SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 1

Question 1

The Belmont Report established a framework of basic ethical principles for research involving human subjects. Which of the following are the three core principles identified in this report?

Accepted Answer

Respect for Persons, Beneficence, and Justice

Answer

The Belmont Report, published in 1979, identified three fundamental ethical principles for all human subjects research: Respect for Persons, Beneficence, and Justice. These principles form the foundation for the ethical conduct of clinical research in the United States.

Question 2

A clinical trial is designed to test a new medication for a common chronic condition. To ensure rapid enrollment, the research team decides to recruit participants exclusively from a low-income clinic that serves a predominantly minority population. Which ethical principle is most directly compromised by this recruitment strategy?

Accepted Answer

Justice

Answer

The principle of Justice requires the fair and equitable distribution of the burdens and benefits of research. Recruiting exclusively from a vulnerable or conveniently available population, which may not fully enjoy the benefits of the research, violates the principle of fair subject selection.

Question 3

An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) has several key responsibilities in overseeing clinical research. Which of the following is a primary responsibility of the IRB/IEC?

Accepted Answer

Safeguarding the rights, safety, and well-being of all trial participants.

Answer

The primary and overarching responsibility of an IRB/IEC is to protect the rights, safety, and well-being of human subjects involved in a clinical trial. While they review aspects of the study like the protocol and consent form, their core mission is the protection of participants.

Question 4

According to ICH GCP E6 (R2), which of the following is NOT a required element of the informed consent form and discussion?

Accepted Answer

The complete curriculum vitae (CV) of the principal investigator.

Answer

ICH GCP E6 (R2) section 4.8.10 lists the required elements of informed consent. While the investigator must be qualified, providing their complete CV is not a required element within the consent form itself. The other options are all explicitly required to ensure the participant is fully informed.

Question 5

In a scenario where an effective, standard treatment already exists for a serious illness, the use of a placebo control group in a new clinical trial would be considered ethically acceptable ONLY if:

Accepted Answer

Withholding the standard treatment poses no risk of serious or irreversible harm, and there are compelling methodological reasons for its use.

Answer

The Declaration of Helsinki and other ethical guidelines state that using a placebo control is generally unethical when a proven, effective treatment exists. An exception can be made if withholding the existing treatment poses minimal risk of serious or irreversible harm, the participant provides fully informed consent, and there are compelling scientific reasons why an active control cannot be used.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 1