Beneficence

The National Research Act (Public Law 93348) of 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which, among other duties, was charged with the responsibility of identifying, articulating, and fully explaining those basic ethical principles that should underlie the conduct of biomedical [Page 56]and behavioral research involving human subjects throughout the United States. The commission's findings have been detailed in a 1979 document typically referred to as “The Belmont Report” in recognition of the Smithsonian Institute satellite site where it was drafted, the Belmont Conference Center in Elkridge, Maryland. The Belmont Report identified three basic ethical principals for the conduct of research, and one of these is beneficence. (The other identified principles we, justice and respect for persons.) The Belmont Report clearly states that the principle of beneficence has its roots in the long-standing ethical guidelines of the medical profession's Hippocratic Oath generally and, in particular, its maxims instructing physicians to “never do harm” while acting “according to [one's] ability and [one's] judgment.”

From these ideas, three more fully articulated notions have been derived. First is the principle that researchers are obligated, not merely encouraged or expected, to take all reasonable steps to avoid inflicting foreseeable harm upon research participants. Second is that researchers are obligated to work toward maximizing the benefits that research subjects might experience from participation in a research program. This does not mean that it is required that a research program provide direct benefits to its research subjects, however. Similarly, investigators are obligated to attempt to maximize anticipated longer-term benefits that society or people in general might realize as a consequence of the study. Finally, beneficence incorporates the idea that exposing research participants to risk is justifiable. The reality that research is a human enterprise, one that relies upon the individual abilities and judgments of researchers acting within the frameworks of existing knowledge and cultural norms, is recognized. As such, it is ethically acceptable and permissible for research to possess or encompass potential for a protocol or well-meaning actions taken by an investigator to result in harm to participants; typically some level of risk is appropriate, and it is a judgment call as to what that risk level can and should be. To summarize, beneficence represents the process of balancing the trade-off between the potential benefits and the justifiable risk of potential harms associated with participation in research, and it is manifest in investigator efforts to minimize risks while maximizing potential benefits to the individual participant and/or society as a whole.

The term risk refers to both the likelihood of some type of harm being experienced by one or more research participants and the extent or severity of that harm in the event that harm is experienced. Therefore, assessments of the risks associated with a research project may take account of the combined probabilities and magnitudes of potential harms that might accrue to research participants. Furthermore, though one proclivity may be to think of harm as physical insults (such as pain, discomfort, injury, or toxic effects of drugs or other substances), the nature of potential harms can be wide and varied. Indeed, while the potential for physical harms typically is virtually nonexistent in survey research, other categories of potential harms frequently are relevant. These other categories

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