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Exempt Survey Protocol FAQs

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Survey modifications to Non-Medical Exempt protocols

Modifications in survey questionnaires only require IRB review when the modifications may impact the study’s risk profile or Exempt status. Minor modifications (that do not impact the protocol risk or exempt status) to previously reviewed survey questionnaires may be implemented without additional IRB review. 

Examples of survey modifications that require a protocol modification include:

  1. Adding potentially sensitive questions to existing questionnaires. Sensitive questions may increase risk to participants. Examples of potentially sensitive topics include:
    1. The participant’s mental health or other questions about personal trauma
    2. Illegal activities the participant may be involved in
    3. Questions that may place subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, educational advancement, or reputation.
  2. Adding new questionnaires
  3. Introducing any collection of Personally Identifiable Information (any information that could potentially be used to identify an individual).