For Investigators

Exempt From IRB Review

In order for a study to qualify for exempt review, the study must fall into one of six categories defined in the federal regulations (45 CFR 46.101).  These categories represent studies that present minimal risk to participants. Although the category is called "exempt," at FRI the determination of exemption must be made by the IRB Chairperson or his/her designee.

If the project is found to be exempt, it will not need to follow continuing review procedures and the other requirements of 45 CFR 46 unless significant changes are made to the research protocol.  Research involving vulnerable participant populations, as well as survey research involving children, is not exempt from federal regulations

Some examples of exempt level research are:

  • Anonymous surveys;
  • Interviews of adults about non-sensitive topics;
  • Educational tests;
  • Observation of public behavior.

To apply for an exempt review, the investigator must submit a complete application for exemption, including supporting documentation, as applicable:

  • Protocol;
  • Consent form, information sheet;
  • Recruitment materials;
  • Surveys or interview questions;
  • Application for Exemption from IRB Review.

Exempt review applications are accepted whenever an investigator submits them and are reviewed outside of the regular IRB meeting time.

Additional Regulatory Protections for Children and Prisoners

Federal regulations allow for additional protections for vulnerable populations.  The categories of research that can NOT be exempt are as follows:

  • Research involving prisoners;
  • Research involving survey or interview of children;
  • Research involving the observation of public behavior of children, unless the investigators do not participate in the activities being observed.