International Research - SBE (ID 509) Questions and Answers 100% Solved

International Research - SBE (ID 509) Questions and Answers 100% Solved Which of the following is the least important activity when protecting human subjects in international research? Assessing transportation conditions It is essential that researchers have sufficient knowledge of the local research context to be able to design and carry out research in a way that protects the rights and welfare of the subjects. This includes knowledge about unique risks subjects might face given the local socio-economic conditions. Community consultation is particularly important when research has the potential to affect the community as a whole and when there are gatekeepers for the community (for example, a tribal council). 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? There are several factors that determine what kinds of review are needed for international research, including if the researcher have collaborators at the research site abroad. If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher's home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed. A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. 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. A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution's IRB or an institutional official - those decisions are left to institutional policy. If research involves collaboration with an institution that is "engaged" in research in the foreign country, the collaborating institution will need to have 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. These procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency. The written procedures for reporting unanticipated problems are institutional policy, the procedures outlining randomization should be covered in the research plan/protocol, and the procedures in place to comply with ethical principles is the Federalwide Assurance (FWA), not "assurance of compliance." 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. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research. Which of the following activities constitutes engagement in research? Obtaining informed consent and conducting research interviews. The age of majority in international research is determined by the Laws, customs, and norms in the area in which the research will be conducted. If an institution obtains informed consent and conducts research interviews it is engaged in research. The age of majority should be the recognized age of majority in the country or region where the research takes place. What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?