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.
A professor ...
International Research- SBE
quiz Accurate 100%
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.
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 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?
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.
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