What is the investigator's responsibility in assessing the risks and benefits according to the principles of the Belmont-Report?
to examine whether the proposed research is properly designed
to determine whether or not to participate in the research
to determine whether the risks that will be presented to subjects are justified
All of the above
The Correct Answer is C
A. to examine whether the proposed research is properly designed: Ensuring that research is properly designed is primarily the responsibility of the Institutional Review Board (IRB) or ethics committee. While investigators design the study, the formal evaluation of methodological soundness and ethical compliance is conducted by an independent review body.
B. to determine whether or not to participate in the research: Determining participation is the responsibility of the potential research subject, based on the principle of respect for persons. Through informed consent, individuals decide whether the potential risks and benefits are acceptable to them. This decision-making authority belongs to participants, not investigators.
C. to determine whether the risks that will be presented to subjects are justified: Under the principle of beneficence in the Belmont Report, investigators are responsible for conducting a thorough risk–benefit assessment. They must minimize potential harms and ensure that anticipated benefits justify any risks involved. This includes designing procedures that reduce exposure to unnecessary physical, psychological, or social harm.
D. All of the above: Although multiple parties share ethical responsibilities in research oversight, the investigator’s specific duty under beneficence focuses on assessing and justifying risks relative to benefits. Therefore, not all listed options fall under the investigator’s direct responsibility.
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Related Questions
Correct Answer is D
Explanation
A. Protect all warm-blooded animals except rat, mice and birds bred for research and clinical trial: The Belmont Report does not address the protection of animals; it focuses specifically on ethical principles for human subjects in research. Animal protection is governed by separate regulations and guidelines, such as the Animal Welfare Act.
B. Protect human subjects and animals in research and clinical trial: While both humans and animals require ethical oversight, the Belmont Report specifically targets the protection of human research participants. Animal welfare is outside the scope of this report and is covered by different regulatory frameworks.
C. Protect animals used in research and pre-clinical trial: The Belmont Report does not address animals or preclinical studies; its principles are limited to human subjects and ensuring ethical treatment, informed consent, and risk–benefit analysis.
D. Protect human subjects in research and clinical trial: The primary objective of the Belmont Report is to ensure the ethical treatment of human participants. It establishes the foundational principles of respect for persons, beneficence, and justice to guide researchers in protecting the rights, safety, and welfare of individuals involved in research.
Correct Answer is A
Explanation
A. Stratified randomization divides participants into subgroups (strata) based on key prognostic variables such as age, sex, or disease severity. Randomization is then performed within each stratum to ensure that these characteristics are evenly distributed across treatment groups, reducing confounding and enhancing study validity.
B. The number of participants assigned to each treatment group is balanced within each block, which can help maintain balance between treatment groups throughout the study: This describes block randomization, not stratified randomization. Block randomization ensures roughly equal numbers of participants in each group at intervals throughout enrollment but does not specifically account for distribution of prognostic variables.
C. Each participant has an equal chance of being assigned to any of the treatment groups, making it a straightforward approach to achieve random allocation: This reflects simple randomization. While stratified randomization uses random allocation within strata, its primary purpose is to balance important variables, not merely to ensure equal chance to all participants.
D. All of the above: Only option A accurately describes the unique goal and function of stratified randomization. The other options pertain to other randomization methods and do not fully represent stratified randomization principles.
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