How to Inform the IRB That Approval is Not Required
To promote University-wide consistency in the application of federal IRB requirements and the ethical requirements of our respective professions, all study activities that involve human subjects must be described to the IRB – even those which the principal investigator believes does not need explicit approval.
Typically, the IRB chair [or designee(s)] can agree/disagree that IRB approval is not required – action need not await the next meeting of the full IRB.
There is no specific form for informing the IRB that approval is not required. Thus, address a letter to the IRB chair with the following information:
- Provide the name and contact information (e.g., e-mail, telephone, address) of the principal investigator or member of the WPI community who is responsible for the activity.
- A brief description of your activity (including the scope of the activity), with an emphasis on interaction and intervention with subjects.
- Specifically describe why your human studies activity does not include a systematic investigation, (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge.
NOTE: If the IRB does not agree that approval is not required for your activity, then you will be asked to submit for an exemption, or an expedited or full IRB application.