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. The authors of the Belmont Report drew upon medical tradition when considering the ethical principle of beneficence. 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. 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). 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. It further requires investigators to minimize the probability and magnitude of injury to individual research subjects. 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. 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. Risks, however, are borne by individual subjects. Benefits may accrue to individual subjects or, through the development of generalized knowledge, to society, perhaps in the form of better health care. 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. 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. 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. Beneficence, as described in the Belmont Report, obligates the investigator to follow two general rules. 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.
0 Comments
Leave a Reply. |