Ms. Maureen A. Cadorette
Johns Hopkins Univeristy Bloomberg School of 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"
Principal Investigator: Dr. Brian S. Schwartz, Johns Hopkins University Bloomberg School of 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: 04/24/01
IRB approval number: RPN #96-04-23-01
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/23/01
IRB approval number: LANL 98-05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 765
Reporting period for number of human subjects:
Fiscal Year 2001
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 9/30/01, approximately nine thousand one hundred and forty-three (9,143) 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 9/30/01, approximately four hundred (400) former workers completed this short questionnaire.
2) Conduct a confidential exposure and medical history interview with former LANL workers who agree to participate in this program. These interviews are done in the program office in Espanola, NM. We have completed one thousand three hundred and twenty-two (1322) interviews with former LANL workers since March, 2000.
3) Perform a medical examination program for former LANL workers at two sites. We have completed one thousand and eight examinations (1008) since 4/11/00. The two sites are:
(a) the Los Alamos National Laboratory Occupational Medicine Clinic in Los Alamos, NM. The LANL Occupational Medicine Clinic has completed one hundred and thirty-one examinations (131) since 6/13/00.
(b) the Former LANL Workers Program Office in Espanola, NM. The Espanola Program Office has completed eight hundred and seventy-seven examinations (877) since 4/11/00.
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. We have completed thirty (30) medical record reviews since 9/30/00. Thirty-three (33) medical record reviews are pending, that is, awaiting records or consent forms, and forty-five (45) letters to former workers will be mailed in the near future.
5) Develop risk communication materials for the program. We developed a two hundred-page book that describes all aspects of this program. This book titled “Medical Exam Program Handbook for Former Workers at LANL” will be given to every former worker who has had or will have an examination or medical record review. In October of 2000, sixteen (16) former workers attended focus groups in Espanola, NM. The former workers reviewed the initial drafts of the book described above and an overall program satisfaction survey. The satisfaction survey will be pilot tested in November.
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 chest x-ray is one view only and the radiation received is the same as that received during a routine medical chest x-ray.
All records, test results, and chest x-rays are sent to the Johns Hopkins Bloomberg School of 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 records, test results, 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. Program data is stored in a computer at the Johns Hopkins Bloomberg School of Public Health in Baltimore. The data is stored without unique identifiers and access to the data is restricted to the Principal Investigator and the data manager. All reports sent to DOE contain group data. No individual is identified in these reports.