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 Dear : Enclosed you will find the complete set of records we have in our file for [NAME] including a xerox of a photograph that was taken of them as a resident; any immunization, medical, and dental records; and, any birth, confirmation or baptismal records we could locate. Before you read the records, I wanted to personally apologize for the archaic, and frankly, insulting language of that era that you may find in this old records. The use of the terms such as "moron", "imbecile", or "idiot" were actually the standard medical terminology of the day. However, the use of such terms is appalling to those of us who serve citizens who are retarded today. Also, it is important to note that not all residents of Fernald were admitted due to mental retardation. Society allowed many persons to be admitted to Fernald School for a multitude of reasons aside from mental retardation and no one should assume that they are mentally retarded just by virtue of their having been a student here. There is also a possibility you will see similarly disparaging language or reporting on the parents of our former residents/students. Please understand that it was the type of judgment and categorization allowed at that time. However, it can be very upsetting to read today by our former residents, their spouses, children, or significant others. Again, please accept my sincere apologies for any disturbing language you find and know that we are working diligently today to assure the dignity of all of our citizens, residents and consumers served by the Department of Mental Retardation do not face such derogatory language or treatment again. Very truly yours, Philip Campbell Commissioner WHAT HAPPENED? Of significant note is that no research was identified by the Task Force that involved testing the effect of radiation on human beings by introducing radioactive materials purposefully into their bodies to measure or monitor such effects. The nutritional research studies used small amounts of radioactive material as tracer elements to understand how the body functioned or obtained elements from the diet; the Thyroid studies used small to large amounts of tracer materials, also to learn about body functions; and , the so-called Cold War study at Wrentham differed in that the tracer materials were used to find the point at which administration of iodine blocked the uptake of radioactive materials that would be found in nuclear fallout. Nutritional Research Studies 1946 Iron Study 17 subjects: all identified 1950-53 Calcium Studies 17 separate experiments done over three years 57 subjects total: all identified 1955 Radioactive Calcium Study Proposed but no confirming records found 33 potential subjects: all identified Thyroid Studies 1952 Thyroid Function in Myotonia Dystrophica 6 subjects: identities still undetermined 1957 Thyroid Function in Down Syndrome: Fernald 28 subjects: identities still undetermined 1961 Nuclear Fallout Study: Wrentham 70 subjects: identities still undetermined 1961 Thyroid Function in Down Syndrome: Wrentham 104-167 subjects: 12 identified to date Therapeutic/Diagnostic use of Radioactive Isotopes 1962-73 Five archival records were found documenting tracer studies or the therapeutic use of radioactive materials involving residents with specific metabolic disorders 14 To address the issue of the potential risk incurred by these dosage levels, five opinions by experts within the fields of radiation and epidemiology have been included to outline an assessment of that risk factor. The full text of these opinions can be found in Appendix G. Also, a brief summary of the nature of ionizing radiation and what is meant by the effective whole body dose equivalents is included in Appendix F.  Research Studies Identified by the Task Force This section contains all of the facts that the Task Force has been able to identify, as of this time, concerning the research studies that involved residents at two Massachusetts state schools: Ferna1d and Wrentham. Many of the findings and discussions in other sections of the report are based on the material presented in this and the next section, "Archival Record Chronology." The information is presented objectively, including on1y those notes necessary to assist the reader by clarifying or expanding the information being presented. The chart on the previous page summarizes all of the studies found. A study-by-study outline follows. The research studies are grouped into the following three categories:  Nutritional Research Studies Two nutritional research studies were done that used radioactive iron (1946) and radioactive calcium (1950-53) as metabolic tracers. Both research studies were carried out using Fernald residents as subjects. These are the two studies that archival records have allowed this report to present in great detail. The Task Force can positively identify all of the subjects from these studies and have found the six journal articles that arose from them.  Thyroid Studies Throughout the 1950s and l960s there were three identified research studies in which radioactive iodine was used as a tracer to understand the function of the thyroid gland. These appear to have involved residents of Fernald, family members of Fernald residents, and residence of Wrentham. However, the amount and type of tracer materials used went beyond the minimal tracer levels of the nutritional research studies and into levels that create concern for the need of follow-up medical and epidemiological study. The Task Force will allow the follow-up working group to conduct that next level of research and analysis for reporting at a later date and so will not focus on these studies in this report. One Thyroid study in 1961 stood out from the others. This was a study, using children who were residents of Wrentham, to determine how much normal iodine was needed to be added to the diet of children to block the uptake of radioactive iodine from fallout following a nuclear attack or accident. This study can be called a Cold War experiment and stands alone in fitting that categorization. The Task Force learned that the results of this study were actually referenced at a 1989 European conference after the nuclear accident at Chernobyl.  Therapeutic Diagnostic Use of Radioactive 1sotopes Archival records were found that dealt with the use of radioactive isotopes for therapeutic or diagnostic testing on a select number of residents who had specific medical conditions. 15 Nutritional Research Studies During the time period leading up to and surrounding these studies, the focus of experimentation nationally had shifted in part to nutritional and digestive issues relating to malnutrition and feeding of large populations: "The study of human digestion was a major focus of American medical research [and] metabolic studies of both normal and sick children were also reported. As early as the 1870s, physicians used dyes and other chemicals for gastrointestinal studies in adults. Beginning about 1909 pediatricians conducted similar studies infants and children."1. The purpose of the research involving the residents at Fernald was to understand how the body obtained the minerals iron and calcium from dietary sources and to find out whether compounds in cereals affected their absorption. It had been known from nutritional studies of bread in the late l93Os that a class of chemical compounds, inositol hexaphosphates (commonly called phytates), could form insoluble compounds with iron to prevent its absorption from food. Phytates are commonly located in the outer covering (integument) of grain and were present in poorly milled white flour. Some cereals (e.g. rolled oats) contained phytates; others (e.g., farina, commonly known as Cream of Wheat) did not. The immediate goal of the research was to understand if either of these cereals was preferable from a nutritional point of view.  Iron Study: 1946 This study involved 17 subjects who received seven breakfasts, each with a minute amount of radioactive iron as a tracer mixed into the milk that was served over the cereal. The subjects received the first five breakfasts over a period of about 12 weeks. After a wait of25 weeks, they received two more breakfasts: the sixth at week number 37 and the seventh at week number 40. Calculating the dose was complicated, because different amounts of iron were absorbed from each breakfast, and two different kinds of radioactive iron were used ("Fe and Fe"). However, there was sufficient information available in the single published article2 as well as in the doctoral thesis of Dr. Leonard M. Sharpe, submitted to the Task Force by the Massachusetts Institute of Technology (MIT), to permit this ca1culation. The chart (see Figure l) shows the amount of radiation each subject received from participation in the Iron study, along with the 300 millirem annual effective whole body dose equivalent of radiation from natural background sources in the Boston area. For comparison, the higher 400 millirem natural background dose received by a resident of Denver is also shown. The researchers were from MIT and Fernald. The research was supported by the Quaker Oats Company.  Calcium Studies: 1950-53 The same motivation for understanding the role and impact of phytates was the foundation for this study, but the researchers now used a minute amount of radioactive calcium tracer. This study involved 15 subexperiments conducted over a three-year time frame and served as the basis for five published articles. The best knowledge of this research comes from Dr. Felix Bronner's doctoral thesis. A series of progress notes that had been sent to Dr. Clemens E. Benda, Medical Director at Fernald at that time __________________ 1 M.A. Grodin and L.E. Glantz, Children as Research Subjects: Science, Ethics & Law (New York City, Oxford University Press), 1993, p.9 2 L.M. Sharpe. W.C. Peacock, R. Cooke, and R.S. Hara. "The Effect of Phytate and Other Food Factors on Iron Absorption," J. Nutrition 41, 433-446 (1950). 16 were secured from the papers donated by his estate to Harvard University. Three of the published articles3 4 5 also contained substantial information that allowed these calculations. In the main set of experiments, there was a total of 54 subjects, who were listed only by weight and age in the appendix of Bronner's thesis. There were 8 subjects who were not mentioned in the published articles but were noted in the progress report as having served as controls. The next 36 subjects received two breakfasts with 0.85 microcuries of45 CA in each. Another 9 subjects each received a single injection of 0.75 microcuries of 45CA, as well as a single breakfast containing an additional 0.85 microcuries of 45CA. These subjects each weighed between 63 and 92 pounds and received 1.0 microcuries of 45CA orally. The effective whole body dose equivalents they received ranged from 6.4 to 4.4 mil1irems. There was I unidentified adult who also received an injection containing 2.02 microcuries of 45CA. The final 3 subjects (for the final total of 57 subjects overall) were not involved in the main set of experiments but received a single injection each for a "long-term follow-up study." The largest effective whole body dose equivalent received by any of the subjects was 15 millirems, and the smallest was 4 millirems. Figure l illustrates the amount of radiation each subject received from participation in the Calcium studies, along with the dose equivalent of radiation from natural background sources in the Boston and Denver areas as previously discussed. For comparison, the doses persons receive today in common medical diagnostic procedures, ranging from a chest X-ray to a brain scan, are also given in a third chart. One of the subexperiments within the calcium metabolism study involved a 10-year-old patient who was terminally ill with Hurler- Hunter syndrome (which in that time period was also referred to by the archaic and unacceptable term "gargoylism"), a degenerative disease of the nervous system associated with defective mucopolysaccharide metabolism. The patient was given 80 microcuries of 45CA and was found to have abnormal calcium metabolism, but he died before the study could be completed. The researchers were from MIT, the Harvard Medical School, and Fernald. The research was supported by the Quaker Oats Company and the Atomic Energy Commission. The risk assessment done by Dr. Joseph L. Lyon, an outside epidemiologist with a specialty in radiation medicine (see full text in Appendix G), was very reassuring to the Task Force on these nutritional research studies. Dr. Lyon not only concurred with the dosimetry done by Dr. Lister (also in Appendix G), and supported the findings of the other three expert opinions received, but he was also able, as an epidemiologist, to state that "children exposed to ionizing radiation generally manifest the excess risk of leukemia in the first 15 years after the exposure." Between 40 to 50 years have now passed since these research studies were done, allowing Dr. Lyon to speculate that if the subjects did not exhibit a leukemia between 1961-1970, then it is unlikely that they would suffer this most severe of potential medical risks from either the Calcium or Iron tracer studies. ___________________ 3 F. Bronner, R.S. Harris, C.J. Maletskos, and C.E. Benda, "Studies in Calcium Metabolism. Effect of Food Phytates on CA Uptake in Children on Low-Calcium Breakfasts," J.Nutrition 54, 523-542 (1954). 4 F. Bronner, R.S. Harris, C.J. Maletskos, and C.E. Benda, "Studies in Calcium Metabolism. Effect of Food Phytates on 45CA Uptake in Boys on a Moderate Calcium Breakfast," J.Nutrition 59, 393-406 (1956). 5 F. Bronner, R.S. Harris, C.J. Maletskos and C.E. Benda, "Studies in Calcium Metabolism. The Fact of Intravenously Injected Radiocalcium in Human Beings." J. Clin. Invest. 35, 78-88 (1956). 17 Figure 1: Calcium & Iron Studies Compared wiuth Annual Background Exposure to Radiation in Boston, in Denver, and in Common Medical Procedures FOR REFERENCE SEE (4bb11) 18 SPECIAL NOTE: During the archival review, the Task Force compiled a comprehensive set of records that address key areas of concern. These include an outline of the understanding of tracer studies in the 1940s; the rationale for the nutritional research studies; reasons the studies were done at Fernald; the existing policies and guidelines for conducting research on human subjects in that era, including steps taken by the researchers to gain permission from the state and federal authorities to conduct the research; and the methods used to obtain consent from parents/guardians. Permission for wards of the state to participate was given by the superintendent of the institution. An outline of the contents of these records is in the following section, "Archival Record Chronology," and copies of the original archival records can be found in Appendix B.  Thyroid Studies Unlike the nutritional research studies, this report will not contain dose interpretation or risk assessment for the Thyroid studies. This will be conducted by the follow-up working group.  Nuclear Fallout Study: Wrentham This study was singled out for special and immediate treatment due to the nature of the study. A press release was issued by the Task Force on February 8, 1994, alerting the public to its discovery. Studies of this nature fall under what society has come to call "Cold War experiments," focusing on the medical -effects a civilian population will suffer from fallout following a nuclear attack or accident. The body requires iodine as a nutrient, and uptake of the small amounts normally present in the diet is high. The purpose of this study was to determine how much normal iodine was needed to be added to the diet of children to block the uptake of radioactive iodine they might be exposed to from nuclear fallout. The study6 involved 70 subjects, who ranging in age from l to 11 who were residents of the Rental School. The 63 primary subjects were given daily dietary supplements of stable (nonradioactive) sodium iodide, ranging from 100 micrograms to 1,000 micrograms, for a period of 12 weeks. An additional 7 subjects were given a single dose of 1,500 micrograms per square meter of body surface of stable iodide. Radioactive iodine, 131I, was given as a tracer to measure the rate of uptake of stable dietary iodine. One of the researchers has since died and the other two were unable to provide any significant additional details, but it appears from Figure l of the article7 that l microcurie131 I was given to 5 2-year-old subjects every 2 weeks for l4 weeks. Thus, each subject received a total of 8 microcopies of131I. Similar doses were probably given to the other subjects in the study. The researchers were from the Harvard Medical School, Massachusetts General Hospital, and the Boston University School of Medicine. The research was supported by the Division of Radiological Health, Research Branch, of the U.S. Public Health Service. __________________________ 6 K.M Sanena, E.M. Chapman, C.V. Pryles. "Minimal Dosage of Iodine Required to Suppress Uptake of Iodine-131 by Normal Thyroid." Science 138. 430-31 (1962). 7 Ibid 19 The Task Force has been informed by the outside experts that the stable iodine should have posed no risk in and of itself as it is a normal dietary requirement. Literature cited in the journal article arising from this study stated that even unusually high levels of ordinary iodine would only pose problem if administered for several years. With enriched flour and other foods, the modern diet can easily include about 1,000 micrograms per day of iodine. Of concern, however, is the dose of the radioactive iodine to the thyroid and the potential for the subjects to have developed thyroid nodules and cancers. Previous studies, completely unrelated to residents of these state-operated facilities, had shown that some children treated with large doses of X-rays to the head and neck developed both. Yet, in other nationally published studies, injection of 131I has appeared to be about three times less likely than an equivalent external dose of X-rays to produce disease, probably because the dose is spread out in time and is less uniformly distributed in the thyroid. Further investigation revealed a large epidemiological study of 35,074 patients in Sweden8 who were given 131I for diagnostic purposes. The patients did not show an increase from the normal risk of cancer found nationally after periods of 10 to 20 years. The average dose to the thyroid gland in the Swedish studies was 50 rads, about the same as the maximum dose to any subject in the Wrentham study. Yet, again, opposing statistics were found in a second large epidemiological study9 of persons living in the United States who were followed for evidence of thyroid disease as a result of exposure to radioactive fallout from weapons testing. These subjects did show an increase in the percentage of thyroid disease above the expected range. Clearly, there is no definitive theory as to the absolute long-term risk in the area of 131I exposure. Wanting to err on the side of not ignoring any potential for risk, one of the authors of, this latter study, Dr. Lyon, was one of the experts called upon for an opinion of risk assessment on the nutritional research studies for this report.  Thyroid Function in Down Syndrome: Wrentham There was a second study published in 196510 by two of the three authors of the Wrentham nuclear fallout study noted above. From conversations the Project Coordinator had with Dr. Saxena, this second study was created with some degree of overlap in subject data. The purpose was to test the thyroid function in children with Down syndrome and to compare it with children whose thyroid function was normal. The study involved 53 children with Down syndrome, along with 51 other children with mental retardation of other etiology from Wrentham: ages ranged from l through 15. The published article does not give information on the dose of radioisotopes the subjects may have received. Neither Dr. Saxena nor Dr. Pryles have any records from that study still in their possession. The conclusion from the research was that iodine uptake and plasma levels of thyroid hormones were within the normal range for these subjects. The researchers also concluded that red blood cell uptake of the thyroid hormone triiodothyronine labeled with 131I could be used as a test of thyroid function. This was an in vitro test and did not require giving radioactive iodine to the children. The researchers were from the Harvard Medical School, Massachusetts General Hospital, and the Boston University School of Medicine. The research was supported by the Division of Radiological Health Research Branch, of the U.S. Public Health Service. __________________ 8 L.E. Horn, K.E. Wiklund, G.E. Lundel, N.A. Bergman, G. Bjelkengren, E. S. Cederquist, M.E. Lidberg, H.V. Wicklund and J.D. Boice, Jr, "Cancer Risk in Population Examined with Doses of I-131," J. Nat. Cancer Inst. 81, 302-306 (1989). 9 A Cohart Study of Thyroid Disease in Relation to Fallout from Weapons Testing, "JAMA 270, 2076-2082 (1993) 10 K.M. Saxena and C.V. Pryles, "Thyroid Function in Mangolism," J Pediatrics 67, 363-370 (1965.) 20  Thyroid Function in Myotonia Dystrophica This research involved a study at Beth Israe1 Hospital of thyroid function in 6 patients with myotonia dystrophica,11 a severe chronic neurological disorder. Thyroid pathology had been observed to accompany this disease, but the relation between myotonia dystrophica and thyroid problems was unknown. The goal of this study was to clarify the situation. The 6 patients were all male and are identified by their initials in the published article but their ages are not given. The only indication they might be connected with Fernald is that Dr. Benda, the Medical Director for Fernald at that time, was the first author of the published article. Just as this report was going to press, the Task Force had received additional papers direc1y from the Benda estate, and there appears to be more definitive and identifying information available to the follow-up working group. The conclusion was that thyroid function in these subjects, as measured by uptake of the radioactive tracer, was within the normal range. As pathology reports indicated that the thyroid gland was found to be larger than normal in most patients with myotonia dystrophica, the authors concluded that in patients with this disease the thyroid gland operates at a lower than normal capacity, but the capacity is sufficient to maintain an output that is clinically, biophysically, and biochemically within normal range. The researchers were from MIT, the Harvard Medical School, and Fernald. The research was supported by the Atomic Energy Commission and other unidentified sponsors.  Thyroid Function in Down Syndrome: Fernald At the time of this study, the origin of Down syndrome (mongolism was the archaic and unacceptable term used for this syndrome at that time) was unknown, but children with this condition were reported to have abnormal thyroid glands, as were their mothers. The purpose of this research12 was to examine thyroid function in 21 residents at Fernald as well as in 7 parents. The parents who were used as subjects in this study did not necessarily their own children participating in this study but had been recruited by Dr. Benda who knew them as parents from Fernald. The level of radioactive iodine tracer 131I used in the study, again, caused the Task Force serious concern and will be a key study in the follow-up analysis being done by the working group. The conclusion was that thyroid function in both the subjects with Down syndrome and the parents was normal. Those with Down syndrome demonstrated higher turnover rates of iodine, which suggested that a smaller effective portion of the thyroid gland was working at an intense rate in order to maintain normal levels of thyroid hormones. The researchers were from Harvard Medical School and the Beth Israel Hospital. The research was supported by the National Institute of Arthritis and Metabolic Diseases and the Atomic Energy Commission. __________________ 11 C.E. Brenda, C.J. Maletskos, J. C. Hutchinson, and E.B. Thomas, "Studies of Thyroid Function in Myotonia Dystrophica," AmJ. of Medical Sciences 228, 668-672(1954) 12 G.S. Kurland, J. Fishman, M.W. Hamolsky, and A.S. Freedberg, "Radioisotope Study of Thyroid Function in 21 Mongoloid Subjects, including Observations in 7 Parents," J. Clin. Endoc. and Metab. 17, 552-560 (1957) 21 Archival Record Chronology This section presents a chronology of events and facts leading up to and encompassing the Iron and Calcium studies that were done using Fernald School residents as subjects. They are reproduced here in their entirety to allow full disclosure of all the facts found. Copies of the actual archival letters and reports referred to in this chronology may be found in Appendix B. LEGEND OF MAJOR NAMES FOUND IN THIS CHRONOLOGY AEC Atomic Energy Commission DMH Department of Mental Health F Fernald School MIT Massachussetts Institute of Technology NBL Nutritional Biochemistry Laboratories, MIT Abersold Dr. Paul C. Abersold, Isotops Branch, AEC Benda Dr. Clemens E. Benda, Medical Director, Fernald Bronner Dr. Felix Bronner, Primary Researcher in the Calcium studies for his doctoral thesis, MIT Evans Dr. Robley D. Evans, Professor of Physics, MIT Farrell Dr. Malcolm J. Farrell, Superintendent, Fernald Harris Dr. Robert S. Harris, Director, NBL, MIT Lough S. Allan Lough, Chief, Radioisotopes Branch, AEC Perkins Dr. Clifton T. Perkins, Commissioner, DMH Sharpe Dr. Leon M. Sharpe, Primary Researcher in the Iron studies for his doctoral thesis, MIT Tadgell Dr. Henry Tadgell, Superintendent, Belchertown,and Secretary to the DMH Advisory Committee on Psychiatric Education and Research --> The use of this symbol shows an archival record the Task Force felt to be of special significance. 22 1945 July l, 1944-June 30, 1945 (Appendix B-1) Report of Progress in Research/MIT: NBL annual report announcing their intended study of "Effect of Phytates upon the Absorption and Excretion of Calcium, Phosphorous and Iron," on page 15 of the report. December 19, 1945 (Appendix B-2) ----> Correspondence from Harris (MIT)to Farrell (F) identifying the general reasons for the studies contemplated and why Fernald was selected as the site. Most illuminating are references to the advantages of conducting such experiments with institutionalized populations. Nutritional scientists had been alerted by animal research which suggested that phytates in cereal products block absorption of calcium and iron. It is stated in this letter that initially animal studies would be carried out to work on experimental techniques and to establish procedures. However, to examine the role of phytates in the human diet, it was desirable to study children who ingested standardized diets in a controlled setting; hence, the decision to use residents of Fernald. Fernald's proximity to universities is also mentioned as a reason for its selection. Harris notes that radioactive iron tracers would be used and explains that radioactive minerals are metabolized in the same manner as nonradioactive forms and thereby could be used to trace the metabolic process in the human body. In other words, a small "tracer" dose of radioactive iron would be added to ordinary nonradioactive iron in phytate-containing cereral that would be served to the subjects as part of their breakfast meals. The dosage of radiation intended to be received by the subjects would "emit less energy than from the cosmic rays continually bombarding people living at the altitude of Denver, Colorado." A two-year follow-up study of medical students who had received three to five times the dosage of radioactive substances revealed that "there is absolutely no ground for caution regarding the quantities of radioactive substances which we would use in our experiments." ----> (Note: A draft of a letter from Evans [MIT] to Abersold [AEC] is included in B-2/A because it gives a good summary of the current thought on the risks associated with the use of radioactivity in the 1940s.) For one month prior to the beginning of the study, vitamins would be administered to the subjects to ensure that vitamin deficiencies would not influence the studies. Harris also offer "if there is any way in which we can reward our subjects, we would be glad to do so." The letter ends by noting that "the results of this investigation will be of great importance and will influence our thinking in terms of the nutrition of mankind." (Note: Interestingly, during the review process a letter was found concerning the recruitment of subjects noting that the researchers preferred male subjects to female subjects due to the "issues of collecting urine and stool specimens." However, it was stated that if enough males had not been identifed, they would have used females. This was not the case and no female subjects were used in this study.) December 27, 1945 (Appendix B-3) ----> Correspondence from Perkins (DMH) to Farrell(F) appears to show that the proposed iron tracer study was actually the first research done at Fernald with outside collaborators, for Perkins writes: "Perhaps you have not yet become familiar with our procedures in research activities. These proposed activities go through the Advisory Council on Research and Teaching." This is also the first evidence the Task Force found that some method had been established for review and approval of proposed research studies involving the residents of Fernald. Farrell is advised to contact the council. It appears that there is little likelihood the project would be rejected, however, for Perkins advises Farrell to go ahead and select the "fifteen or so patients" and to get the "necessary family approvals." Farrell is given permission to start administering the prestudy vitamins for the next month. December 29, 1945 (Appendix B-4) Correspondence from Tadgell (DMH) to Farrell (F) informing him that the proposed research study will be 23 brought before the committee and inviting him to attend the meeting. 1946 March 29, 1946 (Appendix B-5) ---> Correspondence from Perkins (DMH) to Farrell (F) noting that the Advisory Committee unanimously approved the proposed iron tracer research, that the Department of Mental Health concurred, and that he was free to proceed "in the research at the full and proper level." July l, 1945-June 30, 1946 (Appendix B6) Report of Progress in Research/MIT: NBL annual report confirming that the iron and calcium components of the research proposal have now been divided into two separate studies and that the Iron study has been chosen to be done first. 1948 July 1, 1946-June 30, 1948 (Appendix B-7) Report of Progress in Research/MIT: NBL annual report showing the findings of the Iron study and announcing that the Calcium study (to be called "Effect of Phytates upon the Absorption of Radioactive Calcium") is now in the planning stage. It is noted that animal studies will be done first to prove that radioactive calcium is not toxic for human beings. 1949 March 23, 1949 (Appendix B-8) Correspondence from Harris (MIT) to Benda (F) enclosing an outline of the research experiment using radioactive calcium that had been discussed with him at a luncheon the week before. Another luncheon for further discussion with Evans (MIT) is offered A copy of this original outline was not found. April 13, 1949 (Appendix B-9) Correspondence from Harris (MIT) to Benda (F) concerning the revised outline and setting a time and date for the luncheon discussed in the previous letter. A copy of the revised outline is included in B-9/A. April 20, 1949 (Appendix B-IO) Correspondence from Benda (F) to Tadgell (DMH) requesting the DMH Advisory Committee (whose function was to review any research proposals) consider the Calcium study proposal. Benda states that "the study does not include any danger to the life or health of the patient" and that it "appears desirable" to get the committee's approval. He also notes the previous approval of a similar study, presumably the one using radioactive iron. April 26. 1949 (Appendix B-11) Correspondence from Joel B. Bulkley (MIT) to Benda (F) sending him copies of AEC Form 313 prepared for his signature, a copy of a letter from Evans (MIT) to attach to the final set of forms, and a reminder set of instructions on what he must do to complete the AEC application process. This is presumably a request for the radioactive calcium isotope. (Note: The isotopes used in the earlier Iron study were made in the MIT Cyclotron.) May 7, 1949 (Appendix B-12) Correspondence from Tadgell (DMH) to Farrell (F) notifying him that the protocol for the proposed Calcium study had been presented to the DMH Advisory Committee and after "a goodly amount of discussion" it was voted to defer approval until it was further discussed at the next meeting. Benda (F) was invited to attend to discuss "any questions that may arise." (Note: The Task Force searched for, but did not find, any minutes or correspondence to clarify the discussion held at the Advisory Committee meeting.) May 18. 1949 (Appendix B-13) Correspondence from Farrell(F) to Abersold (AEC) confirming the formation of an Isotopes Committee and, as its chairman, giving his approval of the proposed calcium research. This is part of the process requested by the AEC as referred to in Bulkley's (MIT) earlier correspondence (April 26, 1949). 24 On the next page (B-13/A) Benda (F) has sent to Abersold a list of the names of this new committee to comply with the AEC requirements. The membership included Farrell, Benda, Dr. Maximilian Weinberger (an assistant physician), and Dr. Elizabeth Belmont (a physician), all from Fernald, and Dr. Earle Chapman from Harvard Medical School. The committee's responsibility was to "supervise the proposed research." June 8, 1949 (Appendix B-14) (Graphic) Correspondence from Tadgell (DMH) to Farrell (F) announcing that the DMH Advisory Committee gave unanimous approval to the Calcium study's protocol and thanking Benda (F) for attending and answering questions. September 28, 1949 (Appendix B-15) Correspondence from Lough (AEC) to Benda (F) providing the authorization number (#3435) for the "procurement of up to three millicuries of 45CA of high specific activity from the Massachusetts Institute of Technology." Enclosures noted as attached (included in Appendix B-15/A-C) are: 1. Copy of a letter from Lough (AEC) to Evans (MIT) 2. Form No. 374 3. Form No. 313 4. Certificate No. 3435 (Note: This is the only attachment that was not found.) (Note: An AEC Order Blank and a listing of AEC documents (B-15/D-E) that were available for purpose through the Technical Information Branch are included because they illustrate the type of studies being conducted nationally at that time which utilized radioactive materials.) September 28, 1949 (Appendix B-16, 17, & 18) ----> Correspondence from Lough (AEC) to Evans (MIT) explaining that the "one irradiated unit of CA 45" that was applied for (listed as CaCO3, item #13A) contains "about three millicuries." (Note: That would be enough for 3,000 doses of one microcurie each.) Evans is advised that he can order smaller, specific amounts that would be adequate for their needs. ----> In the third paragraph, Lough refers to the letter sent to Benda (F) mentioned above and notes that the AEC Subcommittee on Human Applications had stipulated that "only one dose of Ca 45 is to be administered to each normal child used in the study." This appears to bear witness that the federal-level Research Advisory Board of the AEC, which reviewed research applications for studies involving human subjects, had also given approval to this study's protocol. (Graphic) Appendix B-17, October 27, 1949: Correspondence from Benda (F) to Lough (AEC) stating that although he has apparently consulted with a physicist, he still has a question whether or not the "one dose" the AEC said could be given to a child subject consists of the entire three millicuries. (Note: This would actually be the maximum total amount of material the researchers were authorized to obtain for the whole study.) Benda asks for clarification of the size of the allowed dose. (Graphic) Appendix B-18, November 3, 1949: Correspondence from Lough (AEC) --signed by James R. Mason-- to Benda (F) answering his question about dosage. Lough quotes from the original application to the AEC for permission to have the isotopes and reminds Benda that the application stated that no subject would receive more than one microcurie. (Graphic) The AEC application also stated the researchers were interested in using subjects in more than one test. The AEC clearly preferred that the subjects receive only one dose of radioactive calcium (not to exceed one microcurie). Recognizing that the researchers wanted to have some of the subjects participate in more 25 that one study, Lough agrees to allow this for "mentally deficient" subjects provided they did not receive more than the stipulated maximum of one microcurie. He added that the AEC Subcommittee on Human Applications recommended that "normal" control subjects only be allowed to participate in one study with an identical maximum dose of one microcurie. (Graphic) The letter appears to be evidence that the AEC made a distinction between "normal" and "mentally deficient" subjects in terms of their use in multiple experiments, even though the maximum allowable dose was held the same. No explanation was offered in any of the documents for this distinction. (Graphic) (Note: The Task Force review did note that most of the subjects received 1.7 microcuries, instead of the 1.0 microcuries permitted by the AEC at that time.) November 2, 1949 (Appendix B-19) (Graphic) Correspondence from Farrell (F)to the parents/guardians of the proposed subjects requesting permission for their children to participate in the study. Farrell does not include information that there are radioactive tracers involved but highlights the fact that the subjects wi1l have a "special diet" rich in iron and vitamins and implies that there will be "gains in weight and other improvements. Farrell notes that there will be multiple blood tests, and assures that the tests are the same type the residents had experienced previously and that they would cause "no discomfort." Once again Farrell states there may be possible improvement from participation. He goes on to say that MIT "plans to reward patients taking part." He ends by personally assuring the parents that he feels this project "will be of great importance and that much valuable information concerning nutrition can be obtained which eventually will be of considerable benefit to mankind" and again asks for their cooperation. 1950 March 10, 1950 (Appendix B-20) Correspondence from Harris (MIT) to Farrell (F) giving the results of a one-week survey on the food served to the general population at Fernald. The full results are given with the notation that "the food being served at the Fernald School does pretty well in meeting these estimated requirements" established by the Food and Nutrition Board, National Research Council. 1953 May l, 1953 (Appendix B-21) ---> Correspondence from Harris (MIT) to Benda (F) outlining the next proposed study "of five different calcium sources." It discusses the need to recruit 15 subjects to participate. Harris writes that Bronner (MIT) had "lined up" ten subjects but "three of these subjects objected to be [sic] included in the study and this reduced the number to seven". He further notes that five of the boys who had participated in the earlier study, were interested in joining this one; however, they had already received one microcurie of 45CA so they would not be able to participate in this new study. It was planned that each subject would participate in five separate experiments within the study, receiving one microcurie in each experiment. (Note: The Task Force could not verify if the AEC did or would have approved that, although records show that the allowable maximum dose was requested to be raised to five microcuries.) Harris notes that they had "neglected the Fernald Science Club angle"; he suggests a baseball game be lined up. He also asks that an assembly be arranged so they could encourage the boys to participate and to "feel satisfied their small pain is really worthwhile." (Note: The letter shows two aspects of the "recruitment" process. First, the residents were offered" incentives that would be hard for an institutionalized individual to resist. Second, the residents were given some opportunity to decide whether or not to participate in the research study. In conversations with the Project Coordinator, both of the primary researchers from the Iron and Calcium studies expressed a level of personal involvement and 26 friendship that developed with many of the boys. It is Dr. Bronner's recollection in one of the conversations that funds were not secured for this particular experiment as outlined and it was not conducted at Fernald after all. Bronner also recalled that the studies were continued on animals. The Task Force secured a copy of a MIT press release from 1957 announcing that Harris received funding for calcium nutrition studies from another source and the subjects would be primates. The Task Force did find an abstract in Federal Proceedings [15, 575-76 (1956)] reporting a comparison between human and animal calcium metabolism. It includes primates and the human data results appear to be from the nine boys and one adult subjects from the earlier Calcium injection subexperiment done as a part of the Calcium study.13) May 3, l953 (Appendix B-22) Handwritten note from Dr. Kelley (a physician on staff at Fernald) to Benda (F) listing seven boys who had "signified their willingness to participate" as well as five boys "who have previously been in the science tests [and] are willing to participate again if accepted." (Note: Any archival record that reveals a resident's name is reproduced in this report with blocked out to respect the individuals right to confidentiality.) May 28, 1953 (Appendix B-23) (Graphic) Correspondence from Benda (F) to the parents/guardians of the proposed subjects requesting permission for participation in the study. Again, there is no indication that radioactive tracers are being used in the studies explained in this letter. Benda states only that the meals will have "a certain amount of calcium." The taking of of blood is revealed and "privileges" such as "a baseball game, [a trip] to the beach, and to some outside dinners" are given as incentives/rewards. (Graphic) Significantly, this letter states that "if you have not expressed any objections [by the given date] we will assume that your son may participate." (Note: The lack of information concerning the use of radioactive material again renders it impossible to obtain informed consent. In addition, no affirmative act was reqired by a parent for consent to have been assumed. In other words, the act of nonresponse was assumed to provide consent.) June 5, 1953 (Appendix B-24) Graphic) A list of "Science Club Boys" from Boys Hall (BH). Two of the boys have a notation after their names that show a parent/guardian had given permission for their participation, and three other boys had notations of their birth year, mental age, IQ, and weight. There is also a list of names (B-24/A) that had an envelope attached which had been stamped "return to sender." It appears to have been kept in the records to verify the effort to contact that parent/guardian. The Task Force also found a copy of a letter that was marked as having been addressed to both parents, living at separate addresses, which appears to again verify the administrators' efforts to reach either or both parents. (Note: This same method of detailed record keeping of the outrtach done and consent forms received, listed by name and relationship, was found for all of the nutritional research studies.) June 29, 1953 (Appendix B-25) Correspondence from Benda (F) to a parent regarding her plans to take her son on vacation. It notes that the son is cooperating in a Science Club study and requests that she delay the pick-up for two days due to his participation in the study. (Note: The letter appears to imply that she was not aware of the dates of the study. The Task Force cannot determine if this was due to her having not been contacted, having been one of the parents who had not responded one way or another, or simply not recalling that the study was still ongoing at the time of writing. In Bronner's thesis [MIT], it states that one of the boys did not participate in one of the tests because he was away on vacation. We can infer her answer to this requested change in plans was no.) ____________________ 13 F. Bronner, R.S. Harris, C.J. Maletskos, and C.E. Benda, "Studies in Calcium Metabolism. The Fate of Intravenously Injected Radiocalcium in Human Beings." J. Clin. Inves. 35, 78-88 (1956). 27 July 1952-June 1953 (Appendix B-26) Annual Report of the Research Laboratory Ferald highlighting the calcium metabolism studies (on page 3). It verifies that studies using 45Ca were still ongoing through this time period. September 29, 1953 (Appendix B-27) (Graphic) Correspondence from Benda (F) to the AEC requesting permission to inject 50 uc (microcuries) of 45Ca into "a moribund gargoyle" (an archaic and unacceptable term used at that time for persons with Hurler-Hunter syndrome) who was hospitalized at Fernald. This was a ten-year-old boy whose "life expectancy is now limited to a few months." It is noted that "permission for the use of higher doses administered to moribund patients has been granted by you to other investigators, as evidenced by the report of Sallin and Lassio (Science 117, 331-4, 1953)." (NOTE: This is the only record the Task Force found of the administration of a radioactive isotope to a terminally ill resident at this or any state-operated facility.) October 6. 1953 (Appendix B-28) Correspondence from Benda (F)to a parent noting that "we cannot find that we have ever received a reply to our letter of August 7 asking permission for your son to participate in examinations in connection with the nutritional department of the Massachusetts Institute of Technology." He states that the studies are designed "to improve the nutrition of our children." Benda also states that the young man in question has "expressed willingness" and asks that the permission slip be signed and returned. December 2, !953 (Appendix B-29) Correspondence from Harris and Bronner (MIT) to Farrell (F) outlining plans for the Science Club members' Christmas party. 1955 October 18. 1955 (Appendix B-30) A list of 37 boys, with a notation identifying parents/guardians to be contacted, or a designation of "no relatives," meaning they would be deemed "state wards." Thirty-three letters are noted as having been sent to parents for permission for the boys to participate in the study. (Note: The Task Force has not found any records relating to this last Calcium study proposal; therefore, it cannot be determined if the study was funded or carried out. However, the two Task Force members who were residents at Fernald and who have memories of being members of the Science Club did not live at the facility during the time of the earlier studies. As a result of their memories, the Task Force believes that another Calcium study or studies did occur and are actively seeking information.) October 18. 1955 (Appendix B-31) Correspondence from Benda to a parent/guardian following up on his request for permission for her son/ward to participate in "some planned research." He states that "most of the parents have given permission" and requests a reply. This letter has the approval line signed by Farrell (F). (Note: Again, this would relate to the study for which no archival records have been found.) 1956 June I, 1956 (Appendix B-32) Correspondence from Dr. Jack R. Ewalt, Cornmissioner of DMH at this time, to the Superintendent at Fernald requesting a listing of current research projects, to be submitted to the Governor and "certain members" of the legislature to support their budget request. As the records reveal, these studies were carried out openly, with permission from the appropriate state and federal agencies given oversight in that era. Outreach for permission was carefully documented, including all steps taken to secure it. The results of these studies were freely published in the scientific literature of the day. Despite these governmental approvals, the accepted level of permission outreach of the day, and the publication 28 of the research findings, four troubling themes pervade these findings: Full disclosure of all relevant information (specifically that radioactive materials would be used) was not given to the proposed research subjects' parent/guardian to assure informed consent. .The apparent attraction of state-operated institutions as the location for research studies to be done due to the controlled environment; The use of a potentially coercive factor, even if not intended in that fashion, by way of a set of "rewards" that would be almost impossible for an institutionalized person to resist, was offered in opposition to the opportunity that was given to the boys to withdraw or refuse to cooperate as subjects; and The lack of affirmative action required for the actual granting of consent. 29 How Could It Have Happened? The question "How could it have happened?" has been the topic of numerous articles, talk shows, and personal discussions since these reseach studies were disclosed at the end of 1993. This section will only briefly highlight the factors that contributed to the atmosphere of permission for the studies which occured in the state-operated facilities administered by the then Departmentment of Mental Health (now the Department of Mental Retardation) in the l940s through the 1960s. These factors served as subtle contributors to the pervasive atmosphere of the time that influenced the behavior of all persons involved. These influences include the following:  The laws that surrounded the issues of guardianship for those committed as state wards' and  The laws and policies of the day concerning informed consent for research studies. The section concludes with some compelling first-person narratives. They were submitted to the Task Force by persons who were themselves residents or family members of residents who lived at the Fernald School during this era. These documents provide insight into the everyday life within an institutionalized setting as no other archival record could ever achieve.  Background on Guardianship & State Wards from 1940 to 1960 The laws of guardianship can be traced through most of the legal systems in the civilized world. Dating back to Roman law, governments provided protection of property of individuals deemed to be incompetent. The legal principle, once established, flourished and became standardized in English law for persons who were mentally ill (as all persons who also had any form of cognitive disability, social or cultural issues, or mental retardation were once termed). Much of the law of the United States is deeply rooted in English law. "Statutory provisions for the restraint and care of the mentally ill dates from the seventeenth century. In 1676, town selectmen [in Massachusetts] were charged with the care of distracted persons... that are unruly, whereby not only the families wherein they are; but others, suffer much damage by them so that they do not damnify others."14 In 1694, Massachusetts expanded the statute regarding the appointment of a guardian for persons deemed mentally disabled. The statute provided that municipal officers must "provide for the relief, support and safety of any person who is naturally wanting of understanding so as to be incapable to provide to him/herself or who shall fall into distraction and become non compos mentis."15 In 1726, the Commonwealth enacted the first statute pertaining to the appointment of private guardians for "any ideot [sic] non compos, lunatik [sic], or distressed person."16 The same statute provided for judicial determination of mental incompetence. The statutory standard that mandated the appointment of a guardian if an individual was found not capable of taking care of him/herself remained the prevailing standard for more than 150 year. ____________________ 14 Doe v. Doe, 377 Mass. 272-275 (1979) citing 5 records of the Governor and Company of the Massachusetts Bay in New England 1674-1680, 80 [1854]). 15 Cross et al., Supra, 1-10 (quoting Province Laws 1693-1694, c. 18 1) 16 Doe v. Doe, 377 Mass. 272-275 (1979( (quoting Province Laws 1726-1727, c. 12 1). 30 The statutes pertaining to persons with mental illness were incorporated into the 1932 General Laws of Massachusetts, Chapters 123 and 201. Section 2 of Chapter 123 provides in part the state's role: "[The Commonwealth shall have] the care, control and treatment of all insane, feeble-minded persons...the care of whom is vested in it by law, and of each person who shall hereafter be received by any state hospital." Through this section, the Commonwealth of Massachusetts retained exclusive control over and custody of those deemed mentally ill. Section 4 of Chapter 123 continues to outline the responsibilities of the Commonwealth by mandating that "the commissioner shall administer the laws relative to persons in institutions under the general supervision of the department." The Commissioner, or Superintendent of a particular facility, possessed great anthority in the regulation of not only the affairs of the institution but also the affairs of the individuals within the institution. In addition, in Section 11 of Chapter 123 the statute directs the Department of Mental Diseases to "encourage scientific investigation by the medical staffs of the various institutions, [and it] shall publish from time to time bulletins and reports of the scientific and clinical work done therein." Chapter 201 of the General Laws provided that a "guardian of a minor shall have the custody of his person and the care of his education, except that the parents of the minor, jointly or the surviving parent, shall have such custody and said care unless the court otherwise orders." The statute continues to define the rights of the guardian in Section 12, which provides that the guardian "of an insane person ... shall have the care and custody of the person of his ward except as provided in Section 24 [regarding married women] and the management of all his estate." In a very real sense, the guardian took responsibility for the care and custody of the ward. In cases of a child whose parents or other family members were not involved, the superintendent became the guardian and the child was considered a "ward of the state."17 In Dr. Stanley Herr's book, Rights and Advocacy for Retarded People, there is a compelling quote that reflects the level of authority and power that was vested in an institution's administration when it came to day-today control it had over the residents' lives: "Once an individualL was committed, the legal system's role abruptly ceased. Rights were permanently abrogated by conditions that destroyed any expectation of claiming them. The rule of the superintendent substituted the rule of law. The courts, like the rest of society, expected the superintendent to act on behalf of residents. Institutions had practically full authority over every aspect of their residents existence. With virtually nothing to fetter their discretion, institutional staff exercised powers over theindividual unique in American life."18 The Commonwealth has a traditional power and responsibility, under the doctrine of parens patriae, to care for and protect the "best interest" of the persons residing in its institutions. However, the definition of "best interest" was left in the hands of the Superintendent or Commissioner to define. In other words, the Superintendent had total control and authority over every aspect of an institutionalized resident's existence.  The Development of Informed Consent It was only during the twentieth century that the idea of providing information about procedures to patients and/or research subjects began to be considered important. The history of informed consent as it relates to the research studies from the l940s to the 196Os can best be understood by dividing its development into two distinct periods: pre-World War II (up to 1945) and post-World War II(1946-1972). The changes that occurred from 1972 to the present will be covered in the next section, "Could It Happen Today?"  Pre-Wor1d War II (up to 1945) Prior to World War II, the doctrine of informed consent began developing based on a judicial deference to individual autonomy and the belief that a person should not be forced to act against his or ______________________ 17 MGL c201 12 (1932) 18 S. Herr. Rights and Advocacy for Retarded People (Lexington, Mass Lexington Book 1993 p.0 31 her will. For example, in 1914 Justice Benjamin Cardozo stated: "Every human being of adult years and sound mind has the right to determine what shall be done with his own body.19", Early consent doctrine was based on the common law tort of battery, defined broadly as an "unconsented to touching." Being based on the tort of battery, the idea of informed consent during this time period was, in fact, quite limited. For a physician to meet his/her duty under the law, s/he generally needed only to explain the procedure in general terms to the patient.20 There was no common law requirement that the physician disclose to the patient the risks of the procedure, other treatment options, or any of the other substantive components of today's informed consent requirements. In addition, there was nothing in the law which specifically required that the patient actually understand what the physician was telling him/her. So long as the physician gave the required explanation to the patient, and the patient seemed to understand what was being told to him/her, the physician was held to have met the reqirements under the common law consent doctrine of the time. There was even less concern with informed consent prior to World War II from the statutory side of the law. To state it succinctly, there were no statutory and very few other formal codes for informed consent prior to 1946. The pre-World War II law of informed consent with respect to children was based on the traditional view that children were legally unable to give consent. Based on the common law, the parents of the child, or his or her legal guardians, were the ones entitled to give consent for any procedures the child might undergo.21 In the case of Bonner v. Moran (125 F2d 121[D.C. Cir. 1941]), a federal appellate court considered the question of consent, by a minor and affirmed by a minor and affirmed the general rule that the consent, either expressed or implied, of a parent/guardian is necessary for any operation on a child. The court did note that there were exceptions to the rule where there was an emergency, the child was emancipated, or the child was so close to maturity that the surgeon could rely on his/her own consent. However, in such cases, the procedures were for the benefit of the child whose consent was accepted.  Post-World War II (1946-1972) The starting point for most discussions of informed consent is Nuremberg, Germany, at the trial of the Nazi doctors. From December 1946 through August 1947, twenty-three defendants were put on trial, charged with crimes against humanity. During those eight months, dozens of witnesses and over a thousand documents were presented, all of which told a story of the cruel and inhumane experiments conducted at the hands of Nazi doctors - experiments in which unwi1ling subjects were tortured and ultimately killed in the name of research. At the conclusion of the trial, in which death sentences were imposed on seven of the defendants, the governing body created a set of ethical guidelines for future human experimentation. This set of guidelines became known as the Nuremberg Code (see Appendix H). The first section of the Nuremberg Code states the following: "The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision...The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibllity which may not be delegated to another with impunity." The tribunal that put forward the Nuremberg Code consisted of judges from the United States. Elements of the Nuremberg Code, including the informed consent requirement, became the framework for two new federal regulations that increased the rights of research subjects. During the late l95Os, the Clinical Center of the National Institutes of Health (NIH) adopted guidelines for research volunteers. The Food and _______________________ 19 Schloendorf v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). 20 See Furrow et al., Health Law at 322. 21 For a discussion of the history of children in research, see Grodin & Glantz, Children as Research Subject: Science, Ethics & Law, 1993. 32 Drug Administration (FDA) also issued informed consent regulations, but only after the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1962 were enacted. Both of the federal regulations, however, were limited in their applicability. The NIH regulations applied only to research that was conducted by researchers at the National Institutes. With the FDA regulations, sanctions for not obtaining consent were levied against drug sponsors, not individual physicians. Therefore, these guidelines provided little direct incentive to individual researchers to ensure that all research subjects were giving an informed consent. Within the research community itself, the acceptance of the Nuremberg Code was less well received. In part this is due to the fact that researchers in the United States felt that the basis of the Nuremberg Code (i.e., the Nazi atrocities) were so unlikely to occur in this country that the Code might not be necessary. For example, one physician said, "I think we must read the Nuremberg Code in reference to the conditions under which it was written. This is a wonderful document to say why war crimes were atrocities, but it is not a very good guide to clinical investigation which is done with high motives."22 In addition, there was concern that the Code was too legalistic and difficult to apply in actual research settings.10 Against this backdrop, the research community organized and developed a new set of ethical principles to guide researchers. Known as the Helsinki Declaration, it was adopted by the World Medical Association in 1964 (see Appendix H). The Helsinki Declaration is unlike the Nuremberg Code in that it clearly stresses the importance of research, stating that "it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity." Developed by physicians for physicians, and explicitly recognizing the importance of research, it is not surprising that the Helsinki Declaration was greeted warmly by physicians in the United States as a preferable alternative to the Nuremberg Code. Why then did research still occur in this time period that was in direct contradiction to the guidelines set forth in these documents? In part, the legal and political systems may be to blame. For all the initial talk of the importance of informed consent and the Nuremberg Code, not a single U.S. court even cited the Nuremberg Code until 1973 over years later. In reviewing state common law, the Task Force found that even in Massachusetts, which has a history of being in the forefront of medical research, there was no judicial recognition of a right to informed consent until after 1982. There were, however, precursors within the Massachusetts court system to the doctrine of informed consent.11 A number of decisions in Massachusetts stressed a support for a broad, rather than a narrow, construction of the related issue of a physician's duty to disclose to a patient.12 These cases indicated that the court system was leaning toward the right of the patient when it came to whether or not information should be given the patient by the physician. During the years 1946-1972, there was little evolution of the law of informed consent as it applied specifically to children. As it was prior to these years, a child was generally deemed legally incompetent, and any decisions on being a research subject were left to his/her parent or guardian. The Wheeling Declaration specifically states that, "Clinical research on a human being cannot be undertaken without his free consent [and] if he is legally incompetent, the consent of the legal guardian should be procured." _______________________ 22 P. Beacon, "Panel Discussion: Moral Issues in Clinical Research," Yale Journal of Biology and Medicine 36, p. 464 (1964). 10 GJ. Annas and M.A. Grodin, The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (New York City: Oxford University Press), 1992 p. 204. 11 Forner v. Koch, 272 Mich. 273, 261 N.W. 762 (1935); Bonner v. Moran, 125 F.2d 121 (D.C. Cir. 1941); and Prince v. Massachusetts, 321 U.S. 158, 170 (1944). 12 Madsen v. Harrison, No. 68651 Eq. Mass. Sup. Jud. Ct, June 12, 1957 Huskev v. Harrison, No. 68666 Eq. Mass. Sup. Jud. Ct., Aug. 30, 1957; Foster v. Harrison, No. 68674 Eq. Mass. Sup. Jud. Ct., Nov. 20, 1957. 33 No federal or state regulations were promulgated dealing with children as research subjects until the 1970s, and any judicial cases during that time were decided on the basis of guardianship issues and not informed consent. (Note: Additional research provided by two attorneys who were members of the Task Force on the issue of informed consent is in Appendix L.)  Narratives Life was very different for residents in state-operated facilities and their families from the 1940s through the 1960s. Many residents were there because physicians and other "experts" advised parents or guardians that state schools were the only solution to the medical and social problems facing them. Superintendents exercised almost absolute authority. The threat to "send the resident home" was enough to dissuade most parents from asking too many questions or disputing school practices. Until the 1970s, buildings were dirty and in disrepair, staff shortages were constant, brutality was often accepted, and programs were inadequate or nonexistent. There were no human rights committees or institutional review boards. If the Superintendent (in those days required to be a medical doctor) "cooperated" in an experiment and allowed residents to be subjects, few knew and no one protested. If nothing concerning the experiments appeared in the residents' medical records, if "request for consent" letters were less than forthright, or if no consent was obtained there was no one in a position of authority to halt or challenge such procedures. Hence, if the Superintendent failed in his duty to the residents, there were few if any witnesses or advocates available to safeguard the interests of the residents. The following is a series of observations of life at the Fernald School during this period, written by those who lived it firsthand. My Days at the Fernald School by Charles L. Dyer March 4, 1994 Looking back at my younger days during the years 1955-1961 one would say I have a lot of mixed thoughts and emotions. When I first entered the School I thought I was going there to learn and maybe better myself. But the days turned to months and the months to years with little understanding as to why I was there. As time went on, I guess I started to get bitter: not really having any freedom and finding out that it wasn't a school for learning, but in fact an institution for the mentally retarded. One can't help but ask ... why me? I saw a lot of abuse going on while I was there. Not only to myself but to others as well. During one instance, I saw an employee burning a mentally retarded child with a lit cigarette. My bitterness then turned to rebellion. I didn't care anymore, I just wanted out. To this day, I can't tolerate someone telling me what to do and when to do it. I believe I was mislead not knowing right from wrong, I would agree to anything if it meant freedom (as I knew it). Getting out of the four walls that I felt held me captive. Upon my release from the School, I was put on parole. Now if that doesn't make a person feel like a prisoner then I don't know what does. It's time that all those promises that were made years ago finally be kept today. My only hope is that times have changed for the better. 34 Austin LaRocque's Memories March 8, 1994 Dear Rev. West: You asked me to share my memories of having been a resident of Walter E. Fernald School back in the years 1950-1960. From the understanding I have gotten from the documents I've received from the Fernald State School, I was put into the school for my "best interest" in terms of the areas of learning and receiving an education, but unfortunately this did not happen - and I hope that in the future such problems will never occur with other children. Once I was committed into the school, I was put in a building called B.D. I had many difficulties while in this particular building for two years, such as trying to adjust to taking orders without getting into trouble and getting punished for stupid little things such as talking back to the attendant with your honest opinions. Therefore, this has made me very bitter toward the Institution. It also makes me feel no trust in anyone other than myself. I was then informed that I had a sister Rose Marie LaRocque here at the Fernald State School and this did give me a lift up in life. This made things easier to accept because the school allowed me to visit with her occasionally. This helped to fill my feelings of rejection when other children had visitors and I didn't. I didn't feel quite as alone. In approximately 1955 or 1956 I was transferred to B.H. This time I was offered the right to become a mail delivery person throughout the school and I accepted the job gladly because it gave me the opportunity to see my sister on a daily basis. And then the next opportunity came when someone came to ask use if we would like to join a "Science Club." Because of the need for independence and recognition, we would gladly join anything to receive a small token of appreciation. Technically, I feel that this particular "Science Club" was very dishonest with the children that joined, mainly due to the fact that they did not explain to these children what they were going to do to them and what kind of future effect it would have on them. Therefore, I feel that they should be held accountable for all medical problems that have occurred to these children. Also, anyone else who was involved with this particular program - especially Malcolm J. Farrell who is just as responsible as anyone else because he agreed to the "Science Club" and allowed this program to occur. In my honest opinion I feel that he has done an injustice to all of these students. Only because, to the best of my knowledge, Malcolm J. Farrell was supposed to have medical knowledge and because of this I feel there's no excuse for his allowing it. Dorothy Bourdon: Resident of Fernald since 1947 By Doris Manson March 1994 In 1947, on the advice of my physician, I brought my daughter, Dorothy, to Fernald to be evaluated. She was then 5 1/2 years old and had spoken a few words. Since she had ceased to speak, I was told she had regressed to a lower level of organization and probably would not now develop mentally beyond the age of a 5-year old. They advised that she be admitted to Fernald. Dorothy is non-verbal, and I doubt that she understood the spoken word at this time. She was constantly frustrated, banging he head on points of furniture, door knobs, etc.. She would bite the backs of her hands until she drew blood and they became calloused. Many a day she would put her head through the windows and almost monthly had to be rushed to an emergency room for stitches. This behavior continued after she was admitted. I was at my wits end. I finally, on May 5, 1947, brought her to be admitted to the West Building of the Fernald School. 35 I was advised not to visit for 2 months or more, to give her a chance to become acclimated to her new surroundings and hopefully to wean her away from me. This never happened. The first Sunday of each month was the only time visiting was allowed. When I arrived, I was not allowed beyond the foyer. Dorothy was brought to me. I never saw where she ate or slept for many years. On these visits, I would hold her and rock her the whole time, and when it was time to leave she would cling to me desperately, crying and sobbing until she was forcibly removed. Each month I would hope that maybe in another month I would find her happier. When I look back on this period of my life, I wonder how I ever parted with my only child. I was convinced at the time that I was making the best decision for her, protecting her from the Community ills and providing a roof over her head with three meals a day in the event of my death. Since then I have questioned the fact that I was young and maybe trying to "get a life" s the kids would say today. West Building is the oldest building on campus. It left much to be desired as far as living quarters and care. On visiting, I occasionally got a glimpse of the day room. It was a large, bare room with a cement-like floor. In the middle of the room there was a circular grating where urine and feces were hosed down. Needless to say, the little girls wore no panties. This room had no chairs, the children sat or laid down on the cold flooring. Most of the children laid on the floor because they were given Valium two or three times a day. Many a controversy I had with the doctor over Dorothy's dosage, to no avail. I never saw the bedroom until much later. It was a very large, ward-like room with many beds only inches apart. The only shower I ever saw was on the back porch. The children were taken naked, outside in view of any passerby, to be showered. I am convinced this could not have been a warm shower. The dining area was one large room with long tables and benches. The children sat side by side and frequently stole food from each others' plates. One soon learned to eat fast. Dorothy was so tranquilized that she could not defend herself. On two separate occasions she had the skin torn off both sides of her face, neck and back. No one could give me an explanation of what was happening to her, only that they found her all bloody each morning. I brought her home each time until she was completely healed and I was successful in getting her sleeping quarters changed. She was moved upstairs. It was here I saw roaches, red ants and mice darting in and out to pick up a few crumbs left on the floor. My daughter was delighted with the mice. This building was ultimately condemned for living quarters and Dorothy was moved to West Kelly Building. It was about this time they decided to integrate the sexes; the ladies were housed on the top floor and had to go down three flights of stairs to each meal. The dining area was very large and noisy and Dorothy was very nervous. I saw children in Dorothy's area restrained in straight chairs and left alone in outside halls with all doors closed to them. There were no rules in place regarding restraints. The bathroom was one long row of stalls with not doors. There was no privacy. By the time many parents had banded together forming the Fernald League for Retarded Children. Subsequently, we were allowed to visit inside the buildings and I was now taking Dorothy home each weekend. It was an experience getting in and out of this building. Dorothy would get very nervous when many of the men would get close to us and would not strike out at them. Many a belt she received in return, before I could intervene. I had to be sure I always had a pocketful of nickels when I visited, otherwise the men milling around on the first floor would bar my way, or would not open the door for me. We also had to pass many men standing around masturbating inside and outside the building. Dorothy suffered a head wound in this building. Her skull was compressed over her left temple and she had several stitches. Again, no explanation was ever given to me. To my knowledge, she was not subject to seizures before this. Sometime after this injury she was placed on Dilantin, twice a day, for seizure activity. I was successful in getting her transferred again. This time she was placed in Withington. Withington Building was always a mystery to me. I never could get beyond the Nurse's office. I do know my daughter was very unhappy here. Her next move was to Sequin Hall. By now the League was 36 successful in their "Class Action Suit" against the State and many changes took place. We were successful in implementing rules and regulations against restraints, injuries, abuse, etc. WE also had toilet tissue in all bathrooms! The League at this time bought many washing machines and televisions for the different buildings and financed their upkeep. We had programs in place for the children: many van trips for ice cream, to zoos and circuses, to see Christmas lights, etc. We had cookouts, family days, Halloween parties, spring balls and Christmas parties. We also had vacation trips to New Hampshire and the Cape. At Sequin Hall we had many fine folks in place, a wonderful caring nurse, Ella Stephens, and many devoted Direct Care people. Dorothy seemed to be doing fine here, but then they decided Sequin had to be renovated, so once again, she was moved to the Woodside Building. At the Woodside Building we had our very favorite, kind, wonderful nurse and many fine Direct Care people. In spite of all this, a rape occurred here involving a wheel-chair patient. Dorothy remained here quite happy, for nearly five years then she was transferred back to Sequin Hall. As Building Representative for Sequin, I have worked very hard getting this building on line, mostly by complaining. Now that I am delighted with everyone and everything in Sequin, they have decided to move most of the clients to the Wallace Building. I have been Building Representative for Wallace and never uncovered too many problems here. Many of the people who work here have been with Dorothy in the past. Since she has to move, I am pleased she will be at Wallace with many of her old friends. I have left out many sad stories: the girl found at the bottom of the pool because someone neglected to take a head count; the girl who wandered out of her building and died in a culvert from hypothermia; the girl who received blows to the head from a male care-taker because she "smeared". This child finally stopped eating before anyone discovered her plight. When taken to M.G.H., she was diagnosed with infection from trauma to the head. When this man was confronted and told we had a witness to his abuse, he quickly disappeared and was never prosecuted. Could he be working in the community with our children today? At the present time, we have a building being investigated due to 12 injuries reported in a year. These are all broken bones and it has not been determined yet if this is abuse or neglect - or is it a case of more and better training needed for the care-takers of these fragile children? I was hoping to go to "Glory " in peace, but I guess that is not to be. Joanna Bezubka: Life & Times at Fernald by George Mavridis February 1994 This is first-person history of Joanna Bezubka, a lady wit Down syndrome. Joanna is a resident of the Walter E. Fernald State School. Profile Joanna was born May 15, 1951, four and half years after her brother Ronald. Joanna was admitted to the Fernald State School in 1966 when her mother died during unsuccessful heart surgery. Joanna's father died in 1969 form Alzheimer's disease. Stella Mavridis, Joanna's maternal aunt, and Walter Bezubka, Joanna's paternal uncle, became co-guardians and I became a co-guardian when my mother died in 1991. Joanna is severely to profoundly retarded. Today at age 43, her mental age is about two. When Joanna is humming, she is happy and feeling well. Joanna communicates by hand signals, coughing with tone inflections, facial expressions and one word requests. Joanna's speech is marked by mild dysfluencies which are displayed as short breaths, shaping and reshaping her lips and mild consonant repetitions. If you respond to the hand 37 signals or coughs, you may never realize Joanna can speak. I do not believe she knows technical family relations; when Joanna wants you she calls, "Maaa!" Joanna does not understand I am her maternal first cousin. Earl Years The first memory of Joanna's care was her mother's concern during the first few months because Joanna was not developing like a normal child. Joanna did not sit up, crawl or show any other normal signs of growing. Joanna's mother and aunt took her to the doctor and were told for the first time that Joanna had severe to profound mental retardation. I assume the doctor knew Joanna had Down Syndrome at her birth and withheld the information from Joanna's parents. No one ever explained why the doctor withheld this information for several months. He certainly did not expect the retardation to disappear. In 1951 the prognosis was that Joanna was profoundly retarded and would not attain the mental age of 2 until she was 12 to 14 years old and would not live past 20. The next memory was the shock and disappointment of Joanna's grandparents when they learned about Joanna's retardation. How could my aunt destroy their son's family by giving him a retarded child? The paternal grandparents never offered to help care for Joanna. However, Joanna's Uncle Walter was the key person during the negotiations with Fernald in 1966 for Joanna's placement. From 1951 to 1966 we did not receive any services for a family with a mentally retarded child. I do not remember receiving any education in the care of a child with mental retardation. The doctor told us to keep Joanna at home as long as possible before placing her at Fernald. Our family knew placement was inevitable and tried to delay as long as possible, but my Aunt's pending heart surgery forced us to place Joanna in the Fernald. Memories In 1966, after my aunt's untimely death, Joanna's care became the responsibility of our grandmother, my parents and me. For personal reasons which are not relevant to this history, Joanna's brother, Ronald and her father could not provide Joanna's care. I do not remember Joanna's reaction to her mother's death. Digressing a minute, I remember her reaction to my mother's death in 1991. The late Father Henry Marquardt, Fernald's Chaplain, and a nurse took Joanna aside and talked to her about my mother's sudden death. Joanna did not seem to listen until Father Henry said my mother had gone away and would not return. He said Auntie Stella still loved her and would always watch out for Joanna. Joanna sat up as Father Henry spoke and paid attention to his words, then she said, "All gone." The next weekend I asked Joanna, "Where is Auntie Stella?". Joanna responded, "All gone." Prior to my mother's death I was the loving cousin Joanna wrapped around her little finger. Mother always said Joanna would be crushed if I ever raised my voice and reprimanded her. After my mother's death Joanna respected me as the final authority during home visits and never walked around the house looking for Auntie Stella. I never asked the question, "Where is Auntie Stella?" again. But I tell her how proud her mother, grandmother and aunt are, when Joanna is doing something well. From 1966 through 1979 my grandmother lived with us and Joanna came home biweekly on Friday afternoon and stayed until Sunday. We took Joanna back for the evening meal. From 1979 through 1988 my parents and I continued the biweekly visits. Today I can not care for Joanna overnight, so I try to take her home every Saturday. Fernald: The Early Years In 1966, the Fernald policy was to isolate new residents for 2 or 3 months from their families. I do not know when this policy was stopped but I know it did not destroy Joanna's family memories and ties. During the early years at Fernald, Joanna lived at Greene. I still remember the long walks down the long second floor corridor past barracks style rooms of people with mental retardation and Joanna's protests about walking to her room. The staff was always in their office on the first floor. No one asked how Joanna enjoyed her weekend at home or how was her health at this time. They just relaxed and continued their conversation. It was obvious they had no idea what was happening on the second floor. The staff at Greene demonstrated the expression "warehousing people with mental retardation" perfectly. 38 Joanna knew the weekend visit was over when we entered the Fernald campus and tried to prolong it. She refused to leave the care, walking up the stairs slowly and reluctantly The return trips were very emotional for my mother. I never let my mother drive to Fernald alone because I knew she would not be able to drive home alone. Mother cried every Sunday night after returning Joanna to Fernald. Consent Decree Six years later the parents sued the Commonwealth in federal court and life for Joanna and the other residents in all the state schools plus those in community facilities started to improve. The first renovated building Joanna called home was a cottage, the next was Warren Hall and today she lives at MacDougall Hall. Joanna moved into MacDougall just before her scoliosis operation. The ladies' apartment is on the first floor. Joanna's first day program was at an unused school in Woburn. Today Joanna's day program is in the renovated Manual Building. The increased staffing allowed Joanna to enjoy finger painting for a few years, to learn some routine chores like folding clothes in the laundry, and clearing dishes from the table after meals. She uses food utensils better and is more relaxed. The return trips to Feranld are not as emotional as they were in the early years. Medical Care My first bad memory of Joanna's medical care was a call from the dentist who extracted all her teeth so Joanna would not be bothered with tooth decay and cavities. Her mother always took Joanna to a dentist and her teeth were excellent in 1966. One or two years later a Fernald dentist extracted all Joanna's teeth for Fernald's convenience. I know my mother did not give any consent and definitely not "informed consent" for the extractions. Since the extractions Joanna must eat pureed or ground food. She cannot enjoy chewing a good piece of meat. The next bad memory was the poor sanitary conditions of Fernald in the early years. Joanna walked on dirty bathroom floors and all her toe nails are deformed. Her toe nails must be cut by a podiatrist. The good memory was a call from Dr. Goldberg of the New England Hospital in 1987. Dr. Goldberg had been monitoring Joanna's scoliosis for several years. Joanna's medical record has a letter which noted her scoliosis was getting worse, but Harrington Rod operations were too difficult for Joanna. The letter was written in the late 1960s. In 1987 technology had improved so Dr. Goldberg proposed two 8-hour operations to straighten Joanna's back. The operations were done in the spring of 1988. The first operation straightened her back 55 degrees and fused all disks. The second operation two weeks later inserted a Harrington Rod and Lukey Rod to reinforce her backbone. Post-operation recuperation lasted six months. Three months were spent in the Fernald acute care clinic lying on a Baxter Frame. I can not say enough good words about the direct care staff who monitored her hospitalization in Boston, the Fernald medical staff and the New England Medical center staff. We visited Joanna every day for six months and observed the staff during all possible situations. My favorite memory was the week a young man was in the New England Medical Center for a similar operation. We agreed to place him in Joanna's room so one Fernald employee could monitor both patients. Department of Mental Retardation social engineers quote privacy regulations; parents use common sense providing services for the individuals. The operations were 100% successful. Joanna's internal organs hang properly and she has not had bronchial illness or regurgitation problems caused by her hiatal hernia since the operation. She can sit upright in a chair, and walked without holding a wall. Dr. Goldberg told my mother and me that authorizing a scoliosis operation for a third person requires at least six months of evaluation. he told us to talk with the Fernald doctors and nurses who would monitor Joanna's recuperation. He was correct. Playing God for a severely retarded person was the most difficult decision mother and I ever made. I will never forget Joanna's eyes; they asked, "Why did you allow this to happen?" after each operation. Post Consent Decree Today, it has been 2 years since my mother died. Joanna comes home 9 out of 10 Saturdays. I pick her up after breakfast and bring her back in time for the evening meal. An average day is playing with Lego toys, eating out my refrigerator and going for a ride. Joanna is very bright. I wish she could have been born 30 years later to take advantage of the improvements in services provided people with mental retardation. One day and advocate remarked, "Oh, what we don't do for the Fernald." My mother answered quickly, "We do nothing for the Fernald, everything is done for the children." "We do nothing for the Fernald, everything is done for the children" is now my motto. Advocates must never take these improvements for granted. The Commonwealth of Massachusetts does nothing voluntarily for people with mental retardation. 39 Could It Happen Today? _ Federal Laws of Protection In the late 1970s major changes began to occur in the protection of human subjects in medical research. In 1974, the federal government adopted a set of regulations specifically addressing the protection of human subjects in experiments. 13 During that same year, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created and given the chore of identifying basic ethical principles for human subjects. These ethical guidelines, which were officially adopted in August 1975, require any institution that receives research funding from the U.S. Department of Health, Education, and Welfare to establish an institutional review board (IRB) to review and approve any prospective research involving human subjects. Furthermore, the IRB must be comprised of individuals from varying backgrounds, including a "lay member" from the public. The concept of the lay member was to ensure some type of public scrutiny over the IRB as a safety measure. Under this law, if a research subject is to be placed at risk, as defined in the regulations, then the subject or his/her legally authorized representative must give informed consent, defined as the "knowing consent of an individual or his or her legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion." Unlike earlier ethical guidelines, such as the Nuremberg Code, these regulations place more emphasis on the rights of research subjects as opposed to their welfare, suggesting the general change from a paternalistic view of subjects to a freedom of choice view. Also, unlike the Code, the regulations allow for a legal representative to make an informed consent for another. This is true, in part, because the regulations deal with both nonbeneficial (nontherapeutic) and beneficial (therapeutic) types of research, while the Code dealt with nonbeneficial research only. For beneficial research, the government did not want to expressly prevent a parent/guardian from consenting to a procedure that could save a child's life. Therefore, both types of research were lumped together with a legal representative having authority to consent to either. Since 1974, federal regulations have been adopted that specifically address the issue of children as research subjects.14 These regulations apply to all research in any institution that receives federal funding for even one human research project. The law defines "children" as persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. Therefore, if a state statute grants a child the right to consent at a certain age, or if the state judiciary has recognized the mature minor rule, these child regulations would not apply, and the general IRB regulations would be used. __________________________ 13 39 Fed. Reg. 18914 (May 30, 1974) (Covered all human subjects involved in research funded by the Dept. of Health, Ed. & Welfare. The coverage of these regulations has since been expanded.) 14 48 Fed. Reg. 9818 (1983). 40 The federal regulations for research on children adopt a four- category sliding scale system to determine what assurances are needed based on the type of research being conducted. The following research categories are: 1. Minimal risk to child, with or without a direct benefit to him/her, 2. Greater than minimal risk and direct benefit to the child, 3. Greater than minimal risk and no direct benefit to the child, and 4. A catch-all provision for any other research that doesn't fall into the other three categories. For any of these categories, the regulations require that provisions must be made for soliciting the assent of the child and the permission of the parent/guardian. With respect to parent/guardian permission, the regulation states that for minimal risk, or risk with direct benefit research (i.e., category l or 2), the permission of one parent may be sufficient However, for research involving risk and no direct benefit to the child, the regulation requires that both parents must give their permission, unless one is deceased or otherwise unavailable, or if only one parent has legal custody. The regulations also provide special requirements for research on children who are wards of the state. There is an outright ban on any research with these children for procedures involving greater than minimal risk and no direct benefit (i.e., category 3 as well as category 4 research). In order to use these children in minimal risk research, or risk with direct benefit research, the IRB for the institution must appoint a child advocate to represent the child, in addition to any guardian or in loco parentis. The advocate must act in the best interests of the child. As stated above, this regulation requires that provisions be made for soliciting the assent of the child, in addition to the permission of the parent/guardian. The term assent was used to separate it from legal consent, which, under some state laws, a child is unable to give. The job of determining adequate provisions for obtaining assent falls on the IRB. It must make an initial determination as to whether or not the child is capable of giving assent based on factors such as age, maturity, and psychological state. This must be done for all the children involved in the research protocol as a group or for each child individually. The regulations are clear that assent is not a requirement for no risk or risk with benefit to child procedures, although it should still be sought. Similarly, if the IRB determines that the children are incapable of assent, the assent requirement can be waived and the protocol can continue without their assent _ Department of Mental Retardation Regulations Protection is also afforded individuals who are contemplated to be subjects in a research study by a set of regulations issued by the Department of Mental Health and the Department of Mental Retardation. Research activity is specifically regulated by 104 C.M.R, 13.00. The regulations codify requirements for advisory boards at the state level. The regulations also set forth additional standards of review, including, among others, the following considerations for inclusion: . The subject's rights to health and physical safety; . The right to confidentiality and privacy; . The right to humane care and dignity; . The right to self-determination and freedom of choice; . The right to adequate care and treatment; . The right to be free of undue discomfort, distress, and deprivation; . The right to fair and equal treatment without discrimination; and . Any other rights of clients that may be relevant to the particular project. These regulations are currently being revised. The "Findings & Recommendations" section of this report includes specific recommendations for improving the language for increased protection for all citizens with cognitive disabilities. . The Role of Advocacy During the l950s and 1960s, mental retardation facilities such as the Fernald and Wrentham Schools were home for individuals who were referred there or committed to their care for a variety of reasons besides mental retardation. Many were placed there by the courts or by state social protection agencies. By the end of the 1960s and early 1970s these facilities had become so overcrowded that they served as little more than human warehouses. Parents and other family members dissatisfied with these deplorable conditions founded parent associations to advocate for improvements in the care of the individuals living in each of these facilities. Belchertown Friends Association (now Advocacy Network), Dever Association, Fernald League, Parents and Friends of Monson, Wrentham Association, and Massachusetts Association for Retarded Citizens (now ARC Massachusetts) were all formed in the 1950s. In the early 1970s, these parent associations poured their money, their hearts, and their talents into a collective pool and filed five lawsuits in federal court against the Commonwealth of Massachusetts and each of the five state schools because of inhumane, constitutionally unacceptable conditions that existed at the state schools. All these cases were settled by court orders known as consent decrees, which included agreements for an improvement in services and living conditions. There have been many improvements in the care given to individuals with mental retardation since that time, leading to the withdrawal of court oversight of mental retardation services in 1993. Each of these groups continues their advocacy efforts today. In addition, many other advocacy groups have now been formed to protect the rights and dignity of individuals with mental retardation living in Massachusetts. Another parents' association, the Hogan/Berry Association, was formed in the l970s. The 1980s saw the beginning of other new groups such as the Massachusetts Coalition of Families & Advocates for the Retarded (COFAR) and Voice of the Retarded (VOR). COFAR and VOR coordinate advocacy on the state and federal levels for the Dever Association,, Fernald League, Hogan/Berry Association, Parents and Friends of Monson, and Wrentham Association. The Massachusetts Down Syndrome Congress (a group of parents and professionals concerned with the well being of younger children with Down syndrome) and local family empowerment organizations were also founded in this decade. State and federal governments have instituted protection and advocacy groups such as the Disability Law Center and the Massachusetts Developmental Disabilities Council. Two university-affiliated programs at the Shriver Center and Children's Hospital also exist for the advancement in understanding causes of mental retardation as well as for the protection and well being of individuals with mental retardation. The Department of Mental Retardation (DMR) has also been required by statute to establish a system of citizen advisory boards at all levels of the department to advise and review DMR policies and practices. Presently there are 29 such boards, involving over 400 citizen advocates. Human rights committees are required of every DMR program or facility to ensure protection. Everyone's desire to provide the least restrictive living conditions for individuals with mental retardation has stopped the commitment of individuals by the courts, state authorities, or their parents without due process. The 1990s are witnessing the beginnings of effective self-advocacy, where consumers of state services are speaking for themselves in the shaping of policy and support services. These advocates have not only been the stimulus for dramatic improvements in services to individuals with mental retardation, but they have also served as a potent force to help prevent future abuses so common in the past. Advocacy organizations are the vital link between the development and implementation of laws and other public policies created to protect vulnerable populations. There can be a vast difference between getting legislation written or passed and actually having it implemented properly to positively impact people's daily lives. The most effective advocates at this level are the consumers and their significant others. No one can portray a need or issue as honestly and effectively as the ones who are actually dealing with it on behalf of themselves or someone they love. 43 Findings & Recommendations FINDINGS (NOT PRIORITIZED) I. The research conducted on human subjects at or from the state schools between 1943 and 1973 that involved the introduction of radioactive substances into their bodies was conducted in violation of the fundamental human rights of the subjects involved in that: _ The researchers failed to satisfactorily inform the subjects and their families that the nutritional research studies were non-therapeutic; that is, that the research studies were never intended to benefit the human subjects as individuals but were solely intended to enhance the body of scientific knowledge concerning nutrition; _ The letter in which consent from family members was requested, which was drafted by the former Fernald superintendent, failed to provide information that was reasonably necessary for an informed decision to be made; _ The researchers delegated the task of obtaining consent to the Fernald superintendent, and failed to ensure that proper informed consent was obtained from family members on behalf of the research subjects _ The provision of special rewards and privileges that were otherwise unavailable to individuals confined in an institutionalized setting, and otherwise unavailable to any other person residing in that institution other than those who were members of the "Science Club", resulted in the research subjects being unfairly enticed by those conducting the research; _ The Atomic Energy Commission allowed the researchers to conduct more than one invasive technique on any subject deemed "mentally deficient", while it limited such techniques to only one with subjects deemed to be of "normal" intelligence, even though it maintained the same maximum dosage for both subject groups; and _ The researchers administered a dosage of radioactive calcium (1.7 microcuries) that was in excess of the maximum dosage authorized at the time of the original licensing (1.0 microcuries). II The Commonwealth of Massachusetts, which was at the time charged with the responsibility of caring for the individuals in its custody, failed to provide basic protection to the individuals who were subjected to the research described in I above, in violation of their humans rights, in that: _ The superintendent's dual capacity in having the authority both to provide consent on behalf of state wards as well as to plan or approve medical research that would involve those same wards, seriously jeopardized the wards' right to protection and safeguard from harm; _ The researchers and facility staff at both Fernald and Wrentham failed to properly enter any information into the permanent medical records of the research subjects. This prevented any knowledge of the research studies to be passed on to future staff, thereby frustrating attempts to study potential long term issues. III. Laws designed to protect persons with mental retardation from being subjected to experimentation are inadequate and need to be strengthened, to include: 44 _ Current laws still permit non-therapeutic experimental research individuals who are unable to give informed consent on behalf of themselves; and _ Current Department of Mental Retardation (DMR) regulations do not adequately protect individuals who are unable to give informed consent on behalf of themselves from non-therapeutic experimental research. IV. In the best judgment of the experts whose opinions were sought by the Task Force, no significant health effects were incurred by the research subjects as a direct result of the nutritional research studies in which radioactive calcium and iron tracers were used. V. The Thyroid study and the so-called Cold-war experiment, conducted at Wrentham, that utilized radioactive iodine, do present, in the expert opinion provided to the Task Force, the need for an immediate in-depth study to determine the nature and degree of any possible health risk. In these studies, no requests for consent have been located to date. As a result, a DMR working group, reporting directly to the Commissioner, shall continue the analysis on these studies. RECOMMENDATIONS (Not prioritized) I. All participants who were involved in human subject research which utilized radioactive materials at Massachusetts operated facilities for persons with mental retardation should be compensated for any and all damage incurred as a result of such research. 2. Participants, both positively identified and those the Task Force has significant reason to believe were involved as subjects, shall be entitled to federal benefits for any and all related health-care assessment and follow-up care indicated. The Task Force shall forward a recommendation to the appropriate federal agency requesting that a special fund be established. This fund shall be used exclusively to pay medical benefits for persons involved with these identified studies. At the very minimum, the persons shall be eligible for automatic medical benefits that shall include an annual examination, laboratory studies or other testing deemed appropriate. 3. DMR and this Task Force shall support the passage of "An Act To Require The Informed Consent of Human Subjects as a Condition of Performing Research Involving the Commonwealth's Facilities, Services or Funds". This legislation was filed on February 24, 1994, by Governor William Weld and given an original tracking number of as H4609 (copy in Appendix H). 4. The DMR's proposed new regulations (copy in Appendix K) on the protection of human subjects in medical research that are currently being revised and recodified shall be revised as follows: _ Section 10.03 (I): delete in its entirety _ Section 10.07 (2)h: add: After the experiment is fully explained, the subject or her/his guardian must be given a reasonable period of time to contact other experts and discuss the proposed research before he/she is asked to sign the consent form. 5. In fulfilling the Task Force's motion of a "duty to inform", DMR shall be charged with formulating and implementing a plan to provide information, referral, and advocacy for potential and identified subjects to address the concerns raised in the Recommendation section of the Final Report submitted by the Contact with Subject Subcommittee (copy in Appendix E). _ Former residents of the Fernald School (or their family members) who have called the "800" number, and whom the Task Force now believes did not participate in any of the major studies, are currently being sent a letter notifying and reassuring them that they were not a part of the identified research studies; 45 _ All known subjects of the research studies shall be so notified orally and in writing within 30 days of the release of this report. As soon as all identified subjects have been notified, they, and others for whom there is concern, shall be invited to a "reunion gathering" at the Fernald School, or another location preferred by the participants. The purpose of this gathering would be to facilitate communication in a supportive atmosphere to allow peer support, contact with Fernald Social Work staff, as well as aid in the locating of other participants/former residents. The initial communication should take place in person, or, if a face-face contact is not possible, it should be done by way of a carefully designed telephone conversation to be made by well- trained and prepared social work staff. A set of written materials should be provided concurrently. _ To facilitate ongoing communication with experiment participants, a "sole correspondent" should be identified for each person (preferably the same person who did the initial communication). This individual should have ongoing access to up-to-date information about risks as well as available resources for health and mental health services. Toll-free access should be maintained; _ For persons without access to mental health services, DMR shall identify options for counseling, including, but not limited to, personnel from the Department of Mental Health; _ If an experiment participant does not have health insurance, the Commonwealth shall provide assistance to facilitate linkage with an existing resource for, medical care coverage (e.g. MassHealth) for services reasonably believed to be related to the research which utilized radioactive materials. If it is not possible to access financial coverage through traditional channels, the Commonwealth shall arrange access to and payment for such health care services; _ A packet of information shall be developed for research study participants to share with their physicians. This material shall include information pertaining to radiation exposure and potential implications for health-care; and _ A program similar to that set out above shall also be placed in effect for the Wrentham School subjects. 6. Any research done at a state-operated facility shall require the following information as part of the application process: _ the location for storage of the records after, the completion of the study must be specified on the research study application; _ a percentage of the funds shall be earmarked for proper, storage and professional cataloging of this information; _ any subjects must be named and noted with current address and social security number; and; A copy of the protocol and specifics of the study shall be put into, the person's permanent file at any institutionalized setting and copy sent to their attending physician and the person themselves or patient/guardian, if applicable. 7. A document shall be placed in the permanent DMR record of each identified subject of any study present or future. This will include a summary of study involvement and drugs/materials used or received as is 46 possible to ascertain. A copy shall be sent to their parent or guardian, if applicable. A special marking, identifiable only to DMR personnel on the medical staff; in medical records and in the social service departments, shall be made on the inside face sheet to indicate that this individual was a subject in a study. This will alert DMR personnel using that record to understand that special handling may be required if there is a request for a copy of the records A referral will be made to the Social Services department for personal follow-up on that individual's behalf, in accordance with the standards set out in this report for contact with an identified subject. If that person has not yet been made aware of her/his involvement due to lack of a contacting address, a notation to that effect be made in their file as well. 8. Long term follow-up epidemiological studies shall be coordinated by the DMR working group, cooperation with the Department of Public Health, as recommended by the Working Group following the completion of its analysis.. 9. The DMR Research Committee whose role it is to assure that proper procedures and follow-up is done all current or future studies, should have of 3 parents or significant others of current or former residents, and a minimum of 3 former consumers or consumer advocates on the board with a rotation of their term to be no more than 3 years. A request for suggested names shall be directed to the consumer organizations. 10. The Department of Mental Retardation (DMR) shall work in concert with the President's Inter-Agency Work Group commissioned to continue the investigation at the federal level. DMR, working with Senator Kennedy and Congressman Markey, shall request an official linkage with it by the naming of a member to as all official liaison. Further it will be requested that a member be named to the National Commission on Biomedical Ethics that is being recommended for formation by Senator Kennedy and Representative Markey. 11. The findings, archival and research materials from the work of the Task Force shall be placed into a permanent study section of the Howe Library. There shall be a request made to the Federal Interagency Work Group and the Presidential Commission to have a copy of their primary findings and records as well to create a comprehensive area for future study in the Howe Library on the topic of research utilizing radioactive materials with human subjects. 47 Appendix A. Listing of Task Force & Advisory Group Members B. Archival Record Chronology C. Information Request Subcommittee D. Methodology Subcommittee E. Contact with Subjects Subcommittee F. Introduction to Radioactivity & Radiation Primer G. Expert Opinions: Radiation Dosimetry & Epidemiology H. Nuremberg Code & Declaration of Helsinki I. Governor Weld's Proposed Legislation J. Consumer Organization List K. Department of Mental Retardation Research Regulations L. White-Lief & Tisei Research on Informed Consent TASK FORCE MEMBERS DR. MARY LOUISE BUYSE, M.D., M.S., graduated from the Medical College of Pennsylvania, Philadelphia in 1970. She is currently Medical Director at the Fernald State School. She has appointments at Massachusetts General and Newton-Wellesley Hospitals. Her specialty is in Pediatrics, Medical Genetics and Birth Defects. Dr. Buyse has extensively published with many articles focusing on birth defects and is the Editor-In-Chief of The Birth defects Encyclopedia. She brings over 20 years of experience in developmental disabilities and medical knowledge to the Task Force. DR. ALLEN CROCKER, M.D., attended Massachusetts Institute of Technology and Harvard Medical School, with training in pediatrics at Children's Hospital. He has been associated with Children's Hospital for over 40 years. He has either written or contributed to over 100 articles and books. He teaches at Children's Hospital, Harvard Medical School and Harvard School of Public health. He continues his long career at Children's Hospital with a focus on Developmental Disabilities. DR. GUNNAR DYBWAD received his J.D. from the Faculty of Laws, University of Halle, Germany, and is a graduate of the New York School of Social Work. He is currently Professor Emeritus of Human Development at the Heller School, Brandeis University and senior staff member of the Center on Human Policy, Syracuse University, New York. Dr. Dybwad was consultant to President Kennedy's Special Assistant on Mental Retardation. He has a life long history of devotion to the betterment of the lives of individuals with mental retardation. He is known the world over for both his and his wife's (Rosemary) efforts in the field of developmental disabilities. CHARLES DYER is a former member of the Fernald School 's Science Club who now resides in Salem, MA. Mr. Dyer is a divorced father of three children: Danny, 28, Kelly Ann, 23, and Crystal Lee, 19. Danny suffers from the same problem as his father, which is small lumps appearing all over his body (doctors have yet to explain this condition). Kelly Ann was born with reversed organs (her heart and arteries are on her right side) and Crystal Lee was born with a hole in her lung which left her asthma and breathing problems. Mr. Dyer was a truck driver for a produce company until 1992 when he was forced to leave due to an injury to his back while working. To take up his spare time, Mr. Dyer enjoys bowling, restoring old furniture and collecting antique cars. DR. ANNE HOWARD received her masters degree in Special Education, Severe Special Needs at Boston College and her Ph.D. in Social Policy (Developmental Disabilities) at the Heller Graduate School for Advanced Studies in Social Welfare, Brandeis University. Presently, she teaches special education courses at Fitchburg State College. She also provides consultant services to various public schools in regard to their special education programs and has written numerous articles in the area of health needs for persons with developmental disabilities. Dr. Howard is a member of the DMR Statewide Advisory Council (SAC). RICHARD KRANT is a retired Special Agent of the Federal Bureau of Investigations and a member of the New York State bar, Past President of Coalition of families and Advocates for the Retarded (COFAR). In addition, he is a member of the Human Rights Committee at Wrentham State School, a member of the Advisory Committee to the Division of Investigations at DMR and a member of the Newton/South Norfolk Advisory Board. He is the COFAR representative to the Task Force. His son Bryan is a resident of Wrentham State School. AUSTIN LAROCQUE is a former member of the Fernald School's Science Club who has resided comfortably, cozy and reasonably in Beverly, MA for 27 years. Mrs. Larocque, wife of 31 years, is a home health aide and mother and a loving companion to Austin. Together they have three children: Leo, 26, married for six years, Michelle Jane Anderson, 30, married for ten years, and Michael, 16, a sophomore at Beverly High School. Mr. Larocque also has a grandson, Bryan, 3 a and a granddaughter, Kayla Ann, 2. Mr. Larocques's special interests and hobbies include playing pool and darts with his older sisters and long-time friend, Charlie Dyer. Mr. Larocque is a has been & professional house painter for 30 years and currently holds the title of Janitor, Custodian and Painter for several Beverly area tenant buildings. DORIS MANSON is a parent of a daughter living at the Fernald State School since 1947. In addition, she has served as a member on the Fernald League Building Representative Committee, the Fernald Advisory Board and other ad hoc committees set up by the Fernald Administration. Ms. Manson accomplished her many goals at Fernald while working for 18 years at the Massachusetts registry of Motor Vehicles in Boston where she has since retired. REPRESENTATIVE EDWARD J. MARKEY has been a member of the Massachusetts delegation since 1976. Prior to that, he served two terms in the Massachusetts State House. In 1986, Representative Markey prepared and released the report entitled "American Nuclear Guinea Pigs", detailing 31 questionable radiation experiments on humans. He is also author of the book Nuclear Peril and a longtime advocate of a comprehensive nuclear test ban. More recently, he authored the Cable Consumer Protection and Competition Act of 1992 and has fought to reduce violence on the air waves. GOERGE MAVRIDIS, P.E. has spent his career being a structural engineer, but has spent his life being an advocate for individuals with mental retardation. He is guardian to his cousin who is a resident at Fernald School and is President of the Fernald League for Retarded Children, Inc. Additionally, he is Vice President of the Massachusetts Coalition of Families and Advocates for the Retarded.. He also serves on DMR's Division of Investigation Advisory Committee, Mission statement Committee and Fernald School 's Human rights Committee and Fernald's Schools' Human Rights Committee and Fernald League's Building Representative Committee. FREDERICK M. MISILO, JR. (Chairperson) is the Deputy Commissioner of the Department of Mental Retardation. He possesses over seventeen years of combined experience in the filed of mental retardation and in private law practice. he holds a law degree from Suffolk University, a Ed.M. in Social Policy from Harvard University ,and a B.A. from the University of Massachusetts at Amherst. Mr. Misilo is admitted to practice law in the Massachusetts and federal courts. He is also a member of the Health Law Section Council of the Massachusetts Bar Association. REV. DR, RICHARD J. ROBISON, D.Min. is the Director of Community Relations for the Department of Mental Retardation. He is the liaison for the Commissioner to advocacy and parent groups, statewide regional and area advisory boards. Prior to that he served he served as Protestant chaplain at the Fernald School. Dr. Robison is an ordained minister for the American Baptist Churches, USA. He graduated with a BA from Northern Illinois University, received his Masters of Divinity and Doctor of Ministry at Eastern Baptist Theological Seminary in Philadelphia, PA. Dr. Robison is the parent of three children, two with Down syndrome. He also is a board member of Mass. Down Syndrome Congress. VIRGINIA TISEI, ESQ. is a sibling of a family member with developmental disabilities and has spent over 20 years advocating for persons with developmental disabilities. She is immediate past President of the Mass. Association for Retarded Citizens, a past President of the Greater Boston Association for Retarded Citizens (and a current Board Member), and has served on a number of task forces and committees for several years advocating for persons with disabilities. She is Asst. Labor Counsel at Grace Corp. in Lexington and is a former Special Assistant Corp. Counsel for the City of Boston. She is also a former educator in the Boston Public Schools. DOE WEST (project Coordinator) is currently completing her dissertation for her doctoral degree form the Law, Policy and Society Department at Northeastern University. Her MS in Rehabilitation Counseling is from Boston University and her M.Div. from Logos Bible College. She is a certified teacher of the speech and hearing handicapped, has served as a marriage counselor and lectured for the past 10 years at Northeastern University and Mass Bay Community College. She has spent over 21 years as a civil rights activist within the disability rights movement and was appointed the first Commissioner of Handicapped Affairs for the City of Boston, and created a national prototype office for Section 504 compliance within the Department of Health and Hospitals. A 1993 nominee to the Whos Who of Emerging National Leaders, rev. West's most recent positions prior to the project included serving as Chief of Staff for a Massachusetts Senator and serving as a Chaplain for local hospitals. DAVID W. WHITE-LIEF is a director of the law firm of Breakstone, White-Lief & Gluck, P.C. He graduated from the University of Vermont and received his law degree from Northeastern University School of Law. His areas of practice include (but not limited to) plaintiff's personal injury, medical malpractice, product liability and other civil litigation. He is the chair of the Human Rights Committee at the Fernald State School. ADVISORY AND SUPPORT GROUP MEMBERS DALE ANDERSON is a Division Director at the Fernald School. Prior to that position, he was Human Rights Officer at Fernald. His responsibilities include developing programs and creating an environment at Fernadld where residents and staff can maximize their learning and social interactions. PAUL BERMINGHAM is the Director of Campus Safety and Chief Investigator at the Fernald School. He also served as Human Rights Office at Fernald. Presently, he is responsible for investigating complaints and reviewing reports of investigation in addition to overseeing the campus police and life safety. KEN CAMPBELL is the Director of the News Office at Massachusetts Institute of Technology. A graduated of Yale University, he has been a reporter in Washington and London as well as for the Boston Globe. He has served as spokesman for the Boston transit system. MARGARET DALE graduated from Boston University School of Low in 1976. She is an Associate Dean at Harvard Medical School and Director of the Office for Research issues. den dale served a vital role in her linkage and liaison to the personnel and resources of Harvard University. Her untiring commitment and perseverance allowed the work of the Task Force to be factually based and professionally finished. REV. PAUL L. DUHAMEL graduated from Albright College and Andover Newton Theological School. He was director of Constituent relations at the Fernald State School. Rev. Duhamel supervised the development of the first archival, research and client library for Fernald staff, residents and the public. JOSEPH P. FOLEY, JR. is currently a Clinical Social Work Supervisor at Fernald School and has worked for DMR of over 15 years at both the Fernald and Dever State Schools. He has a BA in Psychology, an MSW from Boston College School of Social Work and will complete the requirements for a Master's in Public Administration in May, 1994. LINDA GERSHMAN received her BA from the University of Wisconsin and her Masters degree in social work form Boston University. She has worked as a clinical social worker at Wrentham School since 1983 and has prior experience in the area of geriatric social work. SENATOR EDWARD M. KENNEDY has served Massachusetts for 30 years as its Senator. His many contributions to his more vulnerable constituents are documented, including legislation such as Civil Rights for the Handicapped, Comprehensive Child Development Centers, Long-term Care for the Elderly and Disabled, the ADA and many other health-related issues. REPRESENTATIVE JOSEPH P. KENNEDY II was elected to the 8th Congressional District in 1986 and is serving his forth term. Serving on the Banking and Veterans Affairs Committees he has pushed through legislation opening up credit to working class families and people of color and has fought hard for the health-care needs of veterans. His concern for human rights has taken him around the world to places like Northern Ireland, Haiti, Germany and Armenia. KIRSTEN E. KENNETTE has, for the past 22 years, worked wit clients at the Fernald State School in various capacities including direct care, training, and program management. KEVIN W. KIRBY is working in the Investigations Department at DMR while completing his law degree at Suffolk University Law School. He also volunteers time as a special education advocate. DR. LOUIS LASAGNA graduated from the College of Physicians and Surgeons at Columbia University in 1947. He is Acting Chairman of the Department of Pharmacology and Experimental Therapeutics at Tufts University, is Dean at Sackler School of Graduate Biomedical Sciences, is Academic Dean at Tufts Medical School and is Director and Chairman of the Board for the Center for the Study of Drug Development. In addition, he is currently sits on the editorial board of over 20 medical publications. Fr. WILLIAM T. LEONARD is called "Fr. Bill" by all who flourish under his wonderful ministry as the Catholic Chaplain at Fernald. Fr. Leonard was ordained to the Catholic Priesthood for the Archdiocese of Boston in 1969. He served as Parish Priest and Juvenile Court Chaplain at St. Ann's Parish, Somerville where he also worked with children with retardation from 1967-1977. He founded the Somerville Human Services Department in 1976. From 1977 to 1989, Fr. Leonard was Administrator of St. Philip Parish/Warwick House in Roxbury, where he also served as Chaplain to the Solomon Carter Fuller Mental Health Center. In 1989 he was appointed Chaplain at the Metropolitan State Hospital in Waltham. In 1992 he became Chaplain at the Fernald School. KAREN J. LIAZOS is a Clinical Social Work Supervisor at Fernald School. She received he BA at Bard College, NY her MA at Brandeis University and her Masters in Social Work at the University of Connecticut School of Social Work. Ms. Liazos hold 18 years of experience in the fields of mental retardation and mental health. PETER H. O'MEARA (Project Manager) completed undergraduate work at Villanova University and graduated from Boston College School of Social Work. He has been involved in managing mental retardation services for the Pennsylvania Department of Public Welfare for 18 years and has worked the last 9 years for the Department of Mental Retardation, Commonwealth of Massachusetts, as the Facility Director of the Fernald School. Additionally, Mr. O'Meara serves as the Administrator of the Marquardt Nursing Center and oversees a number of statewide contracts that support consumer services. He also serves as the Project Manager for the Task Force. PAULA J. POTVIN received her B.A.. from the University of Lowell and her Masters in Social Work from the University of Connecticut. With over 15 years of experience in the field of mental retardation in various capacities, including 10 years with DMR, Ms. Potvin is currently a social work supervisor at Wrentham State School. Previously, she was employed as a social worker at Hosan center. PAUL PROCACCINI is an Instructional Media Specialist and director of the medial resource center at the Fernald School in Waltham, Massachusetts. The center provides graphic design, media and audio visual production services for use in public relations, communications and training. Paul is also a freelance graphic designer providing design and print production services to companies in the greater Boston area, Boston University, and Johnson & Johnson in Michigan. PHILIP R. REILLY received his law degree for Columbia University and his medical degree from Yale University. He is the Executive Director of the Shriver Center for Mental Retardation, Inc. Dr. Reilly is also a clinical assistant in the Department of Neurology at Massachusetts General Hospital, instructor in neurology at Harvard University School of Medicine and Adjunct Professor of Legal Studies at Brandeis University. JOAN E. RICKETTS has worked at the Fernald School for over 14 years as Assistant to the Director of Social Services and is a member of the Community Development Unit. She also spent 9 years as an Academic teacher's Aide in the Waltham Public School systems. GERALD C. RYAN is the Director of Communications for the Department of Mental Retardation. Prior positions include the Director of Publications at Spaulding Rehabilitation Hospital , Director of Public relations at New England Baptist Hospital and Worcester Hahnemann Hospital. MARGARET (PAT) SCHWALJE is Administrative Assistant to the Fernald School Facility Director. Previously, Ms. Schwalje was Executive Secretary to a Vice President of Pan American World Airways. She has worked at Fernald for 12 years. ROBERT SCHLAPANI is the Director of Client Records at Fernald School and has been the primary contact for archival reviews and requests. BONITA L. STECHER is the Librarian at the Fernald School, Howe Library. She has over 20 years experience as a librarian and over 15 years with DMR. Prior to being Librarian at Fernald, she worked in DMR Region III overseeing libraries at Hogan/Berry and Danvers State Hospital campus. JOE WRINN is the Associate Director of he Harvard University Office of News and Public Affairs. Previously, Mr. Wrinn worked for United Press International and the New York Times. He is a 1977 graduate of Syracuse University. RADIATION EPIDEMIOLOGIST EXPERTS DR. S. JAMES ADELSTEIN graduated from Harvard Medial School in 1953 and earned his Ph.D. from MIT in 1957. He is currently Executive Dean for Academic Programs at Harvard Medical School and Director of the Joint Program in Nuclear Medicine at four Longwood Area hospitals. He also serves as the Vice President of the National Council on Radiation Protection and Measurement. The Task Force was honored by Dr. Adelstein's serving and providing such an active and committed role in the learning process. DR. J. DAVID LITSTER obtained his Ph.D. in physics at Massachusetts Institute of Technology. He is currently a Professor of Physics and Vice President Vice President and Dean for Research at MIT. He was formerly the head of the Division of Atomic, Condensed Matter and Plasma Physics at MIT. His research field is experimental condensed matter physics. He has provided invaluable assistance to the Task Force on an ongoing basis, including the writing of the Appendix on radiation, calculating the radiation does in most of the studies, and by working with Doe West on the writing of Section III of this report. DR. JEFFREY LYON works in the Division of Epidemiology, Biostatistics, and Prevention Research at the Department of Family & Preventive Medicine at the University of Utah. In his prolific writing of articles and research in the fields of radiation biology, Dr. Lyon has studied the long-term effects of radiation exposure in children and adults. He has offered the key research and insight in terms of allowing the medical risk calculations to be done. DR. BRIAN MACMAHON has been a member of or served as the chairperson of over 50 medical, scientific or health related organizations during his distinguished career as Physician and Professor of Epidemiology. He taught at and served as head of the Department of Epidemiology at Harvard University from 1958-89 and served as the Editor of "Cancer Causes and Control" for Oxford from 1990 - 1992. Dr. Macmahon's scientific contributions to the question of risk were again a true cornerstone for the Task Force's understanding. DR. ROY SHORE received both his Masters Degree and Ph.D. at Syracuse University and his Dr.P.H. from Columbia University. He is a Professor at the Institute of Environmental Medicine at New York University Medical School, NY, NY. In addition, he is the head of the Environmental Epidemiology Unit. He has written or contributed to over l00 articles to date. Dr. Shore's name was repeatedly suggested to the Task Force as an Expert whose opinions was necessary for true insight and clarity.