SOCRA CCRP Ethics and GCP 1 — Questions and Answers
Question 1: Which foundational document established ethical principles for research involving human subjects after World War II?
- Declaration of Helsinki
- Nuremberg Code (Correct answer)
- Belmont Report
- Common Rule
Correct answer: Nuremberg Code
The Nuremberg Code (1947) was the first international document to establish ethical principles for research involving humans, developed in response to Nazi medical experiments.
Question 2: The Belmont Report established which three fundamental ethical principles for research with human subjects?
- Safety, Efficacy, Quality
- Autonomy, Beneficence, Non-Maleficence
- Respect for Persons, Beneficence, Justice (Correct answer)
- Consent, Privacy, Accountability
Correct answer: Respect for Persons, Beneficence, Justice
The Belmont Report (1979) established Respect for Persons, Beneficence, and Justice as the three core ethical principles for human subjects research.
Question 3: What is the Declaration of Helsinki and its significance in clinical research?
- A WHO treaty governing drug manufacturing standards
- A set of ethical principles for medical research involving human subjects published by the World Medical Association (Correct answer)
- An FDA guidance document on IND submissions
- A European regulatory directive for drug approvals
Correct answer: A set of ethical principles for medical research involving human subjects published by the World Medical Association
The Declaration of Helsinki is the WMA's statement of ethical principles guiding physicians and researchers in medical research involving human subjects worldwide.
Question 4: What is the principle of 'beneficence' as applied to clinical research ethics?
- Ensuring equal distribution of research benefits across populations
- Maximizing benefits and minimizing harms to research participants (Correct answer)
- Respecting participant autonomy and decision-making
- Ensuring financial compensation to participants
Correct answer: Maximizing benefits and minimizing harms to research participants
Beneficence requires researchers to maximize potential benefits and minimize potential harms and risks to research participants.
Question 5: What does the principle of 'justice' require in clinical research according to the Belmont Report?
- Fair legal representation for research subjects
- Fair distribution of the benefits and burdens of research across different populations (Correct answer)
- Legal accountability for researchers who violate GCP
- Equal access to study drugs for all participants
Correct answer: Fair distribution of the benefits and burdens of research across different populations
Justice requires equitable selection of subjects so that the burdens and benefits of research are fairly distributed and vulnerable groups are not exploited.
Question 6: What is an IRB's primary mandate in the US clinical research system?
- To approve drug safety for marketing
- To protect the rights, safety, and welfare of human research subjects (Correct answer)
- To verify sponsor financial disclosures
- To ensure protocol scientific validity only
Correct answer: To protect the rights, safety, and welfare of human research subjects
An IRB's primary mandate is to protect the rights, safety, and welfare of individuals who participate as subjects in research studies.
SOCRA CCRP Ethics and GCP 1
Which foundational document established ethical principles for research involving human subjects after World War II?