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IRB Law Questions with Certification 

The Belmont principle of beneficence requires that:

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  • The study makes a significant contribution to generalizable knowledge.
  • Subjects derive individual benefit from study participation.
  • Risks are managed so that they are no more than minimal.
  • Potential benefits justify the risks of harm.

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IRB Law Questions with Certification Exam Answers

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A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

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A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

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A waiver of the requirement for documentation of informed consent may be granted when:

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