SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 2 — Questions and Answers
Question 1: What are the three fundamental ethical principles in the Belmont Report?
- Safety, efficacy, quality
- Respect for persons, beneficence, and justice (Correct answer)
- Confidentiality, transparency, integrity
- Autonomy, privacy, nonmaleficence
Correct answer: Respect for persons, beneficence, and justice
The Belmont Report identifies respect for persons, beneficence, and justice as the three core principles.
Respect for Persons: autonomy and protection of vulnerable populations. Beneficence: maximize benefits, minimize harm. Justice: fair distribution of research burdens and benefits. These influenced 45 CFR 46 and ICH-GCP.
Question 2: What protections exist for vulnerable populations?
- No special protections needed
- Additional safeguards including enhanced consent, IRB scrutiny, and regulatory subparts (45 CFR 46 B-D) (Correct answer)
- Vulnerable populations are banned
- Only financial compensation
Correct answer: Additional safeguards including enhanced consent, IRB scrutiny, and regulatory subparts (45 CFR 46 B-D)
Vulnerable populations have additional protections under 45 CFR 46 Subparts B-D.
Subpart B covers pregnant women/fetuses/neonates. Subpart C covers prisoners. Subpart D covers children. Other vulnerable groups require additional safeguards such as enhanced consent and independent advocates.
Question 3: What is the Nuremberg Code and its significance?
- Manufacturing standard
- The first international document establishing ethical principles for human experimentation, emphasizing voluntary consent (Correct answer)
- Laboratory safety protocol
- Pricing guideline
Correct answer: The first international document establishing ethical principles for human experimentation, emphasizing voluntary consent
The Nuremberg Code (1947) was the first major document establishing ethical principles for human experimentation.
Its 10 principles include: voluntary consent is essential, experiments should benefit society, based on prior animal research, unnecessary suffering avoided, subjects free to end participation, and scientists must be prepared to terminate if harm is likely.
Question 4: What is the ethical principle of equipoise?
- Equal numbers in each arm
- Genuine uncertainty within the expert community about the preferred treatment (Correct answer)
- Equal funding for sites
- Equal compensation
Correct answer: Genuine uncertainty within the expert community about the preferred treatment
Clinical equipoise exists when there is genuine uncertainty about comparative therapeutic merits.
Equipoise exists at the community level, not individual physician level. It is essential for ethically justifying randomization. DSMBs monitor whether equipoise is maintained throughout the trial.
Question 5: What ethical considerations apply to placebo use?
- Placebos can always be used
- Placebos may only be used when no proven treatment exists, or when compelling reasons justify use without serious harm (Correct answer)
- Placebos are banned
- Only the sponsor decides
Correct answer: Placebos may only be used when no proven treatment exists, or when compelling reasons justify use without serious harm
The Declaration of Helsinki states placebos are acceptable when no proven intervention exists or when compelling reasons necessitate use without serious harm.
Placebos are acceptable when no proven intervention exists, or when scientifically sound reasons exist AND patients won't suffer serious harm. The FDA allows placebos when conditions aren't serious or existing treatments have significant side effects.
Question 6: What is a conflict of interest and how should it be managed?
- Conflicts don't exist
- Financial or personal interests that could compromise objectivity, managed through disclosure, review, and management plans (Correct answer)
- Only financial relationships qualify
- Only relevant for the PI
Correct answer: Financial or personal interests that could compromise objectivity, managed through disclosure, review, and management plans
COIs occur when financial, professional, or personal interests could inappropriately influence research.
COIs can be financial (equity, consulting fees, patents), professional (career advancement), or personal. Per 21 CFR 54, investigators must disclose financial interests. Management includes disclosure, independent monitoring, and blinding procedures.
SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 2
What are the three fundamental ethical principles in the Belmont Report?