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dc.contributor.advisorWoods, Marianne
dc.creatorMoore, Kymberly Ellisse
dc.date.accessioned2021-01-09T19:53:19Z
dc.date.available2021-01-09T19:53:19Z
dc.date.created2020-05
dc.date.issued2020-07-29
dc.date.submittedMay 2020
dc.identifier.urihttp://jhir.library.jhu.edu/handle/1774.2/63581
dc.description.abstractEngaging in international clinical research is a complicated endeavor that requires special considerations to ensure research participants in host countries are afforded the same protections as domestic subjects. This research sought to examine how well IRBs in the United States address international human subjects’ protections in federally funded clinical studies by comparing current IRB policies and/or guidance documents to an ethical framework based on top five current ethical challenges when conducting multinational research. A systematic review was conducted to identify the top five ethical challenges in multinational research in the last five years, followed by a query using the National Institute of Health’s (NIH) Research Portfolio Online Reporting Tools (RePORT) to identify institutions currently funded to conduct international clinical research projects. Available institutional policies were reviewed to see if the top five ethical challenges were addressed. Finally, statistical analysis was conducted to determine if there were variables that affected the number of ethical challenges addressed in institutional policies or guidance documents. The top five ethical challenges when conducting multinational research were informed consent, social value, community engagement, fair benefits, and local review committees. Institutions were scored and weighed based on how many challenges were addressed in their policy and/or guidance documents. 51% of institutions addressed all five ethical challenges and 95% addressed at least three ethical challenges. In addition, the study revealed a statistically significant correlation suggesting that institutions with separate policies for international clinical research are more robust, encompassing more ethical considerations. Finally, the study showed areas needed for improvement as only half of the institutions addressed challenges related to fair benefits, i.e. post-study access to treatment.
dc.format.mimetypeapplication/pdf
dc.language.isoen_US
dc.publisherJohns Hopkins University
dc.subjectinternational research
dc.subjecthuman subjects protections
dc.subjectethical challenges
dc.subjectInstitutional Review Board
dc.subject
dc.titleADDRESSING HUMAN SUBJECTS’ PROTECTIONS IN INTERNATIONAL CLINICAL RESEARCH: COMPARING DOMESTIC INSTITUTIONAL REVIEW BOARD POLICIES AGAINST AN INTERNATIONAL ETHICAL FRAMEWORK
dc.typeThesis
thesis.degree.disciplineResearch Administration
thesis.degree.grantorJohns Hopkins University
thesis.degree.grantorAdvanced Academic Programs
thesis.degree.levelMasters
thesis.degree.nameM.S.
dc.date.updated2021-01-09T19:53:20Z
dc.type.materialtext
thesis.degree.departmentResearch Administration
dc.contributor.committeeMemberKantor, Jeffrey
dc.publisher.countryUSA
dc.creator.orcid0000-0002-3004-0631


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