Ms. Sylvia
Kieding
2490 S. Garfield St.
Denver, CO 80210
Phone: 303-759-2604
Fax: 303-300-4750
E-mail: skieding@yahoo.com
Number of Human Subjects projects reported: 2
Project Identifier:
PACE-96-DE-FC03-96SF21260
Project Title:
"DOE Gaseous Diffusion Plants K-25, Portsmouth, and Paducah Former Workers Medical Surveillance Program"
Principal Investigator: Dr. Robert E. Wages, Paper, Allied-Industrial, Chemical and Energy Workers Intern
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 04/14/99
IRB approval number: OCAW-1a
Explanation of IRB approval:
The above IRB information pertains to the Oak Ridge IRB review.
Queens College/CUNY approval: 4/28/99, protocol: C-7-1-98-02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 363
Reporting period for number of human subjects:
Other: 04/30/99 to 09/30/99
Explanation:
This project was not previously reported to the HSRD; reporting from IRB approval to the end of FY99.
Type(s) of Human Subjects Involvement:
a. The program objectives are:
1. To conduct a selected medical screening program of former occupationally exposed DOE Gaseous Diffusion Plant workers for health conditions for which secondary prevention is possible.
2. To ensure that former DOE Gaseous Diffusion Plant workers are properly informed about the nature of the risks derived from prior employment, the benefits and limitations of medical screening, and future actions that they can take to protect their health.
b. The program is implemented through a medical screening protocol offered at clinical facilities in the regions where the gaseous diffusion plants are located. There are also separate educational sessions where workers can learn about exposures, risks, and medical screening.
c. This program does not expose any workers to toxic or radioactive materials.
d. Human Subjects:
1. Study Procedures
Screening participants will be asked to participate in one or both of the following activities:
a. Medical Screening: Participants will be asked to complete exposure and medical questionnaires requesting information about prior occupational exposures, past medical history and current symptoms. A physical examination will be conducted. Additional medical tests include a routine chest x-ray (two views); pulmonary function tests (breathing tests); an audiogram (hearing test); a urinalysis, and standard blood chemistry tests that reflect kidney and liver function (blood urea nitrogen; creatinine; and liver function tests).
For former K-25 Gaseous Diffusion Plant workers who report possible exposure to beryllium, they will receive a blood test for beryllium sensitization, the Lymphocyte Proliferation Test (LPT).
b. Education: We will assemble groups of 20 to 30 former workers for a 3 to 4 hour educational session. This session will cover current knowledge about prior occupational exposures at the DOE Gaseous Diffusion Plant, current knowledge about demonstrated health risks at DOE Gaseous Diffusion Plant, how chemical toxins and radiation affect the human body, purposes and value of medical screening, and methods to protect health in the future.
Qualified health care providers in the regions of the gaseous diffusion plants will administer the physical examination and medical tests. These providers will be under contract to the program and will apply the medical screening program uniformly.
This study does not involve any administration of medicines or injection of dyes or radioactive materials.
This medical screening program requires placement of a sterile needle in a vein in the arm in order to withdraw blood, 10 cc's of blood, or 2 teaspoons, will be withdrawn in order to perform the blood chemistry tests. For former workers who report a history of potential beryllium exposure, 30 cc's of blood or 6 teaspoons, will be withdrawn in order to perform the lymphocyte proliferation test.
Participants will receive the results of their medical screening and recommendations about medical follow-up by mail within 4-8 weeks of the date of screening. They will learn of any test abnormalities that require more urgent follow-up by telephone within 2 to 3 days of the date of screening or the complete reading of the chest x-ray. We will provide participants with a toll-free telephone number that they can call if they have any questions about their results or about the overall program.
All information that will be obtained by questionnaire and during the educational sessions, is confidential, to the extent allowed by law, and will not be identified by individual name to anyone external to the study team, except with the participant's written permission. Additional procedures to protect confidentiality are described in section 3 below.
2. Risks
The risk of physical injury in this program is minimal. After drawing blood, there is occasionally a small leakage of blood under the skin, which can produce discoloration and/or a small bump.
An additional risk in this study is violation of confidentiality. The information obtained in the medical screening will be sent by the health care provider performing the screening to the Queens College Principal Investigator and Project Director, Steven Markowitz, MD. Additional procedures to protect confidentiality are described in section 3 below.
Another possible risk is delay or error in sending the medical screening results to the individual screening participants. This will be minimized by establishing two types of contact, written and oral (telephone), with screening participants who have abnormal test results. There will also be a toll-free phone number distributed at the time of medical screening through which participants will have ready access to the project team.
There is a risk of the emotional distress that some participants may feel as a result of discussing prior exposures to toxic agents and radiation and possible subsequent health risks during the educational sessions. We address this risk by providing them with clear communication about the nature of the health risks experienced as a result of working at DOE Gaseous Diffusion Plants and about the ways in which they can protect their health and lessen their likelihood of becoming ill. The toll-free telephone number will also be available to address their concerns.
There are no risks to pregnant women or any vulnerable populations.
3. Confidentiality
Measures will be taken to protect confidentiality, to the extent permitted by law. The project will protect confidentiality by assigning to each participant a unique number identifier that will be used in analyzing the information that is obtained. Program data will be put on electronic media for data cleaning and analysis. Only the study investigators will know the code matching names and numeric identifiers. All individually identified data will be kept in locked file cabinets at Queens College (City University of New York).
The results of the study will be reported to the Department of Energy and all interested parties and may be published for scientific purposes. In reporting results, only aggregate analyses will be issued. No individual's results will be reported in a manner that the individual can be identified.
Project Identifier:
PACE-97-DE-FC03-97SF21512
Project Title:
"Medical Surveillance For Former INEEL Workers (DUPLICATE, SEE INEEL-98-INEEL-IRB-98-001)"
Principal Investigator: Dr. Steve Markowitz, Center for the Biology of Natural Systems - Queens College
Project started in: 1997
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 09/22/98
Explanation of IRB approval:
The IRB information for this project is not yet available for FY99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 10/01/98 to 09/30/99
Explanation:
The Human Subject information for this project is not yet available for FY99.
Type(s) of Human Subjects Involvement:
The study is designed to identify the need for medical screening for health conditions that may be related to occupational exposures experienced by former workers at the Idaho National Engineering and Environmental laboratory. The study plans to obtain existing information about the nature and intensity of chemical and radiation exposures that may have occurred at INEEL in the past; to identify which workers were most likely to have high exposures; and to review existing studies of patterns of health problems among former INEEL workers. The outcome of this study will be a recommendation to the Department of Energy about the need, if one exists, for a medical screening program among former INEEL workers.
All individuals who worked at INEEL for at least 30 days will be eligible for inclusion in the needs assessment process.
The activities include: Focus groups - 2-3 groups of 10-15 former and current workers will be assembled for a 2 hour session to discuss their knowledge of the laboratory and any concerns about health as a result of having worked at the INEEL. These results will be audiotaped and transcribed without attribution of specific comments to named individuals.
Risk mapping - 6 groups of 8-10 former and current workers will be assembled for a 3 hour session to discuss their knowledge of potential radiation and chemical exposures that may have occurred during the history of operations at INEEL. The information will be collected by job location and job title. The information will be summarized in written form without attribution of information to specific individuals.
Questionnaire - Mailed to approximately 1000 former works asking detailed questions about prior exposures, job history, health concerns, and current health care.
All information that will be obtained is confidential, to the extent allowed by law, and will not be identified by individual participant to anyone external to the study team. There is no risk of physical injury in this study. Any risk of violation of confidentiality will be minimized by assigning a unique number identifier that will be used in analyzing the information obtained. The code matching names and numeric identifiers will be known only to the study investigators. All individually identified data will be kept in locked file cabinets at the academic centers that are participating in the study. There is a risk of emotional duress that some participants may feel as a result of discussing prior exposures to toxic agents, radiation, and possible subsequent health risks. This risk will be addressed by providing clear communication about the exploratory nature of the study and presentation of the results of the needs assessment project at the end of the study period in a meeting open to subjects and other former workers.