Bellberry, the Company, has very carefully ensured it has no influence on the decision making of its Committees. The fees charged are for the review of a study, regardless of the outcome. Fees are determined by the Board and CEO and are managed separately to the Committees. The Committees do not see the financial statements of the Company and have no involvement in this facet of the business.
A fee is charged for providing a review of a research project. The review process starts when the investigator clicks ‘submit’. The study review fee is therefore committed to at that time.
New Protocols
The new protocol review fee funds the cost of:
- Any pre-submission assistance
- The initial HREC review
- Post approval, the ongoing review of minor amendments and other reporting, including:
- administrative changes (personnel updates, site name or address updates)
- PICF amendments
- updates to other participant documents such as recruitment and advertising material
- safety reporting
- serious breach notifications
- progress and final reporting
- site monitoring and desktop auditing
The following items incur fees post approval:
- Protocol amendment
- Investigator’s brochure amendment
- Substantial amendment
- Extension study
Review Outcomes
Fees are levied to cover the costs of providing the expert review, regardless of the outcome of that review. To be clear: Fees are charged for the review process, NOT the review decision. Fees remain payable in cases where a study has been rejected by the HREC.
Investigator-Initiated Studies
If you are an investigator funding your own research project, you may contact Bellberry to discuss fees that apply prior to your submission.
Complex Study Designs
In line with our commitment to providing a robust, high-quality, and efficient Human Research Ethics Committee (HREC) review, we allocate additional time for the Committee’s consideration of applications involving complex study designs, including master, umbrella, platform, basket, and adaptive designs. When these complex design studies include multiple protocols and investigator brochures in a single submission, the Committee will review the application across multiple agenda items during the HREC meeting. Consequently, the review fee is determined based on the phase of the included protocols and the number of agenda items under consideration.
We encourage researchers and sponsors to discuss their complex design study applications ahead of submission whenever possible.
Further information on Fees can be found in BA G6 Application Fees
Applications made via REGIS must include the REGIS submission HREC fee form. Further information on REGIS submissions can be found here
Current Fees (as of Jan 2024)*
| Item | Current Fee* (ex.GST) | Current Fee* (inc.GST) |
| New Protocol | ||
| New HREC Review Application | $6,250 | $6,875 |
| New Phase 1 HREC Review Application | $8,750 | $9,625 |
| Multi-centre Applications (per site) | $3,600 | $3,960 |
| Extension Phase and Lower Risk Studies | $3,600 | $3,960 |
| Exemption Letters | $1,000 | $1,100 |
| Major Amendment | ||
| Protocol Amendment (per submission) | $850 | $935 |
| Investigator Brochure Update (per submission) | $850 | $935 |
| Substantial Amendment | $6,250 | $6,875 |
| Minor Amendment | ||
| Administrative Change | Nil | Nil |
| PICF Amendment | Nil | Nil |
| Update to Other Participant Documents such as Recruitment and Advertising Material | Nil | Nil |
| Other Reporting | ||
| Safety Reporting | Nil | Nil |
| Serious Breach Notification | Nil | Nil |
| Progress Reporting | Nil | Nil |
| Final Reporting | Nil | Nil |
*Bellberry reserves the right to alter these fees.
Effective January 1, 2025, Bellberry’s fees will be adjusted in accordance with the Consumer Price Index (CPI) and will apply as follows:
| Item | Current Fee* (ex.GST) | Current Fee* (inc.GST) |
| New Protocol | ||
| New HREC Review Application | $6,500 | $7,150 |
| New Phase 1 HREC Review Application | $9,000 | $9,900 |
| Multi-centre Applications (per site) | $3,600 | $3,960 |
| Extension Phase and Lower Risk Studies | $3,600 | $3,960 |
| Multi-site Applications (ie Tele-health clinical trials – per site) | $250 | $275 |
| Exemption Letters | $1,000 | $1,100 |
| Major Amendment | ||
| Protocol Amendment (per submission) | $900 | $990 |
| Investigator Brochure Update (per submission) | $900 | $990 |
| Substantial Amendment | $6,500 | $7,150 |
| Minor Amendment | ||
| Administrative Change | Nil | Nil |
| PICF Amendment | Nil | Nil |
| Updating participant documents (e.g recruitment/advertising) | Nil | Nil |
| Other Reporting | ||
| Safety Reporting | Nil | Nil |
| Serious Breach Notification | Nil | Nil |
| Progress Reporting | Nil | Nil |
| Final Reporting | Nil | Nil |