The National Statement on Ethical Conduct in Human Research (National Statement) offers a structured approach for Human Research Ethics Committees (HREC) to evaluate the appropriateness of waiving consent.
The National Statement helps HRECs determine the appropriateness of waiving consent, assesses whether the merits and benefits justify such a waiver, and ensures that researchers have established adequate procedures to safeguard participants' rights to privacy and confidentiality.
The right to provide informed consent for participation in research is crucial for upholding an individual's autonomy and dignity. However, in certain research scenarios, obtaining consent may not be feasible. This could be due to the age of records, characteristics of the cohort, or other factors. In such cases, researchers may seek approval from a Human Research Ethics Committee (HREC) to waive the consent requirement.
While conducting research without informed consent may initially seem to infringe upon fundamental rights, with appropriate safeguards in place, it can lead to significant benefits for the public and specific groups who are unable to provide consent. However there is a low public tolerance for using information or material without consent, and any such actions must be justified.
Projects granted a waiver by the RMH HREC
|
Local Project ID |
Study title |
|---|---|
| 2024.219 | Long-Term follow-up of Study 32: an open-label single-arm Phase IIb study of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in patients lacking suitable alternative treatment options |
| 2024.208 | A Multi-center, Retrospective Review of Invasive Aspergillosis Case |
|
2023.049 |
VEDOLIZUMAB Transmural Remission, Clinical Outcomes and Safety in Crohn’s Disease Patients: A Magnetic Resonance Enterography (MRE) Observational Study |
|
2021.230 |
The PROSPECT project (PROmoting Sexual health in young PEople with mental ill-health): Clinical feasibility Trial |
|
2021.122 |
Presentation, management and outcome of Cryptococcus infections: A multicentre retrospective study focusing on patients without HIV infection. |
| 2021.095 | External Validation of IMPACT - Incidental Meningioma: Prognostic Analysis Using Patient Comorbidity and MRI Tests |
|
2020.217 |
Structure and Function of mutation-specific cardiomyocyte lines from patients with Fabry disease: 2D and 3D in-vitro models toinvestigate disease and response to therapy in Fabry cardiomyopathy |
|
2019.133 |
A Phase II randomised, double-blind, placebo-controlled trial of S-Adenosyl Methionine in participants with mild cognitive impairment or dementia due to Alzheimer’s disease |
|
2019.114 |
Bipolar at-risk prospective study: A long term follow-up |
|
2018.313 |
An inception cohort study to determine feasibility of measuring sleep, proportion of patients with a new sleep disorder, and sleep changes over time during critical illness and recovery |
| 2018.216 | The clinical significance of sub threshold versus full threshold Borderline Personality Disorder pathology in young people |
| 2018.011 | The influence of contextual factors on mothers when breastfeeding a late preterm infant within a Special Care Nursery |
|
2017.453 |
The effect of glycine on plasma glycine and muscle histopathology, structure and function in the critically ill |
| 2017.192 | Evaluation of the enhanced kangaroo feeding tube with IRIS technology for post-pyloric placement in critically ill patients: A prospective multicentre international cohort study |
|
2016.195 |
Physical activity and depression: An ecological momentary assessment study with young people |
|
2015.145 |
A single arm, open-label, phase I study to evaluate the safety and tolerability of ISC-hpNSC injected into the striatum and substantia nigra of patients with Parkinson’s disease |
|
2014.254 |
Assessing Predictive and Prognostic Molecular Biomarkers in Prostate Cance |
|
2013.146 |
The Horyzons trial: Moderated Online Social Therapy for maintenance of treatment effects from specialised first-episode psychosis services |
| 2011.159 | Nurse practitioner TIA outpatient assessment and management, Part 1: Patient satisfaction and emotional recovery |
| 2010.011 | National Survey of High Impact Psychosis (SHIP) |
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.