HUMAN RESEARCH ETHICS COMMITTEENT Health and Menzies School of Health Research (EC 00153)

HUMAN RESEARCH ETHICS COMMITTEENT Health and Menzies School of Health Research (EC 00153)

NT HREC ETHICS APPLICATION FORM

4366895-57150Office Use Only

Application ID:

Date Received:

00Office Use Only

Application ID:

Date Received:

Principal Investigators name (including title):

.

Project Title:

..

Simplified Project Title (Optional):

...

Organisation accepting responsibility for the project:

FORMCHECKBOX Menzies School of Health Research

FORMCHECKBOX Northern Territory Department of Health

FORMCHECKBOX Charles Darwin University

FORMCHECKBOX Other (Please Identify)

Enrolment (Students Only):

Name of Course:

Part A.THE INVESTIGATORS

Please ensure that the summary of expertise and qualifications are completed.

Section 1.1(e) of the National Statement on Ethical Conduct in Human Research

Principal Investigators Name :

(This is the person with overall responsibility for the conduct of the project and reporting against it. If this is a student project, including an advanced clinical trainees accreditation project or a higher degree project, then the students main supervisor should be listed as Principal Investigator on this ethics application.)

Qualifications :

E.g., Master of Public Health (MPH). Please list in accordance to this format. Organisational Affiliation : Position : Postal Address : Phone :

Mobile: Fax: Work Email : Role in the project; describe functions to be undertaken in the project: Summary of expertise relevant to this research

(National Statement on Ethical Conduct in Human Research 2007, Chapter 1.1e, 4.8.7 and 4.8.15). Please declare any competing interests (Copy and Paste tables to include more Investigators as necessary.)

Student Investigators

1st Students Name : Qualifications :

E.g., Master of Public Health (MPH). Please list in accordance to this format. Degree Being Undertaken : Enrolling University : Primary Supervisor : Students Postal Address : Phone :

Mobile: Fax: Work Email : Role in the project; describe functions to be undertaken in the project: Summary of expertise relevant to this research NS 4.8.7 NS 4.8.15 Please declare any competing interests (Copy and Paste tables to include more Students as necessary.)

Part B.THE PROJECT

1.Type of research:

Formatting Tip: Tick all relevant boxes by double-clicking on the box and marking Default Value as Checked.

FORMCHECKBOX Funded research (complete Q34) FORMCHECKBOX Un-funded research

FORMCHECKBOX Staff research FORMCHECKBOX Student research

FORMCHECKBOX Commercially Sponsored FORMCHECKBOX Principal Investigator Driven

Clinical TrialClinical Trial

FORMCHECKBOX Clinical Trial Notification Scheme FORMCHECKBOX Clinical Trial Exemption Scheme

(Attach a copy of protocol and(Attach a copy of protocol and

evidence of insurance, and trialevidence of insurance, and trial

registration number to this application)registration number to this application).

FORMCHECKBOX Qualitative Research FORMCHECKBOX Evaluation

FORMCHECKBOX Audit FORMCHECKBOX Other: ..

2.Is this project a continuation of a current or previous project with ethics approval? FORMCHECKBOX Yes FORMCHECKBOX No

If YES, please provide HREC file reference number: .

3.Has this project been submitted to any other ethics committees?

FORMCHECKBOX Yes FORMCHECKBOX No

If YES, please provide the following details :

Ethics Committee

(incl. Human, Animal and Biosafety Committees) Status

(To be Submitted, Submitted, Approved,

Not Approved) Date Copy of Ethics Approval Attached?

*Please note that ethics approval cannot be granted retrospectively.

4.Proposed commencement date of project: .. FORMCHECKBOX As soon as full ethics approval has been granted

5.Proposed completion date of project:

6.Summary of the project:

In the box below, describe the project in 100 words or less.

Formatting Tips: To tab within a box, hold down the Ctrl key when you press the Tab key.

All boxes automatically expand in length.

7.Background to the project:

Briefly describe the history of the topic you intend to address.

A formal and comprehensive literature review should have been conducted and be evident in your application.

Please describe stakeholder involvement in development of the research, if applicable

Section 1.1(a)(c) of the National Statement on Ethical Conduct in Human Research

8.Aims of the project:

Briefly describe your primary research question and what outcomes you hope this project will achieve in 100 words or less.

Section 1.1(b) and 1.1(d) of the National Statement on Ethical Conduct in Human Research

9.Justification:

Outline the justification of the proposal.

What constitutes potential benefit and whether it justifies research may sometimes require consultation with relevant communities and stakeholder groups.

Section 1.1(a), 1.61.9 of the National Statement on Ethical Conduct in Human Research

10.Participants:

Please read the relevant sections of the National Statement, Commonwealth Privacy Acts and Northern Territory Information Act to assist you in completing this question.

Formatting tip: Tick all relevant boxes by double-clicking on the box and marking Default Value as Checked.

Specific Participant Groups Targeted Probable

Incidental Excluded Relevant Section of National Statement/ Privacy Act

Participation of, or impact upon, women who are pregnant and the human foetus FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.1 (NS)

Participation of, or impact upon, children and young people

(see Working With Children Clearance section below) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.2 (NS)

NT Care & Protection of Children Act

Participation of, or impact upon, people in dependent or unequal relationships (i.e. patients and health care professionals; students and teachers; employees and supervisors/employers; prisoners and prison wardens; government authorities and refugees; service providers and recipients of those services). FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.3 (NS)

Participation of, or impact upon, persons highly dependent on medical care who may be unable to give consent FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.4 (NS)

Participation of, or impact upon, people with a cognitive impairment, an intellectual disability, or a mental illness FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.5 (NS)

Participation of, or impact upon, people who may be involved in illegal activities FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.6 (NS)

Participation of, or impact upon, Aboriginal and Torres Strait Islander Peoples FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.7 (NS)

Participation of, or impact upon, people in other countries FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 4.8 (NS)

Will researchers potentially have contact with children even if children are not the targeted participants? FORMCHECKBOX Yes FORMCHECKBOX No

If yes, please provide details below for all researchers involved.

Please attach photocopies of Ochre Cards and Clearance Notices to this Application.

Section 187 of the Care and Protection of Children Act.

Researcher Name NT Ochre Card Number/Police Clearance Clearance Expiry Date

11.Research methodology:

Please read the relevant sections of the National Statement to assist you in completing this question.

Formatting Tip: Tick all relevant boxes by double-clicking on the box and marking Default Value as Checked.

Research Methods NS Reference

FORMCHECKBOX Research involving pre-existing data sets and/or data linkage 3.1

FORMCHECKBOX Qualitative research disciplined inquiry that examines peoples lives, experiences and behaviours and the stories and meanings ascribed to them through interviews, focus groups, observation, archival, on-line, and/or action research 3.1

FORMCHECKBOX Epidemiological research 3.1

FORMCHECKBOX Conducting non-invasive physical experiments or examinations 3.1

FORMCHECKBOX Conducting trials trialling new interventions and therapies, including clinical and non-clinical trials, and innovations 3.1

FORMCHECKBOX Research involving human tissue, human biological samples inc. cell lines 3.2

FORMCHECKBOX Research involving human genomics studying the structure, location, function, expression, interaction, abnormalities and effects of the genes 3.3

FORMCHECKBOX Research involving animal to human xenotransplantation 3.4

FORMCHECKBOX Research involving exposure to ionising radiation (*Attach certificate from ionising radiation expert) Other Considerations FORMCHECKBOX Use of material or procedures of potential danger to the environment FORMCHECKBOX Collecting archaeological data including or impacting upon human remains 12.Site selection, recruitment, selection criteria, and participant involvement:

Section 1.4, 3.1.123.1.22 of the National Statement on Ethical Conduct in Human Research

Please list the study sites.

Please list the inclusion criteria and the exclusion criteria.

Briefly describe on what basis participants will be included in, or excluded from, the project.

Please describe the recruitment process that will be used.

Please describe participants level of involvement in the study, e.g. time or financial commitment.

13.Design & methodology:

Briefly outline the methods you propose using to achieve the aims of the project including data sources and data analysis methodology. Please outline in plain English.

Please attach a copy of the protocol

Please attach copies of questionnaires or other instruments to be used.

All Clinical Trials must be registered with a publically available register

(www.clinicaltrials.gov or www.ANZCTR.org.au) Please provide registration number.

Please refer to Chapter 5.2.6 of the National Statement on Ethical Conduct in Human Research, 2007.

14.Sample size:

TOTAL SAMPLE SIZE NUMBER OF PARTICIPANTS NUMBER OF RECORDS Briefly outline and justify the sample size to be used in this research e.g. provide calculations and/or advice from a statistician.

Section 1.4, 3.1.2, of the National Statement on Ethical Conduct in Human Research

Qualitative researchers should describe their sampling processes and expected individuals/ groups to be included.

15.Collection & use of data:

Please read the relevant sections of the National Statement Chapter 3.1 Element 4, Commonwealth Privacy Act and Northern Territory Information Act to assist you in completing this question.

The National Statement does not use the terms identifiable, potentially identifiable, reidentifiable, non-identifiable or de-identified as descriptive categories for data or information due to ambiguities in their meanings. Re-identification and de-identification are best understood as processes that change the character of information and are only used with this meaning. NS 3.1

Formatting tip: Tick all relevant boxes by double-clicking on the box and marking Default Value as Checked.

Collection and Use of Data FORMCHECKBOX Collection and/or use of non-identifiable data where individual identifiers have never existed or have been permanently removed e.g. anonymous survey FORMCHECKBOX Collection and use of individual data with the individuals consent where the identifiers will be removed, and it will not be possible to re-identify the individual. i.e. it will become non-identifiable. FORMCHECKBOX Collection and use of individual data without the individuals consent where the identifiers will be removed, and it will not be possible to re-identify the individual. i.e. it will become non-identifiable. FORMCHECKBOX Collection and use of re-identifiable data with the individuals consent where the identifiers will be removed and replaced with a code, but it remains possible to re-identify a specific individual (e.g. through linkage of data sets) FORMCHECKBOX Collection and use of re-identifiable data without the individuals consent where the identifiers will be removed and replaced with a code, but it remains possible to re-identify a specific individual (e.g. through linkage of data sets) FORMCHECKBOX Collection and use of individually identifiable data with the individuals consent where individual participants may be identified throughout the study and in final results and publications FORMCHECKBOX Collection and use of identifiable data with a communitys consent where communities may be identified throughout the study and in final results and publications FORMCHECKBOX Collection of identifiable data from records held by a Commonwealth government agency without consent of individuals S95: NPPs (PA)

FORMCHECKBOX Collection of identifiable data from records held by a State or local government agency without consent of individuals NT Info Act

FORMCHECKBOX Collection of identifiable data from records held by a private sector agency without consent of individuals S95A: IPPs (PA)

FORMCHECKBOX Use of data previously gathered for another research project where consent was provided for future use 2.2.14 (NS)

FORMCHECKBOX Use of data previously gathered for another research project where consent was not provided for future use 2.2.18 (NS)

FORMCHECKBOX None of the above 16.How will the identity and privacy of participants be protected?

If identifying information is to be made public, justify the public identification of individual participants or communities.

Section 1.11, 2.2.6(f), 2.3.6(e), 2.3.7(b), 3.1.403.1.62, 3.3, and 5.4.6 of the National Statement on Ethical Conduct in Human Research

17.Outline procedures to be followed in the event of a participant withdrawing consent or dying:

Please refer to Chapter 2.2.19 and 2.2.20 of the National Statement on Ethical Conduct in Human Research, 2007.

18.Will payments or reimbursements be made to participants? FORMCHECKBOX Yes FORMCHECKBOX No

Go to Q19

If YES, please:

Provide Information regarding the nature of, and reasons for, these payments i.e. reimbursement of costs, provision of gift vouchers, incentives to participate, etc.

Explain why it will not form an inducement to participate.

Please refer to Chapter 2.2.10 and 2.2.11 of the National Statement on Ethical Conduct in Human Research, 2007.

19.English as a second language:

Briefly describe how you will ensure that participants whose first language is not English understand the projects aims and what they may be agreeing to.

If applicable, please identify these interpreting and translating services and provide letters of support.

Section 2.2.3, 2.2.8, 5.2.16 of the National Statement on Ethical Conduct in Human Research

20.How will your proposed methodology ensure respect for the cultural, social and religious beliefs and customs, or cultural heritage of participants?

Exclusion: For research involving Indigenous Australians, please complete Section D of the application form and enter Indigenous Australians See Section D in this box.

21. If research is being conducted in countries other than Australia, detail how you will ensure you comply with both Australian requirements and the laws and guidelines of those countries:

Section 4.8 of the National Statement on Ethical Conduct in Human Research

N/A FORMCHECKBOX

Go to Q22

22. Consent Procedures:

Please read the relevant sections of the National Statement 2.2, 2.3, 3.1 Element 3, 3.3, Commonwealth Privacy Acts and Northern Territory Information Act to assist you in completing this question.

Formatting Tip: Tick all relevant boxes by double-clicking on the box and marking Default Value as Checked.

Consent Procedures Any Relevant Documents Attached National Statement reference

FORMCHECKBOX Informed consent documented consent of individual FORMCHECKBOX 2.2, 3.1.233.1.39, 3.3.103.3.17

FORMCHECKBOX Informed consent documented consent of guardian FORMCHECKBOX 2.2.12, 3.1.233.1.39, 3.3.10, 4.43.3.17, 4.2

FORMCHECKBOX Informed consent documented assent of child FORMCHECKBOX 2.2.12, 3.1.233.1.39, 3.3.103.3.17, 4.2

FORMCHECKBOX Informed consent documented support of community, institutions or other properly interested parties representing collective interests. FORMCHECKBOX 2.2.13, 3.1.233.1.39 & 4.7.2

FORMCHECKBOX Limited disclosure not involving active concealment or planned deception. FORMCHECKBOX 2.3.12.3.4

FORMCHECKBOX Limited disclosure involving active concealment or explicit deception FORMCHECKBOX 2.3.22.3.4

FORMCHECKBOX Opt out approach FORMCHECKBOX 2.3.52.3.8, 3.3.15

FORMCHECKBOX Waiver of consent for research using personal information FORMCHECKBOX 2.3.92.3.12

FORMCHECKBOX Waiver of consent for research using pre-existing data that will be de-identified FORMCHECKBOX 2.3.92.3.12

FORMCHECKBOX Other

Explanation: FORMCHECKBOX 23.Will written informed consent be sought?

FORMCHECKBOX Yes FORMCHECKBOX No

If YES, please attach copies of the proposed Participant Consent Form and Participant Information Sheet with this application.

The Participant Consent Form should allow the participant to consent to or give permission to each proposed intervention, the proposed storage or destruction of any biological samples, being videoed or audiotaped, the proposed level of confidentiality and any dissemination of results.

It is important that the participant consent form states in bold This Means You Can Say NO underneath the research title at the top of the page, has a full letterhead with contact details, researchers names and contact details and a space for witness and interpreter signature, name and date in addition to a space for participant signature, name and date.

The Participant Information Sheet should be given to the participant to keep, and should contain contact details for the researcher/s in case of an emergency. It should clearly state in bold: This Is For You To Keep underneath the research title at the top of the page, a full letterhead with contact details, researchers names and contact details in case of an emergency, written in plain English, a paragraph of assurance of confidentiality and a paragraph on concerns and complaints with the contact details and email address of the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research.

Both should clearly identify the organisation responsible for conducting the research and provide information allowing the participant to withdraw from the project at any time without giving a reason or not participate at all.

Please attach these forms with this application.

If NO, will other methods of obtaining consent be sought e.g. oral consent, or acceptance of online survey? FORMCHECKBOX Yes. Please describe. FORMCHECKBOX No Go to Q24

24.Will you be accessing personal information without consent?

FORMCHECKBOX Yes FORMCHECKBOX No

Go to Q25

(a)If YES, from which organisation/s do you intend to collect information?

Please note that receipt of HREC approval does not place any obligation on the proposed organisation(s) to provide the requested information.

Evidence of support from the information provider should be attached to this application.

Organisation Contact Person Phone No.

(b) Provide details about the information you intend to collect:

Detail what sort of information you intend to gather from the listed Organisation(s). You must state whether the Information will be gained in an Individually Identifiable, Re-Identifiable, or Non-Identifiable format.

Section 3.1 of the National Statement on Ethical Conduct in Human Research

If the information is Individually Identifiable or Re-Identifiable, justify the need for the identifying information remember that public interest must outweigh an individuals right to privacy.

(c) Why will individual consent not be sought?

If you are gathering Individually Identifiable or Re-Identifiable information, justify your reasons for not seeking individual consent.

Section 2.2.18, 2.3.9 2.3.12 and 3.1.45 of the National Statement on Ethical Conduct in Human Research

28.Anticipated outcomes:

Detail the anticipated outcomes from the project and how they will contribute new knowledge to the field as well as any potential applications of the findings.

Justify the risks in terms of the likely benefit to be gained.

Section 1.5, 2.1, 4.7.7-4.7.9 of the National Statement on Ethical Conduct in Human Research

29.Intellectual property:

If there is a possibility of commercial exploitation of the results, has agreement been reached with participants in relation to ownership of intellectual property?

Describe any potential abuses or misapplications of the results of your project.

NS Section 3.1.31, 3.1.44, 3.1 Element 7. 4.7.9, 4.7.11; Aboriginal Guidelines pp1719

30.Timeline:

Please provide a proposed timeline for the project from commencement to completion.

Note: The term Completion includes outputs such as feedback of findings, publication of the research, etc.

Please note that ethics approval cannot be granted retrospectively.

31.Risk management strategy:

Describe the potential risks involved with the project and how you plan to manage these.

How will you deal with any contingencies and ensure the safety of:Researchers (inc personal safety and mandatory reporting obligations under NT law)

Study participants.

Organisations involved.

Data.

Facilities.

Equipment.

Procedures proposed.

Other relevant risks.

Section 2.1, 3.1, 4.6.2, 4.1, 4.4, 4.7.4, 4.8.18, 5.1.2, 5.5.2, 5.5.3 of the National Statement

33.Summary of ethical issues:

Briefly summarise all the ethical issues related to this project.

These should include at a minimum Benefit/Risk, Indigenous Involvement and Capacity Building, and Generalisability.

It is important to familiarise yourself with the National Statement on Ethical Conduct in Human Research (NHMRC) before attempting this summary.

Part C.THE RESOURCES

34.Funding:

Name all sources of funding, sponsorship and interested parties)

Please refer to Section 5.2.8 of the National Statement on Ethical Conduct in Human Research, 2007.

Has this project been submitted for funding? FORMCHECKBOX Yes FORMCHECKBOX No Go to Q35

If YES,

Name of Funding Body : Title of Application : Investigators Named on Application : Duration of Support : Status (i.e. Submitted, Funded) : Basis of funding agreement:

Provide details about any agreements regarding payment to researchers for enrolment of participants, power of veto over publication, etc.

35.Access to resources:

Detail what resource support is required for the project to succeed e.g. obtaining data sets, accessing files, use of pathology services, health or community services staff resources and/or facilities etc, and whether you have already obtained the support of the necessary persons to access these resources.

If applicable, please attach any letters of support from resource provider(s). These letters should clearly state that the resource providers have considered the resource requirements from their institution and that they are prepared to meet them.

Please note that receipt of ethics approval does not place any obligation on the proposed organisation to provide the requested information.

Section 1.1(f) of the National Statement on Ethical Conduct in Human Research

HUMAN RESEARCH ETHICS COMMITTEEof NT Health and Menzies School of Health Research (EC 00153)

RESEARCH ETHICS APPLICATION CHECKLIST

Please use this list to ensure the completeness of your application.

Mandatory components for all submissions to a Human Research Ethics Committee YES NO N/A

1. Cover letter signed by the Principal Investigator.

A brief description of the project including the Phase of the study if it is a clinical trial.

A list of all NT sites applicable to the HREC application for the research study.

An explanation of any NT involvement and local investigators if not explained in a multi-site application and a clear explanation of how the project will be facilitated in the NT.

A list of supporting documentation submitted including version dates/numbers.

For commercially sponsored research studies; the name and address of the sponsor organisation/CRO/CRA for the HREC review. (Australian address).

Principal Investigator should not be a student. If the project is student research, then the students main supervisor should be listed as Principal Investigator. 2. HREC Application Form or HREA plus Part D attachment 3. Study Protocol / Project Description

The protocol may contain some of the information in the research ethics application, but the protocol is required because it is the working document for the study; the formal design or specific plan for the research. If revisions occur during the course of the research, a revised protocol must be submitted to the reviewing HREC as an amendment. The protocol must include a version date/number, which is changed as the document is updated. Other components that may be required depending on the research project YES NO N/A

5. Letters of Approval from other Human Research Ethics Committees. 6. Master Participant Information Sheet (PIS)

Full letterhead with contact details.

Mandatory statement underneath research title This Is For You To Keep.

If more than one PIS e.g. different target groups of participants, it should be clear which group the PIS is aimed at, e.g. stated in a header or footer with version number.

Written in plain simple English.

Local researchers name and contact details included. (Site specific).

Contains relevant information (i.e. description of research, aim of research, what is required of participants, storage of data, risks and benefits, future use of samples and data, withdrawal options).

A paragraph on assurance of confidentiality.

A section on concerns and complaints with contact details of this Ethics Committee.(phone: 08 8946 8600, email NTHREC@menzies.edu.au 7. Master Participant Consent Form (CF)

Full letterhead with contact details.

Mandatory statement underneath research title This Means You Can Say NO.

If more than one CF e.g. different target groups of participants, it should be clear which group the CF is aimed at, e.g. stated in a header or footer with version number.

Written in plain simple English.

Local researchers name and contact details included. (Site specific).

Consent for all procedures e.g. access to medical records, audio/video recording dot points for non-optional items; Yes/No boxes only for optional items.

A space for study participants printed name and signature, and date and time of consent.

A space for witness / interpreters printed name and signature.

A space for the researchers printed name and signature. 8. CTN Form(s) include original CTN forms with details for each site. (Clinical trials only) 9. CTX Form (Clinical trials only) 10. Investigators Brochure 11. Questionnaires/surveys/interview guides/other instruments 12. Data collection tool(s) e.g. Data Collection Form, Case Report Form. 13. Certificate of Insurance (Clinical trials) 14. Clinical Trial Registration Number and public register details 15. Form of Indemnity (Medicines Australia HREC Review Only Form) for each participating site. 16. Copy of the Form of Indemnity (Standard Form) for each participating site. (Clinical trials) 17. Advertising materials (including transcript for advertisement, flyers, e-mail, website, letter, telephone calls etc). 18. Letter of invitation / Letter to GP etc. 19. Participant diaries. 20. Participant wallet card. 21. Other correspondence e.g. FDA reviews, correspondence with other HRECs, expert independent reviews, peer review etc. 22. Working with Children Clearance inc. for anyone working in a remote community regardless of whether or not children are the main participants in the research. 23. Aboriginal and Torres Strait Islander Research, Part D of HREC form, also to be included with HREA

Please note that applications will not be accepted without completion of this section if it is applicable in the research study. 24. Community Support

Attach letters of support from relevant participating communities and organisations. 25. Stakeholder support inc. remote health services. Examples: https://www.menzies.edu.au/page/Research/Ethics_approval/4_Stakeholder_site_support_and_permits/Letter of Support.

Funding.

Support staff available.

Agreement of other resources providers involved. (e.g. Pathology Department).

Letters of support from Community Authorities/relevant organisations.

SA-NT Datalink feasibility 26. NT Health Site Specific Authorisation

All research studies conducted at NT Health sites includes all services provided through NT Department of Health, Central Australian Health Service (CAHS) and Top End Health Service (TEHS) require Organisational Site-Specific Authorisation (SSA). This is obtained through the NT Health research governance office (nthealth.rgo@nt.gov.au).

NT Health letter of support is NOT required to be attached to the ethics application 27. Signatures

PI may sign on behalf of other investigators if applicable.

Department head printed name, signature and role in the Organisation/Institution.

Organisational Head or delegate if application is from Menzies School of Health Research researchers

If it is impossible to ascertain original signatures and only electronic signatures can be provided; please attach a letter or email from the researcher involved as evidence of consent for the use of their electronic signature and acknowledgement of support to the research study. Research using gene technology YES NO N/A

27. Ionising Radiation Certificate 28. Institutional Biosafety Committee (IBC) approval letter. 29. Licence for dealings with Genetically Modified Organism (GMO) Research using radiological procedures that are performed for research YES NO N/A

31. For each site in the Northern Territory, either

A letter from the Principal Investigator stating that radiation exposure is part of normal clinical management/care.

If radiation exposure is additional to that received as part of normal clinical management/care, an independent assessment report by a Medical Physicist of the total effective dose and relevant organ doses including risk assessment.

PHM527 Assessment Item 3 2024

Description: Ethics Application including a literature review and research proposal

Value: 50 %

Due date: Mon Sept 23

Length: 3000 words

Preparation: If your research proposal involves people:

- Download the NT Human Research Ethics (HREC) Form from Learnline under Assessment 3.

- Please note: this version of the NT HREC form has been slightly modified & simplified for the educational purposes of this assessment. If you would like to read the full form go to:

https://www.menzies.edu.au/page/Research/Ethics_approval/Forms/HREC_Application_Form/- Please note: this is the NT Human Ethics form. It contains the same information as the national human ethics form, plus a few more details. If you are planning on conducting your research in another state in the future you can use the information in this form to complete the national form at a later date.)

If your research proposal involves animals:

- Read the CDU animal ethics page

https://www.cdu.edu.au/research-and-innovation/industry-collaboration/animal-ethics

- Then download the relevant form from

https://www.cdu.edu.au/research-and-innovation/industry-collaboration/animal-ethics/applying-for-approval/forms- Then please contact the lecturer about your proposal

Task: For this assignment you need to complete an ethics application form, including a short contextual literature review and a research proposal.

Before you attempt to complete the form:

1. First, decide on the topic of the research project you are going to use for your Ethics application

You may complete an ethics application for a research project that you are planning to do in the future as a part of your award (MPH, Master of Health Research, Honours, Other)

or

If you completed PHM 526 Research Design you may use the same topic that you used for Assessment 2 ( Research question/proposal)

or

one of the research project topics that have been designed for the award that you are studying. (See the list below: Addendum to Assessment 3: Research Topic List)

If you are doing this unit and A or B do not apply to you and you cannot find a suitable project under the Research Topic List please consult the lecturer.

2. Second, watch the recorded lectures in the Assessment Help item on the Learnline menu.

Presentation: Notes on completing and submitting the HREC application & supporting documents:

Put the lecturer as the Principal Investigator (Dr Sharon Chirgwin, Associate Dean Teaching & Learning. Qualifications: BSc, Dip T, MSc, PHD, Grad Cert Indig Know, CertIV TAE), and Menzies as the organisation responsible for the research.

Put your name in as a Student Investigator.

Identify any supporting documents that must be provided with the application (Information sheets, Consent Forms, Letters of Support, Ochre Cards etc.) You will have to construct these and attach them (there are quite a few marks for these).

Use the checklist at the end to ensure that you have all relevant documents.

When you have completed the form and attachments, copy the attachments into the form so that you can submit everything as one document.

Assessment criteria: (Note: the marking matrix below will be expanded where there are several items listed. Where needed, marks will be converted to a score out of 50.)

Criteria Marks

Summary of project 5

Background, use of evidence & referencing (includes a short contextual literature review) 5

Aims of the project and research questions 4

Justification (why the project is important) 3

Participants (inclusions/exclusions) 2

Design & Methodology 4

Site, recruitment & sample 3

Data/Privacy/Security/withdrawal 4

Consent 1

Feedback 2

Risks and strategies to manage them 4

Ethical issues 4

Anticipated outcomes & intellectual property issues 2

Community support 1

Attachments 6

Total 50

Addendum to Assessment 3 Research Topic List

The following is a list of topics to be used by students who do not have a research project planned. These topics mostly contain fictitious locations, but the issues are real. They can be used to construct a research question, proposal, justifying literature review and analysis of risk and ethical issues. These will all be required to complete the ethics application that forms assessment 2.

1. For MPH students

1.1 The use of Digital devices to combat obesity

On page 289 Besson et al (2020) propose that

Given their low cost and the size of the overweight population, it appears that public health policies could integrate digital devices more strongly in their efforts to combat obesity.

Construct a research question and design (quantitative, qualitative or Mixed Methods) for your Ethics application to test the impact of one digital device ( from the list of digital devices in 1.1.1 ) on weight loss in one of the specific groups ( Listed in 1.1.2 ):

Digital devices

Fit Bit

Or

Smart phone with exercise app

Population group who will provide your sample

A selection of university students from Charles Darwin University

Or

A group of 60 to 70 year old women from the Boleroo Bowling Club

Reference : Besson, M., Gurviez, P., & Carins, J. (2020). Using digital devices to help people lose weight: a systematic review. Journal of Social Marketing, 10(3), 289319. https://doi.org/10.1108/JSOCM-07-2019-0115

1.2 How much exercise did those in lockdown get during COVID lockdowns?

Ranasinghe et al. (2020) propose that during a COVID pandemic physical activity should not be ignored but rather maintained since it has several benefits, particularly to the immune system. After identifying a suburb in a large Australian city that has been subjected to lockdowns of over a week three times (you can call it Suburb L3) you are going to do a retrospective project to find out from the residents of L3 if they did engage in any physical activity during lock downs and why/why not; and from those that did/didnt engage any infectious diseases contracted during that time. You need to recruit as large a sample as possible in an ethically appropriate way, but should focus on a specific age range. The essential steps to help you complete your Ethics application are in the first instance a short literature review that not only provides the reader background information about former research and justification why the project is necessary, and also an in-depth research proposal.

Reference:

Ranasinghe, C., Ozemek, C., & Arena, R. (2020). Exercise and well-being during COVID 19 - time to boost your immunity. Expert Review of Anti-Infective Therapy, 18(12), 11951200. https://doi.org/10.1080/14787210.2020.17948182. For Grad Cert of Infectious Disease P & C or Medical Laboratory students

SSE facemasks

According to Mosselhey et al. (2021, p.4): Antiviral nanotheranostics simultaneously diagnose (i.e., via colorimetric biosensing, fluorescence signaling, and electrical response signals) and treat (i.e., via prevention of infection initiation, prevention of viral replication and budding, and inhibition of endosomal acidification). The promising application of the antiviral nanotheranostics would be incorporating smart electrospun facemasks and self-disinfecting fabrics, which we propose as Superhydrophobic Self-disinfecting Electrospun Facemasks/Fabrics, SSEF.

You are required to construct an ethics application that details research to test the efficacy of SSE facemasks for an experimental group of 50% of the staff in Howard Springs, the isolation village where those coming from areas of infection, and those with mild symptoms spend 14 days in strict isolation. The control group will be the other 50% who will use the standard (at the moment) recommended non-SSE facemask. The essential steps to help you complete your Ethics application are in the first instance are construction of a testable hypothesis, a short literature review that not only provides the reader background information about former research and justification why the project is necessary, and also an in-depth research proposal.

Reference:

Mosselhy, D. A., Assad, M. A., Sironen, T., & Elbahri, M. (2021). Could Nanotheranostics be the Answer to the Coronavirus Crisis?. Global Challenges, 1 -13 2000112.

3. For Master of Occupational Therapy students

3.1 Spina Bifida teenagers barriers and facilitators to participation in Physical Activity

You are working with a small group of Spina Bifida teenagers (aged between 16 and 19) in Smogtun, a small town in South Australia. Three of the twelve teenagers are avid basketball and Australian rules fans and in the course of your work with them have expressed a longing to be able to participate in these activities, even on a fun basis. As per the work of Volfson et al. (2020) you decide to find out from the group just how many would like to participate in some form of physical activity, what barriers they face in doing so, what they know about physical activity. You also decide that you need to assess the attitude of the local council, the facilities suitable for your group, and any Access and equity funds that they have available for any necessary modifications. Accordingly design a project to ethically conduct this research (an ethics committee would regard the group as extremely vulnerable and any conflict with your role as their OT might need to be addressed). The steps in your design are to decide on one or more research questions, conduct a small literature review on exercise and spina bifida patients, and then develop a research proposal. With this group it is also essential to consider risks and address them.

Reference:

Volfson, Z., McPherson, A. C., Tomasone, J. R, Faulkner, G. E, & Arbour-Nicitopoulos, K. P. (2020). Examining factors of physical activity participation in youth with spina bifida using the Theoretical Domains Framework. Disability and Health Journal, 13(4), 100922. https://doi.org/10.1016/j.dhjo.2020.100922

4. For Master Public Policy students

For many young people Mobile phones have become almost an extension of themselves, the modern way of keeping up with the world and interacting with friends. Researchers have highlighted both benefits and costs to the users in educational settings. On the benefit side it is seen by some educators as increasing the resources available to students so enhancing the educational experience (Kessel, et al., 2020). On the cost side some students may not have phones, or smartphones that cannot provide the access required, and they can become a distraction and anti-social weapon in the hands of others. As per the article by Kessel et al. (2020), whole countries have weighed up the costs and benefits and have banned them in schools. In other instances, it has been left up to individual schools, independent school bodies or school districts. Sacer Secondary school is an independent religious school that caters for senior students in Years 11 to 12. In 2018 50% of the students in Year 12 did not pass their Higher School Certificate, and after online bullying and sexting was exposed as a problem with students, in 2019 after a heated Educational Council meeting the school instigated a policy that banned phones in classrooms from the beginning of the school year 2020, with the compromise that there would be an evaluation of the policy in 2021.You are required to undertake that evaluation and since you will not only be looking at figures , but also interviewing students ( with their parents permission), parents and staff, you have to complete an Ethics application. (Hint: this will be an impact evaluation that uses a Mixed methods approach).

Reference:

Kessel, D., Hardardottir, H. L., & Tyrefors, B. (2020). The impact of banning mobile phones in Swedish secondary schools. Economics of Education Review, 77, 102009.

5. For Master of Nutrition Students

Online shopping for food

Online shopping for food has become one of the fastest growing areas of the supermarket industry in the western world, enhanced by lock downs during COVID-19 (Bhatnagar, et al , 2020). Research into its nutritional impacts has been limited even though Public Health nutritionists are aware of its potential to provide big data on eating habits and nutrient composition tables (Bhatnagar, et al , 2020). For this ethics application you are going to construct a research proposal for the small Western Australian town of Veternum, population 20,000 . Apart from its many small corner shops, this town has two major supermarkets: Woles and Collies who provide an online food shopping service. You are tasked with conducting a Mixed Methods Case study in Veternum to find out if the choice of foods that online shoppers buy have changed since they began to shop online, and their satisfaction with the service. You can choose either a cohort of tech-savvy 25-35-year-olds or a cohort of 2 groups of 65 to 75-year-olds who live in independent cottages in two retirement villages who because of mobility issues like to have food delivered.

Reference:

Bhatnagar, P., Scarborough, P., Kaur, A., Dikmen, D., Adhikari, V., & Harrington, R. (2021). Are food and drink available in online and physical supermarkets the same? A comparison of product availability, price, price promotions and nutritional information. Public health nutrition, 24(5), 819-825.

6. For Master of Environmental Disaster Management Students

As the world begins to grapple with the new reality of more environmental disasters and more frequently, technology offers considerable benefits with respect to disaster assessment, monitoring and provision of targeted assistance ( Sakuri, 2019) . However, some such as van Wynsberghe & Comes (2019) have warned that there can be down sides to the use of technology such as drones in terms of threats to the principle of humanity.

During a recent flood emergency in the Northern rivers area of New South Wales in the (fictional) area of Imber Valley drones were used to identify where stranded people were in both rural and township areas and to drop emergency supplies including urgently needed medication to them, and to prioritise rescues. Six months after the event on the wishes of both the State Emergency services and the Pensioners Association of Imber Valley you are to conduct research in the area to obtain the opinions of those assisted by drones to assess their opinions; specifically, with respect to any feelings of threats to humanity that they experienced when drones were used to assist them.

References:

Sakurai, M. (2019). Information technologies and disaster managementBenefits and issues. Progress in Disaster Science., 2. https://doi.org/10.1016/j.pdisas.2019.100012van Wynsberghe, A. & Comes, M. (2019). Drones in humanitarian contexts, robot ethics, and the humanrobot interaction. Ethics and Information Technology, 22(1), 4353. https://doi.org/10.1007/s10676-019-09514-1For Master of Clinical Audiology students

The Office of Hearing Services (OHS) (hearingservices.gov.au) issues a voucher to eligible clients, these being veterans, pension card holders, children, and young adults (< 26 years of age), and First Nation peoples in Australia. The voucher covers the cost of a hearing assessment, hearing aids, and follow-up. Due to the cost and scale of the program, the OHS is regularly required to evaluate and demonstrate the benefit, satisfaction, and cost effectiveness of hearing devices for the treatment of hearing loss.

You are hired as one of several consultants by the OHS to carry out this research evaluation. The research team is divided to focus their methodology by population:

veterans,

pension card holders,

children and young adults (< 26 years of age), or

First Nation peoples

And outcome measure:

hearing device benefit,

satisfaction, or

cost effectiveness.

Select a population group and outcome measure you would like to work on. Then design a suitable methodology to evaluate your chosen outcome measure. You will need to clearly define what these terms mean and justify the measurement tools you select to measure them. Regardless of the methodology method you choose (quantitative, qualitative, or mixed) you will be collecting data on human participants and so an ethics application is required.

8. For Diploma of Creative therapies and Diploma of Health and social care

Please contact lecturer.

Watch the video The Importance of Human Intelligence in Learning in the ACADEMIC INTEGRITY section of the Learnline unit.