"I am because we are; therefore we are because I am."
... An African proverb
Over the last decades, the United States research community has seen a significant increase in the number of corrective actions taken at academic and research institutions involving concerns over the protection of human subjects from research risks. Numerous investigations and corrective efforts have been undertaken by national authorities at a broad variety of academic and research centers. Some of these garnered greater notoriety than others; all were met with extremely variable reactions. Some regarded the investigations as timely, appropriate, and long overdue, while others regarded them as excessive, factually and empirically invalid, or overly punitive and damaging--not just to institutions and individual researchers but to the reality of research. The debate and the sentiments continue. However one wishes to judge the situation, it is clearly evident that culture in the United States, including the healthcare research culture itself, is increasingly more sensitive to the rapidly expansive understandings of what it means to protect the rights, freedom and dignity of the human person or persons enrolled as subjects in research.
In the past, the focus of human subject protections often centered upon biomedical and psychological protections. This is understandable, given the medical nature of many research efforts. However, various academic and cultural forces have brought this narrow focus into the light of sharp critique. Making the assumption that the central concern of human subjects protection is confined to the physical/medical or psychological can appear to be an exercise in legalistic physicalism. Hence, as long as a medical researcher does not cause a subject physical pain, that subject is protected, and the ethical responsibility of the researcher is met. However, it is safe to assume that the paradigm of human subject protections has expanded proportionally in the last decades to the unfolding understanding of the nature of the human person as a free and equal agent in a democratic and pluralistic world. The challenge is clear as researchers of all disciplines encounter new regulations. What is difficult is to convince participants in this often free wheeling and heated cultural debate to transcend the minimalist level of "regulations" and appreciate the deeper ethical, moral, social, humanistic, and philosophical issues at stake as human society and human research continue in the 21st century.
This article has a three-fold purpose: 1) To summarize, within a very broad highlighting of some of the more significant historical instances of unethical human research, the less well-known case of the 1943-1973 radiation and nutrition studies within the Massachusetts State Department of Mental Retardation, sometimes called the "Science Club" or Fernald/Wrentham School Experiments; 2) To critique such occurrences and their research ethics issues from the perspective of the thought of the Russian philosopher Nicolas Berdyaev; and, 3) To consider what might be the newly emerging essential leadership of research administrators who function as compliance officers in human research protections.
Throughout the 20th century and to the present time, United States society has been touched by a wide variety of historical instances of tragically unethical research. These instances have certainly affected the process and progress of research itself and its role in academic life and industrial advancement. However, on a very ultimate level, these instances have and will continue to have a serious societal and cultural impact on the national conscience and, indeed, on the global community at large. Certainly the atrocities of unethical research performed on individuals during the Holocausts both in Western Europe and in the Pacific region stand out as one of the totems of history reminding culture of the depths to which human beings can sink. While not thought possible in United States during those years, history would eventually come to know that similar atrocities were perpetrated on the low income men of Tuskegee, Alabama, from 1932-1972 during the notorious Public Health Service (PHS) Syphilis Study done there. (Jones, 1993). In 2009-2011, the public discovered that even worse experiments were perpetrated by government physicians on vulnerable populations in Guatemala. Indeed, what was not thought possible absolutely occurred. (Nelson, C., 2012). The impact of these instances from those years will never be purged from the national conscience. Their occurrence has given rise to an enduring legacy where all persons must be committed to preventing the worst by promoting the best. (Katz and Warren, 2011). In today's climate, researchers in various fields are reminded time and again of the possibility of unethical research and human research protections violations that can occur even within studies that might be approved by requisite oversight bodies. Such cases include those that resulted in the deaths of Jesse Gelsinger and Ellen Roche. (Houser, 2012). Hence, it is rightly understandable that the protection of human research subjects is today seen as an intrinsic part of the overall system of research ethics and the responsible conduct of research. (Shamoo and Resnick, 2009).
Yet one must ask the question whether there is a fundamental human substratum out of which sorrowfully arises the many and complex factors and motivations that have led and still can lead to the exposure of human research subjects to tragedy and the violation of their fundamental rights and dignity as persons. One particular case may assist this inquiry.
A 1994 Task Force Report, written for the Executive Commissioner for the State of Massachusetts Department of Health and Human Services, revealed a 30-year series of nutritional/radiation experiments performed on children in the Fernald and Wrentham schools in Massachusetts. These institutions were open for the care of mentally retarded children or other children assigned to these schools but who were not themselves mentally deficient. The report was prepared in response to claims of abuse and the call for compensation for damages suffered by those who were participants in these experiments. The experiments in the report included: 1) nutritional studies from 1946-1955 involving radioactive tracers of iron and calcium placed in children's food; 2) thyroid studies between 1952 and 1961 performed specifically at the Wrentham School, including Cold War experiments conducted to determine at what point iodine would block the uptake of radioactive materials after a nuclear fallout, and thyroid studies with children suffering from Downs syndrome; and, 3) therapeutic/diagnostic studies between 1962 and 1973 using radioactive isotopes for specific metabolic disorders. (Commonwealth of Massachusetts Report, 1994).
While some may have a more focused interest in the medical science aspects of the studies performed, the focus of this article centers upon the violation of human subject protections demonstrated during the 30 years over which these studies were performed. Commentators have remarked that both the Fernald and Wrentham schools were "asylums" in an older almost caricature sense, where children as inmates could easily have been exploited. Both the children and their guardians were enticed to become participants by being offered membership in what was described as a...