关键词：病人；住院治疗；临床研究者；生物医学
摘 要：All of the parties who conduct or have oversight responsibilities for biomedical researchsponsors, clinical investigators, and institutional review boards (IRBs)have responsibility for ensuring that the research complies with applicable laws and regulations and that risks to subjects are minimized. Although selection of clinical investigators and research sites, and determining if an investigational new drug application (IND) or investigational device exemption (IDE) is required are viewed primarily as sponsor responsibilities, FDA is issuing this guidance to clarify IRBs' responsibilities related to these activities and to encourage all parties to work together in order to protect the rights and welfare of study subjects. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required. To enhance protection of human subjects and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies regulatory requirements and guidance for human subject research.