CITI Defining Research with Human Subjects - SBE/ The Federal Regulations – SBE Questions and Answers Graded A

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"? 2 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? 3 Informed consent may be waived when the research presents minimal risk and obtaining consent is impractical. What is an adverse event in research? An adverse event is any negative or unexpected