The Belmont Report states that justice has to do with fairness of distribution, or distributive justice. Distributive justice is concerned with the distribution of scarce benefits where there is competition for these benefits, as well as the distribution of burdens, particularly when it is necessary to impose burdens on fewer than all members of a seemingly similar class of people. Justice, as defined in the Belmont Report, addresses the questions: Who ought to receive the benefits of research, and who should bear its burdens? Injustice occurs when some benefit to which a person is entitled is denied without good reason, or when some burden is imposed unduly. The Belmont Report states that “another way of conceiving the principle of justice is that equals ought to be treated equally.” Burdens should not be imposed on, or benefits provided to, fewer than all members of a seemingly similar class of persons without suitable justification. This raises several questions: Who is equal and who is unequal? What are similar classes of persons? The answer to these questions, as they relate to research, can be found in the following statement in the Belmont Report: “the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.” It would be unjust, for example, if one group in society incurred the risks of research and failed to benefit from the knowledge or application of such research.

This initial concept of justice has since evolved to include the concept of fair access. Fair access requires that individuals (from a class of persons to whom an innovative therapy or procedure applies) should have an equal opportunity to receive the benefits of the innovative therapies or procedures (such as those being developed for treatment of AIDS). This expansion of the concept of justice occurred in the 1980s when individuals with AIDS claimed that the only way they could gain access to the few drugs directed at the cause of the disease was to agree to be subjects in clinical trials designed to determine whether these drugs were safe and effective. Participation in these trials exposed subjects to the risks associated with these drugs, but the trials also offered potential benefit, and there was an outcry for these trials to be accessible to all persons with AIDS.

Justice – Philosophical Foundation

Support for the principle of justice can be traced back to the philosopher Aristotle, who articulated some crucial elements of the concept of justice: justice requires that situations that are similar, in the relevant respects, be treated similarly; situations that are dissimilar are to be treated differently. Notice that the concept of similarity in some “relevant respect” is left uninterpreted. Different criteria have been applied through time for distributing scarce resources. People have been treated differently based on their purchasing power, needs, ability, and age. The National Commission believed that the most morally relevant attribute was vulnerability. 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. The National Commission believed that the vulnerable were entitled to special protections to prevent them from exploitation.

An investigator’s ethical obligation to treat subjects justly is primarily carried out during the process of selecting subjects and defining a protocol’s inclusion and exclusion criteria (See Module 5). However, ethical norms derived from this principle are discussed in each of the modules.