Questions and Answers
Which of the following is the least important activity when protecting human subjects in international research?
What is essential for researchers to have regarding the local research context?
Sufficient knowledge of the local research context to design and carry out research responsibly.
What question should the Big State University IRB ask the researcher when studying attitudes about obesity in Chile?
Will the researchers have collaborators at the research site abroad?
What factors determine the types of review needed for international research?
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If a proposed study qualifies for exemption, review is required at the foreign site.
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What must be described in an 'assurance of compliance' with a U.S. federal agency?
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Nurses are engaged in the research if they only inform subjects about the research.
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A research project may qualify for exemption in the social and behavioral sciences.
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What should collaborating institutions ensure when engaged in research abroad?
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What is the age of majority determined by in international research?
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If an institution obtains informed consent and conducts research interviews, it is engaged in research.
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What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting regarding informed consent?
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Study Notes
Protecting Human Subjects in International Research
- Assessing transportation conditions ranks as the least important activity for safeguarding human subjects.
- Understanding local socio-economic conditions is crucial for designing effective research that respects subjects' rights and welfare.
- Community consultation is vital, especially when research impacts the entire community or involves gatekeepers like tribal councils.
Institutional Review Processes
- Research proposed by a Big State University professor in Chile should prompt the IRB to confirm if local Chilean IRB or ethics committee review is necessary.
- Collaboration with local researchers at foreign research sites influences the type of review required. Without foreign collaborators, the home institution may handle the review process.
- U.S. researchers must follow local policies and regulations, which dictate the review requirements rather than U.S. laws.
Exemptions and Compliance
- Studies that qualify for exemption from federal regulations do not require review at foreign sites according to those regulations.
- An “assurance of compliance” must outline procedures to protect subjects consistent with the Common Rule, necessitating IRB-like independent committee reviews.
Engagement in Research
- Nurses notifying subjects about research without acquiring consent or conducting procedures are not considered engaged in the research under federal regulations.
- Institutions solely providing space for researchers do not qualify as engaged parties unless involved in obtaining consent or actively conducting research.
Age of Majority
- The age of majority for research subjects is defined by the laws and societal customs of the research location.
- U.S. researchers must acknowledge and comply with the recognized age of majority relevant to the community in which the study occurs.
Informed Consent Considerations
- When gathering informed consent, U.S. researchers must account for local cultural norms, legality, and ethical standards to ensure respect and understanding from subjects.
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Description
Test your knowledge on the essential practices of protecting human subjects in international research. This flashcard set covers key concepts and activities necessary for ethical research. Ideal for students and professionals in social and behavioral sciences.
