IRB+Resources

Feel free to explore the following resources and examples to help you move through the Institutional Review Board (IRB) process for your own research.

Video from Class with a Walkthrough of the IRB Application Form at University of Rhode Island media type="youtube" key="vVfcjuOtqiU" width="420" height="315"

>>> 2. **Personnel** (Researchers, Grad Assistants to help with scoring, etc.) >>> 3. **Education** (CITI Training) Attach your results, just in case >>> 4. **Financial Conflict of Interest** >>> 5. **Funding or Other Support** >>> 6. **Other Institutional Approvals** >>> 7. **Location of Research** (INCLUDE letters of support when applicable and link to specific Appendices) >>> 8. **Summary of Research** (non-technical language and brief; research design, procedures, risks and anticipated benefits, importance of knowledge in expected results) >>> 9. **Scientific Background and Literature Review** (very brief) – mostly concerned about collecting related data with undue risk to human subjects >>> 10. **Research Objectives** (be specific) >>> 11. **Research Methods and Activities** (includes checklist): describe interventions, interactions, and data sources, but be brief! Link to explicit Appendix Items whenever applicable to make things clear and easy to find since appendices are all uploaded separately into the system. Doublecheck labels in narrative and in filenames before you finally upload to make sure they all match! >>> 12. **Duration**: estimate total time commitment for each participant; be honest but don’t exaggerate; break into phases if some will only participant in some phases but not others >>> 13. **Number of participants:** Overestimate (within reason) but CAN NOT GO OVER this number so make higher than you think, and explain how this number was derived >>> 14. **Participation Population** (age/type), linked to checklist items; just leave blank if not applicable. VERY IMPORTANT: Inclusion and Exclusion criteria (section 14B and 14C) >>> 15. **Participant identification, recruitment, and selection:** VERY IMPORTANT. Upload flyers, recruiting scripts, evidence that you can recruit and how you will fairly recruit) while protecting participant’s privacy >>> 16. **Incentives to Participate** (not a bad thing, but be honest and then explain) who gets this (at the beginning, during, or only after completion of the study) >>> 17. **Alternatives to Study Participation** >>> 18. **Informed Consent Process** VERY IMPORTANT (consent, assent, scripts, translations, etc.); describe consent process and explain how coercion of undue influence will be minimized – examples >>> 19. **Privacy of Participants** VERY IMPORTANT – use language that has been accepted in other people’s IRBs – this is standard language but very important >>> 20. **Confidentiality of Data** VERY IMPORTANT – use language accepted in previous IRBs; identifiable data or de-identified (could very well count as secondary data analysis!) >>> 21. **HIPAA Health Privacy Authorization** (not usually applicable to educational contexts) >>> 22. **Reasonably Anticipated Benefits** (don’t exaggerate, just be honest and brief) >>> 23. **Risks, Harms, and Discomforts:** VERY IMPORTANT - be brief but put something >>> 24. **Monitoring** (any more than minimal risk) usually n/a >>> 25. **Assessment of Risks and Benefits** (compare #22 and 23) >>> 26. Participant Costs/Reimbursements >>> **Assurance Signature:** DON’T FORGET (Your major professor is the Principal Investigator)
 * [|URI Human Subjects Protections Homepage]includes [|IRB Application Forms] and Sample Documents
 * The main application requires information about the following:
 * 1. **Administration** (start date: UPON IRB APPROVAL)
 * TIPS:
 * Consider [|dates that IRB meets (only once a month for full review)] and pay attention to the submission deadlines that fall before each meeting date
 * Plan several months in advance and expect to have your proposal returned AT LEAST once. Allow a minimum of four weeks for the review process (although sometimes it is shorter and sometimes it is longer).
 * Realize your IRB application needs to be submitted electronically at [|IRB.net] - URI has [|user guides, videos, and workshops] on this digital process you can attend for more help
 * Include ALL pieces, especially all permissions, completed survey/interview protocols, sample tasks, etc. - put all pieces together in a file for your advisor to review, but also keep each element in a separate file to upload into the IRBnet system
 * Label all files clearly and explicitly connect to files mentioned in your proposal (See Appendix B)
 * Use the "standard language" recommended by URI in their example forms and permissions whenever possible to avoid having to revise later to match their wording
 * Be very clear and respectful in your response/revision letter and highlight all changes in the proposal to save reviewers time - they require this highlighting!
 * If you add new schools/students beyond your specific sample, you need to submit an addendum and wait for it to be approved BEFORE you can collect the data.
 * DO NOT copy/use permission forms until they have been officially stamped and emailed to you by IRB! This happens a day AFTER you receive notification that your proposal has been accepted.

>> >> Example of letter with modifications needed (that were made in the final protocol): >> >>> >>> >> >>
 * **Example of accepted IRB Application with 2014 NEW forms (Terry Deeney and Julie Coiro to conduct research in our undergraduate classes - eventually deemed Exempt, but still need all the forms!)**
 * **Example of accepted IRB Application with older forms for classroom research and professional development for middle school teachers (shared with permission from Thalia Wood, PhD)**
 * Final IRB Application
 * IRB Action Report (with requests for modifications) [[file:9-13-10 IRB Action Report.pdf]]
 * Thalia's Summary of Modifications [[file:9-22-10 Thalia Modifications IRB.doc]]
 * Amendment Request Form
 * Teacher Consent Form [[file:Teacher Consent Form TW.doc]]
 * Parent Consent Form [[file:Parental Permission TW.doc]]
 * Student Assent Form (7th graders) [[file:Student Assent Form TW.doc]]
 * **Example of IRB application for online survey and face-to-face research with college students (shared with permission from Carlton Bradshaw, Masters Student)** [[file:Carlton IRB App FINAL 12-31.docx]]
 * **Example of companion IRB application for Providence Schools to conduct classroom research in elementary school (shared with permission from Jeanne Maggiacomo and Michelle Manning, Masters in Reading program)**
 * **Example of IRB application for Julie Coiro to conduct a study of how high school students in multiple school districts use a digital scaffolding tool to read and write argumentation essays**