International Research - SBE Flashcards
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Questions and Answers

Which of the following is the least important activity when protecting human subjects in international research?

  • Conducting risk assessments
  • Obtaining informed consent
  • Assessing transportation conditions (correct)
  • Understanding local customs
  • 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?

    <p>Whether the researcher has collaborators at the research site abroad.</p> Signup and view all the answers

    If a proposed study qualifies for exemption, review is required at the foreign site.

    <p>False</p> Signup and view all the answers

    What must be described in an 'assurance of compliance' with a U.S. federal agency?

    <p>Procedures to ensure that subjects will be protected in line with the Common Rule.</p> Signup and view all the answers

    Nurses are engaged in the research if they only inform subjects about the research.

    <p>False</p> Signup and view all the answers

    A research project may qualify for exemption in the social and behavioral sciences.

    <p>True</p> Signup and view all the answers

    What should collaborating institutions ensure when engaged in research abroad?

    <p>That subjects will be protected in a manner commensurate with the Common Rule.</p> Signup and view all the answers

    What is the age of majority determined by in international research?

    <p>Laws, customs, and norms in the area where the research will be conducted.</p> Signup and view all the answers

    If an institution obtains informed consent and conducts research interviews, it is engaged in research.

    <p>True</p> Signup and view all the answers

    What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting regarding informed consent?

    <p>Considerations include local laws, cultural norms, and ensuring informed awareness of participants.</p> Signup and view all the answers

    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.
    • 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.

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