CITI Ethics Training module 12

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

Which of the following is the least important activity when protecting human subjects in international research?

Assessing transportation conditions

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a 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 researchers have collaborators at the research site abroad?

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability 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.