IRB Forms

IMPORTANT (updated (8/31/23) - some new employee identities are not able to access Kuali or be added to protocols. We anticipate the problem will be resolved by 9/2. If you experience prblems with access, contact kmccrea1@kent.edu.   

Access Kuali E-Protocol to complete an application. (Level I, Level II/III, and IRB Authorization applications.) 

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:

• Brown bag demonstration/training video (1 hour)
• Creating a new protocol
  • Kuali for student, Power Point
  • Creating a new protocol video (10 minutes)
  • Creating a new protocol instructions, Power Point
  • Kuali's documentation 
• Creating an amendment 
  • Creating an amendment  video (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
  • Reviewing a protocol. IRB member resource, Power Point 
  • Reviewing an agenda. IRB member resource, 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 Withdrawn protocols can be resubmitted.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.  
• 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.
  • See the personnel help resource.
• 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.  

​​​​​​Self determinations

Exempt and Class Projects Self Determination - 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

IRB Review Determination Form — Use this online form (Chrome is recommended) if you are unsure whether your project requires IRB review. For your information, this WORD DOC includes the determination form. 

Clinical Trials

• To determine if you are conducting a clinical trial reviewNIH Clinical Trial Decision Tree and NIH's Clinical Trial Definition webpage.
• All personnel engaged in a Clinical Trial MUST complete CITI GCP training.
• All Applicable Clinical Trials must be posted to Clinicaltrials.gov.
  • FDA:https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
  • NIH:https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
  • Some journals may require posting even you are not conducting an Applicable Clinical Trial:http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
• Registration on Clinicaltrials.gov:
  • Contact Kevin McCreary at kmccrea1@kent.edu to obtain credentials.
  • Adhere to clinicaltrials.gov's requirements and review the PRS User Guide.
• Clinical Trial and Biomedical Study Consent Template - (new 11/5/21) use this template for clinical trial and biomedical studies. 
• See also - Kent State User ID and Password Required Clinical Research SOPs

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 7, 2020 - Addition of External Co-PI or Key Personnel

Appendix C — Data Repositories

Appendix D — Deception

Appendix E — Devices

Appendix F — Drugs and Biologics

Appendix G — Genetic Testing

Appendix H — Biological Specimens Repository

Appendix I — Children

Appendix J — Non-English Speaking Participants

Appendix K — Pregnant Women, Fetuses, Neonates

Appendix L — Prisoners

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 — Multi-site Study

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 — Radiation

Appendix W — Adults With Decisional Impairment

Appendix Y — RETIRED! Student Recruitment Online Pools

Appendix Z — Conflict of Interest for Human Subjects Research

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 Kent State 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

Clinical Research Standard Operating Procedures

See Protected Health Information and HIPAA Compliance FAQ (Section 3)

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 these instructions to check the readability of your consent form.

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.