Guidance and Resources
Access policies, templates and checklists to help prepare your submission and manage your study through the Human Research Ethics Committee (HREC) review process — from pre-submission planning to post-approval monitoring.
Pre-approval resources
Resources to help you prepare and submit your application for HREC review.
General guidance
Guidance on types of submissions and the regulatory documents required.
Review Pathways – Higher Risk & Lower Risk Research
Ethical review pathways, lower and higher risk review, review requirements, processes, and timelines
HREC Application Review Flowchart
Step‑by‑step overview of the HREC review process
Conflict of Interest Guidance
Guidance for identifying, disclosing, and managing actual, perceived, or potential conflicts of interest
CVs & Investigator Qualifications
Requirements for evidence of suitability to conduct a research proposal in investigator CVs
Insurance & Indemnity Guidance
Insurance and indemnity requirements for all research proposals submitted to the Bellberry HREC
Medicines Australia Clinical HREC Indemnity 1 October 2012
Medicines Australia HREC Indemnity template prefilled with Bellberry details
MTAA Device HREC Indemnity 10 April 2024
MTAA HREC Indemnity template prefilled with Bellberry details
Bellberry Non-Clinical HREC Indemnity
HREC Indemnity template that can be used for non-clinical research studies
TGA CTN & CTA Schemes
Guidance for appropriate regulatory (TGA) pathway, includes Bellberry CTN contact details
Application Fees
Fees for new submissions, amendments, extension studies, and ongoing oversight
Taking over ethical oversight checklist
Considerations for new applications that have been approved by another HREC
Guidance for specific study designs and products
Specific guidance for different types of study design
Extension Study Application Guidance
Ethical considerations, requirements, and approval conditions for extension (open‑label extension/roll‑over) studies
Multi-Stage Phase 1 Application Guidance
Ethical considerations, submission requirements, and approval conditions applied by Bellberry HRECs when assessing multi‑stage Phase 1 clinical trial designs
Post Marketing/Observational Application Guidance
Guidance for determining if a study qualifies as a post‑marketing (observational) study and what ethical review requirements apply
Cannabis Product Application Guidance
Ethical review requirements, supporting evidence required, and documentation considerations for studies involving cannabis‑related products
Psychedelic Drug Application Guidance
Ethical and regulatory considerations for clinical studies involving psychedelic drugs
Getting started with eProtocol
Step-by-step resources to help you register your eProtocol account and submit your research for review.
eProtocol Registration Guidance
How to register for access to the eProtocol submission platform
Organsational Verification of Personnel (OVOP)
Form required to be completed when registering in eProtocol for an organisation
eProtocol Navigation Guide
Step-by-step guide for navigating, completing, and submitting applications in eProtocol
eProtocol Application Content
eProtocol application questions for a new study submission
Submission Requirements & Responsibilities
New, post-approval and multi-centre submission requirements and associated communication requirements with Bellberry
Submission Requirements Checklist
List of documents and submissions required for the initial application and throughout the life of the study
Application for Lower Risk Review
Form required to be completed and attached into the eProtocol application when applying for review via the lower risk pathway
NSW Health Early Phase Clinical Trial (EPCT) applications
Submission pathways, forms and checklists for NSW EPCT submissions.
NSW Health EPCT Submission Pathways
Submission pathways for NSW Health Early Phase Clinical Trial (EPCT) study applications
REGIS Application Checklist
Form required to provide additional information for NSW Health EPCT new study applications submitted via the REGIS submission platform
REGIS Submission Fee Form
Form required for NSW Health EPCT new study applications submitted via the REGIS submission platform
Protocol development
Resources to help you prepare your clinical and non-clinical protocols.
Participant Information & Consent Form (PICF) development
Resources to help you prepare clear, compliant participant information and consent documentation.
PICF Submission Pathways
Flowchart describing Participant Information and Consent Form (PICF) submission pathway options
Participant Information & Consent Form Development
Guidance for Bellberry HREC required language, wording, requirements, separate consent forms, non-English speaking participants, use of photography, and electronic consenting
CT:IQ InFORMed PICF Template
The InFORMed Project template has been developed to support a participant-centred, simplified, national PICF.
Site-Specific Clauses Document Template
Template and instructions for site‑specific additions, deletions, or replacements to the approved Master PICF
Compensation for Injury Standard Clauses
Bellberry approved compensation wording to be included in PICFs
Confidentiality & Privacy Standard Clauses
Bellberry standard wording for inclusion in PICFs
Participant Payment & Reimbursement Guidance
Bellberry HREC requirements for participant payments and reimbursements
Pregnancy & Sexual Health Guidance
Guidance for designing and conducting studies that involve pregnancy and sexual health considerations including contraception, consent, and reproductive risk management
Pregnancy & Sexual Health Standard Clauses
Bellberry approved wording for pregnancy, contraception, fertility risks, and reproductive health considerations in PICFs
Pregnancy & Pregnant Parner Data Release Template
Template for obtaining consent from a pregnant participant or a pregnant partner for follow up of a pregnancy, birth and health of a child
Researcher Data Storage & Retention Guidance
Bellberry HREC requirements for the management of research data
Ionising Radiation Guidance
Requirements for research involving ionising radiation including when a medical physicist report is required
Ionising Radiation Standard Clauses
Required wording to be included in PICFs to inform participants about ionising radiation exposure, associated doses, risks, and benefits
Radiation Standard of Care Declaration Template
Template that can be used to notify the HREC that ionising radiation is routine standard of care and not additional to what participants would otherwise receive
Third Party Consent Form Template
Template for recording informed consent from a parent, legal guardian, or legally authorised representative when third‑party consent is required
Revocation of Consent Form Template
Template for participant withdrawal of consent from a research project
Advertising requirements
Guidance for advertising your study, including social media and media coverage.
Post-approval resources
Resources to support the ongoing management of your study following HREC approval.
Post-approval submissions
Forms and guidance to help you prepare and submit amendments and progress reports, and safety manage breaches.
Amendment Guidance
Guidance for submission of amendments to approved research projects and documents
Amendment Form eProtocol Questions
eProtocol application questions for an amendment
Change of Principal Investigator Form
Optional form to notify the HREC of a change in Principal Investigator for an approved study (an amendment)
Safety Reporting Guidance
Requirements for safety monitoring and reporting to the HREC for approved research
Safety Report Form (AER) eProtocol Questions
eProtocol application questions for safety reports
Serious Breach Guidance
Guidance for identifying, assessing, and reporting serious breaches and serious or continuing non-compliance to the HREC
Serious Breach (PVR) eProtocol Questions
eProtocol application questions for serious breach reports
Serious Breach Report Form – Sponsors
Form for sponsors to report a serious breach or to provide follow‑up information on a reported breach to the HREC
Serious Breach Report Form – Third Party
Form for third parties to report serious breaches directly to the HREC without submission via eProtocol
Progress & Final Report Guidance
Guidance for submission of Progress and Final Reports to maintain, extend, or close ethical approval
Progress Report Form eProtocol Questions
eProtocol application questions for progress reports
Final Report Form eProtocol Questions
eProtocol application questions for final reports
Batch Submissions Guidance
Guidance on when and how to request HREC processing of an amendment or notification that applies to multiple studies through Bellberry Administration
Batch Submission Application
Form to request and provide authorisation for batch submission processing
External Auditing
Describes Bellberry's responsibilities for site monitoring and how audits are conducted
Withdrawal or Suspension of Ethical Approval
Guidance on the circumstances under which ethical approval for approved research may be suspended or withdrawn, and outlines required actions when this occurs
Delegation of Responsibility Template
Template for documenting the delegation of study-related responsibilities
Policies and Terms of Reference
Key governance documents and policies that inform the review process, including how complaints are handled.
Complaints
Bellberry policy for receiving, managing, and resolving complaints related to HREC review, a Bellberry approved research study or other issues
Bellberry Research Policy
Outlines Bellberry’s commitments and requirements for how our HRECs review and oversee human research to ensure compliance with applicable ethical standards, legislation, and national guidelines
HREC Terms of Reference
Defines the purpose, scope, governance, membership, and operating procedures of Bellberry HRECs to ensure independent, ethical review and ongoing oversight of human research
TGA CTN & CTA Schemes
Bellberry HRECs review research trials using an unapproved investigational product under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) Schemes.
TGA CTN & CTA Schemes — Guidance for appropriate regulatory (TGA) pathway, including Bellberry CTN contact details.
Answers to common queries
The Medicines Australia Standard Form of Indemnity and HREC Review Only Form of Indemnity can both be found at the Medicines Australia website along with the Clinical Trials Compensation Guidelines.
Bellberry does not require the submission of Standard Indemnities — information on Bellberry’s requirements for HREC Only Indemnities can be found in Insurance and Indemnities.
When registering for eProtocol for the first time, you’ll be asked to create a user ID. We recommend using your surname followed by your first name initial — for example, SmithJ. See our Registrations Guidance for more information.
Our typical turnaround is around 21 working days from submission to decision. Meetings are usually held weekly on Wednesdays, with the committee’s decision and any comments communicated via eProtocol within two business days following the meeting.
For more information, refer to Submission requirements and responsibilities.
Still have questions? We’re here to help.
Browse our full FAQs page or contact us for more guidance and information.
How to Apply
Understand the full application process from start to finish. This step-by-step guide shows you how to register, prepare documents, and submit your study for review.
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Multi-Centre Trials
Learn how Bellberry provides a single ethics review for studies running across multiple sites. Our streamlined approach reduces duplication and accelerates national research start-up.
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Our Fees
Review the current schedule of fees for new applications, amendments, and multi-centre studies. Transparent pricing helps you plan and budget with confidence.
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Ready to start or need advice?
If you’d like to speak with a Bellberry team member about your study or need help preparing an application, our customer service specialists are here to assist.
