Ms. Maureen A. Cadorette
Johns Hopkins Univeristy 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
| JHUSHP-97-DE-FC03-98SF21541 | "Medical Surveillance for Former Department of Energy Workers" |
"Medical Surveillance for Former Department of Energy Workers"
Principal Investigator: Dr. Brian S. Schwartz, Johns Hopkins 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 Bloomberg Sch of Public Health Committee on Human Research
Most recent approval: 04/16/03
IRB approval number: H.18.02.03.11.A2
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 02/11/03
IRB approval number: LANL 98-05
Type of Review: Full Board
Approving Institution: DOE Central Beryllium IRB
Most recent approval: 08/04/03
IRB approval number: CBeIRB (02)- 7 LANL
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 400
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Objectives:
The purpose of the program is to identify former LANL workers at increased risk of occupational disease due to past work there, and offer a one-time examination consisting of history, physical, and targeted laboratory tests.
Methodology:
1) Contact former LANL workers through mailings and invite them to participate in this medical examination program. As of 9/30/03, approximately 32,350 letters have been sent to former workers inviting them to participate in this program.
2) Conduct a confidential interview with former LANL workers who agree to participate in this program. The interview involves the completion of a computer-assisted exposure and medical history questionnaire (EQ2). These interviews are done in the program office in Espanola, NM. We completed approximately 421 EQ2s between 10/1/02 and 9/30/03. The total number of interviews done as of 9/30/03 was 2,585.
3) Perform a medical examination for former LANL workers at three sites. We have completed over 400 exams between 10/1/02 and 9/30/03. Total exams done to 9/30/03 are 2015.
The three sites where exams are performed are:
a) The Los Alamos National Laboratory Occupational Medicine Clinic in Los Alamos, NM. The LANL Occupational Medicine Clinic completed 44 exams between 10/1/02 and 9/30/03.
b) The Former LANL Workers Program Office in Espanola, NM. Our physicians at the Espanola Program Office completed 351 exams between 10/1/02 and 9/30/03.
c) The Center for Occupational and Environmental Health (COEH) in Baltimore, MD. Our physicians at the COEH completed 9 exams between 10/01/02 and 9/30/03.
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 completed a total of 91 medical record reviews to 9/30/03. We have completed 2106 exam equivalents as of 9/30/03.
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. We are revising this handbook to comply with the DOE Final Beryllium Guidance that was sent in June 2003.
6) The risks involved with this program are the risks involved with routine medical examinations and testing. The medical exams are focused to evaluate 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.
7) Consent forms are obtained for every former worker who completes a questionnaire, survey, or participates in a focus group. Separate consents are obtained for:
a. surveys or questionnaires,
b. focus groups,
c. medical exam or the medical record review, and
d. a beryllium lymphocyte proliferation test (BeLPT).
8) DOE Final Beryllium Guidance was provided on June 2, 2003. We are now in compliance with all requirements. Revised forms are still under review by Committees on Human Research (CHR), the LANL IRB, and the Central Beryllium IRB.
9) At the request of DOE, we are now also obtaining consent from participants to place their de-identified data in the DOE Comprehensive Epidemiological Data Resource (CEDR) Database. Revised forms are still under review by CHR and the Central Beryllium IRB.
10) 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. Reports sent to DOE contain group data. No individual is identified in these reports. A unique identification number identifies the participant and is used on all blood samples and tests. No personal identifiers are used. Program records and data are maintained in locked files and password protected databases. No information is given to anyone without the written permission of the former worker. Certain laws or a subpoena may alter the confidentiality of these records. This information is in all of the program consent forms.