The Huron IRB system is now live.
For details on navigating the IRB process at Ohio State, visit our transition page for the latest information.
All research activities involving humans as research participants must be reviewed and approved by an Ohio State Institutional Review Board (IRB), unless the Office of Responsible Research Practices (ORRP) determines that the research falls into one or more of the categories of exemption established by federal regulations.
Exempt research is generally short-term in nature. It usually is performed with very few modifications being made to the study after approval.
These exemptions do not apply when the proposed activity(ies) might expose the participants to discomfort or harassment beyond levels encountered in daily life or when individuals involuntarily confined or detained in penal institutions are subjects of the activity.
Exempt determinations are made by designated ORRP staff and/or IRB members; investigators are not permitted to make their own determinations of exemption. Requests for exempt determinations should be submitted in the Huron IRB system. Subject participation or data collection can not start until investigators have received approval from ORRP that the research is determined as exempt.
Request for Exempt Determination
Investigators conducting research determined to be exempt are responsible for ensuring that the welfare of human subjects participating in research activities is protected and that the methods used and information provided to obtain participant consent are appropriate to the activity.
Requests for exempt determinations are made using the Huron IRB system. Exempt submissions include completing the SmartForm, developing a protocol using HRP-503c- Template- Protocol – Exempt Research, and providing other study documents, as applicable. Only English-language versions of the materials need to be submitted. If you intend to have translated documents available, explain your intent to use non-English materials in the SmartForm and protocol. Please note that IRB-reviewed research has different requirements. Research that includes both exempt and non-exempt activities cannot be determined to be exempt.
Each investigator will receive an email notification that the project is incomplete/requires clarifications, approved for exempt status, or requires IRB review.
Informed Consent
Consent is required for exempt research unless the research cannot be practicably carried out without waiving the requirement to obtain consent. HRP-103 - Investigator Manual and HRP-312 – Exemption Determination require consent if there will be interactions with participants.
International Research
The exempt status is based on U.S. law and Ohio State policy and does not apply outside of the US. Investigators are responsible for assuring that all international requirements are met. The International Research Sites pages of Huron IRB will help guide researchers in site-specific requirements whether the researcher is on-site for activities or not (e.g., research collected via virtual interviews). For a list of regulations, laws, and guidelines pertaining to international human subjects research for selected countries, see International Compilation of Human Research Standards.
Research with Other Institutions
If research is being conducted in conjunction with external collaborators, exempt status must be approved by each institution involved in the project. The only exception is for certain research conducted with Nationwide Children’s Hospital under a reciprocity agreement.
Protected Health Information (PHI)
For access to PHI, the research team will need to contact the appropriate Privacy Officer to request access to the materials in question and provide proof of the exemption or IRB approval. Investigators may also need to provide other information, such as documentation of any approved waivers or partial waivers of HIPAA authorization. In Ohio State’s Wexner Medical Center, contact the department of Medical Information Management to access PHI from patient medical records for the purposes of research. For more information, reference the OSU Medical Center: Guide to Information Access for Research Activities (requires OSUMC login ID).
Additional Information
For questions about exempt research, contact