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: 6
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 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Autopsies were performed on 6 former Rocky Flats (RF) radiation workers, but in Washington State with other funds. No work with human subjects occured at RF.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 16, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
The objectives of the Transuranium Registry are 1) to study the distribution and dose of transuranium radionuclides in people occupationally exposed and 2) to 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 in Washington in recent years, so details could be obtained from them as desired.
No risk to human subjects is involved although the distinction between living and dead should be emphasized.
Project Identifier: RFET-80-RF-94-01
Project Title:
Former Radiation Worker Recall Program
Principal Investigator:
Dr. W. C. Gottschall
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 16, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 200
Type of Human Subjects Involvement:
The objectives of this study were 1) to monitor former radiation workers for early detection of any health problems; 2) to minimize, correct or eliminate any problems; and 3) to 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 analysis for radioactive species are performed as well as standard physical exams. 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.
Project Identifier: RFET-80-RF-94-03
Project Title:
1965 Fire Group
Principal Investigator:
Dr. W. C. Gottschall
Project started in: 1980
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Explanation:
This group is a sub-set of the Radiation Worker Recall Program and as such did not receive separate identifiable funding.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 16, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 25
Type of Human Subjects Involvement:
The objective of this study was to analyze in greater detail, information pertaining to this sub-set of the Radiation Worker Recall Program. Methodology was that of the general program only more detailed and thoroughly analyzed. No human subjects were exposed to any harmful substance or condition in this study. Obviously, however, all participants had been exposed accidentally prior to and as a condition for being included in the study.
Human subjects are not exposed to any risk, in fact benefit from the free exams and lab work.
Project Identifier: RFET-87-RF-94-05
Project Title:
Rocky Flats Antibody Assay
Principal Investigator:
Dr. Arthur W. Stange
Project started in: 1987
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 10, 1995
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 400
Type of Human Subjects Involvement:
The Rocky Flats Antibody Assay Program was designed to screen employees at the Rocky Flats Environmental Technology Site for exposure to beryllium, but also has applications for determining exposures to other substances such as aluminum and silicon. Using vacuum deposition, the beryllium is coated onto immunological microstick plates. These plates are then exposed to plasma of a test subject, and the immunoglobulin (IgG) antibodies present on the beryllium coated microsticks are located and quantified using a unique enzyme-linked immunosorbent microassay (ELISA). All individuals indicating a desire to participate are tested for exposure to beryllium using the ELISA methodology. The only risk to human subjects from this screening assay is the venipuncture, as used for regular medical laboratory testing, and therefore, there is very little risk from this procedure. Retesting is offered periodically to current employees and former employees previously tested for exposure to beryllium who were found to have elevated antibody titers compared to a negative control population without previous exposure to beryllium. Dr. Sara Clark, who developed the test, and her assistant Sally Thurlow are no longer at Rocky Flats. These tests have been suspended.
Project Identifier: RFET-91-RF-94-86
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 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Total Funding: $1,646,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 16, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 1,000
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 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.
Project Identifier: RFET-93-RF-94-04
Project Title:
Short Study to Evaluate New Ultra-Sensitive Analysis Method for Measuring Occupational Exposure to Plutonium-239
Principal Investigator:
Mr. Roger B. Falk
Project started in: 1993
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Involvement of human subjects (11) occurred in FY 1994. Project was not active in FY95. No human subjects were used in FY96, as project was canceled.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: November 15, 1995
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
The purpose of the study was to investigate the utility of a method developed by the University of Utah for the ultra-sensitive analysis of plutonium-239 in the urine samples from a set of occupationally exposed Rocky Flats workers. The method was to analyze 1/2 of the sample by the new method and 1/2 by the conventional method and to compare the results. The subject's involvement was only to submit the urine sample, at no risk to the subject.