Introduction (to Commonwealth of Massachusetts Human Subject Research Report)

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This report contains a f u l l disclosure of the data made available to the Task Force on all identified studies utilizing radioaczive materials involving human subjects who resided in facilities operated by t h e Commonwealth of Massachusstts for persons wiLh.menta1 retarsazion between tne years 1943-1973. It is possible that szudies were done for which no public records exist or exist in a place or manner not identified during this phase of the research and review. The T a s k Force used a vast number of infcx-;nation sources anti consulted multiple experts in related medical, social science, and legal fields to - provide as comprehensive a review as possible. Throughout the past four decades, there have been numerous accounts documenting the experiences of persons whg/have been used as subjects in experiments involving radiation. A well-publicized staff report for the House Subcommittee on Energy Conservation and Power, presented by Massachusetts Congressman Edward J. Markey in 1986. described experiments with human subjects who had received ionizing radiation that provided little or administrative follow-up taken and no further public access to the data provided. ’ no medical benefit 10 those exposed. While there was some public concern raised at the time, there was no Please Take Note Though out this report it will be stated that many of the people who became residents of the Walter E. Fernald School, from its opening in 1848 right through the 19506, were ppspnot admitted with a diagnosis of mental retardation. Societal and cultural noms of the day pernitted persons to be a hit ted to stateoperated institutions fora rider of reasons. All were labeled mentally retarded just by virtue of having lived witkin the facility. The Task Force asks that the general public and members of the press take special note that these labels are grossly inaccurate, misleading, and sin3ly not true. In the spring of 1993, President Bill Clinton directed federal agencies to declassification process that would allow citizens to gain access to archival records that had previously been denied to them. The Depamnent of Energy initiated a massive release of documents for public inspection beginning in the summer of 1993. Subsequently, private citizens. advocacy groups, and the press began i o review these declassified records and make public many previously unknown, or linle-known experiments and research studies that had used radioactive materials throughout the United States.

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In November 1993. the Albuquerque Tribune of New Mexico printed a series of articles by Eileen Welsome that detailed research involving the injection of plutonium into human subjects dating back to the 1940s. The reponing of these events was a catalyst for the establishment, by President Clinton, of the President's Advisory Committee on Human Radiation Studies and its Human Radiation Interagency Working Group. On December 26, 1993,the Boston Globe published an article written by Scott Allen in which he identified the H'alrer E. Fernald School as one of the institutions in Massachusetts where radioactive material was administered to residents by researchers fiom the Massachusetts lnstitute of Technology (MIT). It was reponed that young male residents of Fernald, who were members of a "Science Club," were used as subjects in nutritional studies using radioactive mateyials in the 1940s and 1950s. Out of concern for the nature of the facts revealed in the Globe article, the identified institutions made public s:alements allowing that current staff was unaware of these studies and committing to work in an open and coopentive manner to respond to the netd for a full and accurate public reponing. On December 29. 1993, Philip Campoell. Commissioner of the Department of Mental Retardation (DMR), created the Task Force on Human Subject Research to design and conduct a comprehensive review process to secure all known facts on such studies within facilities operated by the Commonwealth. On January 13, 1994, the Senate Comminee on Labor and Human Resources held a public hearing on the grounds of Fernald that was co-chaired by Senator Edward M. Kennedy and Congressman Edward J. Markey. Amdng those testifjting that day were a number of persons who would serve on the Task Force. Austin and Dean of Research at MIT and one of the experts whose opinions were sought on the medical risk calculation, -eave scientific interpretation of the Iron and Calcium studies based on the published literature; and Frederick M. Misilo, Jr.. Deputy Cornmissioner of the Department of Mental Retardation, testified as the Chirperson of the Task Force on Human Subject Research. h~lisiloreflected deep concern on behalf of all interested parties when he stated: "Tire researclr which involwd ' residents as rlie menrbcn of a Science Club over f o q r years ago clearly did nor obrain the informed consenr of tirose researcii participants. These t a r s sene as a dark reminder of rhe vulnerabiiig of institurionali:ed persons nith dintinisired capacity ro be txploired, ofrtimes in name of some grearer good. *' This report is divided into six major information sections: The Task Force: An overview of the specific work, policies, and procedures of the Task What Happened?: A review of t h e radioactive tracer studies identified to date: t h e number of subjects involved; the radioisotope tracers used ; and the dose of exposure A comprehensive chronology of events and facts leading up t o and encompassing the Iron and Calcium tracer studies conducted at Fernald. These archival records address issues such as the knowledge of the day concerning the use of radioisotopes, the rationale for and selection of Fernald asthe site for the studies, correspondence with state and federal administrative agencies, and outreach to parentdguardians for permission for the subjects to participate in the research studies. By reproducing these documents in their entirety, the Task Force seeks t o fulfill its mission of "full disclosure of all the facts found " in a very real and

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a HOWCould It An examination’of the environment and circumstances that allowed these resezrch studies to occur. including background on guardimship and state wards and the development of informed consent. Included in this section are first-person narratives written by former residents or parents/family members of residents of FCmald at that time. m Could This An examination of the current federal laws and DMR regulations that address protection in biomedical research and the significant role that the advocacy movement plays in the development of and ongoing oversight for such protective standards. Findings B: A set of findings and recommendations that address procedural safeguards, policy revisions aimed at creating or increasing safeguards for vulnerable populations, and arcas that require follow-up action. The Task Force snongly emphasizes that those responsible for the care of persons residing in institutions or supervised placements cannot rest on these laws, regulations, or funher recommendations made by this Task Force alone. The operation of these safeguards, and effectiveness of social policies meant to offer. such protection must be regularly reviewed and reassessed. In the words of the Depamnent of Mental Retardation’s Commissioner Philip Campbell, **Ifyuu rhink rlrese kinds of experiments can ’t happen again, then t h q prubabb will. **