IRB Review

NIH investigators should be knowledgeable as to whether their research activities meet the definition of human subjects research and require IRB review. Proposed human subjects research must be submitted in PROTECT (eIRB system) for IRB review or consideration of an exemption from IRB review prior to commencing research activities.

• Getting Started

  This guide highlights the logistics, requirements and instructions for each type of IRB submission for new projects. Review instructions and associat…

• Do you need to submit to the IRB?

  All NIH investigators conducting activities that meet the definition of both "research" and "human subject" must submit for Institutional Review Boar…

• Not Human Subjects Research

  Not Human Subjects Research (NHSR) is any activity which falls outside the definition of human subjects research.

• Exempt Research

  Exempt research involves human subjects and meets the requirements of one or more exemption categories within federal regulations for protecting huma…

• Non-Exempt Research

  When your research involves human subjects and doesn't qualify for exemption under federal regulations, it's called non-exempt human subjects’ resear…

• Secondary Research

  Secondary research refers to the use of biospecimens or data collected from humans for purposes other than the current research. This means that the …