Download HREC Waiver of Consent in accordance with sections 2

Waiver of Consent
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
Reporting Period: 01 January 2008 – 31 December 2008
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.
HREC Number
2008.082
Project Title
IV droperidol and olanzapine as adjuncts to midazolam for the acutely agitated patient in
the Emergency Department: a multicentre, randomized, double-blind, controlled trial.
Brief Plain English Summary
Symptoms of acute agitation include restlessness, excessive responses to stimulus and
inappropriate verbal or physical activity. If not managed promptly, agitation may
progress to aggression and violence posing a risk to the safety of the individual and
others. In the Emergency Department (ED), the goal of managing the acutely agitated
patient is safe and rapid control of aggressive or violent behaviour that allows the
underlying illness to be investigated. Techniques include ‘talking the patient down’,
physical (shackling) and chemical (drug) restraint.
Traditionally, two classes of medicine have been commonly used to sedate the acutely
agitated ED patient - benzodiazepines (e.g. midazolam) and antipsychotics (e.g.
droperidol). There is interest in a new antipsychotic medication (e.g. olanzapine) due to
reportedly fewer side effects (e.g. movement disorders) compared with older
antipsychotics. Although olanzapine is marketed for intramuscular (IM) use, it is
administered intravenously (IV) in the ED. Benzodiazepines (e.g. midazolam) are highly
effective for rapid sedation although may be associated with respiratory difficulties and
the requirement for re-sedation. Because of this, it is common ED practice for droperidol
or olanzapine to be administered IV with IV midazolam. Such combinations are thought
to sedate the patients quickly, require lower total drug doses, induce fewer side effects
and have less need for re-sedation. However, there is no evidence to support these
contentions. In addition, the safety of IV droperidol and olanzapine, as adjuncts to IV
VMIA Research Governance Framework Project v_14_10_08
midazolam, has not been compared.
The aim of this project is to determine the safety and efficacy of IV droperidol and
olanzapine, as adjuncts to sedation with IV midazolam, for the sedation of the acutely
agitated patient in the ED. The methodology is designed to reflect what occurs in clinical
practice presently. Patients in three Victorian Emergency Departments experiencing
acute agitation (resulting from either substance abuse or mental illness) will be given one
of three combinations of treatments: droperidol and midazolam, or olanzapine and
midazolam, or midazolam alone. By examining these treatments, we can compare the
time it takes for sedation, side effects and the difference between using combination and
sole therapy. We also aim to explore the resource implications associated with these
combinations. The findings will provide valuable evidence upon which the development of
acute sedation guidelines in the ED can be based.
VMIA Research Governance Framework Project v_14_10_08