Which of the following is an ethical principle included in the Belmont Report?

The Belmont Report states 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.” Securing a research subject’s well-being falls under the principle of beneficence. Beneficence, as described in the Belmont Report, obligates the investigator to follow two general rules. The first is to “do no harm,” and the second is to “maximize possible benefits and minimize possible harms.” With respect to the first general rule of beneficence, the authors of the Belmont Report did not intend for investigators to reach the standard of “above all do no harm” (primum non nocere), which is commonly said to be the first principle of medical ethics. Rather, the Commission intended to forbid the deliberate injury of a human subject for the purpose of developing generalizable new knowledge, no matter how important that knowledge might be. They endorsed the acceptability of exposing an individual subject to a possibility (or statistical probability) of injury as long as an IRB determined that this was justified in light of the probability and magnitude of the sought-for benefits. Benefits may accrue to individual subjects or, through the development of generalized knowledge, to society, perhaps in the form of better health care. Risks, however, are borne by individual subjects. The risks and benefits of research are not always known, and investigators, along with the IRBs that approve their protocols, must decide with imperfect knowledge when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The second general rule of beneficence obligates investigators to design their protocols so as to maximize the probability and magnitude of benefits to individual research subjects as well as to society. It further requires investigators to minimize the probability and magnitude of injury to individual research subjects. It is during the process of informed consent that the risks of participation in research are disclosed and that a promise to pursue the individual or collective benefits is made with each potential subject.

Some authors have argued that the two general rules described above are actually two fundamental ethical principles, beneficence (do good) and nonmaleficence (do no harm). However, others feel beneficence should be viewed as a single principle, because in a research context, it is necessary to consider harms and benefits in relation to each other.

Beneficence – Philosophical Foundation

The authors of the Belmont Report drew upon medical tradition when considering the ethical principle of beneficence. It is commonly said that the first principle of medical ethics is “do no harm.” This principle can trace its origin back over 2,500 years to Hippocrates. However, the National Commission recognized that “even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to the risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients ‘according to their best judgment.’ Learning what will in fact benefit may require exposing persons to risk.” Determining when the pursuit of certain benefits is justified despite the risks is the difficult question faced daily by investigators and IRBs.

Although beneficence is generally viewed as acts of kindness and charity which individuals are not obligated to pursue or bestow upon others, the National Commission viewed beneficence (to do or promote good) as a strict obligation or duty in the research context, because investigators consent or pledge to be bound by it. Investigators pledge to promote good, by creating new knowledge or providing some benefit to subjects, when they accept public support for their work. In addition, during the process of informed consent, investigators pledge to pursue the benefits with potential subjects. It would be unethical to put human beings at risk without the prospect of creating beneficial new knowledge or promoting the social good. In each case, the foundation of the obligation is like the obligation to keep promises.

An investigator’s ethical obligation to treat subjects with beneficence is primarily carried out during the process of assessing and balancing the risks and benefits faced by subjects (See Module 3). However, ethical norms derived from this principle are discussed in each of the modules.