A Report on the Use of Radioactive Materials in Human Subject Research That Involved Residents of State-Operated Facilities Within the Commonwealth of Massachusetts from 1943 Through 1973 (Front...

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on the Use of Human Subject Research Commonwealth of Massachusetts Task Force on Human Subject Research Philip Campbell, Commissioner Commonwealth of Massachusetts Executive Office of Health & Human Services Department of Mental Retardation

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TABLE OF CONTENTS Phiiip Campbell, Commissioner Congressman Eaivard J Markey Frederick AM. Misilo, Jr., Chairperson CHARGE TO THE; TASK FORCE d THE TASK FORCE d ARCHIVAL RECORD CHRONOLOGY IHOW COULD IT HAVE HAPPENED? COULD IT HAPPEN TODAY? A. Listing of Task Force & Advisory Group Members E. Contact with Subjects Subcommittee F. Introduction to Radioactivity & Radiation Primer G. Expert Opinions: Radiation Dosimetry & Epidemiology H.Nuremberg Code & Declaration of Helsinki J. Consumer Organizarion List K. Department of Menral Retardation Research Regulations L. White-Lief & Tisei Research on Informed Consent

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"All peo?le are b o x free and equal ar,d have cercain natural, essential and unalienable rights, among which may be reckoned the right of enjoying and defending their lives ana libercies; that of acquiring, possessing and prstecting property; in fine, that of seeking and obtaining their Article 1: Massachusetts Declaration of Rights I: was ncced by the Humane Society of Washington,D.C., that a public declaration had been mace by a Swedish physician (not named) that he preferred eqerimenting cn inszitn:ionalited children because they are The Huane Society, Washington, D.C. Institutions were f o m d to be the perfect plice to conduct research, because the supervised and standardized conditions came as close as possible "to conditions which are insisted on in considering the course of experimental infection among laboratory animals, but which can rarely be ccntrolled in a study of infection of man." Alfred F. Hess, Medical Director, Hebrew Infant Asylum "Considering the nature of the population from another perspective also presenEs its pros and COCS for research. Traditionallv ins:itutior,s have been assigned the deviant, the troublesoie, and the discarded individuals of society. Their se-Tices have been directed towzrd relieving the community of its problem population and toward modifying the patients' or residents' capacity to function acceptably, "What must be recognized is the enormous ambivalence toward the sick reflected in conflicting wishes to exculpate and to blame, to sanction and not to sanction, to treat and to mistreat, to protect and to Jay Katr, Experimentation with Human Beings "Mentally rezarded individuals are always among the first to have their k,uaaz righ:s denied, the first to be experimented u?on, to be placed in iFASZiC..Lcuc-v.,s,i e- tc be sceriiizec, to be allowed tci wither, and even, to be Eunice Kennedy Shriver, Joseph P. Kennedy Jr. Foundation

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A project of this size and intensity can only be accomplished with the suppon and cooperation of F many individuals, staff and voluntcers. On behalf of the Task Force membership and the Advisov Group, we wish to thank the following Tom Philbin, John Abbotts and David Moulton of Congressman Markey’s ofice Vann Dunne and Jessica Riviere of Senator Kennedy’s office Man. Barnes, Editor Kimberly Fahrenstock, Chris Lang and Ken Pickering for legal research Jim Mclnnis. Northeastern Co-op Student Louisa Orr, Executive Assistant Anne Parker, Shriver Clinical Susan Kilgore 8: Mark Leicester Penny Ford Carlton and Susan Ford, MGH Paul Duhamel, Bonnie Stecher, Paul Procaccini, Debbie Mermllo, Rick Fraser, Dorothy Brand, Janine Dedon, Richard Dutton, Salwa Esa, James Heithmar, Maria Lazzaro, Patricia Mascelluti, Nick D’Alusio (Facility Director), Linda McCarthy and the Consumer Resources Depamnent Staff, Paula Powin and Linda Gershman of Social Services Neri, Joe Foley. Karen Limos, Joan Rickets, Paula Potvin, Linda Gershman, Lisa Bradley, Peter David Maxfield, Judith Rheaume, Stephen Rogers, Kay Schodak, Gail Wangler, Moe O’Connel. Joe W Staff at each of the other DMR facilities including: Monson Developmental Center, Hogan Regional Center, Dever State School, Glavin Regional Center, Templeton Developmental Center Joanne Came!, (Administrative Assistant to Deputy Commissioner Misilo) and Berni Davis H And other individuals too numerous to mention - Frederick Misilo, Task Force Chairperson - Doe West, Project Coordinator

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L TABLE OF CONTENTS Philip Campbell, Commissioner N CHARGE TO THE TASK FORCE ,/ E THE TASK FORCE 1 I ARCHIVAL RECORD CHRO ~ OLOGY

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The Commonwealth of iMassachusetts Executive Office of Health & Human Services Department of Mental Retardation 160 North Washington Street To Whom It May Concern: On December 26, 1993 the Boston Globe reported the discovery of inforsation regarding the use of former residents of the Fernald State School as human subjects f o r research involving radioactive substances during the 1940's and 5 0 ' s . The shock and horrpr of that discovery made news, literally around the world. I shared the public's disbelief that some of the most vulnerable individuals in our society were deliberately exposed to harmful substances without their consent or ability to understand the risks involved. The Department of Mental Retardation (DMR) is the agency of state gov rnment charged with t h e responsibility to support and protect in2ividuals with mental retardation. As Commissioner of DMR, I felt *it was critically important to investigate those reports and fully disclose any research activity at any DMR facility that involved the use of radioactive substances. To accomplish such an immense task in a responsive manner, I appointed a task force of interested individuals who would maintain the best interest of the people involved and work' diligently to discover the truth. I issued a charge which challenged the task force with an urgent time frame, I knowing that it would be very difficult to accomplish. However, f o r the sake of those individuals who believed they may have been involved, the importance of a prompt disclosure could not be The individuals who agreed to accept the challenge and serve on the task force deserve wide recognition for their dedicated service. They are parents, former residents, advocates , doctors , lawyers, clergy, legislators and educators. Their common goal was t o seek the truth no matter what. Since January, the task force and its sub-comnittees have met at least weekly. They have become experts in the history of the type of research that was occurring in that I particularly wish to acknowledge and thank the parents for their unwavering focus on the well being of individuals with mental retardation, and those courageous formerzesidents who shared their insights into institutional life of that day.

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I a l s o wish to acknowledge and thank those scientists, medical personnel, and nationally known experts in matters of radiation and epidemiology who have assisted the task force members t o better understand technical and scientific information. In addition recognition goes to Deputy Commissioner Fred Misilo who agreed to chair the task force, to Peter O'Meara, Facility Director at Fernald who provided the management expertise, and to the Rev. Doe West, who was hired by the Task Force to serve as the official coordinator of the task force activities. Without their expertise and dedication this report would not have been completed. Finally, this disclosure will not be complete if it simply remains a study of history. Instead, the lessons to be learned from the life experiences of those individuals 3, 4, or 5 decades ago must be brought forth for the protection of the rights and dignity of children and adults with mental retardation today and for 3 or 4 or 5 decades yet to come. Indresponse t o someone who asked,. "Could t h e same thing happen today?" I offered the comment, "If you think it can't, then it probably can." The need for diligence and safeguarding vulnerable populations is a task all must accept each and every day. I am grateful to the Task Force for their recommendations and will ensure that all necessary protections are acted upon in a timely Thank you all for a job well done.

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Task Force to Review Human Subjects Research Massachusetts Department of Mental Retardation Post Office Box 9108 Dear Chairperson Misilo: I am pleased to offer comments on the preliminary report of Task Force to Review Human Subjects Research. It is heartening to see the vigor with which the Task Force has pursued its investigation of radiation experiments on children challenged Massachusetts citizens. As you know in 1973 I chaired a series of hearings in the Subcommittee on Health entitled the "Quality of Health Care - Human Experimentation." These landmark hearings brought to light serious violations of subjects rights as exemplified ' in the Tuskegee Syphilis Study, prison research, and the involuntary sterilization of the I sponsored the National Research Act in 1974 which established (he National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was charged with reviewing the policies protecting biomedical and behavioral research subjects and making recommendations to improve those policies. The Commission also issued recommendations for the protection of vulnerable populations, which were adopted with the exception of those protecting the mentally infirmed. The Subcommittee on Health which I chaired, focused on the use of hallucinogenic drugs during hearings in 1975. We learned that LSD was administered by the CIA to individuals without their knowledge or consent, and resulted in a subject's suicide in one instance. I sponsored legislation in 1978 which established the President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research. My committee recognized the need for a President's commission when we discovered the broad range of federal agencies funding biomedical and behavioral research which violated

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In 1983 the President's Commission remrnmended that Congressional '9Committees with oversight responsibility for biomedical and behavioral research monitor the response of administrative agencies to the Commission's recommendations on the protection of human subjects. The Commission also asked for appropriate continued oversight of local institutional review boards. During the hearings at the Fernald School on January 13, 1994, we learned that: (1) The Fernald radiation studies were not ethically justified because they involved the use of a vulnerable population as a means to a researchefs end; and (2) Current federal regulaticns are insufficient to protect t h e rights and welfare of children and the institutionalized mentally challenged. At t h e hearing we heard a call for creating an Ethics Advisory Board within t h e Department of Health and Human Services to provide oversight of h u m a n subject protection for research sponsored by all Federal agencies. Lastly, o u r attention was once again directed to implementing t h e 1978 recommendations for regulations on the institutionatized mentally disabled. Currently I am drafting legislation with Mr. Markey to establish the National Commission on Biomedical ethics for the purpose of determining the scope and effectiveness of current laws to protect human subjects in biomedical and behavioral resdarch. The' Commission will direct its attention to human subjects identified as I appreciate working with you on this important issue. Together we will uncover the full extent of t h e problem and assure this will not occur again.

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ois inc orslct The Task Force to Review Human Subject Research Massachusetts Department of Mental Retardation Post Office Box 9108 Dear Chairperson Misilo: It has been my privilege to be involved with the Task Force, and I am honored by your request for my comments on the occasion of the Task Force report, I am pleased to inform you that the response of officials and institutions in Massachusetts to the experiments at the Fernald School stands in stark contrast to the pa& response at the federal level in regard to experiments with ,ionizing radiation and human subjects. While it has taken years to prompt an adequate response at the federal level, the response in Massachusetts was vigorous from the outset, with the goals of full disclosure and rectification of past events. I wish to commend the members of the Task Force, and to especially acknowledge your leadership as Chairperson. I take special note of the untiring efforts of those whose work supported the Task Force, particularly Project Manager Peter O'Meara and Project Coordinator Doe West, I also appreciate the indulgence of yourself and the other members of the Task Force in allowing members of my s t a f f to attend meetings in my absence. A s you know, in October 1986, I released a staff report of the House Subcomiittee on Energy Conservation and Power, which described experiments with human subjects and ionizing radiation that provided little or no medical benefit to those exposed. This report was based on documents requested from the Department of Energy, related to experiments funded by its predecessor agencies. The staff report recocnended medical follow-up of the subjects of these experiments, and recomnended that experiments of the type described, which apparently ended in the early 197Os, never be conducted again. An Appendix to the 1986 report described current federal regulations on hunan experimentation, including four general

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I,3 Risks to subjects should be minimized; Risks to subjects should be reasonable in relation to anticipated benefits, and the importance of the knowledge that may reasonably be expected to result; Subjects should be selected in an equitable manner; and Informed consent shall be sought from each prospective subject or authorized representative. Informed consent includes a clear description of the risks and benefits of the experimental children, and such experiments generally require a benefit for the subject or a benefit for the health of children generally. Additional restrictions are in effect for experiments with The Subcommittee staff report was essentially ignored by the Reagan administration, and it was left to gather dust on a shelf until Secretary of Energy Hazel O'Leary accepted its findings late in 1993. Secretary O'Leary and the Clinton administration, through its Human Radiation Interagency Working Group, are committed to full disclosure of experiments with ionizing radiation and human subjects, while protecting the privacy of subjects and their families, and to medical follow-up where it is feasible and indicated. Although it has taken a long time for acdon at the federal level, I have been gratified by the &-leadershipof the Clinton adninistration on this issue. n Late in 1993, information was released on the Fernald School experiments, where schoolboys were fed radioactive iron or calcium i n their breakfast meals in the 1940s and 1950s. These experiments violated at least two of the present standards for using human subjects: The children at the school represented a 4 segment of society that deserved protection, not exploitation; and their parents were deceived about the nature of the experiments when they gave their consent for participation (details of these and other experiments are contained in the Task In contrast to the experience at the federal level, officials of the Massachusetts Department of Mental Retardation from the outset registered profound shock and dismay over the experiments. The DER has shown no interest in defending mistakes committed in the past. The formation of the Task Force and the investigation by its staff have been designed to provide full disclosure of the extent of hunan experimentation with ionizing radiation at all DKR facilities. I hnve also been impressed with the response of Massachusetts acadexic institutions, whose affiliated scientists Dr. Charles Vest, present president of MIT, acknowledged that while doses at the Fernald School may …