Exempt (New Studies)

If a new research study conforms to one of the six categories below, the study potentially qualifies for exemption. The IRB must determine if a study qualifies for exemption, not the Principal Investigator. Please submit the request for exemption form to request an exemption.

For more information, please see Powerpoint presentation on requests for exemption and expedited review .

Categories of research exempt from IRB review in accordance with the provisions of 45 C.F.R. §46.101(b):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
   
   
   1. research on regular and special education instructional strategies, or
      
   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      
   
   
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
   
   
   1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
   2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
      
   
   
3. Research involving use of educational tests (cognitive, diagnostic, aptitude, and achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this CFR, if:
   
   
   1. the human subjects are elected or appointed public officials or candidates for public office; or
      
   2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
      
   
   
4. Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
   
   
5. Research and demonstration projects which are conducted by or subject to the approval of Department of Agency heads, and which are designed to study, evaluate, or otherwise examine:
   
   
   1. public benefit or service programs;
      
   2. procedures for obtaining benefits or services under those programs;
      
   3. possible changes in or alternatives to those programs or procedures; or
      
   4. possible changes in methods or levels of payment for benefits or services under those programs.
      
   
   
6. Taste and food quality evaluation and consumer acceptance studies,
   
   
   1. if wholesome foods without additives are consumed or
      
   2. if a good is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the U.S. Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

The U.S. Food and Drug Administration (FDA) has also promulgated regulations regarding research exempt from IRB review. If the research is conducted under the purview of the FDA consult the FDA regulations for guidance.

Specifically, Title 21 Code of Federal Regulations (CFR) 56.104 addresses categories of clinical investigations that are exempt from the requirements of IRB review. Many research proposals qualify for exemption in accordance with 45 CFR 46.101(b)(4). If you are uncertain if your research proposal is exempt in accordance with the regulation consult the Human Subject Regulations Decision Charts.