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. (Level I, Level II/III, and External Reliance Applications.) 

 â€” Use this online form if you are unsure whether your project requires IRB review. 

- Use this to register a class project. THE EXEMPT SELF DETERMINATION WAS BE RETIRED IN DECEMBER 2024.

• Review FAQ 11.10 to learn more about class projects - Class Project Consent Form

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
  • Kuali for student, Power Point
  •  (10 minutes)
  • Creating a new protocol instructions, Power Point
  •  
• Creating an amendment 
  •  (2minutes)
  • Creating an amendment, Power Point
• Responding to IRB comments
  • Responding to IRB comments, Power Point
• Additional Actions
  • Using the main menu, Power Point 
  • CITI and Personnel section, Power Point
  • Consent and recruitment, Power Point
• Committee Resources
  • Reviewing a protocol. Reviewer resource, Power Point 
  • Reviewing an agenda. Reviewer resource, Power Point
  • External member. Reviewer Resource, Power Point
  • Admin Actions, Power Point

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 Withdrawn protocols can be resubmitted.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.  
• CITI certificates are not automatically uploading.
  • See the personnel help resource.
• 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.  

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 if 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 - ¾Ã¾ÃÎçÒ¹ÐßÐßÓ°ÔºÃâ·Ñ¹Û¿´ State User ID and Password Required 
• KSU does not sponsor FDA regulated research and the KSU IRBs do not review FDA regulated research. Please contact researchcompliance@kent.edu for more information. 

Appendix E&²Ô²ú²õ±è;—&²Ô²ú²õ±è;¶Ù±ð±¹¾±³¦±ð²õ

Appendix F â€” Drugs and Biologics

Appendix G â€” Genetic Testing

Appendix H â€” Biological Specimens Repository

Appendix J â€” Non-English Speaking Participants

Appendix L&²Ô²ú²õ±è;—&²Ô²ú²õ±è;±Ê°ù¾±²õ´Ç²Ô±ð°ù²õ

Appendix N â€” Use of HIPAA Regulated Data - 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 â€” REVISED December 20, 2023 - Relying Site Local Context. See Cooperative/Multi-Institute Research (Section 8) in IRB Help.

Appendix U â€” International Setting

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 â€” contact researchcompliance@kent.edu for instructions on amending a legacy project.   

Continuing/Annual Review Form â€” contact researchcompliance@kent.edu for instructions on filing continuing review for a legacy project. 

Closeout Form contact researchcompliance@kent.edu for instructions on closing a project. 

Event Reporting -  use this form to report adverse or non-compliant events. Prior to completing and submitting the form, review the noncompliance and adverse events policies.

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 â€” (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 - (being merged with "Consent Template" at end of CY 2025) a template to be used for online studies

Parental Consent Template â€” a template to be used for parental consent 

Assent Template - (posted 10/21/22) - this template can be used for children 12 years of age and under and some adult populations that may have limited decision making capacity. 

Clinical Trial, Biomedical, and Non-Exempt Funded Research Consent Template - (being merged with "Consent Template" at end of CY 2025) use this template for non-exempt funded research, clinical trials, 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 â€” 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 â€” 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.