Ms. Sylvia Kieding
2490 S. Garfield St.
Denver, CO 80210
Phone: 303-759-2604
Fax: 303-300-4750
E-mail: skieding18@aol.com
Number of Human Subjects projects reported: 2
| PACE-96-DE-FC03-96SF21260 | "DOE Gaseous Diffusion Plants K-25, Portsmouth, and Paducah Current and Former Workers Medical Surveillance Program" |
| PACE-97-DE-FC03-97SF21512 | "Medical Surveillance for Former INEEL Workers" |
"DOE Gaseous Diffusion Plants K-25, Portsmouth, and Paducah Current and Former Workers Medical Surveillance Program"
Principal Investigator: Mr. David Ortlieb, Paper, Allied-Industrial, Chemical and Energy Workers International Union (PACE)
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PACE-96-DE-FC03-96SF21260
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: ORSIRB (Oak Ridge Site-Wide)
Most recent approval: 03/14/03
IRB approval number: OCAW-1
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Queens College/CUNY
Most recent approval: 09/23/03
IRB approval number: C-7-1-98-02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1279
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
a. Objectives:
1. Conduct a selected medical screening program of current and former occupationally exposed DOE Gaseous Diffusion Plant workers for health conditions for which secondary prevention is possible.
2. Ensure that current and former DOE Gaseous Diffusion Plant workers are properly informed about the nature of the risks derived from employment, the benefits and limitations of medical screening, and future actions that they can take to protect their health.
b. Methodology:
Provide low-dose, high resolution computed tomography (CT) scans to current and former gaseous diffusion plant workers with the greatest risk for developing lung cancer based on occupational exposure history, smoking history, and age.
c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which Human Subjects are exposed:
This program uses conventional chest x-ray and low-dose CT scan for medical screening program.
d. Involvement of Human Subjects:
1. Procedures:
Screening participants are asked to participate in one or both of the following activities:
a. Medical Screening: Participants are 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 selected participants we offer a low-dose CT scan of the chest.
For Gaseous Diffusion Plant workers who report possible exposure to beryllium, they are offered a blood test for beryllium sensitization, the beryllium (Be) Lymphocyte Proliferation Test (LPT). For K-25 Gaseous Diffusion Plant workers who report possible exposure to bladder carcinogens, they are offered a urine cytology test to screen for bladder cancer.
b. Education: We recruit groups of 20 to 30 former workers for a 2 to 3 hour educational session. The sessions cover current knowledge about occupational exposures at the DOE gaseous diffusion plants, current knowledge about demonstrated health risks at DOE gaseous diffusion plants, how chemical toxins and radiation affect the human body, the 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 administer the physical examination and medical tests. These providers are under contract to the program and apply the medical screening program uniformly.
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, are withdrawn in order to perform the blood chemistry tests. For consenting workers who report a history of potential beryllium exposure, 30 cc's of blood or 6 teaspoons, are withdrawn in order to perform the beryllium lymphocyte proliferation test (Be-LPT).
Participants receive the results of their medical screening and recommendations about medical follow-up by mail within 2 to 3 months of the date of screening. They 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 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 is 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 is sent by the health care provider performing the screening to the Queens College Co-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 is minimized by establishing two types of contact, written and oral (telephone) with screening participants who have abnormal test results. There is also a toll-free phone number distributed at the time of medical screening through which participants have ready access to the project team.
There is a risk of 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 is also available to address their concerns.
This study does not involve any administration of medicines or injection of dyes or radioactive materials. 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.
"Medical Surveillance for Former INEEL Workers"
Principal Investigator: Mr. David Ortlieb, Paper, Allied Industrial, Chemical and Energy Workers International Union (PACE)
Project started in: 1997
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PACE-97-DE-FC03-97SF21512
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: INEEL IRB
Most recent approval: 09/17/03
IRB approval number: INEEL-IRB-98-001
Explanation of IRB approval:
The above IRB information pertains to the INEEL IRB review. Queens College/CUNY IRB approval: 4/29/03, Protocol #C-99-08-25-01.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 439
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
a. Objectives:
1. To conduct a selected medical screening program of former occupationally exposed Idaho National Engineering and Environmental Laboratory (INEEL) workers for health conditions for which secondary prevention is possible.
2. To ensure that former INEEL 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. Methodology:
The program is implemented through a medical screening protocol offered at clinical facilities in the INEEL area. There are also separate educational sessions where workers can learn about exposures, risks, and medical screening.
c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which Human Subjects are exposed:
This program does not expose any workers to toxic or radioactive materials.
d. Involvement of Human Subjects:
1. Study Procedures:
All individuals who worked at INEEL for at least 30 days will be eligible for inclusion in the needs assessment process. Screening participants are asked to participate in one or both of the following activities:
a. Medical Screening: Participants are 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).
INEEL workers who report possible exposure to beryllium are offered a blood test for beryllium sensitization, the beryllium (Be) Lymphocyte Proliferation Test (LPT).
b. Education: We recruit groups of 20 to 30 former workers for a two to three hour educational session. The sessions cover current knowledge about occupational exposures at INEEL, current knowledge about demonstrated health risks at INEEL, how chemical toxins and radiation affect the human body, the purposes and value of medical screening, and methods to protect health in the future.
Qualified health care providers in the regions of INEEL administer the physical examination and medical tests. These providers are under contract to the program and apply the medical screening program uniformly.
This medical screening program requires placement of a sterile needle in a vein in the arm in order to withdraw blood; 10 cc of blood, or two teaspoons, are withdrawn in order to perform the blood chemistry tests. For consenting INEEL workers who report a history of potential beryllium exposure, 30 cc of blood or six teaspoons, are withdrawn in order to perform the beryllium lymphocyte proliferation test (Be-LPT).
Participants receive the results of their medical screening and recommendations about medical follow-up by mail within two to three months of the date of screening. They learn of any test abnormalities that require more urgent follow-up by telephone within two to three days of the date of screening or the complete reading of the chest x-ray. We 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 is 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 is sent by the health care provider performing the screening to the Queens College Co-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 is minimized by establishing two types of contact, written and oral (telephone), with screening participants who have abnormal test results. There is also a toll-free phone number distributed at the time of medical screening through which participants have ready access to the project team.
There is a risk of 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 INEEL and about the ways in which they can protect their health and lessen their likelihood of becoming ill. The toll-free telephone number is also available to address their concerns.
This study does not involve any administration of medicines or injection of dyes or radioactive materials. 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.