Research with Human Subjects (IRB)
Before you implement research that involves the use of human subjects, your project must be reviewed and approved by the Kent State Institutional Review Board (IRB). The IRB is responsible for ensuring that the research adequately protects the rights and welfare of study participants. The activities of the IRB are coordinated and administered by the Office of Research Compliance (ORC). Please review the IRB Policies before submission.
Per FWA 00001853 (Expires August 12, 2021), the mission of the Human Subjects Protection Program is to protect the rights, dignity, welfare, and privacy of human subjects in all research conducted in accordance with the principles of the Belmont Report, The Code of Federal Regulations (45CFR46), Food and Drug Administration, University policy, and — when applicable — other laws and regulations.
This mission is achieved by:
- Ensuring that research involving human subjects receives the required review and approvals prior to the start fo the research;
- Creating a collaborative environment of dialogues with investigators to facilitate the development of ethical and safe scientific research;
- Providing administrative and educational support to the IRB;
- Providing education to IRB members, investigators, and students about policies and procedures;
- Conducting activities that enhance compliance with the requirements of the HSPP.
How to Determine if Your Research Needs IRB Review
The federal regulations for the Protection of Human Subjects define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (45 CFR 46.102.d)
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” (45 CFR 46.102.f)
If you are unsure whether your project needs review by the IRB, you can submit an IRB Review Determination Form to the ORC. Determinations forms are available on the IRB Forms page.
Types of Review
There are three levels of review for research involving the use of human subjects as defined in the Department of Health and Human Services regulations (45 CFR 46). The IRB is responsible for determining what level of review that is needed.
Exempt from Annual Review (Level I)
This type of review is required for studies that meet exemption categories as defined by 45 CFR 46. Protocols deemed exempt by the IRB are not subject to continuing review. The ethical principles of research conduct still apply to studies deemed exempt from annual review. To make changes to the research design after the IRB has approved the protocol as exempt, you must submit an amendment form to the ORC to ensure that the changes do not disqualify the study from exemption. If you think that your project meets the exemption categories, complete a Level I – Exempt from Annual Review application and supporting documents (CITI completion certificate, instruments, etc.) and send it to email@example.com. Do not begin data collection until you have received an emailed approval from the IRB. Find the forms and more information about what is exempt on the IRB Forms page.
Expedited Review (Level II)
These applications are reviewed by the IRB chair or at least one other IRB reviewer designated by the chair. This type of review is required for studies that involve minimal risk and fit into an expedited review category of research as defined by 45 CFR 46 and the FDA regulations (Title 21 CFR 312.3; 21 CFR 812.3). If you believe that your research project falls into the expedited research categories, complete a Level II/III – Use of Human Subjects in Research Application. Do not begin data collection until you have received written approval from the IRB. Find the forms and more information about expedited categories of research on the IRB Forms page.
Full Board Review (Level III)
This type of review is required for protocols that pose greater than minimal risk to subjects or involve minimal risk and do not qualify for expedited review. Full board review means that the research is reviewed at a convened meeting at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. If you believe that your research project falls into the expedited research categories, complete a Level II/III – Use of Human Subjects in Research Application. Do not begin data collection until you have received written approval from the IRB. Find the forms and more information about what is exempt on the IRB Forms page.
If your study has been identified as requiring a full board review, the ORC will contact you by email to ask you to attend a committee meeting. Please be prepared to discuss the project and address comments or questions from IRB members. Students conducting research for their thesis or dissertation should accompany their faculty adviser (who serves as the Principal Investigator on the IRB application) to the IRB meeting.
Examples of research that needs full board review include, but are not limited to:
- Research involving significant deception
- Research involving prisoners (e.g., individuals in prisons, halfway houses and certain parolees, such as those residing in a treatment facility as a condition of parole)
- Some types of research with children (<18 years old), for example, if a waiver of parental consent is requested
- Research with other vulnerable populations (e.g., institutionalized individuals, pregnant women)
- Research presenting more than minimal risk
Contact the ORCOffice of Research Compliance
Division of Research and Sponsored Programs
207 Schwartz Center