DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. ADVISORY COMMITTEE DOCUMENT REQUEST MEMORANDUM TO RICHLAND OPERATIONS, OCTOBER 19, 1994 I. Ethics Policies and Practices The Committee requests the following: 1. Files of the PNL Human Subjects Committee relating to or referring to the Walla Walla prisoner study and the Promethium studies, (PNL Series.001), and other files of the PNL Human Subjects Committee which refer to human experimentation. The Committee is also interested in proposals for human subject experiments which were denied by the Human Subjects Committee. 2. Any memoranda or communication involving procedures for selection of healthy volunteers, whether employees or outsiders, and procedures for selection of persons in hospitals or other institutions collaborating in human subject research. 3. Any written consent forms, or memoranda relating to such forms. Consent policies may have been established or recorded in protocols or other documentation of experimental activity, or may have been part of admissions procedures at collaborating hospitals or other institutions from which experiment subject populations were drawn. Those records, or references to them in the administrative record, are also requested. II. Backup documentation for the Markey Experiments and other biomedical studies The Committee requests any existing materials (including progress reports and any papers) related to the following experiments: 1. Technetium-95 and -96 administered to eight persons in 1965. AEC funding through Pacific Northwest Laboratory, Richland. Publication: T.M. Beasley et al., Health Physics 12, 1425-1435, 1966. 2. Promethium-143 administered to 14 persons in 1967. Chelation agent (DTPA). AEC funding for Hanford Environmental Health Foundation and Battelle Memorial Institute. Publication: H.E. Palmer, I.C. Nelson. Health Physics 18, 53-61, 1970. These are referenced in the PNL Human Subjects Committee files. 3. Phosphorus-32 injected into five persons in 1963. Three were patients at the University of Oregon Medical School. The injection experiments were funded by AEC and carried out by Battelle at the University of Oregon Medical School and Swedish Hospital in Seattle. Principal investigator: H.E. Palmer, Hanford Laboratory. 4. The single-subject experiment involving Zinc-65 in oysters, by Honstead and Hildebrandt, reported in BNWL-SA-293, a 1965 paper to the Western Industrial Health Conference in San Francisco. One of the authors was the subject of a follow-up study published in Health Physics, 13:649-52 (June 1967). Of obvious interest is the question of whether the same subject was used, or whether some change in policy resulted in the investigator's personal involvement as a subject. 1 5. Studies involving whole-body counters and experiments which led up to, and tested, such devices. (cf. annual and quarterly progress reports,1958-68.) 6. The tissue sampling program. We note that some material was provided by the Department of Energy earlier this year (BNWL-SA-918 and SA-5855). 7. The 1955 radioiron study involving some 20 volunteers and more than 60 patients. Principal investigator: C.A. Finch of the University of Washington. 8. I-131 ingestion by drinking milk, fed with 5 microCuries of I-131. Eight GE employees were listed as subjects. 9. Tritium oxide studies. There were 15 GE employee/volunteers in the study. The committee seeks any documents explaining why no follow-up was done. 10. 1952-58 study of Cr-51, involving some 50 volunteers at the University of Washington-Seattle. Principal investigator: C.A. Finch. III. Interviews Please list any officials or subjects interviewed as part of the inquiry into the background of these experiments and programs. Please provide any oral histories or recollections on the part of officials or medical professionals recording consent or briefing conversations with subjects/volunteers. IV. Data Gathering Involving Children The Committee seeks all information (and, if available, an index) relating to datagathering on schoolchildren, including dietary studies, measurement of radiactive isotopes with body counters, or other datagathering. We understand that 13 cubic feet of documentation is currently identified as PNL Series.016. V. Technical Data Generated For Worker Safety Presumably, the data generated by human subject experiments was communicated to officials directly responsible for the health and safety of workers. The Committee seeks information about the use of the data generated by human subject experiments for use in protecting health and safety of workers. This information may prove to be a useful guide to hitherto undiscovered documentation about the policies, procedures and standards for experimentation. Documentary sources that should be searched and indexed for this type of material include PNL Series.005 of the Human Test Subjects Report. The Committee also seeks documents concerning another study for which H.E. Palmer was a principal investigator, the PNL calibration studies, involving whole-body or chest counting of niobium-92, barium-133 and strontium-85. The lead laboratory for these studies was Lawrence Livermore. The promethium study previously 2 requested (II, 2 above) was also relevant to possible exposures of plant personnel. Other potential sources of documentation: Records of worker safety offices which would shed light on any human subject experimentation commissioned as part of an overall research program intended to improve safety and/or measure exposure on the part of workers, e.g. tissue sampling. Any general definitions or worker directives which established distinctions between ordinary occupational exposures and extraordinary circumstances, as in experimentation, for which workers would be asked to volunteer. Any correspondence or internal communications relative to unions concerned with, or responding to, instances of volunteer workers becoming involved in experimentation. Communications with outside groups, e.g. state prison officials, soliciting participation in human subject experiments. Any related internal communications or orders involving such a process, e.g. memoranda reporting on the dose limits of persons involved in experimentation. VI. Intentional Releases The Committee is interested in information to follow up on the releases listed below: 1. The Green Run. We request the index of classified material prepared for the Technical Steering Panel of the Dose Reconstruction Project. 2. A 1944 release of I-131. According to "Nuclear Safety Discussions With AEC-April, 1958", HW-56701, "In 1944, several hundred curies of iodine-131 were purposely released in one emission so that the army could determine the dispersion and transport characteristics of the atmosphere. This was a one-shot experiment." The Committee seeks information about the execution and purpose of this release. 3. A September 1962 release of I-131. The release was generated through the dissolution of spent reactor fuel at Hanford's Redox plant. Our information comes from the excerpted pages of HS-77387-DEL. The Committee seeks the complete document and other information on the purpose and execution of the release. Information may be available as part of the information requested below on testing of detection equipment. 4. A July 1963 release of I-131. The document HW-87312, entitled "Plans and Hazards Analysis for the First Hanford I-131 Field Release Test," describes the release of 150 millicuries of I-131. The document includes estimates of body burdens downwind, and notes by one participant include thyroid counts for two inhalation volunteers. Please provide any planning documents for human exposures or reports on this experiment. This document states that the project was a cooperative project involving personnel from Radioecology, Environmental Studies and Evaluation, and others. The Committee seeks information on these programs, their origins, purposes, and rules for radiation safety. 3 5. The Committee requests declassification of information on Project "Bluenose," including the following Hanford documents: HAN-40193, HAN-40477, HAN-56895, HAN-58767, HAN-59174, HAN-59297, and HAN-64357. The last of these is entitled "Reporting Bluenose Releases," suggesting that these involved the intentional release of radioactivity, and is the top priority for declassification. VI. Isotope Distribution and Liaison Responsibilities We request an index to PNL Series.010 reported in the Human Test Subjects Report. Other materials which should be reviewed: Annual progress reports or records of supervisory officials, committees or interagency bodies which refer to human subject experimentation. Useful information may be included in budgetary documents or other program guidance concerning the general research funding program for the institutions involved. Correspondence with or directives from the Advisory Committee on Biology and Medicine, the Division of Biology and Medicine, the Interim Committee on Isotope Distribution, or the Human Use Committees of the Radioisotope Division, regarding human subject work. General budget documents or other directives may include useful references, which should also be provided. Any correspondence, reports, records or directives of committees or offices which had oversight responsibilities for research programs with which Hanford was associated. These would include any internal oversight mechanisms, including but not limited to the PNL Human Subjects Committee created in 1967, which may have performed duties comparable to IRBs before the implementation of general federal regulations to this effect. Also, records of any isotope distribution for biomedical purposes. 4