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 : 5 th 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 1 2
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, 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 Confidentiality Introduction • What type of data is being collected? • Who has access to the data? Purpose • How is it being protected? • Why is this study being done and what • How long is it being retained? is the rationale behind conducting it? Costs Involved Study Procedures • Added costs (e.g., Travel, Parking) • What will a participant experience or do Compensation as a result of taking part in the study? • All details must be explained, including • Are the conditions and the amount of procedures that may be optional the compensation described? Study Duration Participant Rights • How many sessions? Conflicts of Interest • Over how long of a time period? Contact Information • How long is each session? Consent Participation Risks • Signatures Confirming Understanding • Clearly articulated, with measures for (or verbal consent/implied consent if mitigating risk justified in the Protocol) Participation Benefits
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
Initial Reviews: The Delegated Process START OHRE PI Receives form, checks Completes Romeo for completeness, Application Form and assigns EO and Board submits to OHRE Member DECISION 1. Approved : No modifications EO required, proceed to “END” Once all 2. Pending Modifications : Recommendations are Changes required to the complete, submission before approval Chair/Delegate sign off, can be provided, process Approval granted to PI continues EO + Board Member END PI Review application & Receives study documents. Recommendations, Provide feedback modifies application (“Recommendations”) via Romeo EO Compiles all Recommendations, sends to PI
Full Board Reviews: The Full Board Process START PI OHRE Completes Romeo Receives form, Application Form checks for and submits to completeness, OHRE assigns EO DECISION EO Once all 1. Approved : No modifications Recommendations are required, proceed to “END” complete, Chair sign PI 2. Pending Modifications : EO + All Board Members off, Approval granted Attending Meeting Changes required to the Receives to PI submission. Review of the Review application & study Recommendations, documents. Provide feedback END modifications are done at modifies application (“Recommendations”) via the ORE, not reviewed at Romeo another FB Meeting. 3. Tabled : Significant modifications required. Board will re-review application in full following modifications Full Board EO Meeting Compiles all Board discusses Recommendations, concerns, makes obtains Chair sign decision on initial DECISION off, sends to PI submission
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
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