Research methods utilizing interventions to obtain study information may consist of physical procedures to gather data (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
A concern for intervention-based methods are harms that may occur from study procedures unique to the research (as opposed to procedures already being done for treatment or diagnosis purposes).
Most intervention-based research is reviewed under expedited procedures or by the full board; however, some may be eligible for exemption. Protocols that include mixed methods may fall within multiple review categories; when this happens the most protective standard will be applied.
More on Levels of Review
Education research (exempt cat. 1) may include an assessment of changes in curriculum or classroom materials
Factors that may preclude exemption: greater than minimal risk (would not constitute normal practice); radically new instructional strategies or randomization of subjects (these methods deviate from normal educational practices).
DHHS funded or approved projects (exempt cat. 5) that study, evaluate or otherwise examine
Taste and food quality evaluations and consumer acceptance studies (exempt cat. 6)
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Collection of blood samples (expedited cat. 2) by finger stick, heel stick, ear stick, or venipuncture
Individual or group characteristics or behavior (expedited cat. 7)
Interventions that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.