Ms. Maureen
A. Cadorette
Johns Hopkins Univeristy School of Hygiene & Public Health
615 N. Wolfe Street, Room 7503B
Baltimore, MD 21205
Phone: 410-955-4587
Fax: 410-955-1811
E-mail: lanlfwms@jhsph.edu
Number of Human Subjects projects reported: 1
"Medical Surveillance for Former Department of Energy Workers"
See also: LANL-98-98-LANL-E5_V
Principal Investigator: Dr. Brian Schwartz, Johns Hopkins University School of Hygiene and Public Health
Project started in: 1997
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: Johns Hopkins University Joint Committee on Clinical Investigation
Most recent approval: 05/09/00
IRB approval number: RPN #96-04-23-01
Explanation of IRB approval:
98-LANL-05
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 02/14/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 770
Reporting period for number of human subjects:
Other: 10/01/98 to 09/30/99
Explanation:
Project began in January 1998
Type(s) of Human Subjects Involvement:
Abstract
The objectives of this program over the past year were to:
1) contact former LANL workers through mailings and invite them to participate in this medical examination program. As of 9/30/00, approximately two-thousand seven hundred and fifty (2,750) letters have been sent to former workers. Former workers with selected job titles who had a high probability of working with the following agents asbestos, beryllium, lead, noise, radiation and solvents received a letter inviting them to take part in the program. Former workers with unknown job titles were sent a short questionnaire to determine eligibility for the program. As of 9/30/00, one hundred and sixty-five (165) former workers completed this questionnaire.
2) establish a program office in northern New Mexico where confidential exposure and medical history interviews with former LANL workers are conducted. This office is located in Espanola, NM. We have completed five hundred and eighty-one (581) interviews with former LANL workers since March, 2000.
3) begin a medical examination program for former LANL workers at two sites. The two sites are:
(a) the Los Alamos National Laboratory Occupational Medicine Clinic in Los Alamos, NM. Medical examinations began on June 13, 2000 at this site and as of 9/30/00 twenty-six (26) examinations have been done.
(b) the Former LANL Workers Program Office in Espanola, NM. Medical examinations began here on April 11, 2000 and as of 9/30/00 two hundred and seventy-four (274) examinations have been done.
4) offer former workers who do not wish to participate in the exam program the option to have a review of selected medical records performed by occupational medicine physicians at Johns Hopkins University. As of 9/30/00, twenty (20) former workers requested this option. We are currently awaiting these records for review.
5) develop risk communication materials for the program. We developed invitation letters, an information pamphlet, results letters, and a short satisfaction survey. An educational meeting was held in Espanola, NM on 11/4/99. Six (6) former workers attended this meeting where educational materials were reviewed and reading levels were assessed. The results letters were reviewed in focus groups prior to their completion. Fifteen (15) former workers attended these focus groups on February 22, 2000 in Espanola, NM.
The risks involved with this program are the risks involved with routine medical examinations and testing. The medical exams are focused to examine for health outcomes related to exposures to asbestos, beryllium, lead, noise, radiation and solvents. The medical tests include spirometry, audiometry, blood tests [CBC with differential, BUN, creatinine, thyroid stimulating hormone, beryllium lymphocyte proliferation test(LPT)], a hemocult test of stool, and a chest x-ray. Not all former workers receive all these exams and tests. The types of examination(s) and test(s) are determined by the exposure and medical history interview. On the day of their examination, former workers are given a form, prior to obtaining informed consent, that outlines which examination(s) and test(s) that they will receive. An informed consent is completed for the medical examination and a separate informed consent is completed for the beryllium LPT test.
All records, test results, and chest x-rays are sent to the School of Hygiene and Public Health in Baltimore, MD for storage. The chest x-rays are B-read at Hopkins. The examination findings, test results, and x-rays reports are reviewed by the program occupational medicine physicians and results letters are sent to the former workers. All record and x-rays are kept in Baltimore in locked files. Access to these files is limited to the Principal Investigator and selected members of the program team.