IRB approval is required for which types of studies?

• A. only interventional studies
• B. interventional and observational studies
• C. only observational studies
• D. neither

Answer: (B)

IRB oversight applies to any research involving human subjects, and that oversight is required for studies whether participants are actively treated or simply observed. Interventional studies involve giving or withholding a treatment, procedure, or behavioral intervention, which creates potential risks to participants. Because of those risks, the study must be reviewed to ensure safety, benefits, informed consent, and monitoring are appropriate. Observational studies don’t change participants’ care, but they still involve collecting information about people, sometimes sensitive health data, raising concerns about privacy and confidentiality. The IRB assesses these risks and decides whether the study needs full review, expedited review, or qualifies for an exempt determination, but some form of IRB involvement is required. So, IRB approval (or an IRB-determined exemption) is required for both interventional and observational studies.