eProtocol

Waiver of Consent Listing

In accordance with the National Health and Medical Research Council (NHMRC) guidelines, Bellberry Limited is committed to upholding the highest standards of ethical conduct and transparency in research.

One key requirement is the publication of a list of studies where a waiver of consent has been granted. This ensures accountability and provides the public with visibility into research activities conducted without direct participant consent, as allowed under specific ethical conditions. The waiver of consent process applies to research where obtaining individual consent is impracticable, and the research aligns with NHMRC principles, including respect for individuals, beneficence, and justice.

HREC ID Study Title
2018-11-1008 Carolyn Trial/ENG 9: A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying α-galactosyl ceramide (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate
2019-12-1141 The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)
2020-06-533 Automated methods for evaluating cardiac computed tomography angiography
2021-03-259 OPT-CLI-023 Optimus CTB Non-Inferiority Analysis Protocol.
2023-04-449 AA-001: Evaluation of an artificial intelligence system for opportunistic detection of osteoporosis on chest radiographs
2023-07-881 OPT-CLI-054 – Performance validation program for a computed tomography of the chest artificial intelligence module (Annalise CTC module)
2023-08-970 Clinical Validation of Australian Human Papillomavirus Assay Project
2023-08-984 OPT-CLI-007: A retrospective, non-inferiority data analysis comparing standalone CXR AI module and unaided radiologist detection accuracy for chest x-ray findings in a non-clinical setting.
2023-09-1139 Analysing the Crohn’s Colitis Care De-Identified Clinical Quality Registry Data Registry: Improving Care and Finding Cure for Inflammatory Bowel Disease
2023-10-1254 OPT-CLI-121 A retrospective, standalone model performance evaluation of CXR AI module detection accuracy for suspected tuberculosis
2023-10-1269 ACCELERATE: PerformAnCe and outComes of tEchnoLogical advancEments in RadiAtion medicine: mulTi-cohort retrospective Evaluation
2023-11-1356 Meijer and Reference Validation Evaluation Project
2023-12-1550 Characteristics and treatment patterns of heart failure patients in Australia: CHEERS study
2023-12-1555 AVE-CSS-2023-0721 Analysis of the use of avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma (UC) in Australia.
2024-06-766 Evaluating novel biomarkers for the diagnosis of IPF
2024-09-1157 Retrospective Clinical Evaluation of Dose Review as decision support for offline Adaptive Radiotherapy
2024-09-1162 A Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 as Adjunctive Therapy in Focal Epilepsy
2024-10-1432 OligoPCa: Retrospective analysis of outcomes following stereotactic body radiation therapy for oligometastatic prostate cancer
2025-03-304 Validation of Blood-Based microRNA Signatures for Breast and Ovarian Cancer
2025-03-377 Validation of MetaPanel, a Metagenomics-based Gastrointestinal Infectious Disease Assay
2025-03-409 Study comparing pathologists HER2 scoring of breast IHC slides when supported by the Ibex Breast HER2 AI-powered solution versus the standard of care
2025-04-571 Inner West Neurology Neurophysiology Database
2025-05-767 An Outcome Evaluation of the NSW Justice Advocacy Services Diversion Program
2025-07-1122 Analysis of MetaPanel In-Market Data
2025-08-1286 23084: Treatment patterns and characteristics of patients receiving Androgen Receptor Pathway inhibitors in a real-world setting in Australia: A retrospective prescriptions data study (TARA)
2025-09-1426 SDBioHPV01: Clinical Evaluation of STANDARD M10 hr-HPV assay

Last updated 01/12/25