SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 1 — 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?
- Informed Consent, Risk/Benefit Assessment, and Subject Selection
- Respect for Persons, Beneficence, and Justice (Correct answer)
- Autonomy, Confidentiality, and Integrity
- Safety, Efficacy, and Scientific Validity
Correct answer: Respect for Persons, Beneficence, and Justice
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?
- Beneficence
- Respect for Persons
- Justice (Correct answer)
- Non-maleficence
Correct answer: Justice
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?
- Ensuring the scientific validity and statistical power of the study design.
- Verifying the accuracy of the clinical data collected at the research site.
- Auditing the financial agreements between the sponsor and the investigator.
- Safeguarding the rights, safety, and well-being of all trial participants. (Correct answer)
Correct answer: Safeguarding the rights, safety, and well-being of all trial participants.
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?
- A statement that the trial involves research and an explanation of its purpose.
- The complete curriculum vitae (CV) of the principal investigator. (Correct answer)
- A description of the reasonably foreseeable risks or inconveniences to the participant.
- The probability for random assignment to each treatment group.
Correct answer: The complete curriculum vitae (CV) of the principal investigator.
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:
- The new treatment is expected to be much more expensive than the standard.
- Participants are unable to afford the standard treatment.
- Withholding the standard treatment poses no risk of serious or irreversible harm, and there are compelling methodological reasons for its use. (Correct answer)
- The sponsor provides a clear justification based on market competition.
Correct answer: Withholding the standard treatment poses no risk of serious or irreversible harm, and there are compelling methodological reasons for its use.
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.
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?
- Persuade the participant to continue, explaining the value of their long-term data.
- Honor the participant's decision to withdraw immediately without penalty or loss of benefits to which they are otherwise entitled. (Correct answer)
- Inform the participant that they must provide a valid reason for withdrawal to be processed.
- Continue using the participant's data collected up to the point of withdrawal but stop all future contact.
Correct answer: Honor the participant's decision to withdraw immediately without penalty or loss of benefits to which they are otherwise entitled.
The principle of Respect for Persons recognizes individual autonomy and the right to self-determination. A key application of this principle is that participation must be voluntary throughout the research, which includes the right to withdraw at any time without penalty or having to justify the decision.
SOCRA - Society of Clinical Research Associates Ethical Principles in Research Questions and Answers 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?