CITI International Research Latest Updated 2023 & Approved

This compilation of laws, regulations, and guidelines is helpful to CITI Program organizations that are involved in international research. They included laws, regulation, and guidelines have been classified into nine categories: • General • Drugs and Devices • Clinical Trial Registries • Research Injury • social-behavioral Research • Privacy/Data Protection • Human Biological Materials • Genetic • Embryos, Stem Cells, and Cloning A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB? Will the researcher have collaborators at the research site abroad? Which of the following is the LEAST important activity when protecting human subjects in international research? Assessing transportation conditions