HUMAN RESEARCH ETHICS COMMITTEE

RESEARCHER ANNUAL/FINAL REPORT

Project No: HRETH
Project Title:
Principal Investigator:
Date of Original Approval:
What was the anticipated date of commencement at time of approval?
What was the anticipated date of completion at time of approval?
Please indicate the type of report:
ANNUAL REPORT FINAL REPORT

HREC Application Approval Details

Select the Committee that approved your ethics application:
VictoriaUniversity Human Research Ethics Committee
Faculty of Arts Education & Human Development HREC
Faculty of Business & Law HREC
Faculty of Health Engineering & Science HREC
  1. Has the project commenced?
  1. Has data collection commenced?
  1. Is data collection complete?
/ Yes
Yes
Yes / No
No
No / Abandoned
  1. Date of completion:

  1. If the approval was subject to certain conditions, have these conditions been met? (If not, please give details - question 2)
/ Yes / No
  1. Data Analysis
/ None / Proceeding / Complete
  1. Have ethical problems been encountered in the following areas?
Study Design
Recruitment of Subjects
Finance
Facilities, equipment
(If yes, please give details – question 3) / Yes
Yes
Yes
Yes / No
No
No
No
  1. a. Has an approved protocol been modified?
b. Have all modifications been notified to the Committee (question 4) / Yes
Yes / No
No
  1. Have participants withdrawn?
/ Yes / No
  1. a) Have all participants signed consent forms
b) Are signed consent forms available for inspection? / Yes
Yes / No
No / N/A
N/A
K.Has the thesis been completed? &/or has a report been published in a Refereed Journal? / Yes / No
L.Has approval expired?
If Yes, do you require an extension? (please give reasons – question 6)
Until when? / Yes
Yes / No
No
M.a. Have there been any adverse events? (question 7)
b. Have there been any negative unpublished results? / Yes
Yes / No
No
N.Any other comments (question 8)

1. Give a brief statement on progress to date (maximum 200 words in length). Please include:

  • summary of findings to date
  • details of any publications accepted or in press
  • details of any presentations given
  • whether participants involved in the study have been informed of the results

2. If the conditions for approval were not met (question E), please give reasons.

  1. Please summarise any problems encountered in the ethical conduct, study design, recruitment, finance or

equipment (from question G).

4. Please summarise any modifications to the protocol that have not been notified to the Committee (from question H). Please include the number of amendments, a summary of substantial changes to the protocol or the Plain Language Statement and latest dates and version numbers. For any modifications that have already been notified to the Committee, please give the date of the notification.

5. If subjects have withdrawn from the project (question I), please give reasons.

6. If you require an extension (question L), please give reasons.

Note that if you require an extension to the program you MUST apply separately to the Committee

7. Please give details of any adverse events (from question M).

8. Any other comments

I confirm that this project is being conducted as originally approved by VictoriaUniversity’s HREC (and subject to any changes subsequently approved) and that all adverse events are reported to the Committee according to the Committee’s guidelines for reporting of adverse events and the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999).

SIGNATURE: DATE:

TITLE: FIRST NAME: LAST NAME:

SCHOOL/CENTRE: CAMPUS:

TELEPHONE: MOBILE NUMBER: EMAIL ADDRESS:

Please complete and return to the approving HREC’s Ethics Officer, VictoriaUniversityHuman Research Ethics Committee at the Office for Research, FootscrayPark Campus or via email at:

VictoriaUniversity Human Research Ethics Committee: .

Faculty of Arts Education & Human Development HREC: .

Faculty of Business & Law HREC: .

Faculty of Health Engineering & Science HREC: .

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