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It is the responsibility of the PI to assess the comprehension of the consent process and only enroll participants who can demonstrate informed understanding of the research study (45CFR46.116).
The Office for Human Research Protections provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research.
These charts are provided by the Office for Human Research Protections (OHRP) and are intended to guide local IRBs in their determination of required oversight. Please schedule a consult with MSOE IRB to talk about your research ideas.
SMART IRB is a platform designed to ease common challenges associated with initiating multi-site research. To use Smart IRB for a study, send an email to IRB@msoe.edu
