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The Federal Regulations – SBE Questions and Answers Graded A+
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The Federal Regulations – SBE Questions and Answers Graded A+ Who enforces the Common Rule? The Office for Human Research Protections (OHRP) enforces the Common Rule in federally funded research. What is the definition of "human subject" under federal regulations? A human subject is a...

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  • October 1, 2024
  • 8
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • the federal regulations sbe questions and answer

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The Federal Regulations – SBE
Questions and Answers Graded A+
Who enforces the Common Rule?


✔✔The Office for Human Research Protections (OHRP) enforces the Common Rule in federally

funded research.




What is the definition of "human subject" under federal regulations?


✔✔A human subject is a living individual about whom a researcher obtains data through

intervention or interaction or gathers identifiable private information.




What is a research protocol?


✔✔A research protocol is a document that describes the objectives, design, methodology, and

ethical considerations of a research study.




What does Subpart B of the Common Rule cover?


✔✔Subpart B of the Common Rule provides additional protections for pregnant women, human

fetuses, and neonates involved in research.




1

, What are expedited IRB reviews?


✔✔Expedited IRB reviews are used for research involving minimal risk and involve review by

one or more IRB members instead of the full board.




What does Subpart C of the Common Rule address?


✔✔Subpart C provides protections for prisoners involved in research, ensuring their

participation is voluntary and ethical.




When is research considered exempt under the Common Rule?


✔✔Research may be considered exempt if it involves minimal risk and falls into specific

categories, such as educational settings or public behavior observations.




What is the role of a Data Safety Monitoring Board (DSMB)?


✔✔A DSMB monitors data during a study to ensure the safety of participants and the integrity of

the data.




What is the Federalwide Assurance (FWA)?


✔✔An FWA is a document that institutions submit to the OHRP to confirm their commitment to

complying with federal regulations for human subject research.

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