Ethics and GCP Flashcards

Which foundational document established ethical principles for research involving human subjects after World War II?

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.

The Belmont Report established which three fundamental ethical principles for research with human subjects?

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.

What is the Declaration of Helsinki and its significance in clinical research?

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.

What is the principle of 'beneficence' as applied to clinical research ethics?

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.

What does the principle of 'justice' require in clinical research according to the Belmont Report?

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.

What is an IRB's primary mandate in the US clinical research system?

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.