Human Ethics research

COVID-19 Research Guidance

In line with government directives on social distancing during the COVID-19 pandemic, research activity that involves researchers being physically present for data collection with human participants (such as face-to-face fieldwork, experimental and cohort studies, clinical trials etc.) cannot currently commence or continue and will need to be deferred and rescheduled. In exceptional circumstances, where such activities are part of priority research, including that directly related to the University’s COVID-19 response, approval to commence must be given by the Central Human Research Ethics Committee (CHREC) after endorsement from the Melbourne Graduate School of Education Human Ethics Advisory Group (MGSE HEAG).

Desk-based elements of your research project can commence or continue, as can data collection that can be conducted online or via telephone, subject to necessary approvals or amendments to ethics applications.

Researchers will be advised by the University when other elements of planned and approved data collection can commence. Please consult the COVID-19 website for research guidance, frequently asked questions and other research relevant updates at the Research Guidance page.

How to Obtain Ethics Clearance

All research projects involving humans are subject to peer review and approval by The University of Melbourne Human Research Ethics Committee (HREC). Research involving human subjects cannot and must not proceed until clearance has been obtained.

The HREC has established Sub-Committees and Advisory Groups to review staff and student ethics applications. The Melbourne Graduate School of Education Human Ethics Advisory Group (MGSE HEAG) suggests that you read the information below and download the kit, which includes procedures for submitting an ethics application, taking note of the MGSE HEAG deadline schedule, under ‘When should I submit an application?’

Human Ethics administration within MGSE is provided by the Human Research Ethics Consultant via email: mgse-ethics@unimelb.edu.au

Download
A detailed Human Ethics research kit 12.5MB

Frequently Asked Questions

  • Who should complete an application?

    Staff

    All academic researchers who are members of staff of the Graduate School and aim to conduct research which involves humans as participants, must submit an application to the Melbourne Graduate School of Education Human Ethics Advisory Group (MGSE HEAG) for review and endorsement, then forwarded for approval by the Education, Fine Arts, Music & Business Human Ethics Sub-Committee (EFAMB HESC).

    Students

    All student researchers in the Melbourne Graduate School of Education, who are enrolled in a thesis or research project subject, and are gathering data from human subjects, must submit an application to the MGSE HEAG for review and endorsement, then forwarded for approval by the EFAMB HESC. The student (as the Student Researcher) completes the ethics application in consultation with their supervisor. The application form must be read and signed by the supervisor (as the Responsible Researcher) before being submitted.

    NOTE: Standard Risk Project applications will only undergo a technical review to ensure all documents are present by the MGSE HEAG. The application will then be forwarded directly to the EFAMB HESC for peer review and approval.

  • What are 'standard risk' and 'minimal risk' projects?

    For the purpose of human ethics, projects are classified as being either 'standard risk' or 'minimal risk' depending on the nature of the enquiry being undertaken and the nature of the participants. As a general indication, projects conducted overseas, involving children, persons undergoing medical treatment or any person likely to be seen as vulnerable will be 'standard risk'. Projects involving consenting adults with non-controversial subject matter will be 'minimal risk'. The online process through Themis will make these distinctions clearer and will usually ensure that the appropriate forms are used.

  • Online application through Themis: Where do I log in?

    All ethics applications are lodged through the Themis Ethics module, as follows:

    1. Log in to www.themis.unimelb.edu.au for the online form
    2. Click on ‘UOM Research Self Service’
    3. Click on ‘Ethics’
    4. Click on ‘Human Ethics Workbench’
    5. Follow the on-screen instructions
  • How can students submit an online application through Themis?

    Students must first be eligible for a Themis account

    Student access to the Themis Human Ethics module is now available for all "research-active" students [i.e. those enrolled in a recognised research degree, such as the D.Ed. and Ph.D.]. Students are assigned the Responsibility of UOM Research Student Self-Service. For the Human Ethics module this will give them access to the same functionality as staff researchers – namely the Human Ethics Workbench, Meeting Schedules and Reporting functionality. Students who are not research-active cannot access Themis. It is possible for individual students to have their status set to "research active", to do this please contact the Themis Service Desk.

    The Themis account must then be activated

    Students activate their Themis account via Account Registration System (ARS) just as Staff do. They will need the following information to activate their Themis account:

    • Full name
    • Student number
    • Date of Birth (format is DD-MON-YYYY)
    • Postcode of home residence
    • Library BarCode

    Using this information, the student logs in to the Accounts Registration System (ARS).

    Themis Help Guides

    These are step by step guides which describe how to apply for human research ethics approval via Themis and can be found on this page under Where can I get help navigating in Themis?

  • Where can I get help navigating in Themis?

    The Research Ethics and Integrity Unit has developed step by step guides which describe how to create, manage, report and action human ethics applications via Themis.

    Introduction guides:

    New application guides:

    Themis screen guides:

    After lodgement guides:

    Annual report guides:

  • When should I submit an application?

    The ‘Ethics@Melbourne’ review recommended major changes to the Human Ethics process which are proposed to take effect later in 2020.

    Please download the submission deadline cycles to assist in planning your application.

    Download Submission Deadlines

  • What human ethics training is available?

    Research Integrity Online Training (RIOT)

    RIOT is the University's Research Integrity Online Training course, available to all University staff and students, via the Campus Learning Management System (LMS). All users will need to self-enrol via the LMS Subjects and Communities Catalog.

    RIOT is the University's endorsed training course that covers the principles of research integrity and their application to the planning, conducting and reporting of research. RIOT also presents other aspects of the responsible conduct of research including human research ethics, the care and use of animals in research, and the broad societal responsibilities of research.

    RIOT aligns with the new Australian Code for the Responsible Conduct of Research 2018 and adapted with University of Melbourne resources and links. The training has activities and quizzes at the end of each module. There is a total of eight modules, each of which follows a different stage of the research process.

    For further information and completing the course go to the RIOT Website. For technical support contact the Service Desk and for non-technical support email: research-integrity@unimelb.edu.au.

    Human Ethics Drop-In Sessions

    The Human Ethics Drop-In Sessions are open to all MGSE staff and students and are scheduled a week before that cycle’s lodgement deadline. Each drop-in session allows staff and students in a first in first served basis to discuss their human ethics application and receive appropriate advice.

    For 2020, the ethics drop-in sessions are as follows:

    Cycle Month

    Date

    Time

    Venue

    February

    Wednesday 29 January

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    February

    Tuesday 18 February

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    March

    Wednesday 4 March

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    March

    Tuesday 17 March

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    April

    Wednesday 1 April

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    April

    Wednesday 15 April

    1:30pm

    Room Q372, Level 3, 234 Queensberry Street

    May

    Wednesday 29 April

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    May

    Wednesday 13 May

    3:30pm

    Room Q372, Level 3, 234 Queensberry Street

    June

    Monday 25 May

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    June

    Thursday 11 June

    12:30pm

    Room Q372, Level 3, 234 Queensberry Street

    July

    Monday 22 June

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    July

    Thursday 9 July

    12:30pm

    Room Q372, Level 3, 234 Queensberry Street

    August

    Wednesday 29 July

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    August

    Monday 10 August

    3:30pm

    Room Q372, Level 3, 234 Queensberry Street

    September

    Monday 24 August

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    September

    Tuesday 15 September

    3:00pm

    Room Q372, Level 3, 234 Queensberry Street

    October

    Wednesday 30 September

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    October

    Tuesday 13 October

    2:30pm

    Room Q372, Level 3, 234 Queensberry Street

    November

    Monday 26 October

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    November

    Thursday 5 November

    12:30pm

    Room Q372, Level 3, 234 Queensberry Street

    December

    Wednesday 18 November

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    December

    Tuesday 1 December

    3:00pm

    Room Q372, Level 3, 234 Queensberry Street

    January 2021

    Monday 14 December

    11:00am

    Room Q372, Level 3, 234 Queensberry Street

    (Current as at 12/05/2020)

    Human Ethics Training Sessions

    The Human Ethics Training Sessions are open to all MGSE staff and students. Each training session goes for an hour and focuses on a specific topic relevant to the researcher navigating through the human ethics process.

    For 2020, the ethics training session are as follows:

    Topic

    Date

    Time

    Venue

    Human Ethics: Completing Forms and Data Retention and Storage

    Tuesday 5 May

    12:30pm

    Room L514/L515, Level 5, 100 Leicester Street

    Human Ethics: Monitoring and Annual Reporting on Projects

    Wednesday 25 November

    3:00pm

    Room Q372, Level 3, 234 Queensberry Street

    More sessions are to be scheduled.

    The topics presented previously can be found on this page under Useful Links: Presentations.

  • Who do I submit the application to?

    One signed, single-sided hard-copy of the entire application must be forwarded in person to Human Research Ethics Consultant, Room LW922.01, Level 9, 100 Leicester Street. Human Research Ethics Consultant will process your application and send to the MGSE HEAG reviewers for comment.

  • What documentation do I need to submit?

    Approximately eight weeks should be allowed for the processing, review and approval of a standard risk application by the EFAMB HESC; and approximately four weeks should be allowed for the processing, review and approval of a minimal risk application by the MGSE HEAG. NOTE: The latter is dependent on the quality of the application submitted, the complexity of the research and the extent of any changes requested.

  • How long will it take for the HESC or HEAG to review my application?

    Approximately eight weeks should be allowed for the processing, review and approval of a standard risk application by the EFAMB HESC; and approximately four weeks should be allowed for the processing, review and approval of a minimal risk application by the MGSE HEAG.

    NOTE: The latter is dependent on the quality of the application submitted, the complexity of the research and the extent of any changes requested.

  • What will the MGSE HEAG do?

    The MGSE HEAG will review your application and do one of two things.

    1. Endorse the application without amendment or;
    2. Suggest amendment to the application before forwarding to the HESC for approval.
  • How can I track the progress of my application?

    Human Ethics at the University of Melbourne is transitioning from a local to a central process. In the interim to track your ethics application through the process, please click this link. The downloadable spreadsheet is sorted by HEAG lodgement date and is regularly updated, so please check often. Also, don’t forget every time you lodge your application on Themis to email: mgse-ethics@unimelb.edu.au and provide the MGSE HEAG with a hardcopy of your signed application form and summary report to the Melbourne Education Research Institute (MERI) on Level 9, 100 Leicester Street.

  • What do I do if the MGSE HEAG endorses my application without amendment?

    If no amendments are required by the MGSE HEAG, the original hard-copy application is forwarded to the MGSE HEAG Chair for endorsement, then forwarded to the HESC for approval.

  • What do I do if the MGSE HEAG recommends changes?

    If the MGSE HEAG requires amendments, the Human Research Ethics Consultant will contact the named researchers via email with the details of the MGSE HEAG comments and suggestions. The researcher[s], or the student in consultation with their supervisor, will make the recommended amendments or provide appropriate arguments why the change should not be made. Amended pages can be submitted to the Human Research Ethics Consultant via Themis in electronic form. The amended original is forwarded to the MGSE HEAG Chairperson for endorsement and then EFAMB HESC for approval.

  • What happens at the EFAMB HESC?

    The EFAMB HESC will review the application and may make further comments for action by the researchers. For details of this part of the process (including timelines, amendments and conditions of approval) please visit the Research Ethics and Integrity Human Ethics website.

  • What happens after the EFAMB HESC has approved the application?

    For Minimal Risk applications

    The approved application is returned to MGSE HEAG to send the approval letter to all named on the application.

    For Standard Risk applications

    The Research Ethics and Integrity website provides details of processes that follow approval on their Managing Approved Projects web page.

    For Variation to application

    If subsequent variations or modifications to the application are required once approval has been granted, a Request for Amendment form must be submitted for approval. If the HEAG considers that the proposed changes are significant, researchers may be required to submit a new application for approval of the revised project. For more information please see the Research Ethics and Integrity Amendments web page.

    For Annual Reports

    The Human Research Ethics Committee requires all researchers to submit an annual report on each of their projects by February of the following year. See the Research Ethics and Integrity Annual Reports web page for further information. Failure to submit an annual report will mean approval for the project will lapse and a new application will need to be submitted to the MGSE HEAG.

  • What happens after the research is completed?

    All research data and records collected, used and maintained in the conduct of research have to be retained and accessible by the responsible researcher in accordance with legal and ethical requirements for a minimum of five (5) years from the date the thesis is passed, or from the date of last publication, or public release of the work of research, whichever is the later in accordance with the Management of Research Data and Records Policy (MPF1242) and the University’s Records Retention and Disposal Authority.

  • What happens after the research is completed?

    All research data and records collected, used and maintained in the conduct of research have to be retained and accessible by the responsible researcher in accordance with legal and ethical requirements for a minimum of five (5) years from the date the thesis is passed, or from the date of last publication, or public release of the work of research, whichever is the later in accordance with the Management of Research Data and Records Policy (MPF1242) and the University’s Records Retention and Disposal Authority.

  • Where do I apply to research in schools and TAFEs?

    Before you go into a school or college to collect data, you must apply to research with the Department of Education for public schools and TAFEs, or the Catholic Education Office for catholic schools. For Independent Schools and Private Training Organisations, please consult with the Principal of the School or the Director of the Training Organisation. Your application must be approved, and a copy of the approval letter must be lodged to the MGSE HEAG before conducting any research in a school. Below is the list of Departments of Education and Catholic Education Offices.

    Public Schools and TAFEs

    In Victoria – Department of Education and Training

    In New South Wales – Department of Education

    In Queensland – Department of Education

    In South Australia – Department for Education

    In Western Australia – Department of Education

    In Tasmania – Department of Education

    In Northern Territory – Department of Education

    In Australian Capital Territory – The Education Directorate

    In the Commonwealth – Department of Education

    Catholic Schools

    In Victoria:

    In New South Wales:

    In Queensland:

    In South Australia - Catholic Education South Australia

    • Archdiocese of Adelaide
    • Diocese of Port Pirie

    In Western Australia - Catholic Education Western Australia

    • Archdiocese of Perth
    • Diocese of Bunbury
    • Diocese of Geraldton
    • Diocese of Broome

    In Tasmania - Catholic Education Tasmania

    • Archdiocese of Hobart

    In Northern Territory - Catholic Education Northern Territory

    • Diocese of Darwin

    In Australian Capital Territory - Catholic Education Office

    • Archdiocese of Canberra & Goulburn

    In non-geographical Dioceses:

    Independent Schools and Private Training Organisations

    All applications to research in Independent Schools and Private Training Organisations must receive an endorsement from the Principal of the School, Director of the Training Organisation or the School Council and be submitted with the University of Melbourne ethics application form at the time of lodgement. In the Letterhead and Special Requirements section, there is a template endorsement letter you can use to meet this requirement. (NOTE: The endorsement letter must be on the Independent School’s or the Private Training Organisation’s letterhead).

  • Who do I contact when approached to collect data or recruit MGSE staff/students?

    All requests to collect data or recruit MGSE staff/students must include a copy of all Plain Language Statements, all Consent Forms, all data collections tools, and any recruitment material which will be disseminated.

    If the request is made by a researcher external to the University of Melbourne, please email the Office of Research Ethics and Integrity (OREI) - HumanEthics-Enquiries@unimelb.edu.au attaching the PLS, Consent, collection tools and recruitment material. OREI will contact you to discuss the request and provide appropriate advice.

    If the request is made by a researcher internal to the University of Melbourne (excludes all MGSE staff and students), please email the MGSE Human Ethics Advisory Group (MGSE HEAG) - mgse-ethics@unimelb.edu.au attaching the PLS, Consent, collection tools and recruitment material. The HEAG will contact you to discuss the request and provide appropriate advice.

    NOTE: All MGSE staff and students must lodge a full human ethics application for review by the HEAG and approval by the HESC to conduct research within MGSE.

Useful Resources

  • Letterhead and Special Requirements

    The MGSE has developed the following documents to assist with the process of ethics applications:

    • MGSE researcher compliance checklists which consist of three checklists (Minimal Risk, Application Form, and Plain Language Statement & Consent Form) to ensure you lodge a compliant ethics application.
    • MGSE letterhead for consent form and plain language statement
    • Checklist requirements for consent form and plain language statement
    • Samples and template of the Consent Form
    • Samples and template of the Plain Language Statement
    • Template Endorsement Letter (NOTE: Do not use for research conducted in public or catholic schools, as the endorsement is obtained through the relevant state[s] Department of Education for public schools or the respective Catholic Education Office for catholic schools).
  • Presentations

    Dianne Vella-Brodrick, Chair of the MGSE HEAG and Tim Mattingsbrooke, MGSE Human Research Ethics Consultant host human ethics studios, with Terry Bowles (Central Human Research Ethics Committee & Humanities, Law and Social Science HESC) and Kylie Smith (Education, Fine Arts, Music and Business HESC), which gives staff and students an insight into the aspects of the human ethics process and protocols.

    Topics presented:

    Also, the Research Ethics and Integrity Unit has given a couple of presentations on human ethics which gives staff and students an insight into the aspects of the human ethics process and protocols.

    Topics presented:

  • Guidelines, Policy and Specific Resources

    National Statement on Ethical Conduct in Human Research

    All Australian human research ethics committees use the National Statement on Ethical Conduct in Human Research (National Statement) as the basis for reviewing and approving human research, and researchers should design their projects in accordance with this document. Committee members use the National Statement to identify common ethical issues and to justify the decisions they make during the review.

    Australian Code for the Responsible Conduct of Research

    The Australian Code for the Responsible Conduct of Research, 2018 provides national guidance in responsible research practices and should be read in conjunction with the University of Melbourne Code of Conduct for Research.

    Conducting Research in Victorian Government Schools and Early Childhood Settings

    The Department of Education and Training (DET) manages applications to research in Victorian government schools and early childhood settings, using a two-tier review process. All research must be designed to add to our understanding of school children and young people and evaluate the effectiveness of health, wellbeing and educational programs. DET approval allows the researcher(s) to approach schools and early childhood settings to request participation in research. The process does not substitute a review by the University Human Research Ethics Committee. Projects commissioned by DET are subject to the same application and review process as projects which are initiated externally.

    Research Integrity and Misconduct Policy

    The objective of this policy is to prescribe standards of responsible and ethical research conduct expected at the University of Melbourne. The policy applies to all academic staff, students, technical and other support staff engaged in research (research workers) in the University.

    Management of Research Data and Records Policy

    The objective of this policy is to prescribe standards for the management of research data and records at the University of Melbourne. This policy applies to research undertaken by University of Melbourne students, staff and honorary staff.

    Research Ethics and Bio-Risk Management Policy

    The objectives of this policy are to ensure: (a) the University meets its obligations to conduct research that at least meets relevant ethics requirements; (b) work with regulated biological material (RBM) is properly regulated and meets compliance requirements; and (c) the University complies with export controls and sanctions obligations. This policy applies to research and work conducted at the University and by University employees and researchers, wherever located, where this: (a) is conducted with or about people, their data or tissue; (b) uses animals or is a teaching activity that uses animals; (c) uses RBM; and/or (d) involves dual-use goods or technologies.

    Graduate Research Training Policy

    The objectives of this policy are to: (a) provide the framework to ensure academic standards and integrity in the University’s research training; (b) set clear responsibilities and accountabilities for decisions affecting graduate research candidates; and (c) ensure that the University’s graduate research training processes are transparent and that decisions affecting graduate research candidates are consistent and fair. This policy applies to all: (a) graduate research courses; (b) graduate research candidates; (c) University staff responsible for graduate research courses and candidates; and (d) persons external to the University appointed as a supervisor or examiner. Note sections 4.15 to 4.22 are relevant to Human Ethics regarding the supervision of research.

  • Higher Risk Resources, Storage, Collection Tools and Data Management

    The MGSE recommends the following higher risk resources, secure online data collection tools, data storage and associated statistical support, which meets the Research Ethics and Integrity guidelines:

    Higher Risk Human Research Ethics Resources by Topic

    Links to external resources with detailed information on specific areas of human research ethics including Aboriginal Peoples, Children, Codes of Conduct, Consent and Risk, Data Management, Dependent Relationships, Digital Data, Illegal Activities, Mental Illness, Cognitive Impairment and Intellectual Disability, Overseas Participants, Privacy, Elements of Research, and Ethical Considerations Specific to Participants.

    File and Cloud Storage

    • File storage options for data, information and files lists some of the information storage options at the University. University Services support all these options. If you are unsure what product is appropriate for your needs, contact the Service Centre via the Staff Services Portalchat online or phone on 834 40888 to discuss your options.
    • Cloud storage and online data-sharing fact sheet explores some of the needs and considerations when thinking about what solution is right for you.
    • Figshare (melbourne.figshare.com) is a safe, secure and easy to use cloud-based repository where you can securely store your valuable research data while remaining in full control of it. You can store it for your private research use, or you can easily expose it and share with others.
    • Cloudstor is a safe, secure and easy to share or transfer of files of any size to colleagues, partners, other institutions or external organisations. It is not intended for long-term storage or retention. Cloudstor is supported by AARNet but remains within the higher education and research network in Australia.

    Collection Tools and Data Management

    • Qualtrics is an online survey tool that allows users to easily create surveys, design them collaboratively and share responses with others, and is available to all staff and research students.
    • Melbourne Statistical Consulting Unit provides high-quality advice on statistical methods to graduate research students and staff at the University of Melbourne.
    • Research Data Management Team are there to assist graduate research students and staff via email, with any questions you might have regarding research data tools, data management, cloud-based repositories and verification of research outcomes.
    • Australian Data Archive (ADA) provides a national service for the collection and preservation of digital research data. ADA disseminates this data for secondary analysis by academic researchers and other users. The archive is based at the Australian National University (ANU).
    • Social & Cultural Informatics Platform (SCIP) offers a range of services to researchers across Faculties and to projects beyond the University, with expertise in processes for capture and curation of data, e.g. social media, online data, APIs; research data management; online/web resources and collections; data analytics and informatics; data wrangling, visualisation and presenting outcomes; and digitisation & digital forensics (recovery of data off old media, damaged disks, floppy disks etc.).

    Research Platform Services offers researchers a range of data storage and management tools that can be used to manage, move, or store, as well as improving the security of your research datasets. If you are unsure of what you want, please contact us, and we can work with you to understand your requirements and research needs.