Research Ethics and Safety

Before Applying

Before applying for approval, you must complete the SOL Research Integrity Professional Development Program. Students can access this via Blackboard, and staff can access this via iPerform.

Application process

If you are applying for ethics approval for a new project, log into InfoEd using your Curtin credentials, create a new record, and go through the process for “New Human Protocol in Human Ethics Development”.

Note for students: In the Chief Investigator screen you must delete your name and add your supervisor’s name. Add yourself as co-investigator and click save to be able to go back into the system and see the form. If you are a staff member but submitting as a student make sure you use your student credentials.

Your application will be submitted to the Ethics Support Officer for your faculty. If you are not from one of the four faculties, or you’re from the Sarawak Campus, your application will be submitted to the Science and Engineering Ethics Support Officer.

On submitting your application the Ethics Support Officer will triage your application to either Negligible risk, Low risk or Non-low risk.

• Negligible risk process:
  Your application will be assessed by the Ethics Office.
• Low risk process:
  Your application will be sent to one reviewer in your school to review your project.
• Non-low risk process:
  If your project has been peer reviewed (i.e. has candidacy or has grant approval from a funding body that uses a peer review process) the application will be assessed by the Human Research Ethics Committee (HREC) only.

If your project has not been peer reviewed it will be assessed by the Advisory Committee to the HREC first. Once your project has approval from the Advisory Committee it will then be assessed by the HREC.

Previously-approved projects

If your project has already been approved by another Human Research Ethics Committee (HREC), you may qualify for reciprocal ethics approval through Curtin. Log into InfoEd, create a new record, and complete a “reciprocal application” form. Along with your reciprocal application form, please upload:

• A completed copy of the lead HREC ethics application form,
• A copy of the lead HREC ethics approval letter,
• A copy of any amendments/adverse events/progress reports as approved by the lead HREC after ethics approval was granted.

Note for students: in the Chief Investigator screen you must delete your name and add your supervisor’s name. Add yourself as co-investigator and click save to be able to go back into the system and see the form. If you are a staff member but submitting as a student make sure you use your student credentials.

Your application will be reviewed by the Manager Research Integrity.

Annual Reports, Completion Report and Auditing Programme

Log into InfoEd to submit annual and completion reports, make changes to the project (through an amendment request) and submit information on reportable events.

• Annual Reports:
  You must submit an annual report every year on the anniversary of approval in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research. Failure to submit an annual report means your project does not have current approval. Your project will approved for an additional 12 months once your annual report has been approved.
• Completion Report:
  You must submit a completion report on completion of the project in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research.
• Auditing Programme:
  

  All ongoing projects which have human research ethics approval from Curtin may be audited in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research.

  Projects are audited to ensure research is conducted ethically, legally, safely and in compliance with the protocol and conditions approved by the Human Research Ethics Committee.

  Projects are selected to be audited based on:

  • Request by the Human Research Ethics Committee
  • Risk
  • Random selection
  • A complaint

  If your project has been selected to be audited you will be contacted by the Clinical Research Monitor who will provide you with more details.

Reportable Events

A reportable event is any event that must be reported to the Curtin Ethics Office. Reportable events may include protocol deviations, serious adverse event or an unanticipated problem.

• Protocol Deviation:
  A deviation is a departure from the HREC approval protocol procedures and/or regulatory guidelines.A deviation is considered major if it:
  • Increases the risk or decreases the benefit,
  • Affects the safety, rights or welfare,
  • Affects the integrity of the study design or data, or
  • Compromises the ethical acceptability of the study.

  If this event does not meet one of these criteria, report this event in your annual report.

• Serious Adverse Events:
  An adverse event is any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or Curtin’s reputation. Adverse events can apply to interventional studies using new drugs or devices, but also to research with interventions such as behavioural modifications. People participating in qualitative research may also experience adverse events that meet the above definition. Adverse events are considered serious if any of the following outcomes occur:
  • Death
  • Life threatening
  • Requires inpatient hospitalisation or prolongation of existing hospitalisation
  • Results in congenital anomaly/birth defect
  • Results in persistent or significant disability or incapacity.

  If the adverse event does not result in any of the above outcomes, but still needs to be reported immediately (rather than in the annual report) because it potentially changes the risk-benefit profile of the study, it should be reported as an unanticipated problem.

• Unanticipated Problems:
  An unanticipated problem is any unforeseen issues that have arisen in your research project. This may relate to an individual or multiple individuals.An unanticipated event needs to meet the following three criteria:
  • Increase the risk of harm,
  • Is unexpected, and
  • Is caused by, or related to, the study.

  If this event does not meet these three criteria, report this event in your annual report.

Amendments

If your study has changed in any way you must submit an amendment request. Amendments to the protocol must not be acted on until approval has been given by the Human Research Office.

Protocol amendments may be defined as major or minor.

• Major amendments:
  Major amendments are defined as changes to the protocol which substantially changes the study design or analysis plan and potentially alter the risk-benefit profile of the study. For example:
  • Change in the primary hypothesis
  • Change to the design of the study
  • Additional outcomes or exposures
  • Use of additional linkages to other databases.
• Minor amendments:
  Minor amendments are defined as changes to the protocol that do not have an impact on the main aims and outcomes of the study. An example is administrative changes to the protocol (e.g. a change in contact details).

Training for Clinical Trials

The Association of Clinical Research Professionals offers a free online Introduction to Clinical Trials course. This one-hour course outlines how medical products are developed and how clinical trial participants are protected.

For a brief introduction to the clinical trials environment in Australia, you may refer to the NHMRC’s clinical trial eLearning modules. These modules consist of three 45 minute videos providing an introduction to the clinical trials environment in Australia, ethical issues relating to clinical research and research governance processes relating to clinical research.

The Therapeutic Goods Administration’s university student education materials contain more information on the regulation of therapeutic goods (drugs and medical devices) in Australia.

Clinical Trials Using Therapeutic Drugs or Devices

Clinical trials involving therapeutic goods, whether drugs or devices, that are not yet entered on the Australian Register of Therapeutic Goods (ARTG) are subject to regulation by the Therapeutics Goods Administration (TGA). These regulations also apply to use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval. There are two schemes under which such trials may be conducted: the Clinical Trials Notification (CTN) scheme and the Clinical Trials Exemption (CTX) scheme. The Australian Clinical Trial Handbook contains guidance on conducting clinical trials in Australia using unapproved therapeutic goods.

All CTNs must be submitted online via the TGA Business Services (TBS) system. Curtin’s Ethics Office submits CTNs on researchers’ behalf once the clinical trial has received ethics and institutional approval.

Good Clinical Practice and ISO 14155

Clinical trials must be conducted in accordance with the Note for Guidance on Good Clinical Practice(CPMP/ICH135/95 – Annotated with TGA Comments), the Good Clinical Practice (GCP) guidelines adopted in Australia. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants.

Free online GCP training is available at:

• Western Australian Health Translation Network Research Education and Training Program –  register to access the GCP online training module

This course meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma.

Medical device trials must be conducted according to ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects (available through the Curtin Library).  This standard is harmonised with the Good Clinical Practice guidelines.

Resources Available from Curtin Library

Fundamentals of Clinical Trials provides further detail on the fundamental concepts of designing and managing clinical trials.

Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research contains practical advice on conducting clinical trials.

A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim contains practical advice on conducting clinical trials.

Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators contains practical advice on conducting clinical trials.

Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality contains information about the business operations related to clinical trials.

Contact

For assistance in designing and conducting clinical trials please contact ORD-clinicaltrials@curtin.edu.au.

InfoEd User Guides

• Create a new human ethics application
• Create a new reciprocal ethics application
• Select the correct chief investigator (CI)
• Edit an existing ethics submission
• Providing electronic sign-off – Chief Investigator/Co-investigator/Student
• Respond to additional information required as a Chief Investigator
• Respond to additional information required as a Co-investigator/Student
• Respond to major/minor amendment
• Submit an annual report
• Submit an amendment request
• Submit a reportable event form
• Submit a change of investigator request
• Submit a completion report

InfoEd Tutorial Videos

• Create a new application
• Respond to additional information required
• Respond to review outcome (minor/major amendments)
• Submit an annual progress report
• Submit an amendment request
• Submit a change of investigator/s request
• Submit a completion report

Good Research Practice Guidelines and Templates

• Participant Information Form Template
• Participant Consent Form Template
• Participant Information and Consent Form Checklist
• Tips for writing in plain English
• Working with children check for researchers
• Payments in research

Ethics Application Practice Form

• Human Research Ethics Application Practice Form

Human Research Ethics Committee

The Human Research Ethics Committee (HREC) is constituted and operates in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007) including all updates.

• Human Research Ethics Committee Constitution
• Human Research Ethics Committee

The Human Research Ethics Office is responsible for managing and facilitating the ethical review process for research involving humans.

Email: hrec@curtin.edu.au

Faculty Officers

• Health Sciences: ORD-ethicshs@curtin.edu.au
• Science and Engineering: ORD-ethicssae@curtin.edu.au
• Business and Law: ORD-ethicscbs@curtin.edu.au
• Humanities: ORD-ethicshum@curtin.edu.au

Observational Studies

Studies are considered observational where animals are studied in their natural habitat.

Studies are not considered observational if:

• Animals are taken out of their natural habitat even for a short period of time.
• Animals are to be trapped.
• Animals are baited to observe behaviour.
• The animals’ natural habitat is disturbed.
• Animals are approached in a manner that may induce stress to the animal.

If your study is an observational study you need to complete the Observational Study Ethics Application form in InfoEd.

Teaching Studies

Teaching studies are considered as any action or group of actions undertaken with the aim of achieving a scientific purpose, where the scientific purpose is imparting or demonstrating knowledge or techniques to achieve an educational outcome in science, as specified in the relevant curriculum or competency requirements.

If your study is a teaching study you need to complete the Research/Teaching Ethics Application form in InfoEd.

Research Studies

Research is an original investigation undertaken to gain knowledge, understanding and insight, other than teaching or observational studies.

If your study is a research study you need to complete the Research/Teaching Ethics Application form in InfoEd.

Annual Progress Report

Each year during the life of a project on the anniversary of the animal ethics approval, the Chief Investigator must submit the completed Annual Progress Report to the Curtin Ethics Office. The report should contain:

• What progress has been made to date and whether the project is meeting its aims;
• Any issues that may have interfered with progress of the project;
• How many animals have been used; and
• Whether the wellbeing of the animals is consistent with that anticipated in the proposal.

Annual Animal Use Report

This report must be submitted each calendar year. The Chief Investigators will report on the number of animals used for the 12 month period ending on 31 December. This is a legislative government requirement that applies to all registered institutions and investigators working for these institutions that have used animals during the year (applies to ongoing and completed projects within WA, interstate and overseas).

The deadline for submitting the report is 20 February the following year.

Amendments

If your study is changed in any way you must submit an amendment request. Amendments to the protocol must not be acted on until approval has been given by the Animal Research Office.

Examples of protocol amendments are:

• Change in the primary hypothesis
• Change to the design of the study
• Additional outcomes or exposures
• Change in definition to the study population (increased or decreased numbers, change in species etc.)
• Extension of time periods
• Additional analysis (statistical or biological) that are not part of the main findings
• Any other deviation from the originally approved study protocol.

Change or addition of investigator

• Curtin students and staff must be approved by the Animal Ethics Committee prior to working with animals.

Adverse Events

You must report all unexpected adverse events to the Animal Ethics Committee within 24 hours of being aware of the events.

To report an adverse event, fill out the Adverse Event form in InfoEd.

The Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition (2014) defines adverse event and unexpected adverse event as follows:

Adverse event – any event that has a negative impact on the wellbeing of an animal. See also ‘Unexpected adverse event’.

Unexpected adverse event – an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity.

An unexpected adverse event may result from different causes, including but not limited to:

• Death of an animal, or group of animals, that was not expected (e.g. during surgery or anaesthesia, or after a procedure or treatment).
• Adverse effects following a procedure or treatment that were not expected.
• Adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study.
• A greater level of pain or distress than was predicted during the planning of the project or activity.
• Power failures, inclement weather, emergency situations or other factors external to the project or activity that have a negative impact on the welfare of the animals.

Forms

• Animal use competency registration form

Log into InfoEd to complete an animal ethics application. You may also submit the following reports through InfoEd:

• Reciprocal ethics application
• Annual animal use report
• Annual progress report
• Completion report
• Protocol amendment request
• Adverse event
• Change of investigator

Procedures

CARL Standard Operating Procedures

• Euthanasia of fish
• Identification techniques in fish
• Aneasthesia of fish
• Ice slurries
• Transport of finfish
• Fish dissection and biopsy collection

Husbandry Standard Operating Procedures

• Handling and restraining mice
• Handling and restraining rats
• Sexing Rodents
• Watering
• Rodent fortnightly cleaning
• Feeding and bedding
• Environmental enrichment
• Disease detection and veterinary treatment
• Maintenance of animal room daybooks
• Clean dirty corridor systems
• Animal procurement
• Entry into Animal Facility
• Emergency plan
• Long term holding of rats and mice in building 300
• Use of animal cadavers
• Use of photography
• Rabbit anaesthesia
• Rabbit euthanasia
• Rabbit blood collection
• Rabbit husbandry

Technical Standard Operating Procedures

• General anaesthesia rodents
• Blood sampling of rodents
• Euthanasia of rodents
• Euthanasia of non-rodent species
• Monitoring tumour growth in rodents
• Rodent dosing
• Principles of Asepsis for recovery rodent surgery
• Rodent health screening programme
• Dispensing of veterinary medicines
• Use of analgesia in rodents
• Preparation for recovery surgeries
• Barbering in laboratory mice
• Subcutaneous osmotic pump implantation in mice
• Health monitoring for mice and rats
• Calculating drug doses
• Suturing techniques
• General anaesthesia of guinea pigs
• Sudden death
• Internal Necropsy Protocol for Rodents
• Feeding medications to rodents via plastic pipette
• Gastric gavage technique in mice
• Monitoring requirements for animals in building 300
• Gastric gavage technique in rats
• Lateral Tail Vein Injections
• Blood Collection from Rodents
• Photography and Videography In Building 300
• Terminal Blood Collection from Rodents

Wildlife Standard Operating Procedures

• Infield aseptic techniques
• Capture of wildlife
• Short term wildlife capture

InfoEd Guides

• Submitting a new Animal Ethics Application
• Submitting a Reciprocal Ethics Application
• Submitting an Adverse Event report
• Submitting an Amendment request
• Submitting a Change of Investigator/s request
• Submitting an Annual Progress report
• Submitting a Completion report
• Submitting an Animal Use report
• Investigator sign-off
• Responding to request for additional information (Chief Investigator)
• Responding to request for additional information (Co-investigator/student)
• Responding to the Animal Ethics Committee

The Animal Research Ethics Office is responsible for managing and facilitating the ethical review process for research involving animals.

The Curtin Animal Ethics Committee is constituted and operates in accordance with the Australian Code for the Care and Use of Animals for Scientific Purposes.

Email: aec@curtin.edu.au

Training

• Microbiological safety and containment standard
  The Australian/New Zealand Standard 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment is your first source of information about biosafety and microbiological lab safety. It’s the Standard that Australia uses to describe the management of biohazards of all kinds. All Curtin’s biosafety systems have been developed from this Standard, and you should always refer to it for guidance.Curtin students and staff have access to the Standard through Curtin Library’s SAI Global account. Search for ‘2243.3:2010’ to get the Standard. Your downloaded copy of the Standard will self-erase after a couple of days, and you’ll need to go back to SAI Global to get another copy each time you need it.
• Biosafety Awareness Statement
  The  Biosafety Awareness Statement details the biosafety systems you need to comply with at Curtin if you want to work with genetically modified organisms, quarantined materials, microorganisms in Risk Groups 2 and 3, tissues or body fluids from humans or animals, or any living creatures that could harm you while you study them, or damage local ecosystems.It contains the full set of information in the feedback from the Biosafety Section of the Hazard Identification Tool (HIT).
• Genetically Modified Organisms (GMOs) training course
  If you work with Genetically Modified Organisms (GMOs), or within a research facility Certified by the Office of the Gene Technology Regulator (OGTR), you need to complete the compulsory Gene Technology Training. This training is given every second month by the Chair of Curtin’s Institutional Biosafety Committee (IBC).The date and time will be advertised by Facility Managers and School Managers in the biosciences areas, so look out for the email announcement.Alternatively, you can get a group together and request a special session by contacting the biosafety advisor.

• Quarantine training course
  Approved Arrangement Accredited Person training is available online from the Department of Agriculture. The training is mandatory for the Responsible Persons who manage Approved Arrangement quarantine facilities, and for holders of Import Permits. See the training details for cost and payment methods.

• Biosafety training on the web
  There are various free training courses available online from non-Curtin sources:The American Biological Safety Association has four videos about animal biosafety.The Victorian Infectious Diseases Reference Laboratory has a video about working safely in a Class II Biological Safety Cabinet.

Guidelines

Download the Biosafety Manual, which contains all of the relevant guidelines for handling biological materials.

• Which class of GMO do I want to work with?
  There are four classes of GM Dealings and the approval process is different for each class. Read the Australian Government documents below for more information.
  • Dealings classified as exempt dealings
  • Types of dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs)
  • What are Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment?
  • What are Dealings involving an Intentional Release (DIR) of a GMO into the environment?

• Exempt Dealings
  Exempt Dealings (EDs) pose the lowest level of risk. Curtin is therefore exempt from having to notify the Office of the Gene Technology Regulator (OGTR) that EDs are being done (like for an NLRD), or from seeking a License from the OGTR (like for a DNIR or DIR). EDs must be contained within a research or teaching facility, and must not involve the release of the organism into the environment. If you want to perform an ED, before you begin you must advise the IBC by filling in the GM Dealing Application Form on InfoEd. The Biosafety Advisor will get back to you within a couple of days to confirm that you are planning to perform an ED or to ask you to submit an application to perform a different kind of dealing.
• Notifiable Low Risk Dealings (NLRDs)
  These GM dealings pose a low level of risk. Curtin must notify the OGTR about each NLRD that is being done. NLRDs must be contained within an OGTR-certified research facility, and must not involve the release of the organism into the environment. If you want to perform an NLRD, before you begin you must apply to the IBC for permission by filling in the GM Dealing Application Form on InfoEd. The IBC will assess your planned work, and either issue an Approval or ask you to submit an application to perform a different kind of dealing. You cannot commence your work until you receive Approval, which can take up to two months, so apply early to avoid delays.
• Dealings Not involving an Intentional Release (DNIRs)
  These GM dealings pose a higher level of risk. This class includes all dealings that are not EDs or NLRDs, and which do not involve an intentional release of the organism into the environment. DNIRs must be licensed to Curtin University by the OGTR. To check if your work is a DNIR, read What are Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment? If you want to perform a DNIR, contact the biosafety advisor. They will help you through the application process. This involves applying to the IBC for approval, then the IBC will apply to the OGTR for a license to do the dealing. You cannot commence your work until you receive a license, which can take up to six months, so apply early to avoid delays.
• Dealings involving an Intentional Release (DIRs)
  These GM Dealings pose a higher level of risk. This class includes all dealings involving the release of the organism into the environment, usually field trials of plants. DIRs must be licensed to Curtin by the OGTR. To check if your work is a DIR, read What are Dealings involving an Intentional Release (DIR) of a GMO into the environment? If you want to perform a DIR, contact the biosafety advisor. They will help you through the application process. This involves applying to the IBC for approval, then the IBC will apply to the OGTR for a license to do the dealing. You cannot commence your work until you receive a license, which can take between nine and fourteen months, so apply early to avoid delays.
• Legislation governing the use of GMOs in Australia
  The Gene Technology Act 2000 and Regulations 2001 describe a national scheme for the regulation of GMOs in Australia. The legislation aims to make GM techniques safe for researchers, the public and the environment. However, the safety of recombinant DNA work ultimately depends on the individuals conducting it. The object of this Act is to protect the health and safety of people and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs. The Office of the Gene Technology Regulator (OGTR) is the administrative body under the Act. The OGTR has awarded Curtin status as an Accredited Organisation, enabling us to perform gene technology Dealings, and maintain several OGTR-Certified research facilities.
• Working with GMOs training course
  Learn about the Working with GMOs training course on the Biosafety Training and Guidelines page.

Pathogenic microorganisms

Some of our people study pathogenic or infectious microorganisms, trying to find cures for diseases of people, animals and plants.

All microorganisms in Risk Groups (RG) 2, 3 or 4 need to be handled at the appropriate corresponding Physical Containment (PC) level (eg. PC2 for RG2).

For information about how to handle the samples, refer to Sections 3-5 of the Australian/New Zealand Standard 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment. Curtin staff and students have access to the Standard through Curtin Library’s SAI Global account. Search for ‘2243.3:2010’ to get the Standard. Your downloaded copy of the Standard will self-erase after a couple of days, and you’ll need to go back to SAI Global to get another copy each time you need it.

If you can handle your microorganism at the same PC level as their RG then you don’t need Institutional Biosafety Committee (IBC) approval. This includes handling the microorganism entirely within a Class II Biosafety Cabinet if it can be infective via the respiratory route. However, if you need to use non-Standard methods, contact the biosafety advisor. They will help you to seek IBC assessment and approval of your methods before you can begin work.

We recommended you get the appropriate immunisations listed in The Australian Immunisation Handbook 10th Edition 2015. There may be other vaccinations available that are relevant to the samples you are handling.

Security Sensitive Biological Agents (SSBAs)

• What are SSBAs?
  The Security Sensitive Biological Agents (SSBA) Regulatory Scheme limits the opportunities for acts of bioterrorism or biocrime to occur using harmful biological agents.Curtin is not registered to work with SSBAs, so it’s illegal for any of our people to store or work with SSBAs.SSBAs are weaponisable pathogens or toxins that could be used to make a bioweapon.Tier 1 Agents
  • Abrin (reportable quantity 5 mg)
  • Bacillus anthracis (Anthraxvirulent strains)
  • Botulinum toxin (non-therapeutic forms, reportable quantity 0.5 mg)
  • Ebolavirus
  • Foot-and-mouth disease virus
  • Highly pathogenic influenza virus, infecting humans
  • Marburgvirus
  • Ricin (reportable quantity 5 mg)
  • Rinderpest virus
  • SARS coronavirus
  • Variola virus (Smallpox)
  • Yersinia pestis (Plague)

  Tier 2 Agents

  • African swine fever virus
  • Capripoxvirus (Sheep pox virus and Goat pox virus)
  • Classical swine fever virus
  • Clostridium botulinum (Botulism; toxin-producing strains)
  • Francisella tularensis (Tularaemia)
  • Lumpy skin disease virus
  • Peste-des-petits-ruminants virus
  • Yellow fever virus (non-vaccine strains)
• How do I begin working with SSBAs at Curtin?
  All activities related to SSBAs are regulated by the National Health Security Act (2007) – Part 3. It’s illegal to have any SSBA unless it’s being held following all the requirements of the SSBA regulatory system. Curtin is not registered to work with SSBAs, so it’s illegal for any of our people to store or work with SSBAs.If you want to work with any SSBA in the future, then you must contact the biosafety advisor and the Chair of the IBC R.Steuart@curtin.edu.au immediately to discuss the possibility once the proper registration has been gained from the Federal Government Department of Health and Aging.It’s possible to culture an SSBA from an environmental sample or a biological sample without specifically meaning to do so. If you become aware that you have cultured a presumptive SSBA, you must immediately contact the biosafety advisor or the Chair of the IBC R.Steuart@curtin.edu.au.
•  Legislation governing the use of SSBAs in Australia
  

  Part 3 of the National Health Security Act 2007 and Regulations 2008 describes a national scheme for the regulation of SSBAs in Australia and builds on Australia’s obligations under the Biological and Toxin Weapons Convention (1975) and UN Security Council Resolution 1540 (2004).

  The Department of Health and Ageing (DoHA) is the administrative body under the Act. Any institution that intends to store or perform research with, SSBAs must be registered with DoHa before the agent is imported into their site.

  See the Department of Health’s page about SSBAs for more information.

Transporting biological materials

• Transport guidelines
  • Transport by walking
  • Transport by vehicle (car, truck, bus, train)
  • Transport by post or plane

• Transport regulations
  • The IATA Dangerous Goods Regulations
  • The Australia Post Dangerous and Prohibited Goods guidelines
  • Australian Code for the Transport of Dangerous Goods by Road and Rail
  • International Maritime Dangerous Goods Code (IMDG Code)
  • The Office of the Gene Technology Regulator (OGTR), Guidelines for the transport of GMOs
  • Australian Standard for packaging for surface transport of biological material that may cause disease in humans, animals and plants (AS 4834). (All Australian Standards are accessible through the library)
  • United Nations Recommendations on the Transport of Dangerous Goods – Model Regulations

Storing biological materials

• Biological containment facilities
  • Curtin has several biological containment facilities used to contain its biohazardous microbiological/plant/animal research and teaching activities.We have a number of research facilities that are certified by the Office of the Gene Technology Regulator (OGTR), in which teaching and research with genetically modified organisms can be undertaken. There are PC2-level lab, plant, and animal facilities available.We have a number of research facilities that are Approved Arrangements by the Department of Agriculture, in which teaching and research with quarantined biosecurity materials can be undertaken. There are QC2-level lab, plant, and animal facilities available.
• Accessing research facilities

  • To access any of these facilities, contact the biosafety advisor, who will direct you to contact the Facility Manager in charge of an appropriate facility.

    Alternatively, you can apply to have your current facility Certified or Approved by contacting the biosafety advisor.

Biosafety Advisor

Dr Bernadette Bradley
Mobile: 0401 103 655
Phone: +61 8 9266 1383
Email: bernadette.bradley@curtin.edu.au

Institutional Biosafety Committee

Curtin’s Institutional Biosafety Committee (IBC) oversees all the research and teaching at Curtin involving the use of genetically modified organisms (GMOs), quarantined biological materials, infectious microorganisms, and other biohazardous materials.

Before starting any work involving radioactive substances, high powered lasers (class 3B or 4), x-ray or neutron emitting apparatus or UV transilluminators, you must have approval from the Radiation Safety Officer or Committee. If your supervisor already has approval to cover your work, they can apply for an amendment to add your name to their project. If not, you must start a new application.

To apply, log into InfoEd using your Curtin credentials, create a new record, and go through the process for “InfoEd Radiation Project UserGuide – Create New Application”.

Note for students: In the Chief Investigator screen you must delete your name and add your supervisor’s name. Add yourself as co-investigator and click save to be able to go back into the system and see the form. If you are a staff member but submitting as a student make sure you use your student credentials.

The application will be reviewed by:

1. The Chief investigator for the project
2. The Radiation license holder(s) for the substances or equipment
3. The local Radiation Safety Supervisor (or, if this role is vacant, the Head of Department)

Contact
Mr. Kelvin Wong Kin Yin
Phone: +60 85-443939, Email: wongkinyin@curtin.edu.my

Radiation Safety Officer
The Radiation Safety Officer (RSO) is a legislated role that coordinates radiation activities at Curtin to ensure compliance with the Radiation Safety Act 1975 and other regulations. The RSO is responsible for instituting and maintaining a system of radiation safety at Curtin and is monitored by the University Radiation Safety Committee, comprising members from across the University.
Matt Carroll
Office of Research and Development (ORD)
Phone: (08) 9266 1708
Email: radsafety@curtin.edu.au

After review, the University Radiation Safety Officer (RSO) will triage your application as either Low-Risk or High-Risk. Low-Risk applications will be processed by the University RSO, whereas High-Risk applications will be assessed by the Radiation Safety Committee.

How to get a licence

You must follow specific processes for acquiring, storing and disposing of radioactive material.

• Ordering
  You must submit a radiation project application or amendment before you purchase any new radioactive material, class 3B or 4 laser, x-ray instrument or transilluminator. Some facilities may require modifications to accommodate certain radionuclide activity levels or types of equipment. For repeat orders of radioactive materials already covered by an existing project it is only necessary for you to inform the local Radiation Safety Supervisor (RSS) to ensure activity limits for the location are not exceeded.

• Importing
  If you’re ordering radioactive materials from overseas, you must obtain an import permit from the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). Failure to obtain a permit will result in the shipment being held by Customs. Complete the relevant form (leaving licensee name and license number fields blank) and submit it to the Radiation Safety Officer (RSO). The RSO will provide the University license details and submit the form to ARPANSA. Payment is to be made by the group/department ordering the radionuclide(s).

• Storage and usage
  Every radiation laboratory is registered with the State regulatory authority to store or use a maximum activity of radioactive material or make use of a specific laser, x-ray or transilluminator. The RSS will have a copy of the registered limits and equipment. Inform the RSO and local RSS immediately if radioisotopes in excess of the registered activity limits or new equipment is to be stored, used or moved to another University area not already approved on an existing project. In such an instance you must submit a radiation project application or amendment.

• Records and receipts
  You must keep and regularly update records following the movement of radioactive substances and radiation equipment. Records must detail the properties of the substances or equipment, supplier, arrival date, use details, disposal method and disposal date. You should include comments on the form of packaging and perhaps the quality of the packaging. Obtain signed receipts where possible.

Facility Requirements

• Requirements for radioisotope facilities
  All laboratories using radioactive materials must be approved for use by the WA State Government Regulator before any work is conducted. The Regulator will assess the architectural, plumbing and ventilation plans for the laboratory to decide if the laboratory is suitable for radioactive materials work. Architectural, plumbing or ventilation changes can be time consuming and costly, so contact the RSO to begin the approval process many months before work commencing in case the Regulator requires changes.

• Requirements for laser facilities
  Laser facility requirements are detailed in the Radiation Safety (General) Regulations 1983 and refer to Australian Standard AS/NZS 2211.1:2004 for specific items. Allow time before work commencing to ensure these requirements are met. In some cases it may take a few months to arrange for the laboratory to have the appropriate security and safety systems in place.

• Requirements for x-ray facilities
  Rooms containing x-ray generating instruments, whether for analysis or diagnostic purposes, may require walls and windows to have appropriate shielding. The WA State Government Regulator must approve the plans for the facility prior to work commencing. The room where the apparatus is located and the surrounding area may also be required to undergo a three month radiation survey when work begins, or at any other time as specified by the Regulator, to confirm radiation levels are below the legislated limits.

Disposal

If any radioactive material, class 3B or 4 laser, x-ray instrument or transilluminator is to be disposed of or moved to another organisation, you must inform the RSO and local RSS so they can update the registration details. The method of disposal depends on the type of material or equipment. For disposal of radioactive materials it may be necessary to store them to allow for radioactive decay. If so, Curtin has a Radiation Waste Storage facility for this purpose – contact the RSO for access. The group/department disposing of the radioactive materials or radiation equipment is responsible for the costs of disposal.

Methods of disposal

• Disposal of radiation equipment
  Final disposal of any irradiating apparatus or electronic product must be carried out by a licensed service person in accordance with the methods below:
  • X-ray equipment
    At minimum the x-ray tube must be disabled, by eliminating the vacuum inside the x-ray tube by physically breaking the glass envelope, and the high-tension cables must be severed, to render the equipment inoperable. It would also be preferable to remove the circuit board controlling the high voltage generator where possible.
  • Lasers
    Removing the power supply (by severing the cord) and removing the critical optical components and the amplifying medium to render the equipment inoperable.
  • Transilluminators
    Removing the power supply (by severing the cord) and removing the UV lights from the unit and destroying them will render the equipment inoperable.
• Disposal of liquid radioactive waste (water soluble)
  Liquid radioactive waste is best disposed of via the sewer system. Such waste must only be disposed of via flushing sinks connected to approved radioactive drains provided for this purpose. Ensure that the activity per flush is below the legal dilution concentration limit for each radionuclide and that the waste complies with the Water Corporation’s ‘Acceptance criteria for trade waste’.
• Disposal of sealed, solid or liquid (non-soluble) radioactive waste
  Segregation You must segregate waste according to the radionuclide and the type of waste. For example:
  • Sealed sources
  • Biological material (e.g. food, animal carcasses)
  • Sharps (e.g. syringes, broken glass)
  • Scintillation cocktail from counting tubes
  • General laboratory waste (e.g. gloves, paper towels)

  Long-lived radionuclides must not exceed the following activity box limits:

  Long-lived Radionuclide	Box Limit
  	MBq	mCi
  3 H	48	1300
  14 C	3.4	92
  36 Cl	2.2	59

  Packaging

  Seal solid waste in a red plastic bag. Other liquid waste must be sealed in a screw top bottle or vial before being sealed in a red plastic bag. Any sharps, such as needles or broken glass, must be enclosed in a hard container (metal tin or plastic sharps container).

  The red plastic bag or hard container must be placed in a cardboard box or multi-walled paper bag with the words ‘Radioactive material’ printed clearly on the outside.

  The box or bag must then be sealed with tape that is suitable for storage (50 mm wide masking tape is commonly used).

  Labelling

  Label the waste box or bag with the type of waste it contains together with a contact name and location of where the waste comes from.

  Write the radionuclide and provide an estimate of total activity. Only use units of activity (Bq, Ci and their derivatives). Do not use other units such as counts per second or Bq per mL.

  Transportation

  Confirm whether the activity of the waste is low enough to be transported as an ‘excepted package’.

  Liaise with the University Radiation Safety Officer to arrange a time for delivery to the University radiation waste store and transport the waste at the designated time.

  Ensure the waste is handed directly to staff at the store. Do not leave radioactive waste unattended at any time.

The objective of radiation monitoring is to ensure that existing safety procedures are effective at keeping dosage and exposures from scattered or incidental radiation as low as reasonably achievable (ALARA).

Personal radiation monitoring badges

Required for users of radioactive substances and x-ray or neutron equipment.

If you work with ionising radiation, you’ll need to apply for a personal radiation monitoring badge. These badges are issued on a monthly or quarterly basis and monitor exposures from incidental and scattered radiation. The badges are not appropriate for low energy beta emitters such as ³H or ³⁵S. To obtain a badge contact your local Radiation Safety Supervisor (RSS). When the badge arrives you can collect it from your RSS or nominated badge coordinator.

Biological monitoring

Required for users routinely handling equal or greater activities per procedure of the following radionuclides: 120 MBq ³H, 5 MBq ¹⁴C, 5 MBq ³⁵S or 0.1 MBq ¹²⁵I.

Urinalysis is required for users of ³H, ¹⁴C or ³⁵S. Thyroid analysis is required for ¹²⁵I. The frequency of monitoring will be determined by the University Radiation Safety Officer (RSO) for different categories of workers and submitted to the WA Radiological Council for approval.

Wipe testing

Required for users of low energy beta emitting unsealed radioactive substances or contamination testing in radioisotope areas with high level background fields.

Groups using unsealed radioisotopes are required to conduct monthly wipe tests of all radioisotope laboratories. A summary of the results of the wipe test must be forwarded to the local RSS and RSO.

Download the instructions and results form for performing a wipe test.

Radiation surveys

Required for users of radioactive substances and x-ray equipment.

If you’re using beta and gamma emitting radionuclides, survey your area before and after any procedure involving radionuclides to ensure no contamination is present. A Geiger counter (preferable for betas) or Scintillation monitor (preferable for gammas) is normally used. Clean any contamination immediately.

If you’re using partially enclosed x-ray units, perform a radiation survey on a monthly basis to check for radiation leakage from the machine. For totally enclosed x-ray units, perform the radiation survey quarterly. The dose at any accessible point 5 cm from the surface must not exceed 25 µGy per hour whilst the instrument is operating at maximum power.

Radiation Safety Supervisor

If you are planning to conduct radiation related work or you have questions about radiation safety, your local Radiation Safety Supervisor is your first point of contact.

Mr Kelvin Wong Kin Yin

Phone: +60 85-443939

Email: wongkinyin@curtin.edu.my

Radiation Safety Officer

The Radiation Safety Officer (RSO) is a legislated role that coordinates radiation activities at Curtin to ensure compliance with the Radiation Safety Act 1975 and other regulations. The RSO is responsible for instituting and maintaining a system of radiation safety at Curtin and is monitored by the University Radiation Safety Committee, comprising members from across the University.

Matt Carroll
Office of Research and Development (ORD)
Phone: (08) 9266 1708
Email: radsafety@curtin.edu.au

Chemicals and substances that have the potential to harm human health, property or the environment are regulated in the workplace. Learn more about managing chemicals at Curtin.

Before conducting research or teaching activities at Curtin, you must identify the hazards inherent in your work, document your safety protocols in a written risk assessment, and seek any approvals you need from Curtin or Government regulatory bodies. The Hazard Identification Tool for hazardous materials will help you identify the hazards that you may be working with.

Hazardous materials are chemicals and other substances present in the workplace that have the potential to harm the health of persons, causing illness or disease. This general definition also includes dangerous goods and poisons. Biological and Radioactive agents are covered under different guidelines.

Common examples of hazardous materials include toners, cleaning products, paints, fuels, herbicides, and laboratory chemicals.

To minimise the risks to health, and in order to meet the requirements of the Occupational Health and Safety Regulations 1996, the following minimum standards must be met.

Minimum Standards

• All chemicals present in the workplace must be correctly Labelled.

Reading Labels

Reading the label on containers is the first step in getting health and safety information on the chemicals used in your workplace. Hence it is essential that all containers that hold hazardous substances are appropriately labelled. This includes decanted substances that are not used immediately.

How do I obtain compliant labels?

In most cases the simplest method to produce compliant labels is to print them from Chem Alert.

Unfortunately it can be difficult to achieve labelling compliance where you create new products. In such circumstances, the following Label template has been provided to assist you.

• A Safety Data Sheet (SDS) must be available for all hazardous materials.

What is a Safety Data Sheet (SDS)?

While reading the label is the first step in identifying the hazards associated with a chemical product, the SDS provides more detailed health and safety information. An SDS is a document prepared by the manufacturer of the product to provide information to the end-user.

SDS Requirements

For each hazardous substance supplied to the University:

An SDS must be obtained before or on the first occasion that it is supplied

The SDS must be readily available to any employee or student who could be exposed to the substance

How do I obtain an SDS?

For most substances the simplest way to obtain an SDS and to ensure it is readily available is to use Chem Alert. Unfortunately, there are some substances that do not exist in Chem Alert, in which case they can be obtained from the manufacturer.

It is the responsibility of the manufacturer to provide Safety Data Sheets for the hazardous substances they supply. Hence you can contact them directly to obtain an SDS.

• A Register of all hazardous materials present in the workplace must be maintained.

Chemical Register Requirements

Each area is required to maintain a register of all the hazardous substances held. As a minimum, this register must include:

A list of each substance

Storage location

A Safety Data Sheet

This register must be readily accessible to all affected employees.

Emergency Services Manifest Requirements

For the purposes of identifying hazards during an emergency, all buildings are required to have a separate manifest stating:

Aggregate quantity of Dangerous Goods broken down by their classification

Storage locations within the building

These manifests must be readily accessible to all affected employees, and a hard copy must be kept at the buildings fire panel.

How do I Access the Registers relevant to my area?

At Curtin University, this information is available from the “Stock” tab of Chem Alert. You will need to obtain a user name and password to access this information for your area.

How are the Registers Maintained?

Regular audits and subsequent updating of Chem Alert is required to ensure that registers remain accurate.

• A Risk Assessment must be completed for each hazardous material.

Before using any product that has been classified as a Hazardous Substance and/ or Dangerous Good (as detailed on the MSDS), a risk assessment must be undertaken to determine the possible hazards of the product and the control measures required for its safe use.

To complete the assessment you will:

Identify the hazardous substances to which staff and/ or students are exposed;

Utilise your own knowledge of the chemical;

Review the Safety Data Sheet and Label to further identify the risks;

Review the use of the product, including the concentration and duration;

Review the existing procedures for safe handling according to the Hierarchy of Controls.

Review the use of personal protective equipment.

This assessment will enable you to determine the likelihood of injury or harm.

The following chemical assessment worksheet has been designed to assist you to meet these requirements, and prompt you to think about the hazards you face:

Chemical Risk Assessment Worksheet (One chemical involved only) (Example Risk assessments: Red, Amber, Green)

Research Project Safety Analysis (Where multiple chemicals involved)

All risk assessments must be completed online using the C.H.A.R.M Risk Assessment Module.

Reassessment

Further investigation is required whenever it is determined that there is:

Uncertainty about the degree of risk;

Significant risk to health.

The Health, Safety and Emergency Management team should be contacted on ext.4900 for assistance in these instances.

Completed assessments should be reviewed at least every 5 years, or earlier where:

There is significant change to the work process;

The substance is involved in an injury or near miss;

New information about the substance or process becomes available.

• All chemicals must be appropriately Stored.

General Principles

The following general principles apply to the storage of most chemicals:

Do not store in alphabetical order. Ensure incompatible substances are appropriately segregated;

Minimise the quantities stored;

Ensure the containers are sound (properly sealed and free from damage);

Use appropriate storage vessels (such as a flammable cabinet);

Store heavy items between knee and shoulder height;

Protect items from falling (use of a barrier or a lip on shelving);

Ensure there is adequate natural and/ or mechanical ventilation to prevent accumulation of gases, mists, vapours or dusts;

Locate removed from:

Direct sunlight and/ or rain;

Heat or ignition sources;

High energy sources;

Areas occupied by people (offices etc);

Critical resources (computer resources etc).

Compatibility

Chemicals can react with each other to cause fire or the release of toxic gases. As a result, it is essential that incompatible substances are appropriately segregated, view Chemical Segregation Chart.

Segregation shall be achieved by firstly following the specific storage requirements detailed on the Safety Data Sheet.

Secondly, where more than one class or sub-class of Dangerous Goods is stored, they must be segregated in accordance with the following table:

Table 1: Segregation of Dangerous Goods (reproduced from the Western Australian Explosives and Dangerous Goods (Dangerous Goods Handling and Storage) Regulations 1992.)

LEGEND:

L – Substances which are liquids

S – Substances which are solids

0 – No general segregation required

1 – Segregate by a distance of at least 1 metre

3 – Segregate by a distance of at least 3 metres

X – Segregate in separate depots that are at least 5 metres apart or segregate by a distance of at least 5 metres with use of a screen wall.

• All staff and students must be provided with adequate Information and Training.
• All chemicals must be purchased according to the University’s Purchasing Requirements.
• Hazardous waste must be appropriately Disposed of.

Chemical Disposal Process:

Print your ChemAlert stock register/s for your chemical stores.

Identify any chemicals that are not listed on your stock register/s.

Identify chemicals for disposal.

Prior to combining chemical waste, ensure product/by-product and storage requirements are known.

Use the ChemAlert Custom Product module to create a label to ensure all chemical waste containers  accurately reflect their contents.

Ensure that chemicals for disposal are stored appropriately until collection (labelled, segregated, bunded, ventilated, sealed and secured appropriately).

Complete the Chemical Disposal Request Form together with the Chemical Disposal Manifest and email them to the Health and Safety Department by close of business two weeks prior to the disposal date.  Manifests sent after this date will not be included in the collection.

Update your ChemAlert stock register to reflect retained chemicals within two weeks of collection.

Print the ChemAlert Storage Incompatibilities Report and include the Segregation Guide in the appendix to identify the correct segregation and storage of retained chemicals

HAZCHEM reports are produced two weeks after the collection.

Please note that Toxfree will not dispose of ‘unknowns’.  If you have any ‘unknowns’ you will need to contact ChemCentre on 9422 9800 to have them analysed and identified prior to disposal.

Please note that this manifest document is the only manifest format that will be accepted.

Waste Chemicals Manifest
Chemical Disposal Manifest

Chemical Disposal Request Form

• Special Precautions must be followed for certain materials.

Curtin’s Chemical Committee provides advice to the University about the regulation of hazardous substances, dangerous goods and poisons used in research and teaching activities. The committee consists of representatives from each faculty Health and Safety Committee, as well as advisors from Health, Safety and Emergency Management and the Research Office at Curtin.

Please contact the Executive Officer and Hazardous Substance Advisor with any inquiries for the Chemical Safety Committee:

Ms Amy Bowater
Phone: +61 8 9266 1724
Email: a.bowater@curtin.edu.au

A poison is defined as any substance that is included in the Schedules of the Medicine and Poisons Act 2014 & Regulation 2016. The availability of poisons is restricted by the Medicine and Poisons Act 2014 & Regulations 2016 in order to protect public health. Curtin requires a research/education permit to purchase, use and hold certain scheduled poisons.

Before conducting research or teaching activities at Curtin, you must identify the hazards inherent in your work, document your safety protocols in a written risk assessment, and seek any approvals you need from Curtin or Government regulatory bodies. To help you understand the regulatory environment that applies to your work with hazardous materials complete the Hazard Identification Tool.

The various poison schedules as defined in section 4 (1) of the Medicines and Poisons Legislation 2014 are:

You can also find poisons in Safety Data Sheets under Section 15 – Regulatory Information or by searching the Federal Therapeutic Goods Administrations Poisons Standard.

Curtin requires a permit to purchase, use and hold poisons in Schedules 2, 3, 4, 7 or 8, while Schedule 9 substances may only be used for certain research and teaching purposes under a separate permit, approved by the Department of Health CEO.

Poison permits and purchase of Poisons should be coordinated through Schools/Departments in order to identify if a suitable permit is already in place or to identify a suitable person to apply for a permit. Permit holders are responsible for ensuring that all permit conditions are met. After discussion with your supervisor, you can download an application form for a permit to purchase poisons for the purpose of research and/or teaching from the Medicines and Poisons Regulation Branch website.

Please contact the Hazardous Substance Advisor (HSA) for enquiries about new or existing poisons permits. Additionally please provide details to the HSA of any poisons permit applications, amendments or renewals. An online Medicines and Poisons management system is currently under development.

Please contact the Hazardous Substance Advisor (HSA) for more information on or assistance with poisons legislation at Curtin:

Ms Amy Bowater
Phone: +61 8 9266 1724
Email: a.bowater@curtin.edu.au

Controlled goods and technologies are listed on the Defense and Strategic Goods List (DSGL). This list includes the controlled goods and technologies that require a permit to export under the Defense Trade Controls Act. This list is available through the Defence Export Controls Office and includes:

Part 1: Defence and Related Goods

Goods and technologies designed or adapted for military purposes or those that are inherently lethal, incapacitating or destructive.

Part 2: Dual Use
Commercial items and technologies that may be used or adapted for use in a military program, for the development or production of a military system or weapons of mass destruction, or contribute to the development and production of chemical, biological or nuclear weapons.

Australian legislation controls the export of controlled goods and technologies under two Acts:

• Customs Act 1901 (Cth) controls tangible goods.
• Defence Trade Control Act 2012 (DTCA) controls intangible goods.

Tangible exports are controlled goods and technology that leave Australia in the tangible (physical) form. This may include blueprints, plans, technical data etc., and includes controlled technology stored on a physical medium such as a USB, computer hard drive, CD, etc.

Intangible exports are controlled technology that is sent from Australia electronically rather than in a physical form. This may include supply via email, fax, password access to electronic files, etc.

Intangible supply also includes brokering. Brokering is when one person arranges the supply of goods listed in the DSGL or supply of DSGL technology to a place outside of Australia.

Intangible supply also refers to publishing. This is where a person publishes or disseminates DSGL technology to the public by electronic or other means.

To determine if you need a permit, or if you need further information on the DTCA, please contact:

Dr Catherine Gangell
Manager, Research Integrity
Phone: +61 8 9266 7093
Email: Catherine.Gangell@curtin.edu.au

Training is available through the Defence Export Controls Awareness Training Program.