Dr. Francis J. Furman
Dyncorp of Colorado, Inc.
P.O. Box 464-Building 122
Golden, CO 80402-0464
Phone: 303-966-2895
Fax: 303-966-2873
Projects are approved by an IRB located at: Rocky Flats Environmental Technology Site.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
Number of Human Subjects Projects reported: 3
Project Identifier: RFET-68-RF-94-02
Project Title:
United States Transuranium Registry
Principal Investigator:
Dr. W. C. Gottschall
Project started in: 1968
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Work on former Rocky Flats (RF) radiation workers might have been performed at Washington State University with other funds. No work with human subjects occured at RF nor have we been informed of any activity.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
The objectives of the Transuranium Registry are to: 1) study the distribution and dose of transuranium radionuclides in people occupationally exposed, and 2) assess the effects of exposure on their health. The methodology was to autopsy the bodies of volunteers.
Individuals only participated after death, so exposures to anything is not applicable. All work has been done at Washington State University in recent years, so details could be obtained from them as desired.
No risk to human subjects is involved although the distinction between the living and the dead should be emphasized.
Project Identifier: RFET-80-RF-94-01
Project Title:
Former Radiation Worker Recall Program (RFET-80-RF-94-03 from FY97 database has been combined with this project)
Principal Investigator:
Dr. W. C. Gottschall
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: RFET-80-RF-94-01
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 210
Type of Human Subjects Involvement:
The objectives of this study are to: 1) monitor former radiation workers for early detection of any health problems; 2) minimize, correct or eliminate any problems; and 3) determine if any correlations could be observed with any exposures received while working at Rocky Flats. The methodology is to identify those workers who received the highest doses relative to other workers or the population in general and monitor their health every 3 years. Lung (and wound if applicable) counts as well as urine analyses for radioactive species, and standard physical exams are performed. No human subjects were exposed to any harmful substances or conditions in this study. Obviously, however, all participants had been accidently exposed prior to, and as a condition for, being included in the study.
Human subjects are not exposed to any risks, and in fact benefit from the free exams and lab work.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 76
Type of Human Subjects Involvement:
A compelling body of scientific evidence demonstrates that the integrity of the genetic information in human cells can be compromised when exposed to ionizing radiation. Major advances in the detection of gene and chromosomal mutations in human cells provide new opportunities to evaluate the biological effects of low-dose radiation in humans exposed either externally or to internally-deposited radioactive materials. The applicability of cytogenetic techniques in biological dosimetry is based on the fact that ionizing radiation induces structural aberrations in the chromosomes of exposed cells. These abnormalities can be readily observed microscopically and quantified in metaphase preparations of human lymphocytes whether exposed in vitro or in vivo. Radiation induced chromosome breaks can also be detected indirectly in larger cell samples using the micronucleus assay that has been shown to be sensitive to acute radiation doses as low as 5 rem (cSv). Cytogenetic changes are, thus, useful biological endpoints for surveillance of radiation effects in nuclear workers because of their sensitivity, biological memory of past exposure and universal application in exposed or potentially exposed individuals.
We propose to evaluate the cytogenetic status of peripheral blood lymphocytes sampled from former plutonium workers with life-time exposure histories in the low (<10 rem) and high (>50 rem) exposure categories for comparison with a matched, non-exposed control group of current workers. Specifically, we will examine the relationship between the total (external plus internal) effective dose equivalent and the cytogenetic integrity of lymphocytes as measured by the frequency of micronuclei and chromosomal aberrations in mitogen-stimulated cells. The three study cohorts will be matched by age, smoking and medical status (including medical irradiation) for comparison to each other, as well as to historical control values published in the literature. To accomplish this goal, we will utilize both interphase and metaphase cytogenetic methods to evaluate the chromosomal integrity of former plutonium workers. Three specific aims will guide this investigation. We will: 1) test the hypothesis that lymphocyte micronucleus frequencies will correlate with the effective dose equivalent after correcting for age and smoking history, 2) test the hypothesis that the frequency of chromosomal translocations (i.e., stable rearrangements) in lymphocytes will correlate with the effective dose equivalent after adjusting for age and smoking history, and 3) evaluate the sensitivity of both micronucleus and chromosomal translocation assays as biomarkers of radiation exposure and whether they can provide dose estimates for workers where exposure data are missing, suspect or incomplete.
Project Identifier: RFET-91-RF-94-06
Project Title:
Rocky Flats Beryllium Health Surveillance Program
Principal Investigator:
Dr. Arthur W. Stange
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $2,150,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 1,500
Type of Human Subjects Involvement:
The Rocky Flats Beryllium Health Surveillance Program (BHSP) was designed to identify new cases of chronic beryllium disease (CBD), and beryllium sensitization in individuals who have had the potential for exposure to beryllium while employed at the Rocky Flats Environmental Technology Site. The BHSP has completed its seventh year, and has identified 62 new cases of CBD and 172 additional cases of beryllium sensitization. The BHSP is composed of 5 interrelated tasks and includes the identification, notification, scheduling, testing, and retesting of current and former employees of Rocky Flats who believe they were exposed to beryllium during their employment at the Site. The identity of nearly all employees of Rocky Flats (former and current) who had the potential for exposure to beryllium has been established. All individuals indicating a desire to participate are tested for sensitivity to beryllium using the peripheral blood Lymphocyte Proliferation Test, and given a chest x-ray. The only risk to human subjects from the beryllium sensitivity screening is the venipuncture, as used for regular medical laboratory testing, and therefore, there is very little risk from this procedure. Further medical evaluation to determine the presence of CBD is offered to those identified as beryllium sensitized or found to have suspicious lung pathology on chest x-ray B-Reader examination. Risks to human subjects from additional procedures undertaken by two leading medical centers for the clinical evaluation of CBD (bronchoalveolar lavage, bronchoalveolar lung biopsy) are on a voluntary basis, and are under the guidelines established by individuals previously tested for sensitivity to beryllium who were found to have normal test results. Retesting is offered every year to individuals who had a positive blind test for sensitivity to beryllium that was not confirmed or who had an abnormal chest x-ray possibly associated with CBD.