Certification for IRB Professionals (CIP) Practice Exam

The Belmont Principle of beneficence requires that what is justified?

1. Potential benefits justify the risks of harm

2. Informed consent is mandatory

3. Research is conducted by qualified professionals

4. Participant recruitment is unbiased

The correct answer is: Potential benefits justify the risks of harm

The Belmont Principle of beneficence emphasizes the obligation to minimize potential harms and maximize potential benefits in research involving human subjects. This principle dictates that when assessing a research study, the potential benefits must be weighed against the risks of harm to determine whether those risks are justified. In this context, potential benefits refer to the positive outcomes or advancements that may arise from the research, such as new medical treatments or increased understanding of a condition. The risks of harm include any physical, psychological, or emotional harm that could occur to the participants. The principle requires that researchers conduct a thorough evaluation to ensure that the anticipated benefits significantly outweigh any possible risks. This justification is a critical consideration for Institutional Review Boards (IRBs) when reviewing research protocols. The other options, while important in the ethics of research, do not directly relate to the principle of beneficence. Informed consent pertains to ensuring participants are fully aware of the risks and benefits of a study before agreeing to participate, but it is not the core focus of beneficence. The qualifications of researchers contribute to the integrity and quality of the research, and unbiased participant recruitment ensures fairness, but these concepts do not embody the essence of beneficence itself.