HUMAN RESEARCH ETHICS COMMITTEE
For all queries, please contact:
Research Ethics Officer
Edith Cowan University
270 Joondalup Drive
JOONDALUP WA 6027
Phone: 6304 2170
Fax:
6304 2661
Email:
[email protected]
MONITORING OF APPROVED RESEARCH PROJECTS
The National Statement on Ethical Conduct in Research Involving Humans (1999) requires ethics
committees to ensure that there is appropriate monitoring of the conduct of all approved ongoing research
until completion. Monitoring of approved projects is to establish that a research project is being or has been
conducted in the manner proposed to, and approved by, the Human Research Ethics Committee (HREC) in
order to ensure that the welfare and rights of the research participants are adequately protected.
Compliance with monitoring requirements is a condition of approval.
1.
An Ethics Report Form must be submitted at least annually and at the completion of the project.
2.
Compliance with the approved research protocol is a condition of approval, and any changes to the
research design must be reported to the Committee.
3.
Amendments to the research design that may affect participants and/or that may have ethical
implications must be reviewed and approved by the Committee before commencement.
4.
If an extension of the approval period is required, a request must be submitted to the Committee.
Please ensure that requests for extension of approval are submitted before the original approval
expires.
5.
It is a condition of approval that researchers immediately report anything that might warrant review of
the ethical approval of the protocol, including:

Any serious or unexpected adverse effects on participants

Proposed changes in the research protocol

Any unforeseen events that might affect continued ethical acceptability of the project.
6.
If the research project is discontinued before the expected date of completion, researchers should
inform the HREC as soon as possible, giving reasons.
7.
The Committee retains the right to require a more detailed and/or more frequent report if the
research is deemed to be of high risk, and to recommend and/or adopt any additional appropriate
mechanism for monitoring including random inspections of research sites, data and signed consent
forms, and/or interview, with their prior consent, of research participants.
PROCEDURES FOR COMPLETION OF THE ETHICS REPORT FORM
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A request for an ethics report form will be sent to the Chief Investigator prior to the due date. Failure to
submit a satisfactory Ethics Report Form may result in withdrawal of approval. If ethics approval is
withdrawn, a researcher must not continue the research.
The Ethics Report Form should be completed using typewriting or word processing. Please ensure that
the correct project code is used.
Researchers should answer all applicable sections and provide sufficient information. Further pages may
be attached if necessary.
The Ethics Report Form should be signed by the Chief Investigator, the supervisor (for student research
projects) or the Associate Dean, Research and Higher Degrees (for staff research projects).
The completed Ethics Report Form may be submitted via email for processing, but the signed Ethics
Report Form should be submitted in hard copy to the Research Ethics Office.
The Ethics Report Form is available from the Ethics website
http://www.ecu.edu.au/GPPS/ethics/human_ethics_forms.html
HUMAN RESEARCH ETHICS COMMITTEE
For all queries, please contact:
Research Ethics Officer
Edith Cowan University
270 Joondalup Drive
JOONDALUP WA 6027
Phone: 6304 2170
Fax:
6304 2661
Email:
[email protected]
ETHICS REPORT FORM
PROJECT DETAILS
Project code
Project Title
Dates of ethics approval
From:
Type of Project
Staff Research
Honours
To:
Masters (Coursework)
Masters (Research)
Doctorate/PhD
Other:
CHIEF INVESTIGATOR
Title and Name
Faculty
B&L
Other:
Address
Degrees/Qualifications
CHS
E&A
RPS
Contact Telephone Numbers
Home:
Work:
Email Address:
Supervisor (for student projects)
STATUS OF PROJECT
ONGOING PROJECT
COMPLETED PROJECT
Commenced
Not Commenced
Completed
Discontinued
If the project has not commenced or has been discontinued, please provide reasons why
EXTENSION OF ETHICS APPROVAL
Will the project need an extension of the dates of ethics approval?
YES
NO
If YES, please indicate the new expected date of completion.
NOTE: Please ensure that enough time is requested. Ethics approval is required for both the collection
and use (i.e. analysis) of data.
CONDITIONS OF APPROVAL
Was the research project approved with any specific conditions of approval?
YES
If YES, please provide a brief report on compliance with the conditions of approval
NO
PROGRESS/OUTCOME
ONGOING PROJECT
Please provide a brief outline of the progress to
date including:
 Number of participants
 Data collected to date
 Any results and/or conclusions
COMPLETED PROJECT
Please provide a brief outline of the outcome of
the research project (include a list of any
reports or publications)
CONDUCT OF RESEARCH
YES
NO
Has participation in the research project resulted in any adverse effects on
participants (distress, embarrassment, physical harm)?
NO
Was it necessary to refer participants for counselling or any other form of support? YES
YES
NO
Were there any complaints from participants in the study or from others affected
by the study?
If YES, please provide an explanation of the events, indicating how the situation was resolved
below
SECURITY AND MAINTENANCE OF CONFIDENTIALITY
ONGOING PROJECT
COMPLETED PROJECT
Please indicate:
Please indicate
 the form in which information, data and/or

the form in which information, data and/or
samples collected from participants will be
samples collected from participants will be
stored during the research project (identified,
stored after the completion of the research
potentially identified, or deidentified)
project (identified, potentially identified, or
 location of storage
deidentified)
 precautions that are being undertaken to ensure 
location of storage
the security of information, data and/or samples  the length of time for storage
collected from participants containing names

how information, data and/or samples will be
and/or other identifying information
disposed of when no longer required
Please provide an outline of the measures taken to ensure security and maintenance of
confidentiality, including the points noted above
NOTIFICATION OF CHANGES (ONGOING PROJECTS ONLY)
Have there been any changes to the research project?
Please indicate the changes and provide a brief explanation below
Participants
Changes to the recruitment methods used
Changes to the number of participants
Participants have withdrawn from the research project
Data collection
Changes to approved data collection procedures e.g. method of interviewing
Changes to approved data collection instruments e.g. change of questions
New data collection procedures
New data collection instruments
Research personnel
Change of Chief Investigator (and/or contact details)
Changes to the members of the research team
Change of supervisor
Other changes that may affect ethical approval of the research project
Have these changes been notified to the Human Research Ethics Committee?
Please provide an explanation of the changes to the research project
YES
NO
YES
YES
YES
NO
NO
NO
YES
YES
YES
YES
NO
NO
NO
NO
YES
YES
YES
YES
YES
NO
NO
NO
NO
NO
DECLARATION
As the Chief Investigator, I declare that:
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I have read and understood the guidelines contained in the National Statement on Ethical Conduct in
Research Involving Humans (1999) and the ECU Policy for the Conduct of Ethical Research Involving
Humans and I accept the legal and ethical responsibilities associated with this research project.
The research project has been/will be conducted in the manner approved by the Human Research
Ethics Committee, which includes any approved amendments to the research design and/or any
specific conditions of approval.
Any identifiable or potentially identifiable data, information and/or samples collected from or about
participants will not be used for any other purpose or released to any third party not specified in the
approved application, without the consent of the participant.
Data, information and/or samples will be stored securely, and the confidentiality of all data, information
and/or samples collected from or about participants will be maintained.
Any further changes to research design, timeline or investigators will be notified in writing to the
HREC.
Chief Investigator
Name
Signature
Date
As the Supervisor, I declare that:

I have read the Ethics Report Form and confirm that I believe that this student research project has
been/will be conducted in the manner approved by the Human Research Ethics Committee, which
includes any approved amendments to the research design and/or any specific conditions of approval.
I confirm that the chief investigator accepts the legal and ethical responsibilities associated with this
research
Supervisor (for student research)
Name
Signature
Date
As the Associate Dean Research, I declare that:

I have read the Ethics Report Form and confirm that I believe that this staff research project has
been/will be conducted in the manner approved by the Human Research Ethics Committee, which
includes any approved amendments to the research design and/or any specific conditions of approval.
I confirm that the chief investigator accepts the legal and ethical responsibilities associated with this
research
Associate Dean Research (for staff research)
Name
Signature
Date