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
2019-03-254 PACIFIC-R: First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy – D4194R00005
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.
2022-11-1292 DISCOVERY HCV – Identifying Undiagnosed People with Hepatitis C Virus by Applying a Machine Learning Prediction Algorithm to Electronic Medical Record Data: An Australian Pilot
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
2023-11-1350 Retrospective chart review of Clareon Toric Intraocular Lens Outcomes (ILS241-RA1)
2023-11-1356 Meijer and Reference Validation Evaluation Project
2023-11-1427 The epidemiology, management, and the associated burden of migraine in Australia

C4951065

2023-12-1542 Antipsychotics prescription patterns in Australia (ARIEL)
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.
2024-02-229 Insomnia management in Australian pharmacies: A simulated patient study
2024-03-267 NSW Engagement and Support Program Evaluation
2024-03-407 OBESITY-AUS: Observational study of clinical characteristics, treatment patterns and outcomes in high-risk patients with obesity in Australia – a chart review (2023-13166)
2024-06-759 Multi-scanner diagnostic accuracy study of a software tool assisted with a deep-learned algorithm for the automatic evaluation of liver fat fraction using magnetic resonance imaging. (PRO-4)
2024-06-792 Prevalence of pelvic floor myalgia, pelvic floor tension myalgia and associated symptoms in adult women presenting with symptoms suggestive of endometriosis.
2024-08-1003 MIND-AUS: Observational study of Alzheimer’s disease patient characteristics, disease progression and treatment patterns in Australia – a chart review (2023-13155)
2024-08-996 Observational Study to Describe the Current Pathology Practices and the Utilization of Computational Pathology Algorithms in Patients Diagnosed with Breast Cancer (CASCADE)
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