Federal regulations require hospital based researchers to obtain the approval of ------- prior to conducting clinical trials

• A. An ethics committee
• B. A research ethics panel
• C. A hospital review council
• D. An institutional review board

Answer: (D)

Protecting participants in human subjects research requires oversight by an institutional review board. Federal regulations (the Common Rule) require that any hospital-based research involving human subjects obtain IRB approval before starting and obtain ongoing oversight for the study. The IRB is a dedicated committee that reviews the research plan, informed consent documents, and recruitment methods to ensure risks are minimized, risks are reasonable in relation to anticipated benefits, and that the rights and welfare of participants are protected. In this regulatory framework, the institutional review board is the recognized entity charged with safeguarding subjects, making it the correct choice. Terms like ethics committee or research ethics panel refer to similar bodies used in other contexts or countries, and a hospital review council is not the specific federally required mechanism.