Is IRB approval required for nursing research involving human subjects?

• A. False
• B. True
• C. Only for federally funded studies
• D. Not required for minimal risk studies

Answer: (B)

IRB approval is required to protect people who participate in research. Federal regulations define human subjects research as projects that collect data through intervention, interaction, or identifiable private information about living individuals. When a nursing study involves such activities, an IRB must review the protocol to weigh risks and benefits, ensure informed consent is appropriate, and safeguard privacy and confidentiality. This applies even if the study is minimal risk; the IRB will determine whether the project qualifies for exempt or expedited review, but initial IRB involvement is typically needed. So, IRB approval is needed for nursing research with human subjects.