Boston University School of Public Health

Funding for Human Subjects Research:

DOE: Office of Health Services

$1,163,622.00 for: Fiscal Year 2005
10/1/04-9/30/05
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

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: 07/06/05
IRB approval number: H-23264
Explanation of IRB approval:
Multiple amendments and reviews. IRB changed data management program which led to change of protocol approval dates.

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California - San Francisco
Most recent approval: 07/22/05
IRB approval number: H5157-15154-08

Type of Review: Full Board
Approving Institution: Nevada Test Site
Most recent approval: 04/15/02
IRB approval number: C640-KH-02-0206
Explanation of additional approval:
Pending approval of Central Beryllium IRB.

Type of Review: Full Board
Approving Institution: Central Beryllium IRB, ORAU
Most recent approval: 08/15/05
IRB approval number: CBE IRB (05)-23 BU

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 540
Reporting period for number of human subjects: Fiscal Year 2005

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For clinical research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.
• Using existing data that were collected for other purposes or projects.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

A. Objectives

Federal Legislation enacted in 1993 required the U.S. Department of Energy to develop a medical screening and surveillance program for workers who participated in its nuclear weapons program. The DOE issued a Request for Application (RFA0 in 1996 after which the Environmental Health Program at BUSPH along with the Occupational Medicine Program at the University of California at San Francisco (UCSF) and the Southern Nevada Building and Construction Trades Council were awarded the grant to assess the health status of the former nuclear weapons workers from the Nevada Test Site (NTS). No major research or intervention program had yet been attempted to address the health concerns of civilian workers at the NTS despite more than four decades of nuclear weapons testing. The purpose of the proposal was to develop and deliver a medical surveillance and screening program for former workers in consortium with UCSF and the Southern Nevada Building and Construction Trades Council. Objectives: 1. Identify individuals at risk of work-related diseases while employed at the NTS from 1951 to 1992. 2. Locate, notify, and invite former workers to medical screenings. 3. Conduct medical screenings and provide information about work-related health hazards. 4. Provide follow-up information about screening-based health assessments. 5. Provide information and assist program participants with applications for state and federal compensation programs. 6. Provide early detection, intervention, and treatment to former workers of the NTS who may have been at risk of beryllium exposure.

Individuals at risk of work-related diseases due to beryllium, silica, ionizing radiation, asbestos, noise, and other substances due to work performed at the Nevada Test Site from 1951 to 1992 are identified and notified about the Boston University organized medical screening and surveillance project via community outreach programs, union partnership efforts, and mailings. Individuals are identified from lists provided by contractor payroll records from the Nevada Test Site. Individuals are contacted and invited to attend medical screenings held quarterly in Las Vegas, NV. The individual participant completes an occupational and medical questionnaire and has blood tests including a beryllium lymphocyte proliferation test (Be-LPT), audiometry and spirometry, chest x-ray, and physical examination. Project physicians provide referrals as indicated.

A screening program for beryllium sensitivity and chronic beryllium disease has been provided to former workers in the Worcester, Massachusetts area who have been employed at the Wyman-Gordon and Norton Company facilities. Screenings focus on beryllium hazards and include a Be-LPT and chest x-rays and spirometry as indicated.

Participant satisfaction surveys are completed at the screening exam. Test results are reviewed by project staff. Immediate follow-up is conducted for anyone with a serious abnormality. All participants receive a screening results letter within 6 to 8 weeks. Referrals are made to state and federal compensation programs, as appropriate. Follow-up, confirmatory Be-LPT tests are conducted for all borderline and positive beryllium results. We offer periodic screening evaluations to individuals as indicated, where past exposures are expected to confer on-going risk, targeting those with chronic disease outcomes: asbestos, silica, beryllium, and ionizing radiation. Current Former Worker Program guidelines recommend periodic screening every three years.

The UCSF 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.

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 as well as the Occupational Health Center at Marlboro Hospital, Marlboro, Massachusetts. If the patient agrees to be in this project the following will happen:

1. The patient will fill out a work history and health status questionnaire. This will take about one hour to complete.
2. The patient will have a physical examination.
3. The patient will have an x-ray of his lungs.
4. The patient will have a breathing test (spirometry).
5. The patient will have a hearing test (audiogram)
6. Some individuals will have a blood sample drawn from a vein in the patient's arm to measure the complete blood count. A total of two teaspoons of blood will be drawn.
7. Some individuals will have a second two-teaspoon blood sample drawn to test for the participant's sensitivity to beryllium.
8. Patients are given an information sheet explaining the procedures, and possible risks/discomforts, as well as other pertinent information.
9. Informed consent, which highlights the potential risks and benefits associated with beryllium screening, is provided to program participants.

Project Identifier: BUSPH-05-Northern California

"Medical Surveillance for Former Department of Energy Workers at Lawrence Bekeley National Laboratory, Lawrence Livermore National Laboratory, and Sandia California."

Principal Investigator: Dr. Lewis D. Pepper, Boston University School of Public Health

Project started in: 2005

Project Funding Information: