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Exam (elaborations)

Certification for IRB Professionals (CIP) Exam Questions with Verified Solutions

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Certification for IRB Professionals (CIP) Exam Questions with Verified Solutions **Explain the concept of respect for persons as per the Belmont Report.** Respect for persons requires that research subjects enter into studies voluntarily and with sufficient information about the risks and benefits involved. **Define the ethical principle expressed by fair outcomes in the selection of research subjects, according to the Belmont Report.** Justice **Why is a poorly designed protocol considered unethical in research?** A poorly designed protocol can put research subjects at risk or inconvenience them without sufficient justification. **Under what circumstances should an IRB suspend or terminate approval of research?** An IRB should suspend or terminate approval if the research is not being conducted in accordance with the IRB's requirements or if there are significant concerns about the safety or welfare of participants. **What constitutes a quorum for a convened IRB meeting?** A quorum requires the presence of at least one nonscientific member among other required members. **What is necessary in research involving no more than minimal risk with children?** Research involving children requires adequate provisions for obtaining the child's assent and permission from parents or guardians. **What are the written procedures that federal regulations mandate each IRB to have?** IRBs must have written procedures for the initial and continuing review of research protocols, as well as for reporting their findings and actions to investigators and institutions. **Name the three ethical principles discussed in the Belmont Report.** Respect for Persons, Justice, and Beneficence **Provide an example of applying the Principle of Beneficence in a study with human subjects.** Ensuring that a study maximizes benefits for participants while minimizing risks is an application of the Principle of Beneficence. **What ethical violation primarily occurred in the Harvard "Tastes, Ties, and Time (T3)" study ()?** The primary ethical violation

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