SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 2

Question 1

What are the three fundamental ethical principles in the Belmont Report?

Accepted Answer

Respect for persons, beneficence, and justice

Answer

The Belmont Report identifies respect for persons, beneficence, and justice as the three core principles.

Question 2

What protections exist for vulnerable populations?

Accepted Answer

Additional safeguards including enhanced consent, IRB scrutiny, and regulatory subparts (45 CFR 46 B-D)

Answer

Vulnerable populations have additional protections under 45 CFR 46 Subparts B-D.

Question 3

What is the Nuremberg Code and its significance?

Accepted Answer

The first international document establishing ethical principles for human experimentation, emphasizing voluntary consent

Answer

The Nuremberg Code (1947) was the first major document establishing ethical principles for human experimentation.

Question 4

What is the ethical principle of equipoise?

Accepted Answer

Genuine uncertainty within the expert community about the preferred treatment

Answer

Clinical equipoise exists when there is genuine uncertainty about comparative therapeutic merits.

Question 5

What ethical considerations apply to placebo use?

Accepted Answer

Placebos may only be used when no proven treatment exists, or when compelling reasons justify use without serious harm

Answer

The Declaration of Helsinki states placebos are acceptable when no proven intervention exists or when compelling reasons necessitate use without serious harm.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 2