Legislation:

Research Ethics & Compliance

Dr Simon Barrett

Manager, Research Ethics & ComplianceMonash Research Office

Legislation: Prevention of Cruelty to Animals Act 1986 NHMRC Act 1992 ARC Act 2001 Prohibition of Human Cloning Act 2002 Research Involving Human Embryo Act 2002 Gene Technology Act 2000 Quarantine Act 1908 National Health Security Act 2007 Privacy Act 2000

Codes of Practice NHMRC & ARC

– Australian Code for the Responsible Conduct of Research– Australian Code of Practice for the Care and Use of Animals

for Scientific Purpose– The National Statement on Ethical Conduct in Human

Research– Guidelines for Ethical Conduct in Aboriginal and Torres

Strait Islander Health Research………………………………………….And many more

Review Processes Monash University Human Research Ethics Committee

Animal Ethics Committees (10 x local)

Monash University Institutional Biosafety Committee

What is Human Research? Taking part in surveys, interviews or focus groups Undergoing psychological, physiological or medical testing or

treatment Being observed by researchers Researchers having access to personal documents or other

materials Collecting organs, tissues, fluids or exhaled breath Access to information (individually identifiable, re-identifiable or

non-identifiable) as part of an existing published or unpublished source or database

Risk and Benefit benefits justify the risks

level of ethical review should reflect the level of risk

Consent Participation is voluntary

Consent must be informed

– Sufficient information to understand the purpose, demands, risks and potential benefits.

Applications:

“Low Risk” Research (Form LR)

~ 2 weeks Greater than “Low Risk” Research (Form 1)

~ 8 weeks Multi Centre

~ 1 week

Animal Ethics Review: All Monash scientific activities (teaching or research) using animals

requires approval from a Monash AEC before work can commence.

Animal Welfare General Principles: Justification

Responsibilities

Replacement

Reduction

Refinement

Applications:

Applications are made to local AEC

Must be reviewed by full committee in “face to face” meeting.

Application usually require amendments

Often approved once amendments are received by secretary and reviewed by chair.

Average approval ~ 60 days

Gene Technology (GT) Act, 2000

Introduces a national scheme for the regulation of GMOs in Australia

Protect the health and safety of Australians and the environment

Identify and manage the risks posed by or as a result of gene technology

Requirements of the GT Act Organisations undertaking dealings are “Accredited” Dealings are classified based on their level of risk

– Exempt– Notifiable Low Risk Dealings– Licensed (non-intentional release & intentional release)

Facilities for certain “Dealings” are “Certified”

Applications: Application received at anytime.

Approvals

– Exempt - immediate– Notifiable Low Risk Dealings ~ 2 weeks– Dealings Not Involving Release or Dealings Involving Release

must await approval from OGTR ~ up to 90 business days

Quarantine Act 1908 (Regulations 2000) Controls Australia’s borders to minimise the risk of exotic pests and

diseases to agriculture industries and the environment

Import and Export Inspection and Certification

Australia is currently free from a number of biological threats, such as foot and mouth disease, that have had major economic and environmental consequences for other countries

Import PermitsImport permits are required for the following examples of goods:

– Human/animal tissue, blood, fluid, sera samples– Cell lines– Laboratory Reagents

• Eg. Proteins, peptides, lipids, hormones, enzymes, etc.– Genetic Material– Micro-organisms– Antibodies/antiserum– Diagnostic Kits

• Eg. ELISA kits– Soil/water samples– Plants– Animals (including insects)

Import Permits Allows researchers to import goods which are subject to quarantine

Contains post entry conditions requiring that the goods be restricted to specified quarantine facilities, also known as Quarantine Approved Premises (QAPs)

Specifies the level of containment required for the goods

ALL import permits for the University are now applied for through the Research Compliance Office

Funding Bodies Requirement of clearances

– Funds aren’t released until clearance approvals have been sited.

Code for the Responsible Conduct of Research

– “Compliance with the code is a prerequisite for the receipt of NHMRC and ARC funding”

What you need to know.That……

Approvals for you work are in place

You names are added to any existing or new approvals

Be familiar with the content of the approved application

Be familiar with any conditions of approval…..and comply with them