18 december 2019 prof a pert the university of …...18 december 2019 prof a pert architecture,...

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18 December 2019 Prof A Pert Architecture, Building and Planning The University of Melbourne Dear Prof Pert I am pleased to advise that the Humanities Law & Social Sciences Human Ethics Sub-Committee approved the following Program: Program title: MSD Minor Thesis Researchers: Prof A Pert Ethics ID: 1955415.1 The Program has been approved for the period: 18-Dec-2019 to 31-Dec-2020 It is your responsibility to ensure that all people associated with the Program are made aware of what has actually been approved. Programs are normally approved to 31 December of the year of approval. Programs may be renewed yearly for up to a total of five years Please note that individual Projects developed within this Program will require approval from the relevant Departmental Human Ethics Advisory Group before research can commence. Also note that the following conditions apply to your approval. Failure to abide by these conditions may result in suspension or discontinuation of approval and/or disciplinary action. (a) Limit of Approval: Approval is limited strictly to the research as submitted in your Program application. (b) Variation to Program: Any subsequent variations or modifications you might wish to make to the Program must be notified formally to the Human Ethics Sub-Committee for further consideration and approval. If the Sub-Committee considers that the proposed changes are significant, you may be required to submit a new application for approval of the revised Program. (c) Monitoring: All Programs are subject to monitoring at any time by the Human Research Ethics Committee. (d) Annual Report: Please be aware that the Human Research Ethics Committee requires that researchers submit an annual report on each of their projects at the end of the year, or at the conclusion of a project if it continues for less than this time. Failure to submit an annual report will mean that ethics approval will lapse. Note that separate annual reports will be required for this Program and for individual projects developed within this Program. If you have any queries on these matters, or require additional information, please contact me using the details below. Please quote the ethics registration number and the name of the Program in any future correspondence. On behalf of the Sub-Committee I wish you well in your research. Yours sincerely Ms Belinda Kelly – Human Ethics Committee Secretary Phone: (03) 903 59095, Email: [email protected] Research, Innovation and Commercialisation Incorporating UoM Commercial Ltd Alan Gilbert Building, Level 5, The University of Melbourne, 161 Barry Street, Victoria 3010 Australia T: +61 9035 5943 | W: research.unimelb.edu.au | unimelb.edu.au

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Page 1: 18 December 2019 Prof A Pert The University of …...18 December 2019 Prof A Pert Architecture, Building and Planning The University of Melbourne Dear Prof Pert I am pleased to advise

18 December 2019 Prof A Pert Architecture, Building and Planning The University of Melbourne Dear Prof Pert I am pleased to advise that the Humanities Law & Social Sciences Human Ethics Sub-Committee approved the following Program: Program title: MSD Minor Thesis Researchers: Prof A Pert Ethics ID: 1955415.1 The Program has been approved for the period: 18-Dec-2019 to 31-Dec-2020 It is your responsibility to ensure that all people associated with the Program are made aware of what has actually been approved. Programs are normally approved to 31 December of the year of approval. Programs may be renewed yearly for up to a total of five years Please note that individual Projects developed within this Program will require approval from the relevant Departmental Human Ethics Advisory Group before research can commence. Also note that the following conditions apply to your approval. Failure to abide by these conditions may result in suspension or discontinuation of approval and/or disciplinary action. (a) Limit of Approval: Approval is limited strictly to the research as submitted in your Program application. (b) Variation to Program: Any subsequent variations or modifications you might wish to make to the Program must be notified formally to the Human Ethics Sub-Committee for further consideration and approval. If the Sub-Committee considers that the proposed changes are significant, you may be required to submit a new application for approval of the revised Program. (c) Monitoring: All Programs are subject to monitoring at any time by the Human Research Ethics Committee. (d) Annual Report: Please be aware that the Human Research Ethics Committee requires that researchers submit an annual report on each of their projects at the end of the year, or at the conclusion of a project if it continues for less than this time. Failure to submit an annual report will mean that ethics approval will lapse. Note that separate annual reports will be required for this Program and for individual projects developed within this Program. If you have any queries on these matters, or require additional information, please contact me using the details below. Please quote the ethics registration number and the name of the Program in any future correspondence. On behalf of the Sub-Committee I wish you well in your research. Yours sincerely

Ms Belinda Kelly – Human Ethics Committee Secretary Phone: (03) 903 59095, Email: [email protected]

Research, Innovation and Commercialisation Incorporating UoM Commercial Ltd Alan Gilbert Building, Level 5, The University of Melbourne, 161 Barry Street, Victoria 3010 Australia T: +61 9035 5943 | W: research.unimelb.edu.au | unimelb.edu.au

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Research Ethics and Integrity | Human Ethics Program Application Form | Version 1.2.10 | Dec 2018

Page 1 of 19

HUMAN RESEARCH ETHICS

PROGRAM APPLICATION FORM

How To Use This Form

1. A Program application is only a research template

A Program application is a template of research from which a series of low risk Projects within Program can be derived. A

Program application is reviewed and approved by a HESC. Research cannot commence until an individual Project within

Program that conforms to this template has been reviewed and approved by the relevant HEAG. Further information about

Program applications and Project within Program applications can be found here

2. Consider and refer to relevant guidelines and regulations.

References to specific guidelines are provided, with hyperlinks, throughout this form. The primary guide for human research

ethics in Australia is the National Statement on Ethical Conduct in Human Research (2007) - Updated 2018. Human

research ethics applications at the University of Melbourne are reviewed and approved under the warrant of the National

Statement. References to the National Statement are abbreviated (e.g. NS §2.1.)

3. Use plain English.

Use clear, non-technical language in your application. Be concise. Spell out the first instances of acronyms and

abbreviations. Avoid jargon. Do not repeat information. Following these directions ensures effective review of your

application. It will avoid unnecessary delays which result if applications are not clear and concise.

4. Consider ethical principles.

Your application will be reviewed according to the principles of ethical research outlined in the National Statement, namely:

• Research Merit and Integrity (NS §1.1 - §1.3)

• Justice (NS §1.4 - §1.5)

• Beneficence (NS §1.6 - §1.9)

• Respect (NS §1.10 - §1.13)

5. Save your completed application with attachments as a PDF and upload it to Themis.

Contact your local Human Ethics Advisory Group (HEAG) for detailed instructions on how and when to submit your

application.

ANSWER ALL OF THE QUESTIONS IN THIS FORM

Ethics ID number: (assigned by Themis)

19455415.1

Program Title: (as recorded in Themis)

MSD Minor Thesis

Responsible Researcher: (as recorded in Themis)

Professor Alan Pert

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Research Ethics and Integrity | Human Ethics Program Application Form | Version 1.2.10 | Dec 2018

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1. Program Details

1.1 Program Summary Summarise your research Program in plain language.

[Limit: 300 words]

A) Aims and Objectives

[Briefly describe the broad aims and objectives of this Program.]

The Melbourne School of Design (MSD) offers 8 coursework masters degrees with a minor thesis

subject.

The minor thesis research training provides students with the opportunity to devise and conduct

original research of their own choosing, and to pursue this over a sustained period. This is done under

supervision of and with frequent advice from appropriately qualified academic staff. The supervised

student theses are 10,000 words in length, and typically include a literature review, explanation of the

problem and methodology, outline of the research undertaken, findings and conclusion.

This ethics application covers enrolled students undertaking an MSD minor thesis subject, including

Master of Environmental Science minor thesis students with an MSD supervisor, whose research is of

negligible or low risk. Applicants will submit a Project within Program application and undergo ABP

HEAG review. The application aim is to provide an efficient ethics approval process for MSD Minor

Thesis student projects, while still ensuring the ethical review is high quality.

B) Key Question(s)

[What question, or questions, does the Program of research intend to examine? Where relevant, state

the specific hypothesis to be tested.]

Through discussions with a supervisor, the student will obtain advice and guidance to develop an

individual research question that can be completed within the limited timeframe and is low risk. The

minor thesis programs are intended to provide students with a grounding in research, analysis and

presentation.

Examples of minor thesis low risk projects include:

• Surveying pedestrians about their perceptions of safety with regards to shared cycling paths in

the Docklands precinct

• Surveying local council residents about their engagement in the planning of street trees

• The investigation of factors contributing to the creation of congestion in Melbourne during off-

peak hours

• Investigating how a local community can affect a in brownfield development

• The Investigation of students' needs for a co-working learning space

• Investigating the adaptation of Adelaide’s water management policies to facilitate transition

towards a water sensitive city.

C) Program Justification and Features

(i) Why are you framing this application as a Program of research rather than as a standard Project

application?

This application is for ethics approval for multiple theses, by selecting a Program application each

thesis can be checked against the criteria in this application through a Project within Program

application.

The MSD Minor Thesis programs have the following features:

- Research training

- Supervised by experienced researchers (Responsible Researcher)

- Low risk projects

- Limited timeframe

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Research Ethics and Integrity | Human Ethics Program Application Form | Version 1.2.10 | Dec 2018

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The Faculty already currently manages all ethics approvals for minor thesis students either as Minimal

Risk applications, or through the previously approved Program applications for Urban Planning

(1341095) and Property (1646643) students. It is anticipated that processing all Faculty minor thesis

applications under as Projects within Program applications will streamline the process. It is also

anticipated that the process will result better applications from the students due to updated and clearer

guidance documents.

(ii) What is the nature and scope of individual Projects within Program (PWP) that are to be derived

from this and the common features they will share (e.g. same research question, same methodology,

same participant cohort, same consent process)?

The individual projects will all be:

- Undertaken by coursework masters students enrolled in a minor thesis subject (Student

Researcher) for research training

- Supervised by ABP academics (Responsible Researcher)

- Low risk projects

The projects will use common PLS and Consent (where appropriate) form templates.

(iii) What types of tasks might participants be asked to do across the range of PWPs?

Projects will be limited to those that involve one or more of the following:

• Paper based survey/questionnaire (participant or student taking notes)

• Open-ended and/or semi-structured interview conducted face to face or via phone/video

conferencing (audio-recorded)

• Online survey

• Observation of public space use (including photography where individuals are not identifiable or

are de-identified by blurring the image)

• Focus groups (audio recorded and/ transcribed)

• Examination of public documents

• Analysis of archival materials

• Use of social media posts, posted on public forums/pages. All identifying information will be

removed i.e. names, profile images, addresses, experiences that may be personal or sensitive

in nature where it could be reasonably expected that the individual would not like the

information to be used in research. Information will not be taken from closed groups

Participants will be members of the public, professionals in built environment and related disciplines,

public servants, key actors in the field of research e.g. NGO/ community group representative etc.

(iv) What is the nature and extent of any risks that participants could encounter across individual PWPs

and how these will be managed?

All projects will be low risk, risks may include:

• The possibility of a participant being identified due to the limited size of the cohort/professional

group

• Participants may feel minor discomfort through the interview process

Participants will be notified in the PLS of the potential risks and will be advised that participation is

voluntary and they can withdraw from the project at any time without explanation or prejudice,

additionally they can withdraw any unprocessed data provided.

(v) What is the proposed project within Program schedule (how many and over what period)?

Approximately 100 - 110 projects per year, minor thesis subjects are offered in semester 1 and 2

however the majority or research projects will be conducted during semester 2 of each year.

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(vi) Are there any other features of this Program that need highlighting?

Copies of the attached Minor Thesis Application form including the Plain Language Statement and

Consent Form templates will be made available to all minor thesis students via the minor thesis co-

ordinator in the relevant discipline. The student and supervisor will tailor the application to the

individual project and submit a Project with Program Application for review to the ABP HEAG prior to

individual fieldwork commencing.

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Specific Guidelines Checklist

Type an “X” in the left-hand column beside all items that apply to your research Program. Linked sections of the National Statement contain relevant guidelines and requirements that you need to address when completing your application.

Children and/or young people (< 18 years old) will be recruited as participants. → Refer to NS §4.2.

People in dependent or unequal relationships will be recruited as participants.

(There are pre-existing relationships between participants and researchers, or between participants and others involved in facilitating or implementing the research. E.g. student/teacher, patient/doctor, employee/employer.)

→ Refer to NS §4.3.

X People in countries other than Australia will be recruited as participants. → Refer to NS §4.8.

One or more of the following describes the research:

• it will be about Aboriginal and/or Torres Strait Islander individuals or peoples, their health, or their culture(s), language(s) or histories;

• it will be about the impact(s) or effect(s) of some phenomenon or phenomena on Aboriginal and/or Torres Strait Islander individuals or peoples;

• it will specifically target Aboriginal and/or Torres Strait Islander people to be recruited as participants;

• it will be conducted in a geographic location where a significant number of the population are likely to be Aboriginal and/or Torres Strait Islander.

→ Refer to NS §4.7.

→ Refer to Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018).

→ Refer to Guidelines for Ethical Research in Australian Indigenous Studies

→ This research is ineligible for Program or Project within Program review.

One or both of the following describes the research:

• it will specifically target women who are pregnant to be recruited as participants;

• it will be focused on women who are pregnant and/or the human foetus (including human foetal tissue or human embryos).

→ Refer to NS §4.1.

→ This research is ineligible for Program or Project within Program review.

People who may be involved in illegal activities will be recruited as participants, and the research project could potentially expose such activities.

→ Refer to NS §4.6.

→ This research is ineligible for Program or Project within Program review.

People with cognitive impairment, intellectual disability, or mental illness will be recruited as participants.

→ Refer to NS §4.5.

→ This research is ineligible for Program or Project within Program review.

People who are highly dependent on medical care will be recruited as participants.

→ Refer to NS §4.4.

→ This research is ineligible for Program or Project within Program review.

None of the above applies to this research Program.

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Research Ethics and Integrity | Human Ethics Program Application Form | Version 1.2.10 | Dec 2018

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Additional Modules Checklist

Type an “X” in the left-hand column beside all items that apply to your research Program. This checklist will help you determine if you need to complete any other modules in addition to this application form. Linked sections of the National Statement contain relevant guidelines and requirements that you need to address when completing this form and any applicable additional modules.

This research will involve the creation of a databank (i.e. your stored data will be made available to other parties for secondary use in future research projects).

→ Refer to NS §3.1.

→ Complete and attach the Privacy and Databanks Module.

This research will involve the collection of information for a databank (i.e. your stored data will be made available to other parties for secondary use in future research projects).

→ Refer to NS §3.1.

→ Complete and attach the Privacy and Databanks Module.

This research will involve accessing information from an existing databank (i.e. you will be accessing and making use of stored data that was previously collected – not for this specific project – by other parties).

→ Refer to NS §3.1.

→ Complete and attach the Privacy and Databanks Module.

This research will involve obtaining identifiable (or potentially identifiable) personal information (including health information) about individuals without their consent.

→ Complete and attach the Privacy and Databanks Module.

This research will involve the collection and/or use of human tissue/biological samples or materials (e.g. blood, saliva, cheek swabs, hair, human embryonic or foetal tissue).

→Refer to NS §3.2.

→ Complete and attach the Body Tissue and Genetic Research Module.

This research will involve genomic research.

→ Refer to NS §3.3.

→ This research is ineligible for Program or Project within Program review.

→ Complete and attach the Body Tissue and Genetic Research Module.

This research will involve medical interventions, therapies or trials.

→ Refer to NS §3.1.

→ This research is ineligible for Program or Project within Program review.

→ Complete and attach the Interventions, Therapies and Trials Module.

This research will involve administration of ionising radiation.

→ Complete and attach the Ionising Radiation Module.

x None of the above applies to this research Program.

2. Background and Method

2.1 Background and Significance

Provide a summary of background information. Explain the significance of the proposed research in the context of this background. Refer to NS §5.2.5 and NS §3.1

[Limit: 500 words]

A) Background:

[What is the current state of research/knowledge/discourse in this area?]

This will vary depending on the project. The current research will be identified by the student

researcher in consultation with the thesis supervisor.

B) Significance of This Research:

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[Explain the significance of the proposed Program in light of existing research, knowledge or

understanding. How does the Program help to fill a gap in the literature? You may include relevant

references, within the word limit.]

This will vary depending on the project.

2.2 Research Design and Method

Provide details of your research design and your proposed method. Refer to NS §5.2.5 - §5.2.6 and NS §3.1

Attach a copy of any measures, scales, questionnaires, survey instruments (including online surveys), interview questions/themes, and/or focus group topics/questions that may be used in any individual PWP.

A) Participants (or their records):

[Describe the sample, i.e. the intended participants or their records. Explain the basis on which this

sample was chosen. Include the number and age range and any other relevant demographic

characteristics of participants that will be used in an individual PWP, as well as any eligibility

constraints (i.e. inclusion/exclusion criteria). If the Program involves the use of records or previously-

collected data/samples, rather than direct contact with human participants, state that.]

As a generic project application, such information cannot be supplied. The potential participants will be

identified by the student researcher in consultation with the thesis supervisor.

As a broad rule:

• Participants will be between 18 to 65 years

• Participants who are identified in Section 4 of the National Statement will not be targeted (Women who are pregnant and the human fetus, Children and young people, People in Dependent or unequal relationships, People highly dependent on medical care who may be unable to give consent, People with a cognitive impairment, an intellectual disability or a mental illness, People who may be involved in illegal activities, Aboriginal and Torres Strait Islander peoples).

• Participants may be people in other countries. Countries with a DFAT travel advisory warning of 'Reconsider your need to travel' or 'Do not travel' are excluded from overseas research.

It is expected that surveys and questionnaires will rarely involve more than 100 participants, and usually far fewer. Projects using qualitative interviews typically use fewer than 30 interviews. Focus groups are likely to involve up to 12 participants. The student researcher and their supervisor (Responsible Researcher) will determine the appropriate sample sized based on the research question.

B) Recruitment:

[Describe how recruitment will occur for an individual PWP or the Program as a whole. Explain how

potential participants will be identified and approached. Who will do this? Refer to NS §3.1. If you will

be using records or data only, and you will be completing the Privacy and Databanks Module, state

“N/A.” If you will be using records or data only, but you will not be completing the Privacy and

Databanks Module, explain how the records/data will be identified, collected and accessed.]

Participants will be recruited by the student researchers directly or through community groups and

organisations. Contact will be made using contact details gained through publicly available databases

(e.g. via email or phone).

Where participants are approached in person, the student researcher will approach them and invite

them to participate in their study. A Plain Language Statement will be provided so that the participant

can make an informed decision about participation

Participants may receive information or invitation to participate through a central contact in an

organisation. Where employers are inviting employees on the researcher’s behalf, they will emphasise

that participation is voluntary.

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Student researchers may recruit through personal or professional contacts. Students will refrain from

recruiting through a workplace at with they are actively employed. Students may use social media to

recruit participants, the recruitment materials must be attached to the application.

C) Participant Incentives:

[Do you propose to reward and/or reimburse and/or compensate participants in any way? If yes, give

details here and comment on the special considerations discussed in NS §2.2.10 and NS §2.2.11. If

no, state “N/A.”]

Light refreshments may be provided for participant’s comfort during focus groups or interviews.

D) Participant Task(s):

[What will participants be asked to do in an individual PWP? What is the approximate time commitment

required of each participant? If using records or data only, state “N/A.” If your research will be

conducted in schools during class time, give details of the alternate activity arranged for students in the

class who will not be participating in the research.]

Participant will be invited to be involved in any of the following activities:

• Structured interview and/or brief survey/questionnaire (student taking notes), for up to 15

minutes.

• Open-ended and/or semi-structured interview (audio recorded), using questions and themes

previously agreed to with the supervisor, for a maximum of one hour.

• Online survey (up to 15 minutes).

• Focus groups (audio recorded and/or notes taken by participants and/or students), of no longer

than 1.5 hours in duration.

E) Data/Material Collection Technique(s):

[What data/materials will be collected as part of an individual PWP? Where will the data be collected?

List/describe all sites. How will data be managed?, refer to NS §3.1]

The exact data collection techniques used will be determined by the student in consultation with the

supervisor to ensure alignment with the research aim. Data will be collected in locations convenient to

the participants, and safe for the participants and researchers. For example, either in a public place

(e.g. café, library), community centre or business location (office, studio). Data collected may include

written data, notes taken by student, audio recordings (and corresponding transcriptions), survey data,

photographs, diagrams, map annotations and notes taken by participants (i.e. through focus groups).

Social media data sources, such as using social media for data scraping, are not in this program’s

scope. Social media research will require an HRE application for full ethical review.

F) Data Analysis:

[How will data/materials be analysed? What methods/techniques/theories will be used?]

The exact data analysis methods used will be determined by the student in consultation with the

supervisor to ensure alignment with the research aim and nature of the data collected. A range of data

analysis methods will be employed from qualitative methods including coding and thematic analysis;

through to quantitative data analysis – employing statistics. Data management software may be used

including: NVIVO, SPSS, GIS etc.

3. Risks, Benefits and Monitoring

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3.1 Potential Risks to Participants

Does your research Program pose any potential risks to participants? What are those risks? How will they be negated, minimised or managed? Refer to NS §2.1.

Note that the risks you identify here should also be described in your Plain Language Statement (PLS). Attach a copy of any distress protocol or adverse event protocol (if applicable).

A) Potential Risks

[Identify, as far as possible, any potential risks to participants associated with the research Program.

Risks may arise from the nature of questions that participants are asked (such as discussing sensitive

or distressing topics), or the tasks that participants will do, or the procedures that they will undergo.

Potential risks might be physical, psychological, emotional, social, legal or economic in nature (this list

is not exhaustive). Risks also may be associated with the research setting (e.g. outdoors, in unsecure

housing, or in countries other than Australia). If you believe that any potential risks are minimal, please

state this and explain why.]

Projects governed by this project must be of negligible or low risk. While it is difficult to gauge the

individual project risks given the broad variety of project, those projects seeking coverage under this

application will not pose not physical, psychological, legal or economic risk to participants. The social

risk which may apply is likely only to be the possibility that the anonymous source of quoted material

may be identified by a reader. This has potential to be a serious issue, and all efforts will be made by

student and supervisor, and ethics review body to ensure this risk has a suitable risk management

strategy. In projects where there is potential for responses to be identifiable, participants will be notified

through the PLS of this potential.

Some respondents may feel minor discomfort through the interview process if they are unable to

answer certain questions.

B) Risk Management Strategy

[Describe what measures you have in place to negate, minimise or manage the potential risks you

have identified. Depending on the type(s) of risks involved, participants may also need additional

support (e.g. external counselling) during or after the study. Attach or include a copy of any distress

protocol or adverse event protocol which you have developed.]

The attached risk checklist completed by students and supervisors will be used to identify any

application that could be greater than low risk and thus out of scope of this application. Greater than

low risk research projects will be required to complete an HRE Project Application Form.

Questions will not include personal issues of a sensitive nature. Should some participants appear to be

experiencing discomfort, the student researchers will be briefed to offer to pause the activity, skip the

question or terminate should the need arise.

Participants will be advised through the PLS and Consent Form and in person (where applicable) that

participation is voluntary and that they can withdraw their participation.

3.2 Potential Risks to Non-Participants

Does your research Program pose any potential risks to non-participants? (This could possibly include risks to researchers or independent contractors.) If so, how will these risks be minimised? Refer to NS §2.1.

[Describe any potential risks and your risk management strategy for non-participants, if applicable.

Risks to non-participants might include things such as potential breach of privacy, stigmatisation of a

particular group, or knowledge about familial genetics. If you believe that any potential risks to non-

participants are minimal, please state this and explain why.]

Students and supervisors need to recognise the issues at stake for each specific project and to each

take responsibility for avoiding such risks. The attached MSD Minor Thesis Ethics Application,

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including the Minor Thesis Risk Assessment, will require examination of any potential risks to students,

and/or participants or non-participants so that potential risks can be mitigated.

3.3 Risks, Benefits and Justification

In light of the risks and expected benefits of the research Program, explain how the expected benefits of the research justify any risks it may pose. Refer to NS §1.6 - §1.7 and NS §2.1.

A) Expected Benefits

[Describe any expected benefits of this research. Include potential benefits to the community or

society, and any specific potential benefits to participants, beyond general positive feelings that may

arise from participating in research and having one’s voice heard. Note that it is generally not

necessary to demonstrate specific benefit to participants in order to show that research is ethically

justifiable.]

The benefits of individual studies are various in the planning stages, during and after completion.

Research training not only gives students experience in ethically-conducted, methodologically sound

research, but also has the potential to contribute to the wider body of knowledge in their discipline.

B) Justification of Risks by Expected Benefits

[Explain how the expected benefits of the research justify the risk(s) which you identified in questions

3.1 and 3.2. Pay particular attention to any risk(s) to participants that are greater than inconvenience.]

All projects will be of negligible or low risk to ensure the benefits identified in 3.3 A outweigh the risks

identified in 3.1 and 3.2.

3.4 Management and Monitoring

How will researchers manage and monitor the conduct of this research Program? Refer to NS §5.5.

A) Management

[Provide details of how and by whom the research Program will be managed over time, to ensure that it complies with the protocols set out in

this application, and with all relevant legislation and regulations. How will the Responsible researcher ensure that all PWPs conform to the

approved Program? Address cases where several people are or may be involved in recruiting, interviewing, obtaining data or data analysis.]

Throughout the life of the project the student and supervisor will meet regularly to discuss the progress

of the project, and to ensure it complies with the protocols set out in the application – particularly

relevant through the data collection phase. It is likely that more frequent meetings (in person or via

skype/phone) will be conducted during this time.

B) Monitoring

[If the research will be carried out at some distance from the responsible researcher (i.e. interstate or in

countries other than Australia), describe the systems in place to ensure compliance with the research

protocols you have outlined in this application. If the research will be undertaken by a student, describe

how the student will be supervised to ensure compliance with the protocols, including details of any

local supervision to be organised for research conducted overseas or interstate.

Students will obtain supervisors in the first few weeks of the project, either in consultation with the

thesis co-ordinator or through their own endeavours. Student researchers are required to remain in

close contact with their supervisors through regular supervision meetings. Supervisors are available to

students for consultation through email (and/or telephone) throughout the duration of the project.

Students will be briefed on protocols set out through the university's ethics guidelines, the Australian

Code for the Responsible Conduct of Research and the National Statement on Ethical Conduct in

Human Research

Should students be undertaking in person research in overseas locations, establishing a local

supervisor will be required. In most instances overseas students will return to their home town/country

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between semesters to conduct field work e.g. China, Mexico etc. Close email contact with supervisors

will be maintained and the local supervisor provided will have expertise in the discipline to help with

any day-to-day contingencies.

C) Independent Contractors

[If any independent contractors (i.e. persons not listed in Themis as researchers on this program) will

be carrying out any part of the research, provide details of the contractors involved, explaining their role

and their qualifications/experience to fulfil this role. Include details of any training that will be provided

to the contractors. Confirm that the contractors will be provided with a copy of the approved ethics

protocol and advised of their responsibilities in relation to the research. If no independent contractors

will be involved, state “N/A”.]

In rare circumstances students may engage a transcription service to transcribe audio recordings of

interviews / focus groups. This will be discussed with supervisors, and an appropriate company

engaged who will be notified of the ethics protocol

4. Consent

4.1 Obtaining Informed Consent

Type an “X” in the left-hand column beside as many of the following options as apply to your research program. Use the space provided below to explain how you will obtain informed consent from participants. If you seek a waiver of consent, or the use of an opt-out approach, use the space provided to justify your request. Refer to NS §2.2, NS §2.3.

X Written consent will be sought from (or on behalf of) participants.

→ Refer to NS §2.2.6.

→ Attach a copy of the consent form(s) that will be used as a model for each Project within Program.

X Verbal consent will be sought from (or on behalf of) participants.

→ Refer to NS §2.2.5 - §2.2.6.

→ Explain why you have chosen this method of consent, and how an individual’s consent to participate will be recorded.

→ Attach a copy of the consent script(s) that will be used as a model for each Project within Program.

X Consent will be implied, rather than explicitly obtained. → Refer to NS §2.2.5 - §2.2.6.

→ Explain why you have chosen this method of consent.

Third parties (e.g. parents/guardians of minors) will provide consent on behalf of participants.

→ Refer to NS §2.2.12.

→ Explain who will be providing consent on behalf of participants and why.

Third parties (e.g. community elders, school boards) will be involved in whole of community participation decisions.

→ Refer to NS §2.2.13.

→ Provide details of which third parties will be involved, why they will be involved, and how this will be accomplished.

This application seeks a waiver of consent. → Explain why you are seeking this option. Justify your request by referring to the conditions described in NS §2.3.10 - §2.3.11.

This application proposes to use an opt-out approach. → Explain why you are seeking this option. Justify your request by referring to the conditions described in NS §2.3.6.

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[Write your responses here. If you will be obtaining consent from participants, describe who will obtain consent and whether this will be common for all PWPs. Explain how it will be established that potential participants are competent to understand the research and to participate voluntarily, particularly if they are in a dependent relationship with the researcher(s). If you will not be obtaining consent from individual participants, justify your request for a waiver of consent, or for use of an opt-out approach.]

Written consent will be sought using the template consent form for participant tasks apart from online or face to face anonymous surveys. Verbal consent may be used where appropriate for the individual project.

Implied consent will be sought for online and face to face anonymous surveys.

4.2 Limited Disclosure

Do you propose to use limited disclosure, concealment or deception as part of this research Program? (Answer Yes or No. If Yes, use the space below to explain.) Refer to NS §2.3.

YES or NO: NO

[If NO, you may leave this space blank. If YES, provide a justification for the limited disclosure, concealment or deception. Comment on the

special considerations discussed in NS §2.3. Indicate whether you intend to debrief participants and justify that

position. If you are seeking a waiver of consent for all participants, select NO.]

4.3 Future Use of Data, Materials, or Tissues

Do you intend for the data and/or materials and/or tissues collected for this research Program to be reused in future research? Type an “X” in the left-hand column beside as many of the following options as apply to your research. Use the space provided to specify which data/materials/tissues will be reused, if any. Refer to NS §2.2.14 and NS §3.1

X Consent will be specific. → Data/materials/tissues will be used only for this research Program (i.e. no future use). Make this clear in the model PLS

Consent will be extended.

→ Data/materials/tissues used in this research Program may also be used in future research closely related to this Program, or in the same general area of research as this Program. Make this clear in the model PLS

Consent will be unspecified. → Data/materials/tissues used in this Program may also be used in any future research. Make this clear in the model PLS

[If data/materials/tissues from this research Program will not be reused, select “specific” above and state “N/A” here. If data/materials/tissues will be reused, describe which of them will be reused explain and how such future use will occur. If different conditions of consent apply to different data/materials/tissues, explain which conditions apply to which data/materials/tissues. If you will also be completing the Privacy and Databanks Module, you may simply write “Refer to Privacy and Databanks Module” here.]

All data collected for individual projects will not be used for any other purpose than the student research project for which it was collected.

4.4 Conflict of Interest

Does your research Program present or involve any conflict of interest, whether potential, real, or perceived; or will the researcher(s) have dual roles in relation to the participants? (Answer Yes or No. If Yes, use the space below to explain.) Refer to NS §5.4, University of Melbourne Research Integrity and Misconduct Policy (MPF1318), and Australian Code for the Responsible Conduct of Research §7.2.

YES or NO: NO

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[If YES, explain what the potential conflict of interest is and how it will be managed. If applicable, you may also need to include a comment on

the model Plain Language Statement and model Consent form declaring that potential conflict of interest. If NO, you may leave this space

blank.]

4.5 Information for Participants

How will relevant information about the research Program be provided to potential participants? Attach a copy of the model advertisement (print or online), Plain Language Statement (PLS), consent form, letter, email, telephone script, and/or debriefing statement to be used for each Project within Program. Refer to NS §5.2.25 and NS 3.1. Note these model documents will be used for all PWPs with only minor alterations made that are specific to each project (e.g. research question, contact details)

[Explain how participants will be informed about the research. If applicable, explain what arrangements

will be made for informing participants with low literacy skills, and/or for translation/interpreting of these

materials for participants who are speakers of languages other than English. If you are seeking a

waiver of consent (refer 4.1), state “N/A.”]

The exact information provided to participants will be determined by the student in consultation with the

supervisor to ensure alignment with the research aim.

Information provided to the participants will be aimed at expected level of comprehension (eg. General

public, experts in the field, etc.) and will include information about the purpose. methods, demands,

risks, inconveniences, discomforts and possible outcomes of the research. Plain Language Statement

and Consent Form templates will be provided for each student and supervisor to tailor to the individual

research project. Each participant's consent will be clearly established, either by using a signed

Consent Form or by returning an anonymous survey or recording an agreement for interview.

Plain Language Statement (PLS): Your model PLS must satisfy the requirements set out in the National Statement (NS §2.2.1 -

§2.2.3, §2.2.6). The Research Ethics and Integrity’s website has guidance on composing your plain language statement, as well

as an example PLS template. A list of PLS requirements is also provided at the end of this form. Ensure that your PLS is written

in plain language. Ensure that the information contained in your PLS is consistent with the information in your application.

Consent Form: Your model Consent Form must satisfy the requirements set out in the National Statement (NS §2.2). The Research

Ethics and Integrity’s website has guidance on composing your consent form, as well as an example consent form. A list of

consent form requirements is also provided at the end of this form. Ensure that your consent form is written in plain language.

Ensure that the information contained in your consent form is consistent with the information in your application.

5. Dissemination and Data Management

5.1 Providing Results to Participants

How will the results of the research Program be provided to participants in an accessible format? Refer to NS §1.5 and NS 3.1

[Describe how participants will be given access to the results of the research. If you will only be using

pre-collected data and/or tissue, state “N/A”. If you are seeking a waiver of consent, state “N/A”. How

will the Responsible researcher ensure this is provided for individual PWPs?]

Participants will have the opportunity to request a summary of findings via an email address. The

option in the consent form will allow participants to request a summary of findings be sent to a

designated email address. Online survey participants may also have an opportunity to request a

summary of findings at the end of their survey. All participants will receive a Plain Language Statement

with the Responsible Researcher and Student Researcher’s email address should they require more

information.

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5.2 Reporting Program Outcomes

How will outcomes of the research Program be made public? Refer to NS §1.3 and NS 3.1

[Describe the format and means by which you intend to make the Program’s results public.]

Project outcomes will be reported via a written dissertation, available to the public through the Faculty

library. Some students may also present findings at academic conferences, or in academic journal

articles, or industry news magazines (e.g. Planning News).

5.3 Data Management

How do you propose to manage the data collected via individual PWPs that are derived from this research Program? Specify what types of data will be collected, how they will be stored and in what format. How will access to the data be controlled and by whom? Discuss retention, security, and data sharing plans. What measures will be taken to protect participants’ privacy, and their data?

Refer to NS §1.11, NS 3.1, the Australian Code for Responsible Conduct of Research §2, and the University of Melbourne Research Integrity and Misconduct Policy (MPF1318).

A) Privacy and Confidentiality

[What measures will be taken to protect participants’ privacy and the confidentiality of participants’

data? Describe the format in which the data will be stored (e.g. digital video file, database of survey

responses, paper forms.) Describe whether the data will be identifiable. That is, will it be possible for

researchers or others to match data to specific participants? If so, how will this be possible? If not, how

will such matching be prevented?]

Where participants are not named in the final thesis their privacy and the confidentiality of their

responses will be protected. Students and supervisor will make sure that responses cannot be linked to

individuals in the thesis, or any resulting publication/s, by referring to individuals by a pseudonym, and

not disclosing any information which could lead to their identification (employment position, role in

projects/organisations, etc). Sometimes, this information is crucial to the project outcomes, in these

situations student researchers will explain related risks to participants during recruitment. Students

must only use that information if participants consent to their name or other identifiable information

being used.

Where photography is used, students will ensure faces are blurred so individuals cannot be identified.

Where audio or visual recording is used students will use password secure data storage, separate

storage of participant details to the recordings and publication of only non-identifiable details to

preserve anonymity.

B) Security and Storage of Data

[What short-term storage will you use during the data collection phase? Whose responsibility will it be

to manage this? What long-term storage will you use after the data collection phase? Whose

responsibility will it be to manage this? Who will have access to unprocessed (raw) data? What security

measures will be in place to control access to data?

NOTE: If your research will generate digital and non-digital data, separate this section into two parts:

“Security and Storage of Non-Digital Data” and “Security and Storage of Digital Data.”]

During the data collection period, students will store data in password protected files. They will not

share the data with anyone apart from their supervisor, or in rare instances a co-student who might be

conducting a double coding exercise for qualitative data analysis. Once the thesis is complete, data

storage will be the responsibility of the supervisor.

Students conducting research overseas will be required to address how the research data will be

managed. Students will be advised that data should not be kept on any form of social media (such as

WeChat) or mobile phones, and that data should instead be kept in password protected files or if

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possible, on the student’s password protected University provided data storage accessed via the

University’s VPN.

C) Retention

[For how long will you keep the data generated by this research Program? How will you ensure that

data is retained if/when the researcher(s) leave the University? For data that are not intended to be

kept indefinitely, how will you eventually dispose of the data?

NOTE: the minimum retention period for research data and primary materials is five years after the last

publication, or public release, arising from the research (University Policy). Longer minimum retention

periods apply for certain types of research – refer to the requirements of relevant regulations.]

The raw data will be stored at the University of Melbourne by the student’s supervisor for a minimum of

5 years post publication of the research results. The data will be destroyed after this period.

6. Other Issues

6.1 Other Ethical Issues

Are there any other issues, not addressed above or in additional modules, which are relevant to the ethical review of your research Program and related Projects within Program? Refer to the relevant sections of the National Statement identified in the Specific Guidelines Checklist, if applicable.

[Use this space to address any relevant ethical issues that are not addressed elsewhere in this

application. If there are no other issues relevant to the ethical review of your research Program, state

“N/A.”]

N/A

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Attachments Checklist

Review your answers above to determine which attachments (if any) are required for your application. Type an “X” in the left-hand column beside all items that apply to your research Program. Attach a copy of the items you have selected.

X Plain Language Statement (PLS) for Participants to be used as a model for each PWP

X Consent Form for Participants to be used as a model for each PWP

Additional PLS versions (e.g. for parents, teachers, schools)

Additional Consent Form versions (e.g. for parents, teachers, schools; or assent forms for children)

Recruitment Materials (e.g. advertisement(s), posters, letter(s) or email(s) of invitation) to be used as a model for each PWP

Questionnaire(s) and/or Survey Instrument(s) that may be used for any PWP

Measure(s) and/or Scale(s) that may be used for any PWP

List of Interview Questions and/or Themes that may be used for any PWP

List of Focus Group Questions and/or Themes that may be used for any PWP

Participant Distress Protocol to be used as a model for each PWP

Adverse Event Protocol to be used as a model for each PWP

Debriefing Statement to be used as a model for each PWP

Approval(s) of research by an HREC external to the University of Melbourne

Other External Approval(s) (e.g. schools, communities)

Full Protocol (for Medical Research)

Translations and/or Back-Translations (where languages other than English used)

Privacy and Databanks Module

Body Tissue and Genetic Research Module

Ionising Radiation Module

X

Other Documents (e.g. contracts, agreements) – specify which:

MSD Minor Thesis Ethics Application

HRE Project within Program Application Form

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Plain Language Statement (PLS) Requirements:

1. Clearly identify the University of Melbourne (i.e. by prominent placement of the University’s logo) and the department(s)/

school(s)/faculty(-ies) involved. If printed, the PLS should be on University of Melbourne letterhead.

2. Clearly identify the title of the Program, and the name(s) and contact details of the Principal Researcher and Other Researchers.

For student Projects within Program, specify the student’s level of study.

3. Clearly explain the purpose of the research Program.

4. Clearly explain what participants will be asked to do, and provide an estimated time commitment.

5. If participants will be photographed, audio- or video-recorded, clearly state as much.

6. Clearly explain any risks arising from participation, as well as any procedures or measures in place to minimise such risks.

7. Describe any expected benefits to the wider community. If applicable, also describe any expected benefits to participants.

8. List any payments, incentives or reimbursements to be made to participants.

9. State that involvement in the research is voluntary and that participants are free to withdraw from participation at any time.

Explain any implications of withdrawal, including whether it will be possible for participants to withdraw any data already collected

from or about them.

10. Describe the likelihood and form of dissemination of the research results, including publication.

11. Describe the arrangements in place to protect the confidentiality of participants’ data, and advise participants of any legal

limitations to such confidentiality. If the sample size for the research is small, advise participants that this may make them

identifiable.

12. The Program HREC number (which is the ethics ID number assigned by Themis) and the date and version number of the PLS

must appear on the PLS. If the PLS is printed, put this information in the footer.

13. Explain what will happen to participants’ data after the research Program ends (i.e. how long it will be retained, whether it might

be used again for future research and if so who would have access.)

14. Include the following statement: “This research has been approved by the Human Research Ethics Committee of The University

of Melbourne. If you have any concerns or complaints about the conduct of this research, which you do not wish to discuss with

the research team, you should contact the Manager, Human Research Ethics, Research Ethics and Integrity, University of

Melbourne, VIC 3010. Tel: +61 3 8344 2073 or Email: [email protected] All complaints will be treated

confidentially. In any correspondence please provide the name of the research team or the name or ethics ID number of the

research program.”

15. If the research is externally funded, state the amount(s) and source(s) of funding for the research.

16. If there are any potential conflicts of interest for any of the researchers, sponsors (if applicable) or institutions, disclose these

potential conflicts of interest.

17. If any participants will be in a dependent relationship with any of the researchers, state that decisions about participation will not

affect the dependent relationship. (E.g. students’ grades will not be affected if they decline to participate or withdraw from the

research at any stage).

Consent Form Requirements:

1. Clearly identify the University of Melbourne (i.e. by prominent placement of the University’s logo) and the department(s)/

school(s)/faculty(-ies) involved. If printed, the consent form should be on University of Melbourne letterhead.

2. Clearly identify the title of the Program, the name(s) and contact details of the Principal Researcher and Other Researchers. For

student Projects within Program, specify the student’s level of study.

3. If participants will be photographed, audio- or video-recorded, clearly state as much.

4. State that involvement is for the purpose of research and that it is voluntary. Also state that participants are free to withdraw

consent at any time, and to withdraw any unprocessed data previously supplied.

5. Describe the arrangements in place to protect the confidentiality of participants’ data, and advise participants of any legal

limitations to such confidentiality. If the sample size for the research is small, advise participants that this may make them

identifiable.

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Declaration by the Responsible Researcher

The information contained in this application is, to the best of my knowledge and belief, accurate.

I have read the University’s current human ethics guidelines. I accept responsibility for the conduct of the procedures set out in the

attached application in accordance with: those guidelines, with the University’s Research Integrity and Misconduct Policy

(MPF1318), and with any other condition laid down by the University of Melbourne’s Central Human Research Ethics Committee

(CHREC), its Human Ethics Sub-Committees (HESCs), or by the Human Ethics Advisory Group (HEAG) which will review this

application. I have attempted to identify all risks related to the research that may arise in conducting this research. I acknowledge

our obligations as researchers and the rights of the participants stipulated in the National Statement on Ethical Conduct in Human

Research (2007) - Updated 2018. I certify that the research team has the appropriate qualifications, experience and facilities to

conduct the research described in the attached application, and to deal with any emergencies and contingencies related to research

that may arise throughout the life of the program and related projects within the program.

If approval is granted, the Program and related Projects within Program will be undertaken in strict accordance with the approved

protocol and relevant laws, regulations and guidelines.

I, the Responsible Researcher, agree to:

• start this research only after obtaining final approval for the Program from the HESC, AND approval for the relevant Project within

Program from the HEAG;

• carry out this research only where adequate funding is available to enable the research to be carried out according to good

research practice and in an ethical manner;

• provide additional information as requested by the CHREC, HESC, or HEAG;

• provide progress reports to the CHREC, HESC, or HEAG as requested, including annual and final reports;

• maintain the confidentiality of all data collected from, or about, research participants and maintain security procedures for the

protection of their privacy;

• submit an amendment if any modification to the research design or protocol is proposed (including any change of researchers)

and to proceed with the research only after the amendment has been approved by the HESC (if this is for the overall Program) or

by the HEAG (if this is for a particular Project within Program);

• notify the HESC in writing immediately if any adverse event occurs during the course of the research;

• notify the HESC in writing immediately if any complaints are received about the research;

• comply with an audit of the research undertaken, if requested by the CHREC, HESC, or HEAG;

• use only the data/tissue samples collected for this research, and for which HESC/HEAG approval has been given.

I certify that all members of the research team have read this application and the National Statement on Ethical Conduct in Human

Research (2007) - Updated 2018 and that they have agreed to comply with the provisions of the latter.

Responsible Researcher Name Signature Date

Professor Alan Pert

24/10/19

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Declaration by Human Ethics Advisory Group (HEAG)

For HEAG use only.

Enter the date the application was received, then type an “X” in the left-hand column beside each item as applicable.

Date Application Received:

Technical review has been completed by the HEAG.

The merit of the proposed research Program set out in this application has been reviewed on technical grounds.

Refer to NS §1.1.

The HEAG understands the nature and scope of proposed Projects within Program that will be submitted in due course and agrees to only approve those that align with this Program of research

Ethical review has been completed by the HEAG. The HEAG has reviewed the proposed research Program set out in this application for compliance with the principles of Human Research Ethics.

Declaration

(Program):

The HEAG has reviewed this Program application and considers the technical and ethical aspects of the proposal to be appropriate to the tasks proposed. The HEAG regards this Program as ready to submit to the HESC. The HEAG considers that the researcher(s) has/have the necessary qualifications, experience and facilities to conduct the research described in the attached application in a manner that complies with the University’s policy on the management of research data and records, and to deal with any emergencies and contingencies that may arise. [Note: If the HEAG Chair is also a researcher in this Program, the declaration should be signed by another authorised member of the HEAG.]

Name of HEAG Chair/Authorised Member Signature Date