Charles Darwin University Human Research Ethics Application for Exemption Form

Exemption

Some research projects that utilise existing, publicly available non-identifiable data and which are of negligible risk and do not involve special groups of participants e.g. cognitive impairment, mental illness, First Nations (including possible impact), dependent on medical care, illegal activity, pregnant mother or foetus or dependent/unequal status (often children),may be eligible for exemption as per Chapter 5.1 of the National Statement. A letter of Exemption can also be sought from the CDU-HREC where required.

Submission of Application

Your proposal will be sent electronically via email to ethics@cdu.edu.au. The submission will include the online form and any required attachments.

Review Pathway for Reciprocal Applications

Applications for exemption are reviewed through the Executive Review Pathway. They typically do not require full CDU-HREC review, therefore can be submitted at any time. The submission deadlines and meeting dates do not apply to Applications for Exemption. You can expect a response to your application within 10 days of submitting a complete application.

All proposals require signatures from the relevant Faculty Dean/Institute Director or deputy.

Authorising Officer. Where the appropriate authorising is also a member of the research team this authorisation should be completed by the relevant Pro-Vice-Chancellor or University Secretary.

Further Queries

Should you have any queries regarding human research ethics, or difficulties using this form, please contact the CDU-HREC Ethics Team based within the Office of Research and Innovation by phone (08) 8946 6063 or email ethics@cdu.edu.au

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GUIDE TO COMPLETING APPLICATION 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.
Please review the checklist at the end of this form carefully, to ensure the application is complete. This will assist with a more timely review.
Ensure that all supporting documentation is attached to the application. There is an option to attach documents at the end of this form.

Workflows:

Workflows have been enabled with this form to facilitate authorisations and signatures as follows:

Section 5: Authorising Declaration : Please add the Project Title and email address of the Authorising Officer (Faculty Dean or duly appointed agent). Complete the form and attach documents. Complete the remainder of the form and click 'submit'. This will be sent to the email address provided in Section 5 for the Authorising Officer to complete and sign.
Once the Authorising Officer has signed, they must click 'submit'. This will create the next workflow.
The final workflow will be sent to the Principal Investigator to complete the application checklist and submit the completed application.

Once the Principal Investigator clicks submit after all the above workflows are complete, the application will automatically be sent to ethics@cdu.edu.au in PDF format, along with all relevant attachments.

A copy of the application will also be emailed to the PI listed on the application form.

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HUMAN RESEARCH ETHICS PROPOSAL

Project Title *

Principal Investigator

The Principal Investigator (PI) must be a suitably qualified Charles Darwin University honorary or substantive staff member with sufficient research experience and expertise relevant to this project. Correspondence about the application will be sent to the investigators listed in this section who are asked to distribute it to other researchers involved in the project. The PI for student projects is the primary research supervisor.

Title *

First Name *

Last Name *

Staff ID *

Qualifications *

Role in project *

Describe role if "other" selected *

Email Address *

Phone (business) *

Organisation/Faculty *

Provide details if "other" was selected *

Is this project part of a CDU Course, including Higher Degree Research? *

YesNo

If yes, indicate the type of course

Student

Please enter details for the student if this is a higher degree research project.

Title (student) *

First Name (student) *

Last Name (student) *

Student ID *

Qualifications (Student) *

Role in project (Student) *

Other: *

Email address (Student) *

Phone (Student) *

Organisation/Faculty (Student) *

Other Organisation/Faculty: *

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Proposed commencement and completion dates of the project

Proposed commencement date *

Expected completion date *

Does this project have specific funding? *

YesNo

If you have answered YES, indicate whether the funding is from CDU or external sources, or both. *

CDUExternal

List all funding sources, including grant titles and codes:

For external funding, please provide 'Pure RIS Award ID' *

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Section 1: Special Approval Notifications

1a (i) Is this project considered to be First Nations research? First Nations research refers to any research that relates to, or may have the potential to impact, the collective rights and interests of First Nations Peoples’ lands, waters, cultures and histories. *

YesNo

If YES, ethics review will likely be required. Please complete the CDU HREC Application Form

1a (ii). Have you read the NHMRC Ethical Conduct in Research with First Nations people and communities: Guidelines for researchers and stakeholders and Keeping research on track II and do you agree to abide by the values and principles outlined in these document during the course of your research? *

YesNo

Please click on the following links to review Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities , Keeping research on track II and the AIATSIS code of ethics

1a (iii). If this project is First Nations research, has consultation with relevant First Nations Peoples, communities, individuals and/or groups been undertaken? If Yes, please attach the completed research agreement to this application. The Aboriginal and Torres Strait Islander Research Agreement should include details of the agreed upon aims, outcomes and community benefits of the research. For further information, see Keeping Research on Track II. If No, please provide details below of progress towards consultation with appropriate Peoples, communities and/or groups. *

YesNo

Details of progress towards consultation with appropriate Peoples, communities and/or groups. *

1b. Is this Exempt Research for which you require a confirming letter from the HREC? *

YesNo

1c. Please explain how the research only involves the use of existing collections of data or records that contain only non-identifiable information. *

1d. Please explain why the only foreseeable risk is inconvenience for participants. *

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Section 2: Additional Members of the Research Team

Are there additional members of the research team? *

YesNo

If there are more then four additional members of the research team, please provide details as an attachment to the application.

Title (additional member 1)

Title (additional member 2)

First Name (additional member 1)

First Name (additional member 2)

Last Name (additional member 1)

Last Name (additional member 2)

CDU Staff/Student ID (additional member 1)

CDU Staff/Student ID (additional member 2)

Qualifications (additional member 1)

Qualifications (additional member 2)

Role in project (additional member 1)

Role in project (additional member 2)

Other (additional member 1)

Other (additional member 2)

Email address (additional member 1)

Email address (additional member 2)

Phone (business) (additional member 1)

Phone (business) (additional member 2)

Organisation/ Faculty (additional member 1)

Organisation/Faculty (additional member 2)

Other organisation (additional member 1)

Other organisation (additional member 2)

Title (additional member 3)

Title (additional member 4)

First Name (additional member 3)

First Name (additional member 4)

Last Name (additional member 3)

Last Name (additional member 4)

CDU Staff/Student ID (additional member 3)

CDU Staff/Student ID (additional member 4)

Qualifications (additional member 3)

Qualifications (additional member 4)

Role in project (additional member 3)

Role in project (additional member 4)

Other (additional member 3)

Other (additional member 4)

Email address (additional member 3)

Email address (additional member 4)

Phone (business) (additional member 3)

Phone (business) (additional member 4)

Organisation/Faculty (additional member 3)

Organisation/Faculty (additional member 4)

Other organisation (additional member 3)

Other organisation (additional member 4)

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Section 3: Participants

Will participants be recruited for this project? *

YesNo

3a. Describe the planned participants and population(s) under study, addressing (i) the target group(s) from which they will be drawn, (ii) how many participants will be involved, (iii) their age range and (iv) whether they share any common characteristics (e.g. university students, religious sects). (NS 1.4) *

3a (i) What are the participant inclusion and exclusion criteria for this study? (NS 1.4 (a), 3.1.14 and 3.1.15) *

3a. (ii) Identification, first contact and recruitment of the participant pool: How will participants be recruited? Explain (i) how persons will be identified as potential participants, (ii) how they will be approached initially, (iii) how they will be informed about the research project and (iv) how they will be screened for inclusion or exclusion. If some form of advertisement or flyer is to be used, include the text here or include a clearly titled copy in your submission pack. (NS 2.2.6 and 3.1.12-3, 17-21) *

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Section 4: Description of the Project

Describe the project so that it can be understood by an intelligent, critical lay reader, using clear and concise language. (Approximately 200-250 words - if more space is required please attach a Word document) (NS 5.2.7) *

Section 5: Aims and significance of the project

List the research aims, objectives and/or research questions. Please state the justification and potential significance of the research. (Approximately 150-200 words - if more space is required please attach a word document) (NS 1.1 (b), 1.1 (d) and 3.1.1) *

Section 6: Research Setting

Describe the locations where consultations with stakeholders or participants and data will be collected. Explain any legal, regulatory or ethical issues of relevance such as a requirement for a research visa, the value of a research partner located at an in-country institution.

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Section 7: Research Methods

7a. Describe planned research methods as follows : i) study design and methodology ii) data collection methods, instruments and procedures iii) planned analysis methods iv) sequencing of all research activities v) identification of potential limitations of the study. *

7b. Provide details of the relevant research expertise and experience of the team to conduct the proposed project. (NS 1.1 (e)) *

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Section 8: Applicant Declarations

Project Title (declaration) *

4a. Is the ethical risk NEGLIGIBLE? The ethical risk is negligible if the proposed research protocol has been designed to entail no more than inconvenience to participants and does not entail foreseeable discomfort or harm (NS Chapter 2.1) *

YesNo

4b. Ethical considerations relative to specific categories of participants. In responding to the following questions, note that “involvement” does not occur solely because a person in the designated category might be recruited as a participant. The research should relate to persons or issues in the designated category.

Is this First Nations research? *

YesNo

Is the Aboriginal and Torres Strait Islander research agreement attached? *

YesNo

Does the research involve clinical trials, interventions or therapies, or clinical innovations? *

YesNo

Does the research involve human tissue samples, human genetics (including population genetics) or human stem cells? *

YesNo

Does the research involve women who are pregnant and / or the human foetus or human foetal tissue? *

YesNo

Does the research involve people who are highly dependent on medical care who may be unable to give consent? *

YesNo

Does the research involve people with a cognitive impairment, an intellectual disability or a mental illness? *

YesNo

Does the research involve or investigate illegal activity? *

YesNo

We, the undersigned, confirm that all members of the research team have read this application and the current NHMRC National Statement on Ethical Conduct in Human Research. We accept responsibility for the ethical and appropriate conduct of the protocol detailed in this application, confirm that we will conduct this project inaccordance with the principles contained in the National Statement, and confirm that the research team will comply with any other conditions laid down by Charles Darwin University.

Signed (Principal Investigator - Staff / Supervisor) *

Clear

Date Signed *

Print Name (PI): *

Signed (Student / Co-Investigator)

Draw signature|Type signatureClear

Date Signed (student)

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Section 9: Authorising Officer Declaration

This authorisation is to be completed by the Faculty Dean, or a duly appointed agent, where the research is to be based. Where the appropriate authorising officer is also a member of the research team this authorisation should be completed by the relevant Pro-Vice-Chancellor Or University Secretary.

Please provide the email address of the Authorising Officer. A workflow link will be sent directly to the recipient to complete this section when you hit 'submit'.

( NB: Please note, that you must ' submit' the form, for it to be sent to Authorising Officer. The form will not be submitted to CDU ethics at this stage).

Project Title (authorising officer) *

Authorising Officer Email *

NB : The below is locked for editing by the person completing the application form, as this must be completed by the Authorising Officer.

**Please note , that you must attach all relevant supporting documents below and then 'submit' the form.

This will notsubmit the application to ethics at this stage. This will trigger a workflow and will send the application to email address of the Authorising Officer provided above to review and sign.

Once the Authorising Officer has signed and completed the below section, they must then click ' submit '.

This will not submit to ethics at this stage either.

When the Authorising Officer "submits" the application, it will trigger the final workflow to the Principal Investigator listed on the project to review, edit (if necessary) and submit to CDU ethics.

I have considered this application and the ethical implications of the proposed research and recommend it for consideration by the HREC. I confirm that the qualifications and experience of all investigators are appropriate to the study to be undertaken, and the necessary resources are available to enable this research to be conducted.

Scientific Merit

STEP ONE

The research / scientific merit of this project has been considered (tick one statement): *

By a supervisory panel for PhD projects or peer review for research grantsBy the authorising officerIs yet to be considered

STEP TWO

Is there a need for additional review of the scientific merit of the research? (tick if required)

I believe that this project requires further review of its research merit

Research Safety

STEP ONE

The research safety of this project (tick one statement): *

Does not require special considerationHas been considered by a University workplace health and safety processHas been considered by the authorising officerIs yet to be considered

STEP TWO

Is there a need for additional review of the research safety of the research? (tick if required)

I believe that this project requires further review of research safety

Comments (if required)

Signed (authorising officer) *

Clear

Date Signed (authorising officer) *

Print Name *

Designation *

NB: Once signed and completed, please click ' submit '. This will not submit the form to ethics at this stage. This will trigger the final workflow to the Principal Investigator listed on the project to review and submit to CDU ethics.

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Application for Exemption Checklist

(Please complete checklist prior to submission)

1. Application

All answers have been completed *

2. Research Team

Contact details and qualifications are complete, including staff and student numbers *

Is the Principal Investigator appropriately qualified and experienced, and is a CDU staff member or has an honorary appointment? *

3. Section 3 - Application Declarations

Project title included in all applicable areas *

Risk level checked *

Signatures and dated by PI (and student, if applicable) *

5. Section 4 Application - Authorising Declaration

Project title included on the declaration *

All relevant boxes have been checked *

Application has been reviewed, authorised, signed and dated by the Faculty Dean, or duly appointed agent (Assistant Dean for Research, PVC or University Secretary) *

NB: Please click 'submit' in order to submit the completed application to ethics@cdu.edu.au

Receipt of submission will be acknowledged when you select 'submit', after all workflows are complete. The application form and any attachments will be sent automatically to ethics@cdu.edu.au. A copy of the complete application will also be sent to the email address provided for the Principal Investigator. Please ensure to check spam folders.

Your proposal will initially undergo Executive Review. You should normally expect a response within 10 working days of the review date.

Further Queries

Should you have any queries regarding human research ethics please contact the CDU-HREC Ethics Team based within the Office of Research and Innovation by phone (08) 8946 6063 or email ethics@cdu.edu.au

6. ATTACHMENTS: Supporting Documents

All relevant files have been attached (below) *

YesNo

Attachment 1

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