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Vice President for Research

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Application Process Information

Determining the Level of Review

Research involving human subjects will be reviewed at one of three levels depending upon the IRB's evaluation of the potential risk and benefits to the human subjects and the federal guidelines that define the review process. These are:

  • Exempt
  • Expedited
  • Full Board



Federal regulations allow some human subject research to be exempted from review by the full IRB (45 CFR 46.101 (b)). However, OSU does not authorize investigators to make this determination. Researchers must submit an IRB application for review to the Office of University Research Compliance to determine exempt status.


Approval of research as exempt does not absolve the investigator(s) from ensuring that the welfare of the subjects is protected and that methods used to gain subjects' informed and voluntary consent are appropriate.


To be considered for approval for exempt status, the research must meet the requirements of one or more of six categories listed in the federal regulations (45 CFR 46.101 (b)). A flow chart to assist with determining if a research project qualifies for exempt review is available at




An expedited review process is available for research activities that present no more than minimal risk to human subjects, or that request a minor change in previously approved research that involves no additional risk and that involve only procedures listed below in one or more of the following categories.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Furthermore, the expedited review procedure may not be used for classified research involving human subjects.

Note: These activities should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review process when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Full Board

Any protocol which uses a methodology which is sensitive and of higher probability for causing harm or distress to subjects is subject to full board review.


Additionally, any protocol using prisoners as subjects or involving pregnant women, fetuses and human in vitro fertilization will be reviewed by the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be reviewed by the full board.

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