The Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protections defines the following review levels and definitions:

Exempt Determinations

Exempt research must be minimal risk. If your research involves minors, pregnant women, prisoners or other vulnerable populations, it is not eligible under the Exempt category.

  Exempt categories include (see regulations for full details):  
  (1) Research conducted in educational settings, instructional strategies or techniques, curricula, or classroom management methods...   
  (2)

Research involving surveys, interviews, observation of public behavior, educational tests (cognitive, diagnostic, aptitude, achievement)...

  
  (3)

Benign behavioral interventions in conjunction with the collection of information...

  
  (4)

Secondary research use of identifiable private information or identifiable biospecimens...

  
  (5)

Research and demonstration projects that are conducted or supported by a Federal department or agency...

  
  (6)

Taste and food quality evaluation and consumer acceptance studies...

  
  (7) Storage or maintenance for secondary research for which broad consent is required...  
  (8)

Secondary research for which broad consent is required...

  

Review Level Determination

The following topics or methods are typically NOT eligible for Exempt Review:

  1. Vulnerable populations (prisoners, pregnant women, etc.)
  2. Social or behavioral interactions/interventions with minors
  3. Specifically seeking subject groups of a distinct ethnicity, race, or religion
  4. Initial collection of human biospecimens
  5. Blood draws
  6. Body sensors, body measurements, or physical detection tests
  7. Invasive procedures
  8. Drugs, substances, and medical devices
  9. Matters relating to civil litigation
  10. Research procedures involving deception when the subjects are unaware that they are being deceived
  11. When identifiable, questions posed to subjects seeking answers that, outside the research, could place the subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability, education advancement, or reputation
  12. When identifiable, questions posed to subjects about their own sexual or criminal behaviors or alcohol/substance abuse
  13. Questions posed to subjects about their own suicidal thoughts
  14. More than minimal risk research

Expedited Review

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more categories by the federal Office for Human Research Protections may be reviewed by the IRB through the Expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. 

1. Such applications will be reviewed by at least two members of the Committee with the following possible outcomes:
  a. The reviewers will unanimously approve or disapprove the proposal.  Either reviewer may require that modifications to the proposal be made prior to approval.
  b. Reviewers can recommend that the application be reviewed by the full IRB, in which case it will be considered at the next meeting.
2. The decision of the reviewers will be presented to the full IRB for approval at the next meeting. 
3.

Minor Amendments in previously approved research may be reviewed and approved by the Chair.

Full Committee Review "FCR"

Research involving more than minimal risk and/or vulnerable populations (e.g., children, economically or educationally disadvantaged persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the Full Committee. Research proposals that involve a conflict of interest may also be subject to FCR.

Applications received which require FCR will be reviewed at the next scheduled meeting.

IRB Application Instructions 

Determinations

See the definition of Human Subjects Research for more information. Review level decisions will be made by the IRB but please contact the IRB Office for determination assisatance and review level questions. 

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