IRB Forms
News and announcements:
Kuali IRB and IBC E-Protocols are live.
- Help resources are available under the Kuali IRB Application header below.
- Starting July 1, 2024, Kuali will be used to manage Legacy submissions. Review the informational document for more information.
(November 8, 2023)
IRB Education Series
- Introducing the IRB Education Series 1.0! great for online and in person classes!
- Our IRB Education Series was developed to foster greater understanding of human research subject protections and knowledge of IRB processes at Â鶹¾«Ñ¡ and is designed to be easily accessible and accommodating; all modules include a short video, quiz and tip sheet and are available in series or as individual components.
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Kuali IRB Application and Help Docs
. (Level I, Level II/III, and IRB Authorization applications.)
— Use this online form if you are unsure whether your project requires IRB review.
Requests for support should be directed to researchcompliance@kent.edu.
IRB Help Resources
- Information on levels of review - review this document to learn about levels and categories of IRB review.
- Common mistakes and questions - this has been newly cross posted from the IRB help page.
Kuali Help documents:
- (1 hour)
- Creating a new protocol
- Creating an amendment
- (2minutes)
- Creating an amendment, Power Point
- Responding to IRB comments
- Additional Actions
- Committee Resources
Kuali FAQs:
- What are the "abandon" and "withdraw" features?
- The abandon feature is used to abandon a new submission, renewal, or amendment that is currently being drafted. IMPORTANT - abandoning a protocol that was never approved locks the protocol and it cannot be resubmitted. Abandoning an amendment or renewal only abandons that action; it does not abandon the entire protocol.
- The withdraw feature is used to recall a submission after it was submitted for review. Withdrawing a protocols stops the review process. This feature is typically used if you noticed an error or omission after clicking submit. Withdrawn protocols can be resubmitted.
- I received a "validation error" when I clicked the submit button. What does this mean?
- Validation errors indicate a required field is blank. Errors can be found by scrolling through the application and looking for red text. A protocol cannot be submitted until any validation errors are addressed.
- My project was approved through the old paper process. Do I need to resubmit via Kuali?
- No! We will use a legacy process for already approved studies. You will continue to submit amendments, continuing reviews, and adverse events/noncompliance forms to researchcompliance@kent.edu.
- CITI certificates are not automatically uploading.
- Self-determinations, are they changed?
- No. "Do I need review determination" and "Exempt Self-Determination" are active.
- A KSU affiliated researchers' name is not auto populating or cannot log in.
- Kuali pulls data from Banner so the person's identity must not be drawing from Banner. Add the personnel manually and upload their CITI certificate.
- Notify researchcompliance@kent.edu of these instances.
- Are appendices still required?
- Yes, but we are actively retiring the most frequently used appendices.
- You will also need to upload surveys, consent forms, recruitment materials, any any other documents that may be needed by the IRB.
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Self-Determinations and Clinical Trials
​â¶Ä‹â¶Ä‹â¶Ä‹â¶Ä‹â¶Ä‹Self determinations
- Revised (1/23/2023) - Use this to obtain level I approval for educational practices conducted in educational settings, surveys, interviews (including focus groups) and educational testing of adults or to register a class project.
- Review the Level I guidance document for more information for more information about exempt research.
- Review FAQ 11.10 to learn more about class projects - Class Project Consent Form
— Use this online form (Chrome is recommended) if you are unsure whether your project requires IRB review.
Clinical Trials
- To determine if you are conducting a clinical trial review and and webpages.
- All personnel engaged in a Clinical Trial MUST complete CITI GCP training.
- All Applicable Clinical Trials must be posted to Clinicaltrials.gov.
- FDA:
- NIH:
- Some journals may require posting even you are not conducting an Applicable Clinical Trial:
- Registration on Clinicaltrials.gov:
- Contact Kevin McCreary at kmccrea1@kent.edu to obtain credentials.
- Adhere to clinicaltrials.gov's requirements and review the .
- Clinical Trial and Biomedical Study Consent Template - (new 11/5/21) use this template for clinical trial and biomedical studies.
- See also - Â鶹¾«Ñ¡User ID and Password Required
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Appendices (to be used as indicated in the application forms)
Appendix A/A1 — RETIRED! Amendment forms have been revised so that personnel will be accounted for directly in the form and not as an attached appendix) Addition of KSU Co-PI or Key Personnel
Appendix B — REVISED December 20, 2023 - Addition of Ancillary Personnel; See Cooperative/Multi-Institute Research (Section 8) in IRB Help.
Appendix C — Data Repositories
Appendix D&²Ô²ú²õ±è;—&²Ô²ú²õ±è;¶Ù±ð³¦±ð±è³Ù¾±´Ç²Ô
Appendix E&²Ô²ú²õ±è;—&²Ô²ú²õ±è;¶Ù±ð±¹¾±³¦±ð²õ
Appendix F — Drugs and Biologics
Appendix G — Genetic Testing
Appendix H — Biological Specimens Repository
Appendix I&²Ô²ú²õ±è;—&²Ô²ú²õ±è;°ä³ó¾±±ô»å°ù±ð²Ô
Appendix J — Non-English Speaking Participants
Appendix K — Pregnant Women, Fetuses, Neonates
Appendix L&²Ô²ú²õ±è;—&²Ô²ú²õ±è;±Ê°ù¾±²õ´Ç²Ô±ð°ù²õ
Appendix M1 — Waiver of Alteration of Consent Process
Appendix M2 — Waiver of Consent Documentation
Appendix N — Use of HIPAA Regulated Data - NEW - all projects that require HIPAA Compliance review will be reviewed during a HIPAA team meeting on the the third Thursday of the month. This is due to the significantly increased number of requests that require HIPAA Compliance review. PIs will be invited to the meeting.
Appendix O — REVISED December 20, 2023 - Relying Site Local Context. See Cooperative/Multi-Institute Research (Section 8) in IRB Help.
Appendix P — Collection of Family History Data
Appendix Q — Blood, Injections, or Surgical Procedure
Appendix R — RETIRED! See Adverse Event Involving Risks to Subjects or Others. Event Reporting form under Other Submission.
Appendix S — REITRED! Change in Principal Investigator. Changes in PI can be noted in the body of the amendment form.
Appendix U — International Setting
Appendix V&²Ô²ú²õ±è;—&²Ô²ú²õ±è;¸é²¹»å¾±²¹³Ù¾±´Ç²Ô
Appendix W — Adults With Decisional Impairment
Appendix Y — RETIRED! Student Recruitment Online Pools
Appendix Z — Conflict of Interest for Human Subjects Research
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Legacy Forms (amendment, annual review, event reports)
Submit all of these forms to researchcompliance@kent.edu.
For projects approved via Kuali; continuing reviews, amendments, and closeout forms must be submitted via Kuali.
Amendments or Changes to Study Procedure Form — (not for use in Kuali) All amendments and changes must be reviewed and approved by the IRB before they are implemented.
Continuing/Annual Review Form — (not for use in Kuali) Request continuing review and approval of a research project that involves human subjects. The IRB may approve some continuing level II studies for a three year interval.
Closeout Form (not for use in Kuali) —Complete this form to close out a research project.
Event Reporting - NEW (1/31/20) - use this form to report adverse or non-compliant events. Prior to completing and submitting the form, review the noncompliance and adverse events policies.
Institution Authorization Agreement Request Form — Use this form if you are requesting that either the Â鶹¾«Ñ¡IRB or another institution's IRB serve as the IRB of record for a multi-institutional project.
Individual Investigator Agreement Form — Use this form if your institution does not have an IRB
Appendix N — Use of HIPAA Regulated Data
Class Projects Parameters and Forms - information merged with Self Determinations (1/23/2023)
Data Use and Other Agreements (Please see our Data Use Agreement FAQs)
Clinical Research SOPs
- Information about HIPAA
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Templates (consent and recruitment)
Note: consent forms should be written in a way that facilitates participant comprehension. The general recommendation from the Office of Human Research Protections is that consent forms should read at an 8th grade level. Follow to check the readability of your consent form.
Clinicaltrials.gov a glossary of lay terms is available in the resources section.
Consent Template — (revised 12/20/19) a template that can be used for most studies. This template includes A/V information and a child assent template.
- TIP! make sure your consent form and application consistently describe the study. Lack of congruency across documents is a frequent IRB comment.
Online Study Consent Template - (revised 4/10/20) a template to be used for online studies
Parental Consent Template — a template to be used for parental consent
Assent Template - (posted 10/21/22) - this template can be used for children under 12 years of age some adult populations that may have limited decision making capacity.
Clinical Trial and Biomedical Study Consent Template - (new 11/5/21) use this template for clinical trial and biomedical studies.
Audio/Video Consent Form - RETIRED, relevant information has been merged with the "consent template."
Class Project Consent Form - this template is only to be used for class project applications - do not use this for requests submitted via Kuali.
Letter of Support — A sample letter of support for research from a school/institution/entity, to be used as a template by the investigator.
Recruitment Guidance and Template — This includes information on participant recruitment (including the use of social media) and includes templates for letter, email, and flier recruitment.
Debriefing Template - for deception studies - a template to be used when creating a debriefing script.
Referral Template - This template provides counseling referral contact information for projects that involve sensitive or emotional content. This is not a referral procedure - investigators are responsible for developing their own procedures.