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

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

Informed Consent, Risk/Benefit Assessment, and Subject Selection

Answer

Autonomy, Confidentiality, and Integrity

Answer

Safety, Efficacy, and Scientific Validity

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

Beneficence

Answer

Respect for Persons

Answer

Non-maleficence

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

Ensuring the scientific validity and statistical power of the study design.

Answer

Verifying the accuracy of the clinical data collected at the research site.

Answer

Auditing the financial agreements between the sponsor and the investigator.

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

A statement that the trial involves research and an explanation of its purpose.

Answer

A description of the reasonably foreseeable risks or inconveniences to the participant.

Answer

The probability for random assignment to each treatment group.

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 new treatment is expected to be much more expensive than the standard.

Answer

Participants are unable to afford the standard treatment.

Answer

The sponsor provides a clear justification based on market competition.

Question 6

A research participant, who is a competent adult, initially consents to a long-term observational study. Two years into the study, the participant contacts the site to withdraw. Applying the principle of 'Respect for Persons,' what is the most appropriate action for the research team?

Accepted Answer

Honor the participant's decision to withdraw immediately without penalty or loss of benefits to which they are otherwise entitled.

Answer

Persuade the participant to continue, explaining the value of their long-term data.

Answer

Inform the participant that they must provide a valid reason for withdrawal to be processed.

Answer

Continue using the participant's data collected up to the point of withdrawal but stop all future contact.

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?

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?