Consequently, this process will entail achieving a thorough understanding of direct and indirect benefits and how they influence populations with nuanced vulnerabilities. This may imply consulting personnel who have lived experiences or have conducted research with these groups. Therefore, before fostering well-being, investigators should first understand what this concept truly means to their population of interest. Whereas, in countries like Australia and the United States, well-being is associated with agency, goal-setting, and fulfillment, individual hedonic experiences, and high-arousal positive emotions ( Joshanloo et al., 2021). For instance, in various studies, East Asian cultures have expressed a preference for experiencing low-arousal positive emotions, and have reported sustained attention regarding satisfying social roles, affiliative duties, and relationships, which greatly influence their well-being ( Newman, 2019). Basic well-being is shared across many groups, such as having robust health and financial stability but it is important to acknowledge cultural distinctions. To fully promote beneficence in the research community, well-being must be secured for every research subject. The minor emotional risks associated with this study such as embarrassment or fatigue do not outweigh the benefits associated with participating in this research study. The benefits are an increase in valuable nutritional knowledge and a nutritional counseling session. For example, there is a study examining the relationship between personal food choices and mood by having participants without eating disorders complete a confidential 15-minute survey regarding food choices and reported mood states. A Risk-Benefit Analysis is executed with the intent of determining whether the indirect or direct benefits experienced by human research subjects justify the probability of undertaking risks that are associated with the research activities. IRBs conduct this analysis whenever they review a protocol investigators should demonstrate in the IRB application a refined understanding of the risks and benefits to participants and society. This process involves the implementation of a Risk-Benefit Analysis, where the probability of a risk occurring during the research study and the degree of harm is weighed against the anticipated benefits.
BENEFICENCE ETHICAL PRINCIPLE DEFINITION TRIAL
Alternatively, extensive lab visits or dosage schedules in a clinical trial for disease treatment may be time-consuming for participants. These may include unpleasant, serious, or even life-threatening side effects. In conjunction with the consideration of benefits, harms (or risks) must also be examined. For instance, participants in clinical trials investigating treatments for a specific disease should reflect the population(s) most affected by the disease or the targeted population.
Promoting the common good in research possesses an inherent duality that is best encapsulated by the principle of beneficence, which states that the research process should ensure that “persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being” ( OHRP, 1979).
Foundational Principles in the Belmont Report
BENEFICENCE ETHICAL PRINCIPLE DEFINITION HOW TO
This article will cover the principle of beneficence, outlined in the Belmont Report, and elucidate why it is essential for investigators to achieve a comprehensive understanding of what well-being means for populations of interest and how to maximize direct and indirect benefits while minimizing risks.
In the previous article, “ Bearing the Burdens of Research”, we explored how investigators may apply the principle of justice to their research endeavors by engaging in fair recruitment practices, mitigating risks and barriers to participating in research, and introducing flexibility and cultural sensitivity. This TC IRB blog series, “Fostering Ethical Research in Contexts with Nuanced Vulnerability” presents the three core principles identified in the Belmont Report and explores how to conceptualize these ethical guidelines when conducting research with populations that exhibit nuanced vulnerabilities.
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