The Task Force to Review Human Subject Research Massachusetts Department of Mental Retardation April 29, 1994 Philip Campbell Commissioner Department of Mental Retardation 160 North Washington Street Boston, Massachusetts 02114 Dear Commissioner Campbell: I am pleased to present the report of the Human Subject Task Force to you. This report contains a set of findings, recommendations and an in-depth description of the series of research activities which utilized radioactive material in D.M.R. facilities from the late 1940's to the early 1960's. I would like to acknowledge the work and dedication of Peter O'Meara who served as the Project Manager and Doe West who served as Project Coordinator for the task force. Ms. West, who functioned in her role on a full-time basis, really deserves much of the credit for coordinating, managing and keeping the day-to-day activities of the task force on track. I would also like to acknowledge and thank the task force members who so graciously gave of their time and support to this worthy endeavor. Their contributions to the deliberations of the task force and to the development of the final report are enormous. I would like to personally thank you for the support and confidence you showed in me by providing me with the opportunity to chair this task force. I hope my contributions and the work of the task force have lived up to your expectations. It has been my privilege and honor to serve the Department of Mental Retardation on this task force. Very truly yours, Frederick M. Misilo, Jr. Deputy Commissioner and Chair, Task Force on Human Subject Research The Commissioner's Charge to the Task Force on Human Subject Research The original charge, written on December 29, 1993, stated that the Task Force on Human Subject research was established to review and report on any and all research that utilized radioactive or other potentially harmful materials involving human subjects who resided in facilities operated by the Commonwealth of Massachusetts for persons with mental retardation, with a report due to the Commissioner by March 31, 1994. Within the first 60 days of research and review of archival materials, the Task Force informed the Commissioner that the original charge was too broad to be accomplished within the time frame. The Task Force requested that its reporting be limited to only research that utilized radioactive materials. To continue the archival review for "other potentially harmful materials" would not be feasible in this initial review. The Task Force felt strongly that the research studies utilizing radioactive materials should be a top priority. Furthermore, due to the establishment of federal laws pertaining to the protection of human subjects by way of institutional review boards (IRBs) in 1973, the boundary of the review was requested to end at this year. The beginning boundary was set at 1943 due to the finding of archival materials (noted in this report) that indicated the Iron study which utilized radioactive tracers was the first study done with researchers from outside Fernald. A new charge was issued on March 22, 1994, to include these new boundaries and to set a new due date for the report to be submitted to the Commissioner by April 25, 1994. The original and revised charges follow. The Commonwealth of Massachusetts Executive Office of Health & Human Services Department of Mental Retardation 160 North Washington Street Boston, MA 02114 Philip Campbell Area Code (617) Commissioner 727-5608 TDD Line 727-9866 TASK FORCE TO REVIEW HUMAN SUBJECT RESEARCH A RE-CHARGE OF INTENT There is hereby established a task force to review and report on any and all research projects which utilize radioactive materials involving human subjects within the facilities for the mentally retarded operated by the Commonwealth of Massachusetts between the years 1943 and 1973, said review is to commence immediately. The task force shall report to the Office of Commissioner on or form as the task force members deem appropriate. This re-charge is being enacted to accommodate the request of the members of the task force to target the scope of this initial review to address the studies utilizing radioactive materials. Further investigation into any and all studies that utilized other potentially harmful behavioral studies, shall be done as a next step of review by the Office of the Commissioner at a later date to be identified upon the acceptance of the initial report from this task force. The task force shall be comprised of such individuals with appropriate back ground, training, and interest as the Commissioner shall determine appropriate. There shall be a chairperson of the task force who shall be the Deputy Commissioner, Frederick M. Misilo, Jr. The task force members shall serve at the pleasure of the Commissioner. The task force shall meet on a regular basis and shall make its major progress report to the Commissioner in writing. Re-established this 22nd day of March Philip Campbell, Commissioner Department of Mental Retardation Boston, Massachusetts The Commonwealth of Massachusetts Executive Office of Health & Human Services Department of Mental Retardation 160 North Washington Street Boston, MA 02114 Philip Campbell Area Code (617) Commissioner 727-5608 TDD Line 727-9866 TASK FORCE TO REVIEW HUMAN SUBJECT RESEARCH There is hereby established a task force to review and report on any and all research projects which utilized radioactive and other potentially harmful material involving human subjects within the facilities for the mentally retarded operated by the Commonwealth of Massachusetts, said review is to commence immediately. The task force shall report to the Office of Commissioner on or before March 31, 1994 its findings with a written report in such form as the task force members deem appropriate. This task force is being established due to the recent release of documents by the U.S. Department of Energy. These documents reveal that individuals with mental retardation were previously used by researchers in experiments involving the radioactive materials. The task force shall review and analyze all such research. it shall also attempt to identify each and every resident who participated in such research. It shall also attempt through the Department of Mental Retardation to locate all such individuals who shall be provided with information concerning the research and, particularly, the use of radioactive or other potentially harmful material.. To the extent that individuals are identified who have since died form the time of the experiments, the task force shall attempt to obain records concerning the cause of death of such former residents. The task force shall be comprised of such individuals with appropriate background, training, and interest as the Commissioner shall determine appropriate. There shall be a chairperson of the task force who shall be The Deputy Commissioner, Frederick M. Misilo, Jr. The task force members shall serve at the pleasure of the Commissioner. The task force shall meet on a regular basis and shall make its final report to the Commissioner in writing. Established this 29th day of December, 1993 Philip Campbell, Commissioner Department of Mental Retardation Boston, Massachusetts 1 I. Introduction This report contains a full disclosure of the data made available to the Task Force on all identified studies utilizing radioactive materials involving human subjects who resided in facilities operated by the Commonwealth of Massachusetts for persons with mental retardation between the years 1943-1973. It is possible that studies 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 Task Force used a vast number of information sources and 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 who have been used as subjects in experiments involving radiation. A wee-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 no medical benefit to those exposed. While there was some public concern raised at the time, there was no administrative follow-up taken and further public access to the data provided. Please Take Note Throughout 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 1950s, were not admitted with a diagnosis of mental retardation. Societal and cultural norms of the day permitted persons to be admitted to state-operated institutions for a number of reasons. All were labeled mentally retarded just by virtue of having lived within 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 simply not true. In the spring of 1993, President Bill Clinton directed federal agencies to implement a post-Cold War declassification process that would allow citizens to gain access to archival records that had previously been denied to them. The Department 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 to review these declassified records and make public many previously unknown, or little-known experiments and research studies that had used radioactive materials throughout the United States. 2 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 reporting 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 Walter E. Fernald School as one of the institutions in Massachusetts where radioactive material was administered to residents by researchers from the Massachusetts Institute of Technology (MIT). It was reported that young male residents of Fernald, who were members of a "Science Club," were used as subjects in nutritional studies using radioactive materials in the 1940s and 1950s. Out of concern for the nature of the facts revealed in the Globe article, the identified institutions made public statements allowing that current staff was unaware of these studies and committing to work in an open and cooperative manner to respond to the need for a full and accurate public reporting. On December 29, 1993, Philip Campbell, 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 Committee 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. Among those testifying that day were a number of persons who would serve on the Task Force. Austin LaRocque and Charles Dyer testified as former "Science Club" members. Dr. J. David Litster, Vice President and Dean of Research at MIT and one of the experts whose opinions were sought on the medical risk calculation, gave scientific interpretation of the Iron and Calcium studies based on the published literature; and Frederick M. Misilo, Jr., Deputy Commissioner of the Department of Mental Retardation, testified as the Chairperson of the Task Force on Human Subject Research. Misilo reflected deep concern on behalf of all interested parties when he stated: "The research which involved residents as the members of a Science Club over forty years ago clearly did not obtain the informed consent of those research participants. These tests serve as a dark reminder of the vulnerability of institutionalized persons with diminished capacity to be exploited, oft times in name of some greater 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 Force. . What Happened?: A review of the radioactive tracer studies identified to date; the number of subjects involved; the radioisotope tracers used, and the dose of exposure. . Archival Record A comprehensive chronology of Chronology events and facts leading up to 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 as the site for the studies, correspondence with state and federal administrative agencies, and outreach to parents/guardians for permission for the subjects to participate in the research studies. By reproducing these documents in their entirety, the Task Force seeks to fulfill its mission of "full disclosure of all the facts found" - a very real and tangible manner. 3 . How Could It An examination of the environment haveHappened?: and circumstances that allowed these research studies to occur, including background on guardianship 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 Fernald at that time. . Could This An examination of the current Happen Today?: 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 & A set of findings and recommendations that Recommendations: address procedural safeguards, policy revisions aimed at creating or increasing safeguards for vulnerable populations, and areas that require follow-up action. The Task Force strongly emphasizes that those responsible for the care of persons residing in institutions or supervised placements cannot rest on these laws, regulations, or further 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 Department of Mental Retardation 's Commissioner Philip Campbell, "If you think these kinds of experiments can't happen again, then they probably will. 5 The Task Force Frederick M. Misilo, Jr., Esq. Chairperson Dr. Mary Louise Buyse Doris Manson Medical Director, Fernald School Parent & Advocate Dr. Allen Crocker Rep. Edward J. Markey Governor's Commission on MR U.S. House of Representatives Dr. Gunnar Dybwad George Mavridis Professor Emeritus, Brandeis Family Member & Advocate Charles Dyer The Rev. Richard Robison Former member, The Science Club Parent & Advocate Dr. Anne Howard Virginia Tisei, Esq. DMR Statewide Advisory Committee Family Member & Advocate Riachard Krant The Rev. Doe West Parent & Advocate Advocate & Project Coordinator Austin LaRocque David White-Lief, Esq. Former member, The Science Club Chair, Human Rights Committee On December 26, 1993, a Boston Globe article disclosed that studies using radioactive materials had been conducted at the Fernald School in the 1940s and 1950s. That same day Fernald officials, in concert with Commissioner Philip Campbell, met to identify advocates and professionals to serve on a task force that would accept and carry out the work involved to meet the stated charge. By January 3, 1994, planning sessions were held to develop policies and procedures for review purposes. Representatives from Harvard University and the Massachusetts Institute of Technology (MIT) volunteered to assist in whatever manner deemed appropriate by the Task Force. A Task Force member, Rev. Doe West, was asked to serve as full-time Project Coordinator. The Task Force consisted of two individuals who were themselves members of the Science Club, parents and siblings of former and current residents, lawyers, clergy, advocates, educators, physicians, and administrators. An Advisory Committee was established by the Project Coordinator to create a working group of over twenty persons whose fields of expertise included radiation, epidemiology, bioethics, the social sciences, and medical sciences. Concerned members of the Fernald staff were also asked to serve on the Advisory 6Committee. The membership of the Task Force and Advisory Committee is listed in annotated form in Appendix A of this report. An "800" telephone line (with TTY capability for those not able to use a traditional voice telephone) was established to enable individuals to call in and either provide or request information. In the first two months, over 400 calls and letters were received. At Fernald, a full archival record review was begun that focused initially on the permanent files of those former and present residents who had lived at Fernald during the 1940s and 1950s. The review also involved any individual who was identified in an archival record, who called Fernald's "800" hotline, or who wrote a letter requesting such a review on his/her own record or on behalf of someone who lived on the grounds in that time period. About 600 records have been reviewed as of the writing of this report. It should be noted that the client/medical records are stored on site for current residents and in the state archives in Dorchester, Massachusetts, for former residents. The Task Force went on to review the Fernald Library's archival materials, as well as personnel and administrative records found from this era. These 30-to 50-year-old records often crumbled as they were handled due to their age and condition; the data was often in primitive form or in faded handwriting. The records lacked any standardized or obviously relevant headings. Consequently, it was necessary to conduct a very extensive review of any record or ledger found from the time period. Many records were clearly related to issues the Task Force had identified for review, but others were found in what would at first glance appear to be unrelated files. After a few such seemingly unrelated files were found to contain relevant facts, it was decided that the review had to entail a page-by-page review of literally thousands of pages of information by the Project Coordinator and supporting persons at associated archival sites. The Project Coordinator met with state, federal, university, and hospital librarians and archivists to assure a uniform search methodology and direction that would avoid duplication of effort. Any time a record relating to the tracer studies was found that referenced another organization or institution, it was immediately shared with that organization or institution and a joint follow-up search for related documents was performed. Key records were identified through the following means: . Searches of published scientific literature; . Specific literature reviews of the published works of each researcher identified in the studies; . Copies of old annual, trustee, and departmental reports . A systematic search of administrative and archival files from that era found in libraries, cellars, and attics; . Correspondence files of all administrators and medical staff; and . Personal papers donated to university libraries with original notes and reports from the researchers. Significantly, no original reports or specific official records on the tracer studies were found in any of the client records. On rare occasion there was a copy of a permission letter or a vague reference to outside activities discovered in routine staff notes. On a very rare occasion an indirect reference would serve as a clue that could lead to relevant information or identification; for example, a distinctive type of blood test that was known to be used in a study with no indication of illness or infirmary stay. Even more scarce were copies of letters or staff notes that clearly or obviously referred to a resident participating in a special research study or treatment. Such overt references were significantly infrequent in comparison with the number of records reviewed. Even after positive identification was made of the subjects a second review of their records still yielded no clues to the research studies. Given these hurdles, how was the positive identification of the subjects made? Records donated to Harvard University by the estate of Dr. Clemens E. Brenda, Medical Director at Fernald during the time period, allowed the positive identification of the 57 subjects in the Calcium studies. The subjects names were all recorded by number, and there were specific research notes within the primary researcher's progress reports. Records within the doctoral dissertation archives at MIT allowed the positive identification of the 17 subjects in the Iron study. Again, the primary researcher's notes gave us the subjects' names along with exact experimentation data. 7 However, in the case of the Thyroid studies the Task Force did not find this comparable level of original research records. The Task Force was forced to base its preliminary analysis, as presented in this report, on the limited information found in the published journal articles. For the radioiodine studies at Wrentham, the Task Force has found only 23 sets of initials and birth dates out of a total of between 104-167 subjects (depending on whether or not the Task Force can determine what, if any, of the subject data were used in both studies). By comparing all identified records of all the residents from that time period whose birth year fell within those approximate age ranges, and by matching that group's names with the identified initials of subjects in published articles, the Task Force has, to date, positively identified only 12 potential subjects. In a like fashion, the Thyroid study at Fernald has required an identical search of all residents within that time frame against a listing of ages and initials. The search for the positive identification of subjects is still ongoing. Why was the Task Force able to secure such detailed information on the Calcium and Iron studies and not on the Thyroid studies? The Calcium and Iron studies were nutritional studies that were done by the primary researchers as doctoral dissertations, and the records were kept for sentimental and academic reasons. The Thyroid studies were just one of many research studies done by persons and institutions, and the records were lost or destroyed within this 30-to 40-plus-year time span. No laws or policies existed at the time that required specific records be kept at the site of the research studies or entered in the subject's medical records. Researchers had complete discretion in record keeping during and after any study. All of the researchers whom the Task Force was able to identify and contact revealed that they had not maintained records of any studies they had conducted or participated in from that time period. The following subcommittees were formed to work on specific areas of consideration: . Information Request Subcommittee (David White-Lief, Chair) Archival records revealed that close proximity to researchers, universities, and hospitals, as well as the supervised living conditions at an institutionalized setting, were among the primary reasons Fernald had been attractive as a place to conduct studies for the Boston research community. Also, two archival records addressed the unique opportunities for research that institutionalized settings offered and called for specific research on the causes and treatment of medical conditions found in such settings. The archival records indicated medical research of a varying nature was an ongoing component of daily life at Fernald and other institutionalized settings. This subcommittee was formed to request an archival search, with a follow-up report to the Task Force on any studies identified in that search, by all major universities and hospitals in Massachusetts to assure that unpublished research was not missed in the Task Force's review. Follow-up letters were sent to those institutions failing to submit a report on the date requested. As of the writing of this report, of the thirty institutions contacted, all but four have responded (see Appendix C for a copy of the letter sent and a listing of the institutions contacted; a notation is made next to the nonrespondents). Requests for any federal agencies' records or reviews were coordinated through Senator Kennedy's and Congressman Markey's offices on behalf of the Task Force. The Department of Energy assigned Dr. George Gebus to serve as a direct liaison for the Task Force. . Narrative Subcommittee (Dr. Gunnar Dybwad, Chair) The Task Force decided this report must include a section in which the two former residents and two of the family members who served on the Task Force offer their personal insights and experiences at the time of these studies. These personal statements can be found in the "How Could It Have Happened ?" section. . Methodology Subcommittee (Richard Krant, Chair) The Task Force required assurance that all other facilities operated by the Department of Mental Retardation were conducting identical searches in a systematic manner. This subcommittee was formed to contact each facility and report to the Task Force as a whole on this effort. See Appendix D for its report. 8 A review of a random sample of all the archival records was considered for inclusion in this report. The Task Force decided against doing this type of review for the following reasons: . A representative sample would be difficult to obtain and the results would likely be inconclusive because specific references in residents' records to the subject testing were sparse at best; . Formal record-keeping policies did not exist in the 1940s through early 1960s; . Any meaningful review of the archival records must consist of a page-by-page search to assure that any notations within the staff notes are found. The Task Force estimates that 8,000-10,000 individuals have been residents at the Fernald facility alone, with each person's permanent record ranging in size from the oldest (and smallest) filling a single file folder to the more recent records (which have specific, mandated record-keeping guidelines) filling an average of four file folders. However, an example of the extreme was found with a current resident's record filling one entire filing cabinet; and . When the Task Force reviewed the records of those persons who were positively identified as having been a research subject, no standardized or obvious notation concerning the study was found. To determine whether or not professionals in the statistical field would agree with the Task Force's belief that these variables would negate the advisability of a random sample it was decided to consult outside experts. The Task Force sought the opinion of two statisticians: Dr. Monroe G. Sirken, from the Centers for Disease Control and Prevention, and Dr. Nancy Veeder, from the Boston College Graduate School of Social Work. Given the scope and time limitations facing the Task Force, they concurred that a page-by-page review for a random sample would be impractical and of little utility at this time. Instead, a "nonprobability purposive sample: was suggested. However, the Task Force voted to maintain the right to recommend an inclusive, individual record review in the future should it be deemed appropriate. . Contact with Subjects Subcommittee (Dr. Anne Howard, Chair) Discussion within the Task Force indicated that there were serious ethical, psychosocial, and medical issues that needed to be considered before it could be decided when and how to relate the Task Force findings to the identified subjects. The specific areas for consideration and this subcommittee's preliminary recommendations can be found in Appendix E. However, a few key areas of investigation and discussion are highlighted below. The Task Force was confronted with the question of when and how to respond to inquiries, as well as how to contact those who could be positively identified as a subject in a research study. The issue was whether to inform them immediately or wait until final data and opinions by the radiation and epidemiology experts provided specific information that could be shared with the subjects and their primary physicians at the same time they received notification of their involvement. Our decision was influenced by the two Task Force members who had been members of the Science Club at Fernald. They offered an impassioned plea to wait until specific information was available to share, recounting the terrible effect of uncertainty on their lives. The Task Force decided that the same anxiety must not be inflicted on others. This could be avoided by waiting until complete information regarding the research study details and the potential long-term effects could be communicated. Many persons who were residents at Fernald for the societal and cultural reasons outlined in the "Introduction" section spent their subsequent lives concealing their pasts as residents from their family, friends, and coworkers. This arose out of the very concern that upon learning that they had been residents at this facility, people would assume they were mentally retarded. This would cause that person to have to live with the severe stigma that is attached to that label in our culture. In fact, this very scenario has occurred in the lives of the two Task Force members who came forward to offer their insight as former members of the Science Club. Therefore, the question arose as to whether or not it would be appropriate to initiate contact with all subjects, regardless of their desire to distance themselves from their past as residents of Fernald. What methods must be used to assure their right to 9 privacy? The Task Force had passed a unanimous motion that the Department of Mental Retardation had a "duty to inform " each research subject identified. Did this "duty to inform" override the subjects' right to privacy and/or their desire not to be associated with Fernald in their present lives? A pivotal question became just how much, if any, medical risk had been incurred as a result of any of the identified studies that used radioisotope tracers. The Task Force sought the opinion of five outside experts in radiation and epidemiology in an attempt to determine the potential medical risks associated with each of the identified studies and the differing levels of radiation exposure. These opinions can be found in Appendix G. All five experts agreed that there were significantly differing exposure levels for those involved with the nutritional research studies versus those who had been involved in the Thyroid studies. Reassurance was given to the Task Force on the minimal exposure in the nutritional tracer studies, but serious concern has been raised concerning the Thyroid studies. Furthermore, it was noted by the Task Force that there is a school of thought that there is no such thing as an "acceptable" exposure level. Additional discussions with members of the medical community convinced the Task Force that it was beyond the scope and ability of this group's expertise to handle the depth of discussion associated with the risk that the Thyroid studies deserved within the time frame established for the creation of this report. Therefore, a working group within the Department of Mental Retardation is currently being formed with a mandate to design and coordinate a specific set of tasks: to review and present a policy statement on the issue of medical risk for the Thyroid studies; to create a policy and procedure for contacting and sharing information with persons identified as having been research subjects; and to continue the work of identifying other types of research that had been done in state-operated facilities. This working group is being formed as this report goes to press. 10 Please Note When reviewing the records of former residents of the state-operated facilities, the Task Force became concerned with the archaic, degrading, and judgmental language that was the standard medical terminology of the day. Terms such as "moron," "idiot," "fool," and "imbecile," as well as judgments and descriptions concerning family members, makes these archival records insulting and controversial. A letter of apology and explanation was drafted to accompany any records requested by former residents and their families. The letter is reproduced on the opposite page.