ethics – it’s not that hard … really! tim mattingsbrooke mgse research ethics consultant
TRANSCRIPT
Outline of this session
Is about ‘how to prepare’ an ethics application:• Go through the content within the extract
MGSE HEAG Information Kit.• The three phases: Registration, Preparation
and Submission [subsequent Re-submission].• Helpful tips for submission: pre & post review.• Questions and Answers• If time permits, a compliance check exercise.
The Ethics Information KitThe MGSE HEAG Human Ethics Information Kit can be found at: http://education.unimelb.edu.au/study_with_us/student_centre/graduate_research_ students/human_ethics_ research.
The kit is broken up into three sections:•Section 1: Background Information
– Code of Conduct for Research, document guidelines, deadlines and contact details.
•Section 2: Themis Online– Setting your password, creating an application, and printing it off, with
the requisite summary.•Section 3: Useful Resources
– National Statement on Ethical Conduct in Research, and useful websites, such as the Department of Education and Early Childhood Development (DEECD) and Catholic Education Office, Melb. (CEOM).
Things to particularly note:• MGSE HEAG handling process (see handout)
– Minimal Risk: goes through five stages and one committee (MGSE HEAG)
– Standard Risk: goes through seven stages and two committees (MGSE HEAG & HAPS HESC)
• Application Deadlines (see later slide)– Minimal Risk: use as a guide– Standard Risk: is enforced
• Contact People (see later slide)– such as Themis Help Desk, Office of Research Ethics
and Integrity, and Research Ethics Officer.
Three Phases• Phase 1: Registration
– Log into the Accounts Registration System (ARS) to set up your Themis account
– Log into Themis• Phase 2: Preparation
– Prepare online application first, then download and complete the requisite hardcopy form
– MGSE Letterhead for Consent Forms and Plain Language Statements
• Phase 3: Submission– Submit the application with associate documents to me.
Helpful TipsDon’t leave it
to the last minute … the Human Ethics
Committee submission
deadlines are virtually
inflexible!
• These are the dates you need to know for 2014:– April cycle by Monday 31 March at 5:00pm– May cycle by Monday 28 April at 5:00pm– July cycle by Monday 16 June at 5:00pm– August cycle by Monday 14 July at 5:00pm– September cycle by Monday 11 August at 5:00pm– October cycle by Monday 22 September at 5:00pm– November cycle by Monday 20 October at 5:00pm– December cycle by Monday 17 November at 5:00pm– Note there is NO June cycle!
Helpful Tips: Application Deadlines
• Online Incident Registration: http://servicedesk.unimelb.edu.au/itsc/themis/
• Email: [email protected]• Phone: 8344 9500• Operating Hours: 9:00am to 5:00pm, Monday to Friday
NOTE: If the Themis Service Desk number is busy or you are calling outside operating hours, you areencouraged to log your issue,query or request using the ThemisOnline Incident Registration.
Helpful Tips: Themis Help Desk
When submitting (Pre-Review):
1. Ensure you have a complete application. This generally consists of five components:A. An application summary, with online responses B. An application form, signed by all namedC. All Plain Language Statement/s and Consent
FormsD. All data collection tools, andE. Any other relevant documents, e.g. approval
letter/s, recruitment advertisement etc.
Helpful Tips
2. The MGSE HEAG requires one hardcopy single sided, clipped or place in a plastic sleeve. Do not staple!
3. Use the MGSE letterhead template provided on the MGSE HEAG website for all consent form/s and plain language statement/s.
Don’t forget to populate the footer for all Plain Language Statements and Consent Forms.
Helpful Tips
When submitting (Post-Review):
•Ensure you re-submit a complete signed application, with your responses to MGSE HEAG’s recommendations.
– Suggest you add a column to the right of the recommendation table, to insert your responses.
•Ensure all revisions are uploaded onto Themis and must match the hardcopy you re-submit to MGSE HEAG.
Helpful Tips
Useful Websites• Accounts Registration System (ARS) to access Themis:
https://accounts.unimelb.edu.au/manage/• Themis Login: http://www.themis.unimelb.edu.au/• Melbourne Graduate School of Education Human Ethics
Advisory Group [MGSE HEAG]: http://education.unimelb.edu.au/study_with_us/student_centre/graduate_research_students/human_ethics_research
• MGSE Letterhead for Consent Forms and Plain Language Statements: http://education.unimelb.edu.au/__data/assets/word_doc/0018/621351/Letterhead_for_Ethics_PLS_and_Consent_Forms.doc
A quick five minute exercise
Check your ethics application before you lodge online via
Themis and to the Human Ethics Committee …
A quick five minute exercise
Using the example complete ethics application; try and find the nine issues which would render this application non-
compliant?
NOTE: “the devil is in the detail”!
Compliance Errors/Omissions1. There is a mismatch of the Responsible Researcher named
online via Themis, compared to the hardcopy application form lodged.
2. No data collection tools have been uploaded onto Themis, but yet ‘Sample Interview Questions’ has been lodged in hardcopy.
3. Catholic Education Office Approval Letter has been registered and uploaded on Themis, but no hardcopy lodged.
4. There is a mismatch between the number of Plain Language Statements and Consent Forms – six plain language statements and three consent forms uploaded, but only one of each lodged.
Compliance Errors/Omissions5. Two Consent Forms [Parent/Guardian and Student] not lodged
in hardcopy.6. Five Plain Language Statements [Parent/Guardian,
Principal/Director and Student, plus two revised] not lodged in hardcopy.
7. The Principal/Director Consent Form is not lodged in hardcopy and not uploaded onto Themis.
8. On the application form, in Question 3.1 the boxes checked state ‘use of questionnaires’; ‘online surveys’; and ‘focus groups’, but no questionnaires, screen prints or list of topics have been uploaded onto Themis or lodged in hardcopy.
9. Incorrect MGSE letterhead used.
A couple helpful hints…• Always proof read the application to ensure it is consistent
throughout, and correct any spelling/grammatical errors.• Always ensure you check what you upload onto Themis
matches what you submit in hardcopy to the MGSE HEAG.• A good rule of thumb is: “for every Plain Language Statement
there should be a corresponding Consent Form”. So, if you have five Plain Language Statement , then ensure you have five corresponding consent forms.
• Endorsements from institutions/agencies needs to occur prior to the application being approved by the Human Ethics Committee. This is not to be confused with consent from individual participants, which occurs after approval is granted.
• Meet with your supervisor to discuss your ethics application before you start.
• Set a realistic timeline – it takes longer than you think.
• Don’t submit an application before confirmation.• All students must have ethics training (as of 2013).• Your supervisors must have read your application
before they sign and you submit.• The ethics application is a formal document. Don’t
submit it if it is not ready for review.• Include all information in appendices e.g. interview
questions, workshop outlines etc..
Important information
This should be completed once you have submitted your University ethics application. See http://www.education.vic.gov.au/about/research/pages/conducting.aspx for further information.
Department of Education and Early Childhood
Completing the DEECD Application
• Important note: is 3 and 4 relevant to your research?
• Remember you are required to complete a final report – the reporting template is on the website