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.
This application is to be used by those requesting an exempt determination. The optional components (appendices) are required only when the topics are relevant to the proposed research.
Application for IRB Exemption (version 4.1) - Updated: 5/4/12
- Appendix A1
Ohio State University Co-Investigators & Key Personnel
- Appendix A2
External (non-Ohio State) Co-Investigators & Key Personnel
- Appendix N
Waiver or Alteration of HIPAA Research Authorization
- Appendix U
Research in International Settings
To ensure an effective review, a full description of the planned research (i.e., a research protocol or proposal) must be submitted with the Exempt Application. A research protocol/proposal provides the reader with background information of the problem under study, including the study rationale, a detailed plan for conducting the research involving human research participants, and a discussion of the potential importance of the research.
There is no required consent template for exempt research. However, specific elements of informed consent should be included in consent forms or scripts as applicable.
Only a faculty member may serve as a principal investigator for student research. Each investigator listed on the signature page of the exempt application will receive an e-mail notification that the project is incomplete/requires clarification, approved for exempt status, or disapproved. A detailed e-mail will be sent asking for clarifications or changes to incomplete applications. Please allow three weeks to receive a determination of exempt status.
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.
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 gain participant consent are appropriate to the activity.
Investigators may not solicit subject participation or begin data collection until they have received written or electronic concurrence from ORRP that the research has been determined to be exempt or written approval from the appropriate IRB.
For more information, see The Ohio State University HRPP Policy Exempt Research.
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