Human Research Ethics Committee Annual/Final Report Form

Annual/Final Report For CDU-HREC Approved Protocols

Annual Reports are a mandatory requirement of all CDU Human Research Ethics Committee (CDU-HREC) approved projects, as set out by the NHMRC guidelines. The Principal Investigator is required to submit a satisfactory Annual Report to the CDU-HREC ahead of the anniversary of the approval date. Continuing approval is contingent on submission of a satisfactory annual progress report.

The purpose of the Annual/Final Report is to review the implementation, conduct and continuing progress of your research, to identify and advise the Committee of any changes. Researchers are required to maintain current clearance for their projects until they are completed i.e., submission for publication or thesis/dissertation. If the entire project extends beyond 5 years, a new approval is required. A Final Report including a brief summary of findings and study conclusion are required on completion of the project or when a project ceases.

GUIDE TO COMPLETING THIS FORM

All relevant answers must be completed. Depending on your response to a given answer, additional information may be required. You will be unable to continue until the required answers have been completed.
Progress on this form can be saved and completed at a later stage.
When selecting 'save and continue later', a link will be generated which can be emailed to you. This will allow you to return to complete the form. This will also allow you to share the form with others to complete certain parts of the form. You can then email the link to another (e.g., Student Principal Investigator),to complete/sign and submit. (Please note: if you are a student completing this form, please ensure to include your signature before clicking 'save and continue' and generating the link to be sent to the PI to sign and submit)
Ensure that any supporting documentation is attached. There is an option to attach documents at the end of this form.
Once you submit the form,it will automatically be sent to ethics@cdu.edu.au in PDF format. A copy will also be emailed to the PI listed on the application form.

Researchers conducting research relevant to or involving First Nation peoples and communities must report on individual and community involvement (see Section Two of this form).

Please provide the following information:

Project Title *

CDU-HREC Referece: *

Name of Principal Investigator *

Email *

Faculty/Institution *

Contact Number

Annual / Final Report *

Annual ReportFinal Report

Do you require an extension? *

YesNo

New Expected Completion Date (if extension requested) *

** Please note: Clearance is granted for five years. An updated application may be required after this time. **

Student name

Faculty/Institution (student)

Email (student):

Contact Number (student):

Is this research relevant to or involve First Nation peoples or communities? *

YesNo

If yes, please complete Section 1 and Section 2 of this form

SECTION ONE:

A. Please provide an overview of the work undertaken to date (minimum 200 words) The overview should include a description of participant recruitment, data collection activities, project outcomes and findings. Please detail any ethical issues that arose and if/how they were resolved. *

B. We welcome attachment of a summary report or published paper, otherwise please provide a brief study summary and conclusion here. *

Staff Research: Submission for publication *

YesNoN/A (student research)

Student Research: Submission of thesis/dissertation *

YesNoN/A (staff research)

C. Where is your data stored (including hardcopy and electronic forms of data)? *

D. Please answer the following questions, and attach explanatory statements where required:

1. Has a modification or amendment to the original protocol or associated project document been made? *

YesNo

If you answered YES but have not yet requested HREC approval, please provide a detailed response (or attach a file to this form): *

2.a. Are you aware of any adverse reactions, experiences or comments caused by the research to participants or other parties? *

YesNo

If you answered YES, please provide a detailed response (or attach a file to this form) an attachment *

b. Have any new ethical risks arisen since the protocol was approved? *

Yes No

If you answered YES, please provide details about the actions you have taken or propose to take to address the issues. *

3. Have you adhered to the informed consent procedures outlined in your approved proposal? This includes: i) Providing Information Sheet (ISP) to all participants; ii) Administering Informed Consent Forms according to the protocol; iii) Obtaining permission from relevant authorities (e.g. School Principals, Community elders) . *

YesNo

If you answered NO, please provide an attachment outlining and justifying any variation to the stated procedures. *

4. Have you adhered to the measures outlined in your application for maintaining the confidentiality and privacy of participants in this research? This includes: i) Adhering to assurances given to participants in relation to the recording of personal, identifying information; ii) Ensuring your data cannot be accessed by unauthorised individuals. *

YesNo

If you answered NO, please provide an attachment outlining any variation to the stated procedure, and explain what measures you have taken/will take to minimise any adverse effects on participants. *

5. Have you made arrangements for a copy of the data to be stored at the University or another institution for a minimum of five years, as required by the NHMRC and outlined in the University’s Code of Conduct for Research? *

YesNo

If you answered NO, contact your College to discuss how your data may be stored securely.

6. Were any conditions attached to your previous ethics approval? *

YesNo

If you answered YES, please indicate how you have complied with the conditions of approval. *

7. When do you expect to complete your project? A project is completed when results are submitted for publication or (for research degree candidates) when a thesis is submitted for examination. *

8. Have you read and complied with the National Statement on Ethical Conduct in Research Involving Humans? The National Statement can be access via the link below. *

YesNo

The National Statement on Ethical Conduct in Human Research (2023)

9. I understand that if I leave Charles Darwin University the research data will be left with the college/institute or centre *

YesNo

SECTION TWO (FOR RESEARCH RELEVANT TO FIRST NATION PEOPLES AND COMMUNITIES):

A. Please detail how the Aboriginal and Torres Strait Islander Research Agreement has been upheld specifically in terms of consultation, communication and active involvement. If research was approved prior to 1 July 2019, or an ATSIRA was not required for this project, please specify how the research team has maintained communication and active involvement with Peoples/communities. *

Principal Investigator *

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Date signed (PI): *

Student signature (if applicable)

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Date signed (student):

Please upload any relevant documetation

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