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A researcher wants to conduct a clinical trial where participants sit in a dark room and listen to soft music for 45 minutes.

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Answer #1

Yes the study requires IRB approval because human subjects are involved in the study

IRB approval is required for the projects that

  1. meet the definition of research
  2. involve human subjects
  3. and involves any interaction with human subjects
  4. any intervention with humans or if there is any access to their private information

Data collected through planned experimental design such as clinical trial or through surveys, interviews evaluation procedures is included in the definition of research.  

So in this case definition of research is met and humans subjects are involves therefore, researcher requires IRB approval.

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