Dr. Lewis
D.
Pepper
Boston University School of Public Health
Environmental Health Department
715 Albany Street, T-2E
Boston, MA 02118-2526
Phone: 617-638-4623
Fax: 617-638-4857
E-mail: lpepper@bu.edu
Number of Human Subjects projects reported: 2
| BUSPH-96-DE-FC03-96SF21261 | "Medical Surveillance for Former Department of Energy Workers at the Nevada Test Site" |
| BUSPH-05-Northern California | "Medical Surveillance for Former Department of Energy Workers at Lawrence Berkeley National Laboratory, Lawrence Livermore National Laboratory, and Sandia California. " |
"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
Status of the Research this Fiscal Year:
Study is no longer enrolling, but participants still receive research-related interventions (e.g., still receiving treatment, obtaining blood draws), or interactions (surveys, questionnaires).
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: 06/07/07
IRB approval number: H-23264
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: University of California - San Francisco
Most recent approval: 08/07/07
IRB approval number: H5157-5981-40
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:
ORAU will begin to function as the site IRB for this project beginning in FY2007.
Type of Review:
Expedited
Approving Institution: Central Beryllium IRB, ORAU
Most recent approval: 12/04/06
IRB approval number: CBeIRB(02)-4 BU
Explanation of additional approval:
The CBe IRB no longer requires us to renew our protocol with them annually, we only need to copy them on the annual approval letters from all involved institutions.
Type of Review:
Full Board
Approving Institution: University of Nevada, Reno, School of Medicine
Most recent approval: 12/14/06
IRB approval number: B05-06-021
Explanation of additional approval:
The protocol was officially closed on Sept. 13, 2007.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 222
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
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 direct 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 in Las Vegas, NV. The individual participant completes an occupational and medical questionnaire and has blood tests including a complete blood count (CBC), beryllium lymphocyte proliferation test (Be-LPT), audiometry, spirometry, chest x-ray, and physical examination. Examining physicians provide referrals as indicated.
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 confirm 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.
In the Spring of 2006, we entered into an agreement with the University of Nevada School of Medicine Family Medicine program to have board-certified faculty members and board-eligible residents conduct the medical screenings. Test results are reviewed and immediate follow-up is conducted for anyone with a serious abnormality.
The UCSF Division of Occupational and Environmental Medicine continues to be responsible for reviewing the results of medical screenings and the preparation of results letters. Our goal is to provide all participants with a screening results letter within 6 to 8 weeks.
B. Procedures
Screening examinations are conducted at the University of Nevada Medical School Family Medicine Center in Las Vegas, as well as the Occupational Health Center at Cambridge Health Alliance in Somerville, 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 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.
"Medical Surveillance for Former Department of Energy Workers at Lawrence Berkeley 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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 09/06/07
IRB approval number: H-25827
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 01/10/07
IRB approval number: 5157-27819-02A
Type of Review:
Expedited
Approving Institution: Oak Ridge Associated Universities
Most recent approval: 09/01/06
IRB approval number: CBeIRB(06)-31
Explanation of additional approval:
The CBe IRB no longer requires us to renew our protocol with them annually, we only need to copy them on the annual approval letters from all involved institutions.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 197
Reporting period for number of human subjects:
Other: 01/01/07 to 11/30/07
Explanation:
Number of subjects accrued through 10/17/2007.
Type(s) of Human Subjects Involvement:
The overall objective of this project is to develop and conduct a medical surveillance and screening program for former workers at three U.S. Department of Energy (DOE) laboratories; Lawrence Livermore National Laboratory (LLNL), Lawrence Berkeley National Laboratory (LBNL), and Sandia National Laboratories California (SNL CA) in order to prevent and minimize the health impact of diseases caused by site-related workplace exposures. Phase I of this project, which was recently completed for LLNL and SNL CA, identified relevant laboratory hazards and developed the medical screening and surveillance proposal.
The project will be carried out by the Boston University School of Public Health (BUSPH) Environmental Health Department in collaboration with the University of California San Francisco (UCSF) Occupational Medicine program. Individuals at risk of work-related diseases due to beryllium, ionizing radiation, asbestos, lead, lasers, solvents, silica, and other substances due to work performed at LLNL and SNL CA from 1952 to 2004 will be identified and notified about the BUSPH organized medical screening and surveillance project via community outreach programs, union partnership efforts, and direct mailings. Individuals will also be identified from personnel lists provided by the labs, the ORAU Chronic Beryllium Medical Screening program, and through self-identification. Individuals are invited to attend medical screenings held at regional Northern California Kaiser Permanente Occupational Medicine Clinical sites.
All participants will have a pre-screening interview. The project interviewer will administer informed consent for the questionnaire and medical screening to the in-person interviewees. Documentation of informed consent is waived for phone interview candidates; they will consent verbally for the questionnaire portion of the screening.
Individuals who attend the screening at one of the Kaiser Permanente clinics will spend up to two hours on the day of screening. All participants will register and have the following: 1. A physical exam with a Kaiser provider which includes checking blood pressure and pulse, examining skin, throat, neck, heart, lungs, abdomen, vision, and nervous system. 2. Chest x-ray (PA view only) 3. Spirometry 4. Blood test (complete blood count to screen for leukemia and non-malignant conditions).
A subset of individuals will have additional testing determined by their responses to the occupational history questionnaire. These tests may include: 1. Beryllium lymphocyte proliferation test (Be-LPT). 2. Blood chemistry to measure effects of organic solvents on the liver and kidney (total bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine, ALT, AST). 3. Blood lead test. 4. Urine tests: Beta 2 microglobulin, to measure potential effect of cadmium/chromium on kidney function, and urinalysis, microscopic assessment, to measure effect of bladder carcinogen exposure. 5. Audiometry for excessive noise exposed individuals. 6. Amsler and Ishiharra visual tests for individuals with occupational laser exposure.
All participants will be asked to complete a satisfaction survey at the completion of their visit. Examining physicians will provide medical referrals as indicated. 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 federal compensation programs as appropriate. Project staff will refer former workers who no longer live in Northern California to the National Supplemental Screening Program as appropriate.
Potential risks and discomforts include:
1. Radiation (from x-ray). Doses of radiation may be potentially harmful, but the risk is so small it is difficult to measure.
2. Venipuncture. Risks include lightheadedness, fainting, temporary discomfort from the needle stick, bruising, and rarely infection.
3. Confidentiality. Participation may involve a loss of privacy. Test results are treated as confidential medical records and used or disclosed only as provided by the Privacy Act of 1974, the Americans with Disabilities Act, the Health Information Portability and Accountability Act, or as required by a court order or under other law. Screening test results will be provided to the individual, and upon their request, to their personal physician. Identified data are not used in any published reports.
4. Workers' compensation and other insurance coverage. If a workers' compensation claim is filed as a result of this project, regular medical insurance may not pay for follow-up medical examinations or treatment.
5. Psychological risks. Individuals may become upset or uncomfortable as a result of some questions or tests that are done. They may choose not to answer some questions or not to have some of the examination or lab tests done.