Guiding Ethical Principles and Explanation
The ethical principle of beneficence, as defined in the Belmont Report, calls upon investigators to protect subjects from harm and secure their well-being by following 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, investigators are forbidden to deliberately injure a human subject (this does not include the discomfort associated with some procedures or interventions) for the purpose of developing generalizable new knowledge, no matter how important that knowledge might be. Individual subjects may be exposed to a possibility (or statistical probability) of harm as long as an IRB has determined that this is justified in light of the probability and magnitude of the sought-for benefits. In other words, the potential benefits accruing from the research must be acceptable in relation to the risks. The second general rule of beneficence obligates investigators to design their protocols so as to minimize the probability and magnitude of injury (risk) to individual research subjects and 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.
Maintaining a high level of trust and respect between subjects and investigators is also important. It is during the process of informed consent that the risks of participation in research are disclosed and a promise to pursue individual or collective benefits is made with each potential subject. Exposing subjects to undisclosed research risks or breaking this promise to pursue individual or collective benefits would erode the level of trust and respect between subjects and investigators.
The principle of justice requires that vulnerable subjects be extended special protections with regard to the distribution of the benefits and burdens of research. The vulnerable should be assured of receiving their fair share of the benefits and protected from having imposed upon them more than their fair share of the burdens of research.
Module 1 contains additional information on the ethical principles guiding research with human subjects.