jim is Professor Emeritus of Surgery at Flinders University and has been a Bellberry HREC chair since 2012.

The Reverend Dr Cecilie Lander has been recognised for her significant service to neurological medicine and the Anglican Church of Australia. Cecilie is a Clinical Associate Professor in Neurology who has worked in private practice and at the Royal Brisbane & Women’s Hospital for over 40 years. Cecilie was ordained Priest of the Anglican Church of Australia in 1996 and has served as a Bellberry HREC member since 2014.

Bellberry extends sincere congratulations to both Jim and Cecilie on this honour.

Bellberry is delighted to share that one of our HREC Members, Professor Ian Olver, has been awarded the NHMRC ethics award for his significant contribution to Australian health and medical research ethics over the last decade.

Further information on the award and other award recipients can be found on the NHMRC website.

Ian’s background to his involvement in the ethics scene in Australia can be found on the NHMRC website here.

Many congratulations to Ian on this well-deserved recognition.

Congratulations to Bellberry CEO Kylie Sproston on being a winner of the 2021 ARCS MTP Sector Awards. Kylie was announced as the Innovation award winner at the ARCS 2021 awards dinner in Sydney last night. Other recipients were NSW Health, Pathology, as innovation award winner and Co-Directors Nick Ward and Johanna Hann from PharmatoMarket winners of the Leadership award.

Kylie was honoured to receive the award and said “In accepting this award, I’d like to acknowledge my incredible team at Bellberry: staff, HREC member community and our supportive Board. We’re forever asking ourselves how we can better deliver on our objectives: to improve the welfare of human research participants and improve the quality, efficiency and effectiveness of research.

Delivering on those objectives is only possible with the teamwork that happens every day in the clinical trials environment: research site staff, investigators, CROs and Sponsors coming together to deliver health and medical research. The last word as always should go to the communities in which we operate and our participants, without whom none of this is possible”

Bellberry is the largest independent reviewer of CTN trials in Australia. This year on Clinical Trials Day, we’re pleased to share a summary report which describes research activity overseen by Bellberry HRECs through 2020.

This activity report represents a significant proportion of the Australia wide CTN trial activity across the development lifecycle. It demonstrates capability and capacity in a broad range of research areas. The report also captures the originating funding location for inward investment in Sponsored clinical trials, again demonstrating Australia’s active participation in the global development process.

Bellberry Clinical Trial Activity Report 2020 (168 downloads )

Bellberry has a team of office-based staff who support the administrative function of the HREC process. The team includes secretarial, IT and project professionals.

We currently have a vacancy for an HREC Officer.

It is now several months since Bellberry updated its procedures and we are pleased to report that there has been a significant drop in start-up times for additional sites.

The table beneath is a comparator of Jan/Mar 2020 to 2021. These months have been chosen as Jan/Mar may pre-date any COVID related issues sites may have, and in December 2020, the grace period ceased.

Amendments are tracking at the same turnaround time in Bellberry days (3.8 days). The updated model’s difference is we now ensure all sites are listed on the one approval letter, as appropriate.

We appreciate the teething issues as sites, sponsors, and our administration tackle the changes together. If you have any questions or you would like to schedule a call with the quality team to discuss the practicality of the changes at your site, please email alisonbarr@bellberry.com.au.

Document Updates

We recently made some minor changes to some of our documents and guidance for researchers. A summary of the changes can be found here.

FAQs relating to the process changes rolled out in late 2020

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The Trustees of the Sylvia and Charles Viertel Charitable Foundation are pleased to announce two classes of research grants to be awarded in 2021 and commencing in 2022.

The Viertel Foundation was established to benefit organisations or institutions involved in medical research into diseases and the alleviation of the hardship of the aged and the sick. Bellberry began working in collaboration with the Viertel Foundation in 2016 to offer prestigious, high-value 5-year mid-career fellowships to the brightest research talent which increased the number of available Research Fellowships from two to three.

Senior Medical Research Fellowship & Bellberry-Viertel Fellowship

The Senior Medical Research Fellowship are intended to be amongst the most prestigious awards available to those who wish to continue a career in medical research in Australia. The Fellowship is an integral part of a scheme that is intended to provide both salary and project grant support for outstanding Australian medical researchers. One of the Fellowships available is the Bellberry-Viertel Senior Medical Research Fellowship. It has a five-year tenure at $250,000 p.a. for a researcher from any discipline in medical science to be awarded in 2021 and commencing in 2022.

Viertel Clinical Investigator awards

$85,000 is available for a clinical researcher who has recently completed their clinical and research training and is commencing their first substantive appointment (appointment of 5 years or more) clinical position or has been in such a post for no more than 36 months on 30 April. Up to five awards available this year.

The Foundation intends to award at least one (1) award to an eligible female candidate in both classes. Only Australian nationals or permanent residents are eligible for these awards.

The closing date for both awards is 30 April 2021.

Further information, including eligibility requirements and application forms, is available from The Viertel Charitable Foundation website, or email: charities@eqt.com.au.

To our valued Bellberry community:

In line with South Australian 6-day circuit breaker restrictions introduced today, Bellberry has closed our Adelaide office. At this stage, the closure is planned for 19th-24th November and will be reviewed as more information becomes available. We will be working remotely for the time being.

Bellberry HRECs perform an important role: in terms of review of new research, the oversight of ongoing research and the provision of a participant contact pathway. We are committed to ensuring that our work continues in a safe and seamless manner regardless of what happens with COVID this year.

The Bellberry team initially trialled remote working practices in February and moved to fully remote services for the first time in March. Since then, our office occupation rate has flexed up and down according to the COVID environment in South Australia. We see today’s changes as simply the latest stage of this journey.

For our research users who access our services from across the country: it is business as usual for the Bb team (even if our desk locations are not). Our Bb pets are delighted to have us all at home again!

We support our public health colleagues in their work to control this outbreak and thank them for all their efforts.

Kylie Sproston – Chief Executive Officer – Bellberry Ltd

The last meeting of 2020 will be held on Wed 23 December with a submission deadline date of Wed 9 December. The first meeting of 2021 will be on Wed 6 January with a submission deadline of Wed 16 December.

The Bellberry office will be closed from COB on Thurs 24 December until Mon 4 January at 9 am. There will be no HREC meeting on Wed 30 December.

Meeting Date     Submission Date

Wed 23 Dec            Wed 9 Dec
Wed 6 Jan              Wed 16 Dec
Wed 13 Jan            Wed 23 Dec

Meetings will continue to be held every Wednesday for 2021 with the submission date 2 weeks before the meeting date.

Bellberry Limited is a private, national, independent, not-for-profit organisation, recognised in the McKeon review as a best practice example, supporting the Australian health research community through professionally managed Human Research Ethics Committees (HRECs) serving researchers across Australia.

Due to our continued growth, we are currently recruiting for:

HREC Officers

Officers provide high-level support to the Bellberry HRECs and are responsible for the administration of human research applications utilising the eProtocol online system. All applicants must possess excellent administration and communication skills with a strong focus on customer service.

Click here for the position description

For further information and to apply please visit SEEK

• The lead site is approved 22 May 2020
• Additional site one approved 18 August 2020
• Additional site two approved 05 May 2021.

• The lead site and additional site one have their first progress report due 22 May 2021.
• As approval for site two is within 60 days of the progress report being due, they are an exception, and their first progress report is due 22 May, 2022.

• The lead site is approved 15 April 2016, their term of approval ends 30 August 2020.
• Additional site one approved 25 September 2018; term of approval ends 16 December 2022
• Additional site two approved 02 December 2019; term of approval ends 16 December 2023

• Lead site progress report due 15 April annually, they also submit an extension request in August 2020. The site will be granted an extension until 15 April 2021. In April 2021, the site provides a progress report/extension request.
• Additional site one submits a progress report in September 2020, site two in December 2020. At the time of processing, the Bellberry administration team will realign their reporting with the lead site, revising their terms of approval. The progress report/extension request will now be due 15 April 2021.

Bellberry awarded AAHRPP accreditation

Bellberry has become the first organisation in Australia to achieve international accreditation for excellence and ethically sound processes in running Human Research Ethics Committees (HRECs).

The recognition has come from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which is based in the USA. The AAHRPP site accreditation team visited Australia to conduct an extensive review of Bellberry’s operations earlier this year.

Bellberry’s CEO Kylie Sproston has welcomed the news.

“This is a huge boost at a time when Bellberry is firmly focused on the safe continuation or adjustment of current clinical trial activities and the welfare of participants on those trials,” Ms Sproston said.

Elyse Summers, CEO and President of AAHRPP said that AAHRPP’s Council on Accreditation (Council) met (remotely) and awarded Bellberry full AAHRPP Accreditation.

“The site visit team and Council were highly impressed with Bellberry’s robust human research protections program (HRPP), which serves as an excellent model in Australia for the ethical review of and education about research involving human participants,” said Ms Summers.

Ms Sproston said, “The accreditation is testament to all the hard work undertaken by our staff, the broader Bellberry team, our HREC Community, and the researchers that we serve”.

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. However, the benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Each accreditation advances that objective and helps build public trust and confidence in research.

Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs in the US. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process.

AAHRPP-accredited organisations have been recognised to have more efficient operations, provide more comprehensive protections, and produce high-quality data. AAHRPP-accredited organisations also tend to have more streamlined, effective policies and procedures.

AAHRPP recently published their May newsletter which includes an article on Bellberrys accreditation: https://www.aahrpp.org/