Category: <span>HREC News</span>

The National Statement on Ethical Conduct in Human Research is the principal reference for research involving humans in Australia and is the guiding document for Human Research Ethics Committees. The National Statement is released by the National Health and Medical Research Council (NHMRC) and is periodically updated to stay relevant to evolving research practices, ethical understanding and community needs.

The 2025 revision, originally due to take effect on 1 October 2025, has been postponed until early 2026. However, institutions are encouraged to adopt it earlier and Bellberry will apply the changes from 1 October 2025.

The 2025 revision of the National Statement incorporates a fully revised Section 4 and consequential or minor changes to almost all other sections. The revised National Statement includes the following major thematic changes in Section 4:

• framing the need for additional consideration for individual participants or groups of participants in terms of increased risk of harm, rather than in terms of vulnerability
• emphasis on inclusion of individuals and groups frequently excluded or under-represented in research
• drawing a distinction between research with people who are at increased risk due to characteristics or circumstances, and increased risk due to research contexts
• removal of the need for research involving participants potentially at increased risk to automatically require review by a full HREC, enabling the use of alternative review processes for lower risk research with the same participants, where appropriate.

The revisions also include recognition of issues related to research with Aboriginal and Torres Strait Islander people and communities in the Preamble and Section 1 of the National Statement and a revised Chapter 4.7.

We encourage all researchers to become familiar with the updates. A summary of the changes can be found on the NHMRC website.

Report highlights international confidence in Australian clinical trials

Global investment in Australian clinical trials is strong, with two thirds of Australian clinical trials, reviewed by Bellberry, funded by international companies according to its 2024 Clinical Trials Activity Report (CTAR).

Bellberry is Australia’s largest ethics and scientific reviewer of research involving humans reviewing approximately 40% of CTN (Clinical Trial Notification) trials in Australia.

Every year since 2019, Bellberry has released its Clinical Trial Activity Report (CTAR) to coincide with International Clinical Trials Day on 20 May. The CTAR describes the portfolio of research conducted in the prior year with Bellberry oversight.

Bellberry’s CEO, Kylie Sproston, says the 2024 data shows that Australia is uniquely placed to attract worldwide investment in clinical trials activity due to the high quality of its healthcare institutions and researchers.

“The 2024 Clinical Trial Activity Report shows that early phase trial activity remains a key strength with significant and continued growth over the last six years,” said Ms Sproston.

“The USA is the largest driver of early phase trials conducted in Australia, with Australia coming second and China third. Other top 10 countries include Germany, South Korea, Switzerland, the UK, Canada, France and Japan,” she said.

“Almost 50 per cent of the trials that Bellberry reviews are First in Human or Phase 1 trials, highlighting Australia’s strong reputation for this skilled and complex type of research.”

In 2024, oncology accounted for more than a quarter of the studies reviewed by Bellberry, while non-clinical trials made up more than 15 per cent of Bellberry reviews.

“Interestingly, we have seen a doubling of the number of social science research activities that Bellberry has reviewed in the last six years from 5% to 10% of total reviews,” said Ms Sproston.

“Australia’s capacity to support the full clinical development pathway is highlighted by the representation of trials in the 2024 CTAR from FIH through to Phase 4, devices, observational, qualitative, social science, registry, audit, and evaluation.”

View our 2024 Clinical Trial Activity Report here

Bellberry is a national, not-for-profit organisation that provides streamlined scientific and ethical reviews of human research established in 2004. It is the 2025 winner of the Championing Health Award in the Telstra Best of Business Awards.

For media queries please contact alisonrogers@bellberry.com.au or on 0488 995 868.

International investment strong in Australian early phase trials

Overseas companies invest in two-thirds of all Australian clinical trials reviewed by Australia’s largest reviewer of human research, Bellberry, according to its Clinical Trial Activity Report (CTAR).

Bellberry reviews more than 40% of CTN (Clinical Trial Notification) trials in Australia and each year releases its CTAR on International Clinical Trials Day (20 May).

The data for the 2023 calendar year found that early phase clinical trials (first in human or Phase 1) involved investment from overseas companies (sponsors) with the top countries being the US, China, South Korea, the UK and Switzerland.

Bellberry’s CEO, Kylie Sproston, says the recent data shows that Australia is uniquely placed to attract significant global investment in clinical trials activity due to the high quality of its healthcare institutions and researchers.

“Continuing previous trends, Australia is a lead destination globally for First in Human and Phase 1 trials, with strong interest from overseas sponsors in the Australian clinical trial ecosystem,” said Ms Sproston.

“Less well recognised is the depth in Phase 2 and Phase 3 clinical trials, totalling 28% of the portfolio.  Collectively, Australia can be a key partner for end-to-end delivery of clinical development of new health innovations.

“Other countries investing strongly in Australian clinical trials are France, Sweden, Taiwan, Germany and Canada. The data shows that we are a highly desirable destination for this skilled and complex work.”

Of the clinical trials reviewed by Bellberry in 2023, private sites conducted 89% of the research with 11% by public sites.

“This reflects the breadth and vibrancy of the privately based research sector including phase one units, hospitals, medical centres and research institutes,” said Ms Sproston.

More than a quarter of the clinical trials undertaken in 2023 were in oncology (27%) with other key areas of research including infectious diseases, neurology, dermatology, haematology, devices and social science (each within 5-10% of the total).

Download the 2023 Clinical Trial Activity Report

Bellberry is a national, not-for-profit organisation that provides streamlined scientific and ethical reviews of human research projects across Australia.  Its focus is on improving the welfare of human research participants and the quality, efficiency and effectiveness of medical research through its HREC reviews and philanthropic activities.

For media queries please contact alisonrogers@bellberry.com.au or on 0488 995 868.

Opportunities are currently available to join our ever growing HREC review panels. Please refer to the article below for further information and contact Cathy Stevens if you are interested.

Bellberry are proud to partner with the 2023 AABHL (Australasian Association of Bioethics in Health Law) Conference to offer a grant of up to $2,000 for Early Career Researchers/Higher Degree Researchers to enable travel to undertake or present research related to research ethics. Announcement of and presentation to the Travel Grant recipient will take place at the AABHL Conference in Brisbane being held 19 – 22 November 2023.

This year’s conference focuses on the ongoing change, impact and opportunities that underlie bioethics and health law. The conference program is now available at: https://aabhlconference.com/2023-program

We look forward to seeing you there!

2023 AAHRPP Annual Conference: Challenge and Change in Charm City

HREC meetings are held every Wednesday for the duration of 2023.

HREC meetings are held every Wednesday for the duration of 2023.

From a national pool of exceptional collaborative, multicentre, investigator-driven, and impactful trial nominations, four major awards were presented on Friday 20 May for trials demonstrating significant and positive impacts for patients.

The ACTA Clinical Trials National Tribute and Awards were established in 2016 to highlight the outstanding Australian achievements that advance clinical practice and save or improve the lives of patients every year.

The 2022 ACTA award winners were:

Winner – ACTA Trial of the Year Award
REMAP-CAP: Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia This trial employed a novel design to simultaneously evaluate potential treatments, and efficiently and rapidly generate evidence, which had a significant impact on the care of critical patients during the COVID-19 pandemic.

Other award winners are as follows:

Winner – ACTA STInG Excellence in Trial Statistics Award
The PADDI Trial: The Perioperative Administration of Dexamethasone and Infection – The PADDI Trial This trial presented that dexamethasone can be safely administered to patients to prevent nausea and vomiting when undergoing surgery, without concern about wound infections.

Winner – ACTA Consumer Involvement Award
EMPOWER-SMS: Text messages to improve women’s self-efficacy, quality of life and health outcomes after breast cancer treatment: EMPOWER-SMS randomised clinical trial This trial evaluated the reach and usefulness of a lifestyle-focused text message intervention to support women’s mental and physical health after breast cancer treatment.

Winner – ACTA Industry Partnership Award
Better Knee, Better Me: Effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – a randomized controlled trial This partnership, between the University of Melbourne and Medibank, saw the design and evaluation of two new programs for people with knee osteoarthritis, which were highly rated by participants and health professionals for their effectiveness, simplicity and convenience.

ACTA CEO, Dr Stewart Hay shared: “The caliber and breadth of our 2022 award winners and nominees illustrates the expertise, experience and enthusiasm for conducting clinical trials in Australia. As an industry body, ACTA is committed to supporting and advocating for trial teams to ensure they can continue their great work in providing the community with access to life-changing trials. These awards provide yet another reminder why our work is so important for the sector and patient care.”

Visit the ACTA website for full details of this year’s winners.

The 2022 ARCS Annual Conference is taking place next week in Sydney. Due to the COVID-19 pandemic, Australians have experienced firsthand how changes can be incorporated into our daily routines in a very short time.  Initially, we came together with a common goal, to survive and manage the pandemic.  We implemented the changes through necessity and valued each other’s input. The next step is to continue this collaboration by understanding that working together with a common purpose benefits all of us. These changes are the results of three key actions: A common purpose, technology as an enabler and stakeholder inclusiveness.

Bellberry are delighted to be supporting and exhibiting at this event. Several members of our staff will be attending including Jerneen Williams, Bellberry Early Phase Clinical Trial Manager, who is a panel member for the ARCs panel session C04: Lessons learnt implementing site electronic systems in clinical research on 25 May at 11.15am.

The Trustees of the Sylvia and Charles Viertel Charitable Foundation have announced two classes of research grants to be awarded in 2022 and commencing in 2023.

Senior Medical Research 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. It has a five-year tenure at $275,000 p.a. for a researcher from any discipline in medical science to be awarded in 2022 and commencing in 2023.

Viertel Clinical Investigator awards

$90,000 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.

A reminder that the closing date for both awards is 30 April 2022.

Further information, including eligibility requirements and application forms, is available from The Viertel Charitable Foundation website

ACTA has launched a new Industry Partnership Award in recognition of the important role that industry plays in Australian clinical trials.

Open to Members and non-members, the Industry Partnership Award will celebrate a significant collaboration between an industry company and a team of academic investigators uniting to conduct a high-impact clinical trial.

The winner of this new award will be publicly announced at ACTA’s National Tribute and Awards Ceremony, of which Bellberry are premium partners, held in Sydney on 20 May 2022 to coincide with International Clinical Trials Day. The annual awards honour Australians advancing our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involving trial teams, industry partners and consumers.

The closing date for nominations is midnight, Sunday 6 March 2022.

Visit ACTA for further information on the awards and to make your nomination.

The Power of One campaign is run by the White Foundation. The Foundation was established in recognition of the need to raise awareness about the role of clinical trials in advancing medical science and healthcare.

Applications are now open for the Power of One 2021. The Foundation encourages applications that align with their annual research themes.  This year’s grant is related to INDIGENOUS HEALTH programs that are either:

• Research for curative medicine and preventive health programs; or
• Programs designed to support consumer and community awareness or engagement in clinical trials.

Further information on the campaign can be found on the White Coats Foundation website

CT:IQ is pleased to launch a series of use cases illustrating successful implementation of eConsent in Australia, aimed to be used as a guide for researchers and HRECs seeking to develop and implement eConsent.

In 2019, Chrysalis Advisory, on behalf of CT:IQ, undertook an investigation of stakeholder opinions about the benefits, risks and critical success factors for eConsent implementation, published in a 2019 report. A summary of this report has now been published as a perspective in the MJA.

Following on from this work, the need for use cases to demonstrate practical implementation of eConsent was identified and subsequently developed. The examples, which can now be accessed via the CT:IQ website, show that the use of eConsent is acceptable to HRECs and institutions and should be treated no differently to standard consent processes.

“Our review of use cases revealed that use of digital platforms clearly and unequivocally enhance the informed consent process and are equally if not more acceptable than traditional methods,” says Professor Nik Zeps from Chrysalis Advisory.

There are currently three use cases featured, including the Australian Genomics Health Alliance, Royal North Shore Hospital and Murdoch Children’s Research Institute that demonstrate:

• eConsent
• Dynamic consent
• eConsent for remote/telehealth study recruitment
• Use of video animations in clinical consent
• Paediatric Asthma Re-admissions Study

CT:IQ will continue to provide updates as the bank of use cases on the website grows over the next few months.

Bellberry is one of the four founding members and a proud supporter of CT:IQ.

Research Participant Welfare & Study Changes

As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants, and to support the continuation of on-going trials.

The following are suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations.

Participant communication
Your participants may be reluctant to attend trial visits in a hospital setting, or to a busy clinical practice, or to use public transport to reach you.  Your participants may have questions about how their trial will continue in light of any local outbreak.  In time, you are likely to have participants placed in self-isolation or quarantine.  Participants will undoubtedly have questions about what the emerging pandemic means for their trial participation.  Consider proactively supporting your participants with an FAQ or a helpline contact.  Establishing lines of communication will assist if further pandemic developments trigger additional changes in the coming weeks.

Access and continuity of supply
Consider how to assure ongoing access to trial products and any other items required for delivery of the trial protocol.  Consider whether participants might need a larger supply of investigational product to cover any period of uncertain access.  Consider whether and how that might be dispensed and delivered in a way that minimises risk to participants. Many sites will hear from Sponsors in the coming days and weeks, as they deploy their pandemic planning. Please speak to the HREC for support with amendments, violations or safety reports.

Protocol amendments or deviations
Where changes are anticipated, reach out early and proactively to discuss these with the HREC.  Some investigators are exploring a reduction in protocol-mandated study visits, use of remote consultations and alternative dispensing.  These can be documented proactively in an Amendment for the HREC to review or may be submitted as a Protocol Violation if more urgent changes are required for the safety of participants.

Possible amendments
As the situation is still developing, it may be appropriate to consider substantial changes for a “what if” scenario that might never occur.  In these circumstances, the HREC will consider scenario planning with anticipated changes, and articulation of when and how you would choose to deploy that amendment.  Bellberry HRECs will work with you to ensure sites can make changes in this volatile and rapidly changing environment. Consider submitting a ‘Plan B’ amendment now so that you’re pre-approved to move to new processes if and when you need to.

Participant monitoring
Consider the continuation of participant monitoring if quarantine or isolation measures are required.  Some sites already make use of remote technologies, which are likely to see broader use in the coming weeks.  If you are considering remote technologies you should check whether that method is appropriate and accessible to all participants.  Speak to the HREC about any amendments required.

Health system reprioritisation
Consider whether any location changes might be needed to support the ongoing monitoring of participants.  In some cases, alternative pathology pathways are being explored, along with alternative pharmacy arrangements.

Site screening and travel restrictions
Daily updates on countries considered at risk can be found at health.gov.au, along with advice for travel screening and access restrictions.  This list is changing frequently, so please ensure that you check in with it often.

Signatures
As the use of remote working takes hold, we are likely to see delays in getting hold of wet ink signatures.  Bellberry supports the use of electronic signatures and would encourage you to consider using them even if you haven’t before.

Pandemic Planning
In rapidly-changing scenarios such as the one facing Australia right now, decisions you make today may be out of date by tomorrow.  Consider putting time aside on an on-going basis to manage changes required as the situation develops.

Quality of documentation and reporting
We anticipate a large number of changes to current practice and approved protocols as this situation evolves.  Bellberry HRECs will support you to process amendments, violations and safety reports as they arise.  In such a rapidly-changing situation, it is critical that you keep good records to support compliant reporting.

Safety of trial participants
Participant safety is always our prime focus.  At a time like this, sites should be prepared to re-evaluate trial activities and discuss individual trial participation if the risk profile changes.

Sites running trials approved by Bellberry HRECs are encouraged to reach out early for support.

COVID-19: Considerations for Clinical Trials (327 downloads ) (printable pdf format)