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 |
|---|---|
|
2023.111 |
Trodelvy use in advanced triple negative breast cancer in Australia (TRACIE) |
|
2022.171 |
Sprint National Anaesthesia Project 3: An observational study and audit of frailty, multimorbidity and delirium in older people in the perioperative period (Australasian Arm) |
|
2021.353 |
Prospective, randomized, parallel group, electronic medical record-embedded, clinical trial to determine whether the enteral route is non-inferior to parenteral phosphate replacement in critically ill patients with mild to moderate hypophosphatemia |
|
2021.237 |
Exploring discharge barriers for NDIS patients: a mixed methods study |
|
2021.189 |
Prevalence and clinical outcomes of KRASG12C mutated advanced lung cancer patients in Australia |
|
2021.122 |
Presentation, management and outcome of Cryptococcus infections: A multicentre retrospective study focusing on patients without HIV infection. |
|
2020.341 |
Australian Vinorelbine use in advanced lung cancer (AVAL) |
|
2020.330 |
A pilot, open-label, randomised controlled clinical trial to investigate early efficacy of CYP-001 in adults admitted to intensive care with respiratory failure |
|
2020.009 |
Developing a sensitive case definition for invasive fungal infections |
|
2019.356 |
Patients with advanced TRIple Negative breast cancer in Australia |
|
2019.285 |
Leveraging data linkage to optimise the utility of administrative coding data for detection of cytomegaloviral infection, invasive fungal disease and Staphylococcus aureus bacteraemia in haematology-oncology patients and allogeneic-haematopoietic stem cell transplantation recipients: 2010 - 2017 |
|
2019.182 |
Improving patient and GP information and communication with an Electronic Care Plan |
|
2019.143 |
Kisqali access registry for metastatic breast cancer in Australia |
|
2019.114 |
Bipolar at-risk prospective study: A long term follow-up |
|
2019.102 |
Exploring the factors that influence screening for strongyloides stercoralis prior to immunosuppression: A mixed-methods analysis |
|
2019.084 |
Evaluation of the Adaptation and Impact of SAFEWARDS in 3 emergency departments |
|
2018.321 |
A Phase 2a, single-blind, placebo-controlled safety and efficacy study of two doses of NRP2945 in patients showing drug-resistant typical absence epilepsy as a form of their genetic, generalized epilepsy pattern |
|
2018.283 |
Exogenous vitamin B1 (thiamine) administration in enterally-fed critically ill patients with hypophosphatemia |
|
2018.198 |
Evaluating the uptake of the ‘My Gym’ program and exploring perceptions of physiotherapy and exercise in a neurological rehabilitation population: a mixed-methods study |
|
2018.179 |
A new ECG configuration to improve the diagnostic accuracy of idiopathic outflow tract ventricular arrhythmias |
|
2018.128 |
Road to recovery: Supporting patients undergoing curative upper gastrointestinal surgery with an optimal nutrition care pathway. A feasibility pilot study. |
|
2018.043 |
Tenecteplase versus alteplase for stroke thrombolysis evaluation trial in the ambulance (TASTE-A) |
|
2018.041 |
Screening for prevalence of illicit toxins in Emergency Department Trauma (SPiT-T): An observational study |
|
2017.373 |
Evaluation of safety and efficacy of BIS-001ER for the treatment of adult focal impaired awareness seizures (FIAS) |
|
2017.361 |
Feasibility of utilising routinely collected clinical specimens for monitoring the impact of HPV vaccination in young women |
|
2017.308 |
Comic relief: Targeting social anxiety in first-episode psychosis. |
|
2017.294 |
DM199-2017-001: A randomized, double-blind, placebo-controlled phase II multi-center evaluation to assess the safety and tolerability of DM199 administered intravenously and subcutaneously in subjects with acute ischemic stroke (ReMEDy Trial) |
|
2017.279 |
Improving service knowledge and access among older people from culturally and linguistically diverse (CALD) backgrounds with dementia |
|
2017.270 |
Evaluation of the Tapestry program at Royal Freemasons |
|
2017.195 |
Improving Palliative Care education and training using simulation in dementia (IMPETUS-D) |
|
2017.151 |
Idarucizumab drug administration surveillance program: Evaluation of use of idarucizumab in a clinical practice setting. |
|
2017.150 |
Interobserver variation in scoring colon capsule endoscopy in Crohn’s Disease |
|
2017.129 |
A review of current clinical practice of restrictive interventions within Victorian emergency departments |
|
2017.115 |
Autoimmune encephalitis: A retrospective analysis from multiple centres in Victoria. |
|
2017.073 |
Effectiveness of interdisciplinary management for chronic pain in multiple sclerosis and central neurological disorders: A retrospective study |
|
2017.044 |
Evaluating the efficacy and efficiency of an Early Supported Discharge program for stroke survivors compared with standard care in a public health setting in the western suburbs of Melbourne. |
|
2016.307 |
Reducing the burden of dialysis catheter complications: A national approach |
|
2016.201 |
An open label, multicenter, safety and pharmacokinetic study of YKP3089 as adjunctive therapy in subjects with partial onset seizures |
|
2016.181 |
Screening for prevalence of illicit toxins in the Emergency Department: an observational study. |
|
2016.134 |
Strategies for relatives on-line |
|
2016.127 |
A multicenter, global, retrospective, observational study to characterize real-world clinical outcomes in patients with relapsing-remitting multiple sclerosis treated with disease-modifying therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®) (EFFECT) |
|
2016.113 |
A Study of the Incidence of Pancreatobiliary Disease in Fiji: A Retrospective Audit |
|
2016.101 |
Experiences of engagement with early intervention services for first episode psychosis: a longitudinal qualitative study |
|
2016.091 |
Purpose-built LGBTI aged care facilities: What do older LGBTI consumers and potential staff want? |
|
2016.086 |
The role of interpersonal schema in the experience of auditory hallucinations in borderline personality disorder |
|
2016.077 |
Training residential care staff to respond more effectively to behavioural and psychological symptoms of progressive neurological diseases |
|
2016.029 |
Patients’ perceptions and experiences of therapeutic sedation during a behavioural emergency in the Emergency Department: A qualitative exploratory study |
|
2016.021 |
Longitudinal 10 year follow up of chronic pain in persons with multiple sclerosis in the community. |
|
2016.017 |
Using robots to improve the care of people with younger-onset dementia |
|
2016.011 |
Impact of multiplex random access respiratory array testing versus batch testing on health service outcomes: a prospective quality assurance project. |
|
2015.312 |
Does dietary sugarcane fibre supplement improve blood sugar control and bowel dysfunction in adult diabetic subjects? |
|
2015.309 |
A feasibility and protocol compliance pilot randomised trial of the effect of preoperative focused cardiac ultrasound (FCU) on mortality, cardiovascular morbidity and health care costs after surgery for fractured neck of femur (hip fracture) |
|
2015.279 |
Prevalence and molecular virology of hepatitis D virus in Victoria |
|
2015.276 |
A phase III double-blind, randomized, parallel group, multicentre placebo-controlled trial to study the efficacy and safety of Caplacizumab in patients with acquired thrombotic thrombocytopenic purpura |
|
2015.269 |
Implementation of the Model Disability Survey in people from various cultural backgrounds in a developed country |
|
2015.205 |
Molecular diagnosis to improve diagnostic sensitivity of standard techniques for identification of peripheral lung cancer |
|
2015.197 |
Evaluation of an accelerated diagnostic pathway for Emergency Department management of chest pain |
|
2015.196 |
Post discharge opioid use in surgical patients |
|
2015.183 |
National Guidelines for Spiritual Care in Aged Care |
|
2015.160 |
An open-label, multicenter extension study to evaluate the long-term safety and efficacy of Lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy |
|
2015.159 |
a double-blind, randomized, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of Lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy |
|
2015.147 |
Drug detection dog program evaluation at NorthWestern Mental Health |
|
2015.143 |
Emergency Department utilization by people receiving chemotherapy: an exploratory study of Emergency Department access and quality of care |
|
2015.118 |
Ventilator associated events in a Victorian tertiary intensive care unit: Incidence, risk factors, biomarker profile, morbidity and mortality |
|
2015.048 |
Targeted full energy and protein delivery in critically ill patients (FEED): A pilot randomised control trial |
|
2014.276 |
A multicenter, double blind, randomized, placebo-controlled trial to determine the efficacy and safety of Ganaxolone as adjunctive therapy for adults with drug-resistant partial-onset seizures followed by long-term open-label treatment |
|
2014.262 |
EXTEND-IA TNK: Extending the time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial using intravenous Tenecteplase - A randomized, controlled trial of Tenecteplase versus Alteplase before intra-arterial reperfusion therapy within 4.5 hours of stroke onset |
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.