SBE Quiz International Research Exam 2024
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? - ANSWER-Will the researcher have collaborators at the research site abroad?
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 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? -
ANSWER-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 Researcher proposes to conduct a study at a foreign site that has been determined to
be exempt from the federal regulations by institutional policy. According to federal
regulations, is review required at the foreign site? - ANSWER-If a proposed study
qualifies for exemption, federal regulations do not require review at the foreign site
where it will be conducted.
The age of majority in international research is determined by the - ANSWER-Laws,
customs, and norms in the area in which the research will be conducted.
What are some considerations for a U.S researcher conducting a study in a non-U.S.
setting when obtaining informed consent from subjects? - ANSWER-In addition to the
consent of the research subjects, are there other individuals or groups whose
permission must be sought?
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP? - ANSWER-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.
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