SOCRA CCRP Ethics and GCP 1

Question 1

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

Accepted Answer

Nuremberg Code

Answer

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?

Accepted Answer

Respect for Persons, Beneficence, Justice

Answer

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?

Accepted Answer

A set of ethical principles for medical research involving human subjects published by the World Medical Association

Answer

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?

Accepted Answer

Maximizing benefits and minimizing harms to research participants

Answer

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?

Accepted Answer

Fair distribution of the benefits and burdens of research across different populations

Answer

Justice requires equitable selection of subjects so that the burdens and benefits of research are fairly distributed and vulnerable groups are not exploited.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Ethics and GCP 1