ML19309F759
| ML19309F759 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1980 |
| From: | Budnitz R NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Mishkin B PRESIDENT'S COMM. FOR STUDY OF ETHICAL PROB.IN MED.& |
| Shared Package | |
| ML19309F760 | List: |
| References | |
| CON-FIN-A-2050, CON-FIN-B-2283, CON-FIN-B-5771 NUDOCS 8004300601 | |
| Download: ML19309F759 (4) | |
Text
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y h opy panh UNITED STATES
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NUCLEAR REGULATORY COMMisslON o n n y nn n A M S
WASHINGTON, D. C. 20555 5
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APR 151980
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Ms. Barbara Mishkin Acting Director President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 2000 K Street, N.W.
Suite 555 Washington, D.C.
20006
Dear Ms. Mishkin:
This is in answer to your March 12, 1980 letter to the Chairman of the Nuclear Regulatory Commission regarding research involving human subjects.
We are presently funding three projects which fit the definition given in your letter.
Copies of the project briefs, which give information on the objectives and scope of each study, are enclosed.
The projects conducted by the Argonne National Laboratory and Battelle Pacific Northwest Laboratories are carried o'ut under contract with the U.S. Department of Energy. The other project is conducted by the Bureau of Radiological Health of the U.S. Department of Health, Education and Welfare (HEW).
The Nuclear Regulatory Commission, therefore, relies upon these agencies for determining compliance with the regulations governing protection of human subjects involved in biomedical or behavioral research.
We have not reviewed proposed modifications to the existing HEW regulations and have no plans to take any actions on them.
I hope this reply is sufficient for preparation of your report to Congress.
Sincerely, f
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Robert J. Budnitz, Director Office of Nuclear Regulatory Research
Enclosures:
Project Briefs (3) i
9/18/79 FY80 FROGRAM BRIEF 4
TITLE: TRANSLOCATION OF YELLOWCAKE FROM THE FIN NO.: B2283 HUMAN RESPIRATORY TRACT CONTRACTOR: PNL SITE: RICHLAND STATE: WASHINGTON NRC TECHNICAL MONITOR:
J. D. Foulke PRINCIPAL INVESTIGATOR:
B. Robinson, H. B. Spitz, D. R. Fisher FY80 WORK PERIOD: October 1,1979/ September 30, 1980 OBLIG: $54K OBJECTIVES:
The objective is to detennine the biological half-life of uranium in yellowcake forms in the human lung in order to classify properly the solubility of
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yellowcake for purposes of limiting exposure to airborne yellowcake.
SCOPE:
The research will be carried out in two phases:
j' l Phase I Contact will be established with management at several uranium mills chosen for their experience in having had positive exposures to airborne yellowcake.
Past practices with regard to bioassay programs will be discussed and the procedures reviewed. Both sample collection and analytical chemical methods wi5' be evaluated. A protocol of urine specimen collection and analysis will be established.
Data on the chemical composition of yellowcake will also be collected.
Phase II Following exposure to high levels of airborne yellowcake, the mill operator w 11 d
begin urine collection. The exposed individual (s) will be flown to PNL for a two-week period.
At PNL daily urine sampling and in vivo organ counting will be conducted. After approximately thirty days the indTvidual will return to PNL for two or three mom days of urine sampling and lung counting. It is expected t.iat l
ten cases will be necessary for study.
I Scope of Work for FY80 Phase I will be completed with a program of urine specimen collection and analysis involving split sampling with mill management personnel.
Continuous alpha air monitors equipped with a " respirable fraction" discriminator will be installed at eight uranium mills. These instruments will audibly alann to signal high ' levels of yellowcake in the workers' bmathing zone.
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A new whole body counting room will be equipped at PNL. The increased sensivity will allow measurements to be made on workers who are chronically exposed to provide baseline data.
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10/18/78 FY1979 PROJECT BRIEF TITLE: Follow-Up Study of Patients Who Had FIN NO.: B-5771 I-131 And Other Diagnostic Procedures CONTRACTOR: BRH SITE: Rockville During Childhood STATE: Maryland PROJECT MANAGER:
J. D. Foulke PRINCIPAL INVESTIGATOR:
P. Hamilton FY1979 WORK PERIOD: October 1,1978 - September 30, 1979 OBJECTIVE:
The primary objective is to determine if exposure to diagnostic levels of I-131 in childhood is associated with an increased risk of developing benign and malignant thyroid neoplasia. A secondary objective is to characterize the dose-response curve if one exists.
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, SCOPE:
A study population of 6500 patients who received diagnostic I-131 before 16 years of age prior to 1967 will be developed. Two control groups of equal size consisting of patients who received other thyroid function tests j
and siblings of the exposed patients will be developed.
The exposed and unexposed cohorts will be identified from hospital admission records.
These records will also be abstracted for relevant medical and demographic data.
Information on the current health status of the person, medical data, names, sex, birth year, and vital status of all giblings, and the name of the current physician will be sought by qu2stionnaire. Dosimetry data for the exposed patients will be collected from hospital records.
The medical information on the returned questionnaire will be validated, or if the patient is deceased, a copy of the death certificate and autopsy report will be obtained. The results will be analyzed statisti-cally to evaluate the objectives.
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FY80 PROGRAM BRIEF TITLE: HEALTH EFFECTS OF INDUSTRIAL EXPOSURE TO Fin NO.: A2050 f
THORIUM CONTRACTOR: ANL SITE: ARGONNE STATE:
ILLIN0IS
'l NRC TECHNICAL MONITOR:
J. D. Foulke
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PRINCIPAL INVESTIGATOR:
A. F. Stehney, A. M. Brues, J. Rundo lll FY80 WORK PERIOD: October 1,1979/ September 30,1980 OBLIG: $262
'i OB1ECTIVES:
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~I The main objective is to evaluate quantitatively the health hazards of industrial exposure to thorium. A population of former thorium workers will be studied to li determine whether the pattern of mortality and/or morbidity is different from that
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of persons not exposed to thorium.
A second objective is to detemine the depositional characteristics of thorium and its daughter products and to relate these to radioactivity measurements on ji living persons.
SCOPE:
A survey of mortality among the female thorium workers, as. a separate cohort since their exposum resulted from production of thorium-impregnated gas mantles, will be made from Social Security Administration records and death certificates.
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d Radiation doses to subgroups of former thorium workers will be evaluated on the
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basis of health physics inspection reports, dosimeter readings, and radioactivity L
measurements of workers.
il Medical and radioactivity examinations of the group of 558 most high;y exposed workers will continue. Questionnaires regarding other employment, smoking habits, and other health-related factors will be sent to other subgroups of thorium workers.
When available, autopsy samples and willed bodies will be radiochemically analyzed in order to relate gama ray and thort>n breath measurements to the total thorium burden and to detemine the metabolism of inhaled thorium.
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