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All research on humans conducted on Curtin campuses or by Curtin students or staff must be approved by the Curtin Human Research Ethics Committee before it can commence.
Research can only be conducted within the approved timelines, so if your approval has expired you cannot continue with your research. Non-compliance with these requirements represents research misconduct which will be investigated.
Applying for human research ethics approval
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.
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 Developmentâ€.
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If your project has not been peer reviewed it will be assessed by the Advisory Committee to the HREC first.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.
Log on to InfoEd where HREC meeting dates and applications deadlines can be found under the help tab. If you can’t access InfoEd email infoed@curtin.edu.au for support.
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.
Log into InfoEd using your Curtin credentials to apply for ethics approval and access submission forms.
If you want to play with the system to understand how it works, log into the InfoEd test environment. Information you put in here will not be uploaded to the production environment.
If you are a student and cannot access the test environment, email the ethics support officer in your faculty for a generic username and password.
Maintaining your human research ethics approval
To comply with your ethics approval and ensure ongoing approval of a research study, all existing applicants must submit annual reports, then a completion report when the research has finished.
Log into InfoEd to submit annual and completion reports, make changes to the project (through an amendment request) and submit information on reportable events.
If your study has to be changed in any way you must submit an amendment request prior to implementing any changes, and you must report any events such as protocol deviations, serious adverse events or unanticipated problems as soon as possible after they occur.
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.
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.
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.
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.
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 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 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).
Clinical trials
Curtin uses the WHO / ICMJE 2008 definition of a clinical trial. That is, any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes.
‘Intervention’ refers to manipulation of the participants or the participants’ environment for the purpose of modifying one or more of the study outcomes. The intervention may be a drug, medical device, surgical procedure, diagnostic or screening procedure, a health service change, or a psychological, educational or behavioural strategy.
Interventional studies characteristically involve comparison of one or more interventional groups with a control group.
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 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.
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.
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.
Fundamentals of Clinical Trials provides further detail on the fundamental concepts of designing and managing clinical trials.
If you have questions about how to submit a human ethics application, or would like to make an appointment to discuss your application, please contact the Research Ethics Office at ROC-ethics@curtin.edu.au or (08) 9266 9223.
If you need assistance with these guides or human research ethics please email your faculty officer down below.
The Human Research Ethics Committee and faculty officers
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.
