Archives: <span>FAQs</span>
All HREC meeting are held virtually via Microsoft Teams. HREC members are required to have a computer with a good internet connection.
Proposals and supporting materials are distributed 12 calendar days before each meeting, giving you time to review everything in advance.
Any post-meeting or ongoing items should be actioned within 48 hours. Outcomes and any follow-up are managed through Bellberry’s secure online portal, so everything stays in one place.
Your privacy is taken seriously when you participate in a clinical trial. Researchers must follow strict laws, ethical guidelines, and security procedures to protect your personal information.
Your information is kept confidential
Your personal details, such as your name, address and contact information, are kept confidential. In most studies, you are identified by a participant number or study code rather than your name.
Access is restricted
Only authorised individuals can access your identifiable information, including:
- The study doctor and research team
- Human Research Ethics Committees (HRECs), if required for monitoring
- Regulatory authorities, if required for oversight or auditing
All are required to comply with strict privacy and confidentiality requirements.
Your data is stored securely
Study information is stored in secure systems, such as locked filing cabinets or password-protected databases. These systems are designed to prevent unauthorised access, loss, or misuse of your information.
Study results do not identify you
When study findings are shared or published, your personal information is removed. The results are reported using de-identified, anonymised data, so you cannot be personally identified.
Legal and ethical protections apply
Clinical trials must comply with privacy laws and ethical guidelines. In Australia, this includes the Privacy Act and national health research guidelines. All clinical trials must also be reviewed and approved by a Human Research Ethics Committee (HREC), which helps ensure your rights, safety, and privacy are protected.
You will be informed before you consent
Before joining a study, you will receive a Participant Information and Consent Form (PICF) explaining:
- What information will be collected
- How it will be used and stored
- Who it may be shared with
You are encouraged to ask questions and make sure you understand this information before deciding whether to participate.
You can withdraw from a clinical trial at any time, for any reason, without penalty. Taking part in a clinical trial is entirely voluntary, and you do not have to explain your decision if you choose to leave.
Let your study team know
Tell your study doctor, study coordinator, or research nurse that you wish to withdraw. While they may ask why you are leaving, giving an answer is optional; you are not required to provide a reason.
Your participation will end
You will stop receiving the study treatment and no longer need to attend study visits. In some cases, the study team may ask if you are willing to come in for a final safety assessment.
Your safety remains a priority
Depending on the study and your health situation, the study doctor may recommend follow-up care or monitoring to help ensure a safe transition out of the trial, especially if stopping suddenly could affect your health.
Information already collected may still be used
Data collected before you withdraw will usually remain part of the study and may be used in the final analysis, as outlined in your Participant Information and Consent Form (PICF). Some studies may ask for permission to continue collecting information from your medical records, but you can choose whether or not to allow this.
Your regular healthcare will not be affected
Choosing to withdraw from a study should not affect your access to regular medical care or your relationship with your healthcare providers.
If you experience any problems during your clinical trial, contact your study team. They are there to support you, answer your questions, and help ensure your safety throughout the study.
- Study doctor — Your main medical contact for any health concerns, side effects, or questions about the study treatment.
- Study coordinator or research nurse — Often your first point of contact for practical questions, study-related concerns, or reporting issues.
- 24/7 or after-hours contact number — Most clinical trials provide an emergency contact number on your Participant Information and Consent Form (PICF). Use this if you need assistance outside normal business hours.
In urgent situations: If you have a serious or life-threatening medical issue, call emergency services immediately rather than waiting to contact the study team.
For non-medical concerns: If you have a complaint about the study or concerns about your rights as a participant, contact the Human Research Ethics Committee (HREC) using the details provided on your Participant Information and Consent Form (PICF). For more information, view our Complaints page.
If you experience a reaction to a study drug, contact your clinical trial team (study doctor, study coordinator or research nurse) immediately using the information on your Participant Information and Consent Form (PICF). They can assess your symptoms, provide advice, and ensure you receive appropriate care.
In an emergency
If you experience a serious reaction — such as difficulty breathing, chest pain, severe swelling or rash, or loss of consciousness — call emergency services immediately rather than waiting to contact the study team.
It is important to report any side effects or reactions, even if they seem minor, as this information helps researchers monitor the safety of the study treatment.
Bellberry’s Human Research Ethics Committees provide independent ethical oversight for human research across Australia.
We don’t run studies or recruit participants. Instead, our committees review research proposals and clinical trials to ensure they meet national ethical standards and prioritise participant safety.
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Bellberry’s goal is to provide high-quality and timely review. From the Wednesday submission closing date, applications are usually allocated to an HREC meeting within two weeks. The committee aims to return its decision within approximately 20 working days of submission (excluding any time the application spends back with the investigator for clarifications). This turnaround is recognised as one of the fastest in Australia and supports swift study start-up while maintaining rigorous ethical oversight
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