- Apply for IRB Exemption
- Informed Consent
- International Research
- Research with Other Institutions
- Protected Health Information (PHI)
- Changes to Exempt Studies
- Additional Information
- Report Human Subjects Concerns
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 “as written,” i.e., the investigators do not plan to make changes in the research design, selection of subjects, informed consent process, or study instruments during the course of the research.
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 Buck-IRB. Subject participation or data collection can not start until investigators have received approval from ORRP that the research is determined as exempt.
Apply for IRB Exemption
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 Buck-IRB online system. A full description of the planned research (i.e., a research protocol or proposal) must be submitted. Only English-language versions of the materials need to be submitted. If you intend to have translated documents available, then just explain your intent to use non-English materials in your application and protocol. Please note that IRB-reviewed research has different requirements. A research protocol provides information such as the study objectives, background, detailed plan for conducting the research, and discussion of how the research findings will be analyzed. 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 clarification, approved for exempt status or disapproved. It typically takes around three weeks to receive a determination of exempt status.
Informed Consent
Consent is required for exempt research unless the research cannot be practicably carried out without waiving the requirement to obtain consent. The Ohio State Exempt Research policy requires consent if there will be interactions with participants.
Consent Templates and Guidance
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 Buck-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 Protections.
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).
Changes to Exempt Studies
A new exempt submission must be made for all revisions to the exempt studies, except personnel change requests. Researchers can copy a previously approved study in Buck-IRB and only revise those sections/documents that need to be revised. To revise an exempt study:
- From your Buck-IRB homepage, select study 20XXEXXXX (study number).
- From the Study Actions menu, select Copy Study.
- A new study will be created, with all application information from 20XXEXXXX auto-populated. Note: upload all study documents in the appropriate sections as documents do not auto-populate.
- On the Other Files/Comments page, upload a cover letter explaining that the new study will replace 20XXEXXXX and the changes that were made. This will facilitate review.
- Submit the new exempt application for review.
For questions about exempt research, contact
ORRP
Questions
Exempt Research
exemptinfo@osu.edu
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