Review Process Decision Tree: Question 2

Introduction

Since your activity involves human subjects, some form of IRB action is required. YOU MUST CONTACT THE IRB. Please continue reading.

The WPI 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). Only the IRB chair (or designee) can determine that an activity does not require review.
  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.

Q2: Does your proposed human studies activity require formal IRB review?

Does your proposed activity include a systematic investigation, (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge?

Example activities likely not designed to develop or contribute to generalizable knowledge:

  • Course projects used to explore, teach "textbook" knowledge.

If you answered "No":

Inform the IRB that approval is not required. Here's how... Example activities likely designed to develop or contribute to generalizable knowledge:

  • Project whose results might be published in a scientific journal/conference.
  • Most federally-sponsored investigations; most investigations sponsored by not-for-profit agencies; most industry-sponsored projects (even if the results may be held proprietary).

If you answered "Yes":

Your activity requires IRB review. Proceed to Question 3.

 
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