SOCRA CCRP Ethics and GCP

Question 1

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

Accepted Answer

Nuremberg Code

Answer

Declaration of Helsinki

Answer

Belmont Report

Answer

Common Rule

Question 2

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

Accepted Answer

Respect for Persons, Beneficence, Justice

Answer

Safety, Efficacy, Quality

Answer

Autonomy, Beneficence, Non-Maleficence

Answer

Consent, Privacy, Accountability

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

A WHO treaty governing drug manufacturing standards

Answer

An FDA guidance document on IND submissions

Answer

A European regulatory directive for drug approvals

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

Ensuring equal distribution of research benefits across populations

Answer

Respecting participant autonomy and decision-making

Answer

Ensuring financial compensation to 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

Fair legal representation for research subjects

Answer

Legal accountability for researchers who violate GCP

Answer

Equal access to study drugs for all participants

Question 6

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

Accepted Answer

To protect the rights, safety, and welfare of human research subjects

Answer

To approve drug safety for marketing

Answer

To verify sponsor financial disclosures

Answer

To ensure protocol scientific validity only