IRB Forms | Kent State University

Important information regarding recent IRB changes

 

International Human Research Protections - A listing of over 1,000 laws, regulations, and guidelines on human subjects in over 100 countries, and from several international organizations.

 

IRB Forms

Applications (Level I, II/III and determinations)

Level 1 Exemption Application — Examples include, but are not limited to: anonymous surveys, use of existing data, certain research performed in educational settings or on typical educational processes.

Level II and III Research Application — Examples include but are not limited to: research conducted on human subjects that involves use of vulnerable populations, sensitive subjects, more risk for participants, suicidal thoughts, mental illness, substance abuse, deception, use of devices and/or drugs/supplements, invasive procedures. NEW - The IRB may approve some level II studies for three year intervals.

Self determinations

Exempt self determination - NEW PILOT PROGRAM! complete this online form (Chrome is recommended) if your study is limited to exempt survey or educational testing (cognitive, aptitude, achievement) procedures. For your information, this PDF includes the determination review path and Qualtrics 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 PDF includes the determination review path and Qualtrics form. 

Is Your Research a Clinical Trial? - Use this online tool to determine if your research is subject to the regulations that govern clinical research involving human subjects.

Appendices (to be used as indicated in the application forms)

NEW Appendix A1 - Research personnel for exempt studies - if your study is exempt, use this form to manage study personnel. 

Appendix A — Addition of KSU Co-PI or Key Personnel

Appendix B — 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 Data

Appendix O — Multi-site Study

Appendix P — Collection of Family History Data

Appendix Q — Blood, Injections, or Surgical Procedure

Appendix R — Adverse Event Involving Risks to Subjects or Others

Appendix S — Change in Principal Investigator

Appendix U — International Setting

Appendix V — Radiation

Appendix W — Adults With Decisional Impairment

Appendix Y — Student Recruitment Online Pools

Appendix Z — Conflict of Interest for Human Subjects Research

Other Submissions ( including amendments, annual review, class projects)

Submit all of these forms to researchcompliance@kent.edu

Amendments or Changes to Study Procedure Form — All amendments and changes must be reviewed and approved by the IRB before they are implemented.  

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

Continuing/Annual Review Form — Request continuing review and approval of a research project that involves human subjects. - NEW 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. 

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

De-Identified Data Use Agreement — This is to be used if you plan to share de-identified data with investigators from another institution. The KSU signatory is the investigator's Chair or Dean. The completed form is to be stored in the PI's files.

Data Use Agreement for data containing identifier (not for Limited Data Sets) — This form is to be used if you plan to send data that includes identifiers to another institution. The KSU signatory is the investigator's Chair or DeanThe completed form is to be stored in the PI's files.

Confidentiality agreement - This form is to be used when using non-research personnel (third party) translation or transcription services.The completed form is to be stored in the PI's files.

IS Secured Use & Confidentiality of University Records and Data — This is to acknowledge that investigators understand the rules associated with university records and data confidentiality. 

Clinical Research SOPs

Clinical Research Standard Operating Procedures

Information about HIPAA

Please Note: the HIPAA Privacy Officer is part of the Compliance and Risk Management Office and must review all projects involving access to PHI.

HIPAA Authorization Template — A sample HIPAA Compliance Authorization document; to be used as a template for the investigator, when needed to document HIPAA Compliance Authorization in a study.

Requirements for a HIPAA Compliance Authorization Form — A document explaining when a HIPAA Compliance Authorization Form may be required.

Business Associate Agreements — A business associate is a person or entity, other than a member of the workforce of the covered entity, who performs functions or activities on behalf of, provides certain services to a covered entity that involve access by the BA to protect health information. This form should be signed by the investigator's Chair or Dean For more information, visit: http://www.hhs.gov/hipaa/for-professionals/covered-entities/sample-business-associate-agreement-provisions/index.html.

Data Use Agreement for Limited Data Set — This is to be used if you plan to send or receive protected health information. This form should be signed by the investigator's Chair or Dean For more information, visit: http://www.hhs.gov/hipaa/for-professionals/faq/limited-data-set 

Templates (consent and recruitment)

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 — A sample informed-consent document to be used as a template for the investigator in writing the study consent form.

Parental Consent Template — A sample parental consent document to be used as a template for the investigator in writing the study consent form.

Audio/Video Consent Form — A sample audio/video consent document to be used as a template for the investigator in writing the study consent form.

Online Study Consent Form — An sample of an online web-based study consent form to be used as a template for the investigator in writing the study consent form.

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 - This template can be used when debriefing of deception studies is needed.

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. 

Exempt/Level I Survey and Interview Consent Templates