The primary responsibility of the Institutional Review Board (IRB) is to ensure that the research study- (select all that apply)
-meet commonly accepted ethical standards
-comply with applicable regulations
-protect research participants
-follow institutional policies
Correct Answer : A,B,C,D
A. Meet commonly accepted ethical standards: The IRB ensures that research adheres to fundamental ethical principles, including respect for persons, beneficence, and justice, as outlined in the Belmont Report and other ethical guidelines. This oversight protects participants from unethical treatment and promotes integrity in research conduct.
B. Comply with applicable regulations: IRBs review studies to ensure compliance with local, national, and international regulations governing human subjects research, such as the Common Rule and FDA guidelines. Regulatory adherence is essential to maintain legal and ethical standards in research.
C. Protect research participants: The core mission of the IRB is participant protection. This involves evaluating risk–benefit ratios, ensuring informed consent processes are adequate, and monitoring ongoing studies for safety and welfare of participants throughout the research.
D. Follow institutional policies: IRBs also ensure that research aligns with the policies and procedures of the hosting institution. This includes adherence to internal ethical frameworks, reporting requirements, and oversight mechanisms to maintain accountability and organizational compliance.
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Correct Answer is ["A","B","C","E","F"]
Explanation
A. Must be conducted by qualified scientist: The Nuremberg Code emphasizes that experiments should be carried out only by scientifically qualified individuals. Proper expertise ensures the study is designed and conducted competently, minimizing risks to participants.
B. Must avoid unnecessary physical and mental suffering: Experiments should prevent all unnecessary harm. Only risks essential to achieving scientific objectives may be tolerated, and investigators are obligated to protect participants from avoidable physical or psychological distress.
C. Must have the informed consent of the subject or their legal representative: Voluntary, informed consent is a cornerstone of the Nuremberg Code. Participants must be fully aware of the purpose, procedures, risks, and potential benefits of the research, and must agree to participate without coercion.
D. Is only justified if it benefits only researcher and stakeholders: The Nuremberg Code explicitly rejects this idea. Research is ethically justified only if it aims to benefit society or scientific knowledge, not merely the investigator or other vested interests.
E. Must be based on animal testing and knowledge of the disease being studied: Experiments should be preceded by prior knowledge, including appropriate animal studies, to ensure anticipated results are scientifically valid and to minimize human risk.
F. Must not be conducted if they are likely to cause death or disabling injury: Research that has a high likelihood of causing death or serious injury is strictly prohibited unless the study addresses life-saving interventions under highly controlled circumstances, reflecting the principle of minimizing harm.
Correct Answer is D
Explanation
A. Mix (both qualitative & quantitative): Mixed-methods research incorporates both numerical data and descriptive, narrative data to explore phenomena. In this study, no qualitative data such as interviews, perceptions, or experiences were collected; only numerical and categorical epidemiological data were analyzed.
B. None of the above: The study clearly involves systematic data collection and statistical analysis of confirmed COVID-19 cases, which aligns with established research methodologies, so “none of the above” is not appropriate.
C. Qualitative: Qualitative research focuses on non-numerical data, exploring meanings, experiences, and perspectives. This study did not collect such data; it analyzed case counts, demographics, and outcomes using descriptive statistics.
D. Quantitative: The study is quantitative because it relies on numerical surveillance data, laboratory-confirmed cases, and statistical analysis. Descriptive and univariate statistics were used to summarize epidemiological characteristics, which aligns with a quantitative research design focused on measurable outcomes.
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