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Human Subjects Research >> Submitting an IRB Application >>

Human Subjects Research: Exempt Status Introduction

The federal regulations (45 CFR 46) governing research involving human subjects describes some categories of research as being exempt from the policy relating to IRB review, however, any decision about whether a research project qualifies for exemption must be made by a person who 1) has knowledge of human subject (HS) protections and regulations, and 2) is free of any conflict of interest that might be perceived to influence the decision process (i.e. researchers may not certify that their own research meets the requirements for exemption).  

  Go To Application Page

Exempt Status does not mean "exempt" from considering human subjects protections, it just means your research is exempt from IRB review. The most common types of minimal risk research at Miami that are exempt are:

  • Research involving classsroom activities that would occur in the absence of research, e.g. standard tests.
  • Research using interviews, surveys, or educational tests (subjects >18 years old only) or observation of public behavior where there is no interaction between the researcher and the subject (subjects can be <18).
  • Research using data or specimens collected by someone other than Miami personnel where identifying information is not present in the data set.
  • There are other types of similar research that might be exempt, view the video introduction and see the guidance documents for more information.
Exempt Video
Click for 7 Minute Introductory MP4 Video about Level 1 - Exemption Categories
 
 
The data that is collected in "exempt" research can still be published or presented like any other research.
 

 


Note: The exempt screening process cannot be used for research that has already been conducted. Any human subjects research activities already underway or completed must be submitted using the IRB Post-Hoc Review Procedure. This generally involves review by a subcommittee of the IRB or a full convened meeting of the IRB and, often, results in limitations on how the research results are used in presentations and publications.


Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site:
513-529-3600 or email: sullivnh@miamioh.edu

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