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

Safety, efficacy, quality

Answer

Confidentiality, transparency, integrity

Answer

Autonomy, privacy, nonmaleficence

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

No special protections needed

Answer

Vulnerable populations are banned

Answer

Only financial compensation

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

Manufacturing standard

Answer

Laboratory safety protocol

Answer

Pricing guideline

Question 4

What is the ethical principle of equipoise?

Accepted Answer

Genuine uncertainty within the expert community about the preferred treatment

Answer

Equal numbers in each arm

Answer

Equal funding for sites

Answer

Equal compensation

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

Placebos can always be used

Answer

Placebos are banned

Answer

Only the sponsor decides

Question 6

What is a conflict of interest and how should it be managed?

Accepted Answer

Financial or personal interests that could compromise objectivity, managed through disclosure, review, and management plans

Answer

Conflicts don't exist

Answer

Only financial relationships qualify

Answer

Only relevant for the PI