Dr. Lewis D. Pepper
Boston University School of Public Health
Environmental Health Department
715 Albany St
Boston, MA 02118
Phone: 617-638-4620
Fax: 617-638-4857
E-mail: lpepper@bu.edu
Number of Human Subjects projects reported: 1
| BUSPH-96-DE-FC03-96SF21261 | "Medical Surveillance for Former Department of Energy Workers at the Nevada Test Site" |
"Medical Surveillance for Former Department of Energy Workers at the Nevada Test Site"
Principal Investigator: Dr. Lewis D. Pepper, Boston University School of Public Health
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
Approving Institution: Boston University School of Public Health
Most recent approval: 06/20/02
IRB approval number: 4644/02
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California - San Francisco
Most recent approval: 05/10/02
IRB approval number: H5157-15154-04B
Type of Review: Full Board
Approving Institution: NTS
Most recent approval: 04/15/02
IRB approval number: C640-KH-02-0206
Explanation of additional approval:
Conditional approval pending inclusion of Central Beryllium IRB recommendations.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 799
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
A. Objectives
The overall objective of this project is to carry out a medical screening program for former workers at the Department of Energy's (DOE) Nevada Test Site (NTS) in order to prevent and minimize the health impact of diseases caused by site related workplace exposures. The Program was developed in response to the intent of Section 3162 of the 1993 Defense Authorization Act, which urges the DOE to "carry out a program for the identification and ongoing evaluation of current and former DOE employees who are subjected to significant health risks...during such employment." As one of ten medical surveillance pilot programs funded under cooperative agreements with the Department of Energy, the project at the Nevada Test Site (NTS) focuses on former NTS workers who dug, maintained and re-entered the tunnels, shafts and drill holes used for underground nuclear testing.
The "Medical Surveillance for Former Department of Energy Workers at the Nevada Test Site" project is being carried out by Boston University School of Public Health (BUSPH) in collaboration with the University of California San Francisco (UCSF), and the Southern Nevada Building and Construction Trades Council (SNBCTC). The Department of Environmental Health at BUSPH has oversight of the project and is involved in all aspects of work on the project. The UCSF Division of Occupational and Environmental Medicine has principal responsibility for organizing and conducting the medical screening program. The SNBCTC, which represents 14 unions in the region and is the parent body for the six unions representing the targeted groups of workers, is involved in identifying, locating and notifying former workers for inclusion in the surveillance program, as well as assisting with the Project Advisory Panel which will continue to oversee the operation and effectiveness of the project.
The University of California, San Francisco, Division of Occupational and Environmental Medicine continues to be responsible for the provision of medical screening for former NTS workers. Unlike other DOE sites where contract physicians conduct the screening assessments, our project utilizes occupational medicine physicians from UCSF and BUSPH and Family Medicine faculty and Residents from the University of Nevada School of Medicine. We use this approach to ensure that board-certified or board-eligible occupational medicine physicians will conduct the majority of screening examinations. Our objective is to assure the former workers, the union membership, and the union leadership that the best possible clinical services are provided. The union members of our Advisory Panel have told us that the success of the project depends in large part on the quality of the clinicians. Additionally, we recognize that the project is creating a need that will not disappear once the current program has ended. We therefore hope to develop occupational medicine capacity in Las Vegas to meet this need.
UCSF and BUSPH physician staff has developed a teaching program for residents and faculty of the University of Nevada (UN) Department of Family and Community Medicine. The teaching program incorporates didactic teaching along with clinical skill development. A Family Medicine faculty member and resident participate in each of the clinical screening sessions.
A series of Family Medicine Rounds in Occupational Medicine (OM) is being conducted with the following objectives:
1. To familiarize all Family Medicine practitioners with the basic principles of OM (occupational history, work-site evaluation, workers' compensation);
2. To appreciate how occupational health can be apart of clinical Family Medicine (using the example of the Former NTS workers);
3. To develop a cadre of Family Practice physicians who have core occupational medicine competencies;
4. To encourage the addition of formal occupational medicine teaching into the Family Medicine curriculum;
5. To encourage the development of a clinical program with occupational medicine competencies along the lines of the Association of Occupational and Environmental Clinics' (AOEC) standards.
B. Procedures
The screening examinations have been conducted quarterly since September 1998 at the University of Nevada Medical School Family Practice Center in Las Vegas. The screenings have been conducted by physicians from Boston University, University of California, San Francisco, and the University of Nevada Family Practice Center.
If the patient agrees to be in this project the following will happen:
1. The patient will fill out a questionnaire that asks the patient about his work history and any health problems he may have. This will take the patient about one hour to complete.
2. The patient will have a physical examination. A doctor who is part of the project team will check his blood pressure and pulse, and examine his skin, throat, neck, heart, lungs, abdomen and nervous system.
3. The patient will have an x-ray of his lungs.
4. The patient will have a breathing test (spirometry). The patient will be asked to blow into a machine that measures the amount of air he has in his lungs and how fast he can blow it out.
5. The patient will have a hearing test (audiogram). The patient will sit in a sound proof hearing booth and be asked to say whether he can hear sounds at different levels.
6. A blood sample will be drawn from a vein in the patient's arm. A total of two teaspoons of blood will be drawn.
7. A second two teaspoon blood sample will be drawn to test for the participant's sensitivity to beryllium.
Total participation in the project will take a total of about 2 hours in one day. Patients will receive a letter with in six weeks describing the finding of the examination. If a medical problem has been found, the patient will be referred to his own doctor. A list of physicians will be made available for those patients that do not have their own doctor.
C. Risks/Discomforts
1. Radiation- The amount of radiation a patient will be exposed to is relatively small. Such doses of radiation may be potentially harmful, but the risks are so small they are difficult to measure.
2. Venipuncture- The risks of drawing blood include temporary discomfort from the needle stick and bruising.
3. Confidentiality- Participation in research will involve a loss of privacy; however the records will be handled as confidentially as possible. Data will become part of the Department of Energy system of record No. 88 and protected accordingly. Names will not be used in any published reports about this project. However, the medical staff may release patient records if they receive a subpoena in connection with a workers' compensation or other legal case.
Patients are given an information sheet explaining the procedures, and possible risks/discomforts, as well as other pertinent information. Informed consent, which highlights the potential risks and benefits associated with beryllium screening, is provided to program participants.