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Research that involves the use of human subjects (through human interaction or through obtaining identifiable data or biospecimens) requires IRB review prior to beginning such a project. The Human Research Protection Program (HRPP) is responsible for the administration of the Institutional Review Board (IRB) activities and oversight of human research protections activities such as educational programs and post-approval monitoring.

What You Need to Know [Essential Information]:

• What is human subjects research? Must meet both definitions:
  • "Research" is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • “Human Subject” is defined in the Code of Federal Regulations as a living individual about whom an investigator conducting research: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
• All research team members need to complete the CITI human subjects research training before the IRB application can be approved.
• The IRB must review and approve your study before you involve human participants in your research, including any study advertisement, subject recruitment, and consent forms.