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The Federal Regulations – SBE Questions and Answers Rated A+ What does the Common Rule regulate in research involving human subjects? The Common Rule regulates the ethical standards and procedures for protecting human subjects in federally funded research. What is the role of an Institut...

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  • October 1, 2024
  • 17
  • 2024/2025
  • Exam (elaborations)
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The Federal Regulations – SBE
Questions and Answers Rated A+

What does the Common Rule regulate in research involving human subjects?


✔✔The Common Rule regulates the ethical standards and procedures for protecting human

subjects in federally funded research.




What is the role of an Institutional Review Board (IRB) in research?


✔✔An IRB reviews and oversees research to ensure it meets ethical guidelines and protects the

rights of human subjects.




Which federal regulation requires researchers to obtain informed consent from participants?


✔✔The Common Rule requires researchers to obtain voluntary, informed consent from

participants in most human subjects research.




When can informed consent be waived according to federal regulations?


✔✔Informed consent can be waived if the research poses minimal risk and obtaining consent is

impractical, as determined by the IRB.




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,What are vulnerable populations in the context of research regulations?


✔✔Vulnerable populations include groups like children, prisoners, and individuals with

diminished autonomy, requiring additional protections in research.




What does Subpart D of 45 CFR 46 cover?


✔✔Subpart D provides additional protections for children involved in research, particularly

regarding consent and risk.




What federal regulation governs the privacy of educational records in research?


✔✔The Family Educational Rights and Privacy Act (FERPA) governs access to and protection

of student educational records in research.




How does the Protection of Pupil Rights Amendment (PPRA) impact research in schools?


✔✔PPRA regulates the administration of surveys and research involving students, particularly

concerning sensitive topics like mental health and political beliefs.




What is the purpose of the Health Insurance Portability and Accountability Act (HIPAA) in

research?




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, ✔✔HIPAA protects the privacy and security of individuals’ health information and regulates

how researchers access and use this data.




When is expedited review allowed by an IRB?


✔✔Expedited review is allowed for research that poses minimal risk to participants and involves

procedures listed in the federal regulations.




What type of research is exempt from IRB review?


✔✔Certain low-risk research, like educational tests or public behavior observations, may be

exempt from IRB review under federal regulations.




What does "minimal risk" mean in the context of human subject research?


✔✔Minimal risk means the likelihood and magnitude of harm or discomfort anticipated in the

research are no greater than those encountered in daily life.




What are the main ethical principles outlined in the Belmont Report?


✔✔The Belmont Report outlines three main ethical principles: respect for persons, beneficence,

and justice.




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