What information is the IRB looking for when it reviews a protocol?

The IRB is looking for content in your protocol that will allow it to determine the following:

  • That the participation of all the subjects is voluntary.
  • That the rights and welfare of all the subjects will be adequately protected.    
  • That the consent process will be conducted in accordance with federal regulations and UMass human subjects policies.
  • That the potential harms (risks) to the subjects are outweighed by the study's potential benefits to science and society.

This determination can only be made if the protocol contains a robust description of the study procedures. Note that the IRB can review only the information submitted in the protocol. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification.

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