Review Process Decision Tree: Question 1

Introduction

The Westminster IRB can act via four different mechanisms, depending on the activity. The mechanisms are progressively more involved (and have progressively longer lead times), thus applicants should choose the simplest mechanism to which they are entitled to apply. This flowchart will direct the applicant to the appropriate application. The four mechanisms are:

  1. Non-Reviewed Activity: Certain studies involving humans do not meet the federal standard requiring IRB review. If so, no formal IRB approval is required for the activity (unless the activity changes and no longer falls outside of the federal standards).
  2. Exempt Activity: Certain human studies activities can receive a letter of exemption. Once exempted, the applicant need not have any further contact with the IRB (unless the activity changes and no longer qualifies for an exemption). Only the IRB chair (or designee) can determine that an activity is exempt.
  3. Expedited Review: Certain human studies activities that involve "minimal risk" can be reviewed by a sub-set of the IRB, and can be approved without a vote of the full IRB. Approved activities must provide continuing reports to the IRB at least annually.
  4. Full Review: Human studies activities that are neither exempt nor qualify for expedited review must be reviewed and voted-on by the full IRB. Approved activities must provide continuing reports to the IRB at least annually.

Q1: Does your proposed activity involve the use of "Human Subjects"?

A. Will you collect or utilize data:

B. Will you collect or utilize privately identifiable information (i.e, the identity of the subject can be readily obtained by the investigator or from the information) from/about a person?

Examples include:

C. Is there an intervention or interaction with a living person that would not be occurring, or would be occurring in some other fashion, but for your activity?



If you answered "No" to every question:

Your activity does not need IRB approval. You need not contact the IRB.

If you answered "Yes" to any question:

Your activity requires action by the IRB. Proceed to Question 2.