Health and Medical
REPORT & EXTENSION REQUEST FORM
(for the period of ____________________)
This form must be signed by the Chief Investigator.
Note, handwritten submissions will not be accepted.
Please email the completed form to:human.ethics@utas.edu.au
SECTION
1 - PROJECT DETAILS
Ethics Reference No.
H00
Project Title:
CHIEF INVESTIGATOR DETAILS
Name:
Phone:
Email address:
Contact address:
OTHER INVESTIGATOR NAMES (Co- Investigators, Students)
Names:
CHANGES TO RESEARCHERS
Have there been any changes of Principal Researcher/s, Associate Researcher/s, Research Assistant/s, Research Co-ordinator or any
other members of the research team since the project was approved, that you have not yet informed us about? If yes please provide
details.
Yes
No
Name
Contact Details
Left/Joined Project
Page 1 of 6
Version 11 June 2016
SECTION
2 – STATUS OF APPLICATION
Status
Indicate ( ) which status applies to the project. Include appropriate dates
Category
Indicate Date
Instruction
Completed
Completion date
Go to Section 3
Abandoned
Date of abandonment
Go to Section 4
Ongoing
Date of commencement
Go to Section 5
Extension Request 1
Date of commencement
Go to Section 6
Extension Request 2
Date of commencement
Go to Section 6
Please indicate:
Progress Report 1
Progress Report 2
Progress Report 3
SECTION
3 – COMPLETED PROJECTS
Section 3.1 Please list original aims of the project (from the original approved application):
Section 3.2 Were these aims achieved? Please provide a brief explanation:
Yes
No
Section 3.3 Have study participants been informed of the results? How?
Yes
No
Section 3.4 Where will study documents be archived?
GO TO SECTION 7
SECTION
4 – ABANDONED PROJECTS
Section 4.1 Did the project commence?
Yes
No
Section 4.2 Why was the project abandoned? Please provide brief details, including whether the abandonment created any ethical
issues and if so, how they were resolved. Detail if data was collected, what has been done with it to destroy or secure it.:
GO TO SECTION 7
Page 2 of 6
Version 11 June 2016
SECTION
5 – ONGOING PROJECTS
Section 5.1 Please confirm the number of anticipated participants (from the original approved application):
Section 5.2 How many people have already been recruited?
If you are not recruiting the expected number of participants, please explain how this will be addressed:
Section 5.3 Please provide a brief report on the progress of the project and an indication of any results so far obtained:
Section 5.4 Please list the versions of the Participant Information Sheet and Consent Form, Protocol and Investigator’s Brochure
currently being used (where applicable):
Document
Version Number and Date
Date Approved
Information Sheet and
Consent Form:
Protocol:
Investigator’s
Brochure:
SECTION 6 – EXTENSION REQUEST
Extension of approval beyond initial approval period, to be reviewed by the full HREC.
The procedure of reviewing extension requests has been implemented as the Committee recognises that when reviewing
ethical conduct in research, there are evolving social norms and evolving medical practices. The Committee needs to be
assured that studies are being performed recognising advances in clinical practice. In this case the committee needs to be
assured that there is appropriate consideration of risk versus potential benefit in accordance with the National Statement.
Section 6.1 Why do you want the extension?
:
Section 6.2 Please state which stage the project is currently in, eg recruitment, follow-up etc:
Section 6.3 Revised date of completion, please note extension periods are granted for up to 1 additional year:
Section 6.4 Progress Report
Provide a brief report on the progress of the project and an indication of results obtained:
GO TO SECTION
7
Page 3 of 6
Version 11 June 2016
SECTION 7 – CLINICAL TRIALS
If this study is a clinical trial, please provide the following information. If the study is not a clinical trial please go to
section 8.
Section 7.1 Please indicate one of the following for this study:
Clinical Trial with full industry sponsorship
Clinical Trial with sponsorship from a collaborative or non-profit group
Clinical trial that has been initiated by the Chief Investigator
Section 7.2 Is this study being conducted under either:
Clinical Trial Exemption (CTX) Scheme
Yes
No
Clinical Trial Notification (CTN) Scheme
Yes
No
Section 7.3 Does the study has a Data Safety Monitoring Committee (or similar) which has reviewed the study in the past
12 months? If yes, please attach a copy of the Committee’s report and provide an opinion regarding the potential impact on
ethical acceptability and the need for action.
Section 7.4 If a safety report is not available, is action planned on the basis of any safety
information received in the last 12 months?
Yes
No
Yes
No
If yes, please provide an opinion regarding the potential impact on ethical acceptability and the need
for action.
Section 7.5 Has the trial been registered with a WHO-accredited clinical trials registry? If yes
please provide the names of registries and registration numbers.
SECTION
8 – ETHICAL ISSUES
Please tick YES or NO to the following questions. If insufficient space – please use separate sheet
Section 8.1 Did any participants withdraw from the project during this year? If ‘YES’ please provide
details.
Yes
No
Section 8.2 Did any ethical issues arise during the research?
If ‘YES’ please provide details, including whether or not they were foreseen, and how they were
resolved.
Yes
No
Section 8.3 Have any participants suffered harm or adverse effects?
Yes
No
Yes
No
If YES, has this been reported to the committee?
If not please provide details as to why not and submit the reports.
Section 8.4 Have any complaints been received regarding the project? If ‘YES’ please provide
details of the complaint, and how it has been resolved
Page 4 of 6
Version 11 June 2016
Section 8.5 Have you departed at all from the approved protocol?
If ‘YES’ please provide details.
Yes
No
Section 8.6 Has there been any breach of confidentiality of data, which includes identifying
information?
If ‘YES’ please provide details, including what has been done to remedy the breach.
Yes
No
Section 8.7 Have all records been maintained in a manner consistent with that proposed in the
approved application?
Yes
No
Yes
No
Yes
No
If no, please provide details and submit an amendment request for approval.
Section 8.8 Regarding the maintenance of records (including data), have the security measures
proposed in the approved application been adhered to?
If no, please provide details and submit an amendment request for approval.
Section 8.9 Has the project been audited by the sponsor, the Ethics Office or any other body since the
last progress report was submitted? If yes, please provide details:
SECTION
9 – OPTIONAL SELF AUDIT FOR RESEARCHERS
This section of the form has been designed to help researchers to reflect on their research conduct and to
comply with guidelines for responsible research conduct. The HREC suggest that this tool is used to
facilitate discussion and adoption of best practice research methods. If your project is audited by the
HREC, this is an indication of the criteria which will be applied to your project.
Are all of the following true for your research project?
YES
9.1 If I left suddenly, my project could be completed or replicated because the documentation for my
projects is up to date, accessible, clearly ordered and comprehensible. The Chief Investigator knows
where to find all relevant documentation and has been provided with the passwords to the databases.
9.2 I am conducting the study in accordance with the protocol approved by the Ethics Committee. Any
modifications have been reported to the committee and the relevant documents updated.
9.3 I have obtained signed consent forms from all participants (where applicable) and stored these
securely. They are available for audit.
9.4 I have reported all serious and unexpected adverse incidents to the Ethics Office.
9.5 I have provided all study participants with a copy of the Participant Information sheet approved by the
Ethics Committee.
9.6 I have provided a translator and/or a translated copy of the Participant Information sheet in his/her own
language to all non-English speaking participants.
9.7 I have received ethics committee approval for all public advertising material that seeks volunteers to
participate in the study.
9.8 Approaches to potential participants have been made only by the individuals with full knowledge of the
study protocol and of the risks and inconveniences associated with participation (& approved by the ethics
committee
9.9 All paper-based questionnaires have the identifying information removed immediately after processing
and are then identifiable only by a code. The ‘code-key’ is stored separately under lock and key at all
times.
9.10. All principal computer files containing study data are stored on a secure network drive where they are
regularly backed up.
Page 5 of 6
Version 11 June 2016
NO
N/A
9.11 All computer files containing study data are protected by passwords.
9.12 No personal identifying information has been transferred to portable drives including USB sticks or
portable computers.
9.13 Participants know who to contact if they have a question, complaint or an emergency.
9.14 There is a regular meeting of the study team including the Principal Researcher/s to discuss the
progress of the study and a record of these meetings is maintained.
SECTION
10 – PUBLICATIONS AND CHANGES
10.1 List of publications and presentations: Please list any publications, conference papers, presentations, abstracts of theses
etc., which have resulted from the study, and attach copies to this report:
Yes
Are there any unapproved changes to the research study?
No
If yes, please submit an amendment request for approval of these changes. The amendment form can be found
on our website at http://www.research.utas.edu.au/human_ethics/medical_forms.htm
SECTION 11 – STATEMENT BY CHIEF INVESTIGATOR
I accept that the information provided in this report is a true records of the research undertaken by myself, associate investigators and any
students under my supervision:
Chief Investigator name:
Chief Investigator signature: .............................................................................................................................................................................................................................
Date:
..........................................................................................................................
Page 6 of 6
Version 11 June 2016