IRB Forms

​​​​​​Self determinations

Exempt Self Determination - Re-released (2/3/20) - Use this to obtain level I approval for educational practices conducted in educational settings, surveys, interviews (including focus groups) and educational testing of adults. Review the Level I guidance document for more information and additional exclusions. Approvals are processed by the Office of Research Compliance; there is a small possibility more information will be requested. 

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 A1 - (RETIRED October 7! The Level I, II/III and amendment forms have been revised so that personnel will be accounted for directly in the form and not as an attached appendix) Research personnel for exempt studies - if your study is exempt, use this form to manage study personnel. 

Appendix A — (RETIRED October 7! The Level I, II/III and 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. 

Use these forms if your IRB application was approved via the "paper process" that was used prior to Kuali being live. If your project was approved via Kuali you must file amendments, continuing reviews, and adverse events through the system. 

Amendments or Changes to Study Procedure Form — (Revised 9/28/20) All amendments and changes must be reviewed and approved by the IRB before they are implemented.  

Continuing/Annual Review Form — (Revised 9/28/20) 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—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:

Class Projects Online Form (For your information, this PDF includes the form's questions and decision logic.)

Class Project Consent Form

Data Use and Other Agreements (Please see out 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 form 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 

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." 

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.