Charles Darwin University Human Research Ethics Reciprocal Application Form

CDU is committed to recognising approvals by other registered ethics committees by means of reciprocal approvals.

It is University policy that all research involving human subjects must be approved and monitored by the CDU Human Research Ethics Committee. All CDU researchers (employees, honorary appointees or visitors) and research students must obtain approval from the CDU-HREC for research involving human subjects. CDU r ecognises approvals from other registered ethics committees through the pathway of Reciprocal Approval.

• If you are a CDU researcher or research student named on an application first approved by another ethics committee, you must also obtain CDU-HREC approval for your research. In most circumstances this can be provided as a reciprocal approval derived from the original approval.

• Some researchers and research students hold joint positions at CDU and another institution. You must always obtain CDU-HREC approval in this case, even if you hold a position at the institution providing the original approval. This may seem unnecessary, but CDU must have a record of your ethics approval in the event of a complaint or expression of concern and your best interests need to be considered.

• If a CDU HDR student joins a project approved at another institution, reciprocal approval must be sought and obtained immediately. This is particularly relevant when a CDU HDR student joins a project that has NT Department of Health and Menzies School of Health Reseasrch HREC approval, but which has not received reciprocal CDU-HREC approval.

Prior HREC Review

To apply for CDU approval for a protocol with prior approval by another NHMRC registered human research ethics committee (HREC), see the checklist on the following page.

Protocols requiring ethical approval by the NT Department of Health and Menzies School of Health Research HREC should be first submitted to that ethics committee on their approved form, and then submitted to CDU as a reciprocal application.

Your ethics proposal explains how the research can be conducted ethically and with minimal risks to participants. The University’s human research ethics approval procedures are designed to ensure that all students and staff, as well as the institution, are meeting all obligations under the National Statement on Ethical Conduct in Human Research (2023) and any other relevant legislation or guidelines. Charles Darwin University will not grant retrospective ethics approval. Higher Degree Research applications will be reviewed after Confirmation of Candidature is granted.

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

Reciprocal Applications 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 Reciprocal Applications. You can expect a response to your application within 10 days of submitting a complete application.

All ethics 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

Page 1 of 9

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.

Page 2 of 9

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: *

Page 3 of 9

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' *

Page 4 of 9

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

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

If you have answered YES, (i) explain how the research only involves the use of existing collections of data or records that contain only non-identifiable information, (ii) explain why the only foreseeable risk is inconvenience for participants and (iii) complete the application by moving forward and filling out the Applicant Declaration (Section 15) and Authorising Officer Declaration (Section 16). *

1c. Has this proposal previously been reviewed and approved by an Australian Human Research Ethics Committee registered by the NHMRC? *

YesNo

If you have answered YES, please provide the following:

Name of the approving HREC below
A copy of the original project application submitted to approving HREC
Project clearance/approval from the approving HREC
Completing this Application Form, as well as completing the Applicant Declaration (Section 15) and Authorising Officer Declaration (Section 16) with appropriate signatories.
All other correspondence, responses and support documents (if applicable).

If you have answered NO, please do not complete this form.

Please complete the Charles Darwin University Application Form.

Approving HREC *

Page 5 of 9

Section 3: 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)

Page 6 of 9

Section 4: 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)

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 .

Page 7 of 9

Section 5: 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 *

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.

Page 8 of 9

Reciprocal Application Checklist

(Please complete checklist prior to submission)

1. Original Proposal Application Attached

Original project application submitted to approving HREC *

Notification of project clearance/approval from approving HREC. *

All other relevant correspondence and approving HREC responses (i.e. amendments, notifications etc.)

Supporting documentation (if applicable), such as Information Sheet for Participants and Consent Form, advertisements etc.

2. Application

All answers have been completed *

3. 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? *

4. Section 4 - Application Declarations

Project title included in all applicable areas *

Risk level checked *

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

5. Section 5 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.

NB: 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

Browse

Save and Complete Later

Page 9 of 9