Writing for the Ethical Review Graduate Students Research and - - PowerPoint PPT Presentation

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 Staff

Director Erika Basile Ethics Officers Katelyn Harris, Non-Medical REB Grace Kelly, Non-Medical REB Nicole Kaniki, Health Science REB Karen Gopaul, Health Sciences REB Administrative Support Aneesa Khan Nicole Holme Kelly Patterson

Our Location

• Online: uwo.ca/research/ethics
• By Email: ethics@uwo.ca
• 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

• n what requires ethics approval.

Stage 1 Getting Started

Step 1: Get Set-Up

2 1

Step 2: Who is responsible for your project? Only Research Eligible Faculty can act as the PI

• n 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, assent
• 2. 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, training

4. 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

START END

DECISION

Initial Reviews: The Delegated Process

Full Board Reviews: The Full Board Process

• documents. Provide feedback

• btains Chair sign
• ff, sends to PI

PI Receives Recommendations, modifies application

START END

• ff, Approval granted

DECISION

• submission. Review of the

Stage 5 Submitting Your Response

Ethics Review Process – Pre Approval

Resubmitting 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 Approval

Resubmitting 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
• utstanding.
• 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 form
• 6. Attach all necessary documentation in tracked + clean copies
• 7. Have the PI log in and submit the event (if not started by the PI)

Helpful Tips and Common Recommendations

Thank you!



QUESTIONS?