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CITI Defining Research with Human Subjects - SBE/ The Federal Regulations – SBE Questions and Answers Graded A What is a key principle of ethical human subject research? Respect for persons, which includes informed consent and the right to withdraw from the study. When is an activity co...

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  • October 1, 2024
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CITI Defining Research with Human
Subjects - SBE/ The Federal Regulations
– SBE Questions and Answers Graded A

What is a key principle of ethical human subject research?


✔✔Respect for persons, which includes informed consent and the right to withdraw from the

study.




When is an activity considered "research" under federal regulations?


✔✔When it is designed to develop or contribute to generalizable knowledge.




What role does an IRB play in research?


✔✔The IRB ensures that research studies comply with ethical standards and protect participants'

rights.




What does the Belmont Report emphasize?


✔✔It emphasizes three principles: respect for persons, beneficence, and justice.




When can research be classified as "exempt"?


1

, ✔✔Research is exempt if it poses minimal risk and fits certain categories, such as educational

research or public behavior observation.




Who must give permission for research involving children?


✔✔Both parental permission and the child’s assent are required for research involving children.




What is the main concern when conducting research involving vulnerable populations?


✔✔Ensuring that the population is not coerced and that they fully understand their participation

in the study.




What is beneficence in the context of research?


✔✔It means doing no harm and maximizing possible benefits while minimizing risks to

participants.




What is the role of confidentiality in research ethics?


✔✔Confidentiality protects participants' private information, ensuring that data cannot be linked

back to them without their consent.




When can informed consent be waived?

2

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