The Belmont ethos: the meaning of the Belmont principles for human subject protections.

Introduction: Belmont as Ethos

History, whether of individuals or cultures, is a never ending process of milestones and markers each building upon or veering away from the experience of each other. Sometimes, these markers and milestones stand out and seem to capture the very essence of a person's life or the soul of a culture. Americans look to the signing of the Declaration of Independence and the Emancipation Proclamation as two exemplar events that have marked the conscience of a nation struggling to evolve from a noble experiment to become an experience. In this light, there are any number of historical markers that vividly bring into high relief the profound significance of human subject protections in the evolving history of research. One of the most significant is The Belmont Report of 1979.

On 12 July 1974, the National Research Act was signed into law and established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Among other charges, the Commission was directed to identify and articulate the ethical principles that must form the basis of all human subjects protections in research. Over a four year interval, the Commission convened physicians, behavioral and biomedical researchers, academic theologians, ethicists, philosophers, and lawyers to discuss from a wide variety of perspectives the common bases from which could be articulated the fundamental ethical principles for protecting human participants in any form of research. In April 1979, the Commission issued The Belmont Report and in it identified its three principles that are the foundations for the protection of human research subjects: respect for persons and their autonomy, beneficence, and justice.

Memory and perspective are curious human phenomena. The work of the Commission and its principles are often unfortunately discussed in popular experience from a particular bias favoring law or regulations. However, the work of the Commission was clear that the principles of respect, beneficence and justice are not ethical codes as one might find in other documents. They are not black and white regulations or easy minimalist standards. Rather, these principles and the Report itself are an analytical framework or paradigm better understood by the origin of the word ethics itself.

The term ethics comes from the Greek ethos. Ethics are sets of regulations or standards against which behaviors can be measured. Ethos is the fundamental character of a person, an institution, a society, or a culture. In the ideal, ethics or codes should be born from the originator's ethos (i.e. fundamental character). Ethos is something profoundly more fundamental than any set of regulations. The three principles articulated in The Belmont Report are three fundamental markers of the ethos of human subjects protections.

All paradigms are subject to the process of hermeneutics, namely, the act of interpretation. Under this process, the three principles of "The Belmont Ethos" must undergo a hermeneutic and thereby be understood anew in each age and each context so that research efforts are tempered and shaped by human dignity and integrity. Research is best preserved and protected in this manner as a humane pathway always leading investigators, institutions, human participants, and society toward the good and always away from anything less.

Respect for Persons

Respect for persons is the first of the three foundational principles of The Belmont Report. For all who read The Belmont Report, the principle of respect for persons will conjure up nostalgically the values learned in education and home rearing. Respecting others is basic, and one of the normative lessons of life in the ordinary family or school setting. Respect for others and their personhood is so basic that the nostalgia and ordinariness of this life lesson are what can anesthetize people from its significance in human subjects protections. While the principle of respect for persons is basic, it is far from commonplace and can never be presumed.

Respect for persons has two elementary parts. First, this principle refers to the inviolability of the autonomy of another person. Second, the Report indicates that respect for persons means a special obligation to protect those who have a diminished capacity for making autonomous decisions and self-determination. In essence, each human being has a right to individual autonomy and self-determination that cannot be diminished by the will of another.

The principle of respect for persons as understood by the 18th century had sought to elevate the dignity and worth of the individual human person over tyranny. Evolving gradually over time, the rights of the individual were a crowning achievement in Western thought and formed part of the very cornerstone of the American experiment itself. The implications of this profound principle have not been exhausted and never will. The cultural discussion regarding the protection of equal rights and individual autonomy is far from over. In each age and context, human beings must carefully and honestly look for the emergence of the darker side of human experience that is capable of exploitation, manipulation, bigotry and power. Protecting individual autonomy and those with diminished capacity is as old as civilization itself and has been traditionally one of the major measures of the moral centeredness of a society and its leaders.

The impact of this foundational principle for research and research populations has grown and expanded in line with new insights regarding the inherent dignity and autonomy of women, men and children. New experiences of what it means to be human and humane provide reinterpretation for this first of the three foundational principles of The Belmont Report.

To discover for ourselves what it means to revere this principle of respect for persons, one need only look at the origin of the term. Respect comes from Romance language roots that mean to look back or to regard again. An image may prove helpful to understanding what is meant here. Assume you are riding at full gallop down a road. You come upon a country scene that simply takes away your breath. At full gallop you turn your attention away from the road to "look again" or "look back" simply because you cannot resist the scene. Sometimes, the price for being so transfixed is obvious. But the reality of what is seen cannot be resisted and ultimately seems to be worth the price of falling off one's horse.

Respect for persons occurs when the absolute worth of other human beings suddenly arrests one's attention away from mundane concerns of daily living. One suddenly becomes aware of an other and the magnitude of this other constitutes a manifestation of humanness itself. It invades the perceptions and senses. Strange how this occurs at the most inconvenient times and upends one's assumptions and one's activity. History is replete with stories and examples how the most inconvenient and unlikely of characters became themselves messages about the dignity of human nature to those who were too busy to see and remember. The lowly in these stories unexpectedly invaded the sensibilities of the busy making them stop and wonder and be amazed.

In the act of human subjects research, genius and industry meet in a relationship between researcher and enrollee. In that meeting there always must be something that arrests the attention and makes one wonder. For after all, to be in the presence of another woman or man or child who generously would give of themselves in research to benefit human welfare is certainly enough to make one look back or regard again.

For an Institutional Review Board (IRB) whose mission is clearly the protection of the ethical rights and welfare of human subjects from research risks, the responsibility found in respect for persons is immense. It is to uphold the rights and dignity of individual persons in any culture as pre-eminent over the charging energies arising from the research enterprise. To uphold the autonomy and rights of persons is sometimes an inconvenient "stop" in the busyness of research. In the research culture where produce or perish can be the whisper heard by new investigators, an IRB has a moral obligation to voice more loudly a deeper wisdom: Protect or perish. While one practically must be concerned about what is produced in research for sponsors and for the public trust, to violate or leave unprotected the personhood and rights of human subjects, especially the vulnerable, is, as T.S. Eliot might image it, the deepest treason of them all.

Beneficence

Beneficence is the second of the principles articulated in The Belmont Report. For many, the meaning of beneficence seems rather immediate or familiar. Bene facere is the Latin root phrase that forms our English term. Literally, it means to do well or to do the good. The Report clearly grounds beneficence, the doing of the good, upon respect for persons, its first ethical principle. Respect for persons and their autonomy necessarily must give birth to doing the good. However, in the discussion of this second ethical principle, the Report engages in a series of reflections that take the reader far deeper than a reminder to have the best interests of other people firmly in mind. In what can only be deemed an act of sheer wisdom, the Report's discussion concerning beneficence draws the reader to consider the balance between doing no harm and always doing the good.