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Exam (elaborations)

CITI-EXAM QUESTIONS AND ANSWERS 2024

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CITI-EXAM QUESTIONS AND ANSWERS 2024

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CITI-EXAM QUESTIONS AND ANSWERS
2024
Principles of Belmont Report - Answer-- Respect for persons
- Beneficence
- Justice

Beneficence - Answer-- Do no harm
- Maximum benefits
- Minimal risks

Principle of Justice - Answer-- Belmont report
- Research benefits and risks
- Do not need to manage conflicts of interest

Nuremberg Code - Answer-Voluntary consent of subjects

National Research Act of 1974 - Answer-Established the National Commission for the
protection of human subjects of biomedical and behavioral research

Death of Jesse Gelsinger - Answer-Increased public attention to the IRB system
problems

US Public Health Service Policy - Answer-Raised to regulatory status in 1974 regarding
clinical research of human beings

Informed Consent - Answer-- Belmont principle
- Respect for persons
- Individual autonomy of participation in research

Result of Beecher Article - Answer-Exposed ethical abuses occurring in human
research in the US well after the Nazi regime

Prisoner Research - Answer-- Belmont principle of justice
- Only used to conduct research that only benefits the larger society

IRB ADE Discovery - Answer-- Report ADE in a timely manner
- Follow IRB policies and procedures using mechanism provided by IRB

IRB Records - Answer-- Kept for a minimum of 3 years following the completion of the
study

Expedited Reviews - Answer-Study involves no more than minimal risk and meets an
allowable category for expedited review according to federal regulations

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