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CRA IRB Exam Questions & Answers 2024/2025
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CRA IRB Exam Questions & Answers 2024/2025 The Nuremberg Trials () - ANSWERSDeveloped into: Nuremberg Code • Ethical conduct of medical experimentation 1. Requirements for informed consent, voluntary 2. Benefits to society 3. Avoid Risk 4. Scientifically Qualified The Declaratio...

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  • September 18, 2024
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  • 2024/2025
  • Exam (elaborations)
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CRA IRB Exam Questions & Answers
2024/2025

The Nuremberg Trials (1945-1946) - ANSWERSDeveloped into:

Nuremberg Code

• Ethical conduct of medical experimentation

1. Requirements for informed consent,

voluntary

2. Benefits to society

3. Avoid Risk

4. Scientifically Qualified



The Declaration of Helsinki - ANSWERSJune of 1964 - revised six times •

Built upon the Nuremberg Code •

Recommendations:

- Research with humans should be based on laboratory & animal experimentation

- Research should be conducted by medically/scientifically qualified individuals

- Risks should not exceed benefits

• 1975:

- independent review of protocols & provided requirements for informed consent



The Syphilis Study at Tuskegee (1932-1972) - ANSWERSDeveloped into:

Regulatory Guidance

• National Research Act 1974

- Commission for the Protection of Human Subjects of Biomedical & Behavioral Research.

- Identify the basic ethical principles that should underlie the conduct of biomedical and behavioral
research involving human subjects

, Belmont Report (1979) - ANSWERSInfluenced by Nuremberg Code & Declaration of Helsinki

• Based on three ethical principles



Three Ethical Principles - ANSWERS1. Respect for persons

- Individuals should be treated as autonomous agents

- Persons with diminished autonomy are entitled to protection

2. Beneficence

- Human Subjects should not be harmed

- Research should maximize possible benefits & minimize possible harm

Assessment of risks and benefits

- The nature and scope of risks and benefits must be assessed in a systematic manner

3. Justice

- The benefits and risks of research must be distributed fairly

Selection of Subjects

- There must be fair procedures and outcomes in the selection of research subject



Informed Consent - ANSWERSSubjects, to the degree that they are capable, must be given the
opportunity to choose what shall or shall not happen to them

- The consent process must include three elements:

• Information • Comprehension • Voluntariness



The Common Rule - ANSWERSAssuring compliance by research institutions

• Requirements for the obtaining and documenting of informed consent

• Requirements for IRB • Protections for vulnerable subjects

45 CFR 46 - Basic DHHS Policy for the Protection of Human Research Subjects



Office of Human Research Protection (OHRP) - ANSWERSentity within the Department of Health and
Human Services (DHHS) in charge of implementing the regulations.

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