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Writing for the Ethical Review
Graduate Students’ Research and Professional Career Seminar Series, Faculty of Education
November 8, 2016 12:30-1:30pm
Room 1139
Overview
• Who we are and why we do what we do• Preparing for submission• The review process• Post-approval events• Questions
The Office of Human Research Ethics
Our StaffDirector
Erika BasileEthics OfficersKatelyn Harris, Non-Medical REBGrace Kelly, Non-Medical REBNicole Kaniki, Health Science REB Karen Gopaul, Health Sciences REBAdministrative SupportAneesa Khan Nicole HolmeKelly Patterson
Our Location
• Online: uwo.ca/research/ethics• By Email: [email protected]• In Person: 5th Floor, Support Service Building
Our Responsibility• Manage the review and approval process for all
research involving human participants (initial and post-approval submissions).
• Board of Record for Western and all affiliated research institutions and hospitals.
Each year we see:• 1400 NEW submissions (480 Non-Medical)
• 1350 AMENDMENTS (250 Non-Medical)
The Tri-Council Policy Statement 2
TCPS2
Overarching Canadian policy framework for research with human participants.
TCPS2 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
TCPS2 Tutorial http://www.pre.ethics.gc.ca/eng/education/tutorial-
didacticiel/
Three Overarching Principles
1. Autonomy –• Right to choose (vulnerable participants
protected, informed consent)2. Beneficence –
• Obligation to do good (benefits outweigh risks)3. Justice –
• Right to freely participate (no coercion, fair inclusion)
Research Exempt from Approval
The following are examples of research that MAY be exempt from ethics approval.
•Research relying on publicly available information.•Secondary use of anonymous/de-identified information.•Naturalistic observation of people in public places.
Please visit Chapter 2 of the TCPS2 for more information on what requires ethics approval.
Stage 1
Getting Started
Step 1: Get Set-Up
21
Step 2: Who is responsible for your project?
Only Research Eligible Faculty can act as the PI on a research project being submitted to our office.
The PI is fully responsible for the conduct of the study, everything that is written in the protocol and
for the student conducting the research.
Step 3: Which REB / Level of Review is Needed?
http://www.uwo.ca/research/services/ethics/Resources/which_reb.html
Step 4: Is there a deadline?
Step 5: Log into Romeo and Create your Submission
https://grant3.vm.its.uwo.ca/Romeo.Researcher/
Stage 2
Romeo and Submission Forms
ROMEO
ROMEO
Application Form
Study Procedures:1. What are you doing and how are you doing it?2. Study instruments? 3. What is expected of participants?4. Locations? Time commitments?
Recruitment:1. Who are you recruiting?2. How are you recruiting them?3. Is there any undue influence to participate? (voluntary
recruitment, no pressure to participate, avoid incentivizing language)
Application Form
Consent:1. What type of consent is being obtained?
• Written, verbal, implied, parental, assent2. How are you collecting consent?3. Age of participants?
• Children 7-12 must provide assent along with obtaining parental consent.
• 13+ MAY need parental consent (school requirement? High risk research?)
4. Anticipated communication challenges? • May require translated documents and/or interpreter
Application Form
Risks/Benefits:1. Outline all potential risks, harms, inconveniences.2. Benefits of research to participants? To society?3. How will harms be mitigated?
• Resources, training4. Potential for reportable information to be collected?
• Duty to report
Application Form
Data Confidentiality:• Identifiers – any information collected throughout course of
research that could directly or indirectly identify participants
General guidelines:• Encryption and password-protection• Separate from data• Transferred/transported securely• Retained 5 years• Destroyed using Western-sanctioned data destruction methods
Application Form
Special Considerations:• Research involving Indigenous community?• Within child care/K-12 education system?• Online surveys?• Conflicts of interest?
Attachments• Study Instruments – will vary depending on study
design/procedures, but often include:• Surveys• Proficiency Tests• Interview/Focus Group Guides• Observation guides
• Recruitment Items – will vary depending on selected recruitment strategy, but often include:
• Emails• Posters• Verbal script
• Letter of Information and Consent (and Assent, if applicable)
Letter of Information and Consent Grade 8 Reading Level Introduction Purpose
• Why is this study being done and what is the rationale behind conducting it?
Study Procedures• What will a participant experience or do
as a result of taking part in the study?• All details must be explained, including
procedures that may be optional Study Duration
• How many sessions? • Over how long of a time period? • How long is each session?
Participation Risks• Clearly articulated, with measures for
mitigating risk Participation Benefits
Confidentiality• What type of data is being collected?• Who has access to the data?• How is it being protected?• How long is it being retained?
Costs Involved• Added costs (e.g., Travel, Parking)
Compensation• Are the conditions and the amount of
the compensation described? Participant Rights Conflicts of Interest Contact Information Consent
• Signatures Confirming Understanding (or verbal consent/implied consent if justified in the Protocol)
Stage 3
Submitting Your Application
Submitting Your Application• Have you ensured that all sections of the application are
completed and all study documents are attached in Romeo?• Have the entire application and the accompanying documents
been reviewed thoroughly by your PI? By someone external to the study?
• Have you reviewed our templates/guidance webpage? http://www.uwo.ca/research/services/ethics/nonmedical_reb/NMREB_Templates.html
• Have you ensured that all team members who wish to receive correspondence about your application are listed as Research Support Staff?
• Application must be submitted by the PI
***If not, you may experience unanticipated delays and receive more recommendations***
Stage 4
The Review Process
OHREReceives form, checks
for completeness, assigns EO and Board
Member
EO + Board Member Review application &
study documents. Provide feedback
(“Recommendations”) via Romeo
EO Compiles all
Recommendations, sends to PI
PIReceives
Recommendations, modifies application
PI Completes Romeo
Application Form and submits to OHRE
START
END
EOOnce all
Recommendations are complete,
Chair/Delegate sign off, Approval granted to PI
DECISION1. Approved: No modifications
required, proceed to “END”2. Pending Modifications:
Changes required to the submission before approval can be provided, process continues
Initial Reviews: The Delegated Process
Full Board Reviews: The Full Board Process
OHREReceives form,
checks for completeness,
assigns EO
EO + All Board Members Attending Meeting
Review application & study documents. Provide feedback
(“Recommendations”) via Romeo
Full Board Meeting
Board discusses concerns, makes decision on initial
submission
EO Compiles all
Recommendations, obtains Chair sign
off, sends to PI
PIReceives
Recommendations, modifies application
PI Completes Romeo Application Form
and submits to OHRE
START
END
EOOnce all
Recommendations are complete, Chair sign off, Approval granted
to PI
DECISION1. Approved: No modifications
required, proceed to “END”2. Pending Modifications:
Changes required to the submission. Review of the modifications are done at the ORE, not reviewed at another FB Meeting.
3. Tabled: Significant modifications required. Board will re-review application in full following modifications
DECISION
Stage 5
Submitting Your Response
Ethics Review Process – Pre ApprovalResubmitting your Application
• Have you included a detailed response letter clearly stating that every recommendation was considered, where the change was made and how it was made?
• Have you exported a copy of your Western Protocol (Romeo form) to Word to make TRACKED changes?
• Have you resubmitted both a tracked AND clean copy of all documents that the board has requested you change?
• Have you updated all version dates?
***If not, your response will be returned until all information is received***
Ethics Review Process – Pre ApprovalResubmitting your Application
Do NOT start your research until you have received notification that your approval notice is
available in Romeo
Timing is Important
***Please allow yourself ample time to receive approval for all submissions to the office (both new
submissions and amendments).***
NMREB Timelines:- Initial recommendations are typically sent out 2-3 weeks from
submission date BUT initial approval can take a couple of months, depending on volume of submissions to the OHRE, how quickly researchers submit their response and if subsequent revisions are needed
- Amendments are typically reviewed within 2-3 weeks
Stage 6
Post-Approval Events
Ethics Review Process – Post Approval
• Amendments• Must be submitted for ALL changes to the approved protocol
and associated study related documents• Amendments will only be reviewed if a CER Form is not
outstanding.
• Include ALL revised documents (tracked + clean copies).• Include version dates and descriptions of the uploaded
documents in the Attachment tab. • Include a concise summary of what the change is.
Ethics Review Process – Post Approval
Continuing Ethics Review • Submitted annually or your study may be suspended.
The PI and Research Support staff will receive 4 notices at the following times:– 2 months before the CER is due– 1 month before the CER is due– The day the CER is due – On the expiry date – This final notice will indicate that your study
will be suspended, and 2 weeks after expiry your study will be closed. You will need to resubmit a new study if you wish to continue.
Ethics Review Process – Post Approval
• End of Study• This form is completed at the end of the study.• If you are completing an End of Study form there is no need to
still submit your Continuing Ethics Review form. • Until the End of Study form is submitted you will continue to
receive notices from our office to complete your Continuing Ethics Review form.
• You can complete this as long as there will be no further contact with the participants and no further data collection (but is advisable to keep active until data analysis is complete).
Ethics Review Process – Post Approval
How to Submit a Post-Approval Event
To access an Event Form in ROMEO:
1. Log in to Romeo:https://grant3.vm.its.uwo.ca/Romeo.Researcher/2. Go to "Application (Submitted - Post Review)"3. Go to "Events"4. Select NMREB [Name of event you are submitting]5. Complete the form6. Attach all necessary documentation in tracked + clean copies7. Have the PI log in and submit the event (if not started by the PI)
Helpful Tips and Common
Recommendations
Thank you!
QUESTIONS?
