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What Are Some Considerations For A U.s. Researcher Conducting A Study In A Non-u.s. Setting When Obtaining Informed Consent From Subjects?
When conducting research in a non-U.S. setting, U.S. researchers must consider several factors when obtaining informed consent from subjects. Informed consent is a process that involves providing potential research participants with information about the study and obtaining their voluntary agreement to participate. The following are some of the considerations that U.S. researchers should keep in mind when obtaining informed consent from subjects in a non-U.S. setting:
1. Language barriers: Researchers should ensure that the informed consent process is conducted in a language that the subjects understand.
2. Cultural differences: Researchers should be aware of cultural differences that may affect the informed consent process, such as different attitudes towards research participation or different views on privacy.
3. Local laws and regulations: Researchers should be familiar with local laws and regulations regarding informed consent and ensure that they comply with them.
4. Power dynamics: Researchers should be aware of power dynamics that may exist between themselves and the subjects, such as differences in social status or education level.
5. Vulnerable populations: Researchers should be especially careful when obtaining informed consent from vulnerable populations, such as children or people with mental disabilities.
6. Compensation: Researchers should consider whether compensation will be provided to subjects for their participation in the study.
7. Confidentiality: Researchers should ensure that the confidentiality of subjects is protected throughout the study.
8. Ongoing communication: Researchers should maintain ongoing communication with subjects throughout the study to ensure that they remain informed about any changes to the study or its risks.
9. Ethical considerations: Researchers should consider ethical issues related to informed consent, such as whether deception will be used in the study or whether subjects will be exposed to risks.
10. Institutional review board (IRB) approval: Researchers must obtain IRB approval before conducting any research involving human subjects.
Here are some websites that discuss What Are Some Considerations For A U.s. Researcher Conducting A Study In A Non-u.s. Setting When Obtaining Informed Consent From Subjects?:
1. [National Human Genome Research Institute](https://www.genome.gov/about-genomics/educational-resources/fact-sheets/why-is-informed-consent-required)
2. [UCSF Human Research Protection Program](https://irb.ucsf.edu/obtaining-and-documenting-informed-consent)