Waiver of Consent by a Melbourne Health HREC

Waiver of the Requirement for Consent in Accordance with Sections 2.3.5 – 2.3.8 of the NHMRC National Statement on Ethical Conduct in Human Research 2007

In accordance with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research 2007 (National Statement), sections 2.3.6 – 2.3.8, the Institution’s Human Research Ethics Committee (HREC) waived the requirement for consent for the collection, use and/or disclosure of personal information in medical research or personal health information for the projects listed below.

In reaching the decision to waive the requirement for consent, the HREC considered and applied sections 2.3.6 and 2.3.7 of the National Statement and one or more of the:

(a)   Statutory Guidelines on Research issued under section 22 of the Health Records Act 2001 (Vic) http://www.health.vic.gov.au/hsc/downloads/guideres.doc;

or

(b)   Guidelines approved under section 95A of the Privacy Act 1988 (Commonwealth) http://www.nhmrc.gov.au/publications/synopses/e43syn.htm;

or

(c)   Guidelines approved under section 95 of the Privacy Act 1988 (Commonwealth) http://www.nhmrc.gov.au/publications/synopses/e26syn.htm, as applicable.

Waiver of Consent for Reporting Period:  01 January 2009 – 31 December 2009

2009.098 - Australian Cardiac Procedures Registry (ACPR)   2009.103 - Perioperative Epidural Analgesia for Major Abdominal Surgery and Incidence of Late Cancer Recurrence   2009.113 - Prospective Study of Clinical Outcomes and Analysis of Bevacizumab use in Metastatic Colorectal Cancer   2009.134 - Is there a relationship between serum troponin and clinical outcome in patients with an acute exacerbation of chronic obstructive airways disease? A pilot study.   2009.152 - Cardiac rehabilitation attendance reduces long-term mortality after acute cardiac events   2009.153 - Laboratory confirmed pandemic influenza A (H1N1), Victoria 2009: a case series including validation of vaccination status   2009.200 - Adaptation and implementation of Clinical Guidelines which Support Melbourne Health’s Smoke Free Procedure for Admitted Patients.   2009.205 - Measuring Outcomes in Rehabilitation following Hip and Knee Arthroplasty: Developing and Validating a Tool based on the International Classification of Functioning, Disability and Health (ICF) Comprehensive Core Set for Osteoarthritis (OA)   2009.206 - Chemotherapy Administration within 30 days of death- a 5 year audit of 4 major tertiary hospitals   2009.229 - Intra-dural spinal cord tumours: clinical presentation and outcome

Waiver of Consent for Reporting Period:  01 January 2008 – 31 December 2008

2008.077 -  Retrospective Study of Ultra-early Treatment of Acute Subarachnoid Haemorrhage   2008.082 -  IV droperidol and olanzapine as adjuncts to midazolam for the acutely agitated patient in the Emergency Department: a multicentre, randomized, double-blind, controlled trial.    2008.093 -  Radiology Assessment of Senile Lymph Nodes in the Head and Neck    2008.114 -  The impact on age specific immunity to VZV after the introduction of varicella vaccination to the National Immunisation Program Schedule in Victoria, Australia.    2008.173 -  How do treatment timing and modality affect clinical outcome in patients presenting with grade IV or V Subarachnoid haemorrhage?    2008.177 -  Retrospective study of the Incidence of the “Lazarus Phenomenon" among acute ischaemic stroke patients treated with intravenous tissue Plasminogen Activator, and its association to Time to Treatment and Clot Burden.

 

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