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. Tab I Staff Memorandum--Abstraction of "Markey Report" experiments and recently 'Identified Dept. of Energy experiments STAFF MEMORANDUM To: Members of the Advisory Committee on Human Radiation Experiments From: Advisory Committee Staff Date: July 22,1994 Re: Abstraction of Markey Report experiments and recently identified DOE experiments The experiment records form has been modified over the past two weeks, with particular care paid to the sections on experiment designation, government application, description of the subjects, and suspected themes for which each experiment will be relevant. In addition, a complete set of directions for filling out the form has been written for the benefit of the staff reviewers using the form. A copy of the revised form is appended. 106 experiments have now been abstracted from the Markey collection1 {1 Due to fragmentary data, we are still identifying two experiments identified in the Markey report (category 4.006, no. 93 and category 12.903, no. 174).} and 24 of the 48 "new" experiments released by the Department of Energy. (Summaries of these "new" experiments were publicly issued by DOE on June 27, 1994, and can be found in Briefing Book IV, Tab P.) In the course of this effort, several facts became clear. They are as follows: Existence of classified material: Much of the documentation that was provided by DOE has been publicly available -- published journal articles or annual or semi-annual reports to agencies -- however, actual final reports of specific experiments were rare. In addition, there was only fragmentary internal memoranda documenting potential policy purposes or grant-review processes. Experimental protocols, while referred to in published reports, were lacking. Limits of information in the documents: In the majority of cases, information in the available documents was insufficient to accurately fill out the fields on subject description, consent, dates of research, and details of the grant contract beyond its number. In 99 of 106 cases, there was no reference to the manner in which consent was obtained from volunteers. In over half of the cases, there was so little information on the subjects that the reviewers could discern little more than the sex of the subjects; age, racial mix, military status, institutional and voluntary status, and pregnancy were almost never mentioned. The only descriptive information about the subjects regularly discernible was whether or not they were patients. In at least 51 of the experiments, some of tile subjects were identified as "patients." 1 The "new" experiments A number of the folders which DOE gave to the committee describing the recently-identified 48 experiments contained documents relevant to multiple experiments. Other folders contained scant information on the experiment they relate to. In short, the information in these files, like that in the Markey collection, is incomplete and provides limited basis for analysis of the subjects or consent procedures. The reviewers' effort was most successful in grouping the experiments into types, and in determining the location of the research. A cross check of the five staff members abstracting the experiments revealed consistent agreement of experiment grouping. The reviewers were also successful in identifying the principal and associate researchers, names and dosages of isotopes, types and dosages of external radiation, and host institutions of the researchers. The information abstracted is proving adequate to accomplishing several important tasks. Unique experiment numbers are being assigned to each experiment using the principal researchers name and the last date of research or publication. This allows us to enter succeeding documents into the preexisting data-sheet on a particular experiment as future documents are acquired and reviewed. Additionally, because we are obtaining consistent information on experiment types, institutions, and dates, we are able to begin the task of "experiment mapping". What follows is a breakdown of the seven groups in which the experiments could be categorized according to the form. (No experiments reviewed fit within the groupings "external-- type unknown" and "therapeutic/diagnostic--type unknown".) The experiments are identified by location and experiment date, in chronological order. The number of research subjects, where known, is also noted (U=Unknown). 2 105 Experiments Reviewed Biodistribution (32 total) U. Rochester ('43) n=5 Oak Ridge ('45) n= 1 8 Berkeley ('45) n= I Metallurgical Lab of MED ('46) n= .U. Rochester ('46) n= 16 Los Alamos ('50) n=U Los Alamos ('50) n=6 Oak Ridge (early '50s) n=55 Oak Ridge (early '50s) n=10 Los Alamos ('51 ) n=3 Oak Ridge ('52) n=30 Mass. General ('53) n=12 Oak Ridge ('55) n=U U. of Tennessee ('56) n=4 Oak Ridge ('56) n=3 Crocker Labs ('57) n=6 Oak Ridge ('57) n=U Columbia U. ('58) n=10 Argonne ('59) n=14 Los Alamos ('60) n=2 M.I.T. ('61) n=20 Los Alamos ('61) n=5 Oak Ridge ('62) n=5 Oak Ridge ('63) n=54 BNW ('63) n=5 U. of Rochester ('68) n=3 Batelle Northwest ('70) n=14 Harwell Labs, U.K. ('79) n=21 N.E. Deaconess (-) n=U Los Alamos (-) n=57 Batelle Northwest (-) n=8 U. Chicago (-) n=27 External-Total Body (3 total) U. Chicago ('47) n= 1 4 M.D. Anderson ('51) n=50 U. C. S. F. (-) n=29 External - Partial Body (13 total) ----- ('42) n=U Oak Ridge ('45) n=20 U. Chicago ('47) n= 1 5 Los Alamos ('48) n=U G. E. Richland ('51) n= 1 4 U.S. Army Chem. Lab ('53) n=100 N.Y.U. ('55) n=3 U. Wash. ('63) n=64 Batelle Northwest ('67) n=U Texas Tech. U. ('63) n=U Batelle Northwest ('63) n=67 Swedish Hospital ('74) n=U Fermi Lab ('75) n=100 Tracer (10 total) Brook Haven ('52) n=15 U. of Iowa ('53) n=U U. Wash. ('55) n=44 Oak Ridge ('55) n=U Oak Ridge ('55) n=U U. Chicago (late '50s) n=U Longhorn ('60) n=U Los Alamos (-) n=U U. Wash. (-) n=U Los Alamos (-) n=12 Intentional Release (2 total) Air Force S.W.C. ('56) n=U Oak Ridge ('63) n=17 (continues on next page) 3 Therapeutic/Diagnostic-Experimental (30 total) Metallurgical Lab, Chicago ('44) n=7 Argonne ('47) n=700 ---- ('47) n=2 U.C.S.F. ('48) n=65 Sloan-Kettering ('48 n=55) Berkeley ('49) n=172 U. Wash. ('52) n=50 Donner Labs, Seattle ('54) n=76 U. Wash. ('55) n=80-100 U. Wash. ('55) n=U Oak Ridge ('55) n=U Los Alamos (('55) n=17 Oak Ridge ('56) n=U U.C.S.F. ('57) n=40 Argonne ('57) n=U Oak Ridge ('57) n=U Oak Ridge ('57) n=U Oak Ridge ('58) n=U U. Arkansas ('59) n-l00 NRTS ('63) n=U U. Wash. ('69) n=65-75 U. Chicago ('70) n--44 U.C.S.F. ('75) n=94 U. New Mexico ('82) n=230 Lawrence ('84) n=150 U. Wash. ('84) n=U Los Alamos (-) n=66 Los Alamos (-) n=50 Los Alamos (-) n=5 Therapeutic Diagnostic-Accepted Techniques (I total) Harvard ('59) n=U Experiments of Opportunity (I 5 total) Mass. General ('50) n=many Case Western ('51) n=500 U. Puerto Rico ('52) n--U Oak Ridge ('55) n=2 Oak Ridge ('57) n=8 Beth Israel, Boston (late'50s) n=U Argonne ("62) n=U M.I.T. ('64) n=293 Batelle Northwest ('66) n=44 U. Chicago ('66) n=102 U. Pittsburgh ('66) n=7 Argonne ('70s) n=400 Rochester (-) n=U Berkeley (-) n=U National Lead Co., OH (-) n=284 4