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
| 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 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 Bloomberg Sch of Public Health Committee on Human Research
Most recent approval: 04/17/02
IRB approval number: H.18.02.03.11.A
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 02/11/02
IRB approval number: LANL 98-05
Type of Review: Full Board
Approving Institution: DOE Central Beryllium IRB
Most recent approval: 09/11/02
IRB approval number: CBeIRB ID (02)-7
Explanation of additional approval:
First review by Central BeIRB was 5/8/02. the Central BeIRB approved protocol for continuation for up to 12 months but we needed to reply to the questions, comments, and recommendations from the IRB. This response was submitted on 10/10/02. Awaiting reply from IRB.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 700
Reporting period for number of human subjects:
Fiscal Year 2002
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 8/31/02, approximately 18,400 letters have been sent to former workers inviting them to participate in this program. Former workers with known job titles and exposures were invited to participate in the program in the letter. Former workers with unknown job titles are asked to complete a short eligibility questionnaire (EQ1). Between 9/1/01 and 8/31/02, 407 former workers completed this questionnaire. One hundred and sixty-two did not continue in the program.
2) Conduct a confidential exposure and medical history interview (EQ2) with former LANL workers who agree to participate in this program. These interviews are done in the program office in Espanola, NM. We completed approximately 700 EQ2s between 9/1/01 and 8/31/02.
3) Perform a medical examination for former LANL workers at three sites. We have completed 600 exams between 9/1/01 and 8/31/02. The three sites are:
a) The Los Alamos National Laboratory Occupational Medicine Clinic in Los Alamos, NM. The LANL Occupational Medicine Clinic completed 102 exams.
b) The Former LANL Workers Program Office in Espanola, NM. Our physicians at the Espanola Program Office completed 492 exams.
c) The Center for Occupational and Environmental Health in Baltimore, MD. Our physicians at the COEH completed 6 exams.
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 54 medical record reviews between 9/1/01 and 8/31/02.
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 will begin to use this handbook once the Central BeIRB approves it.
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 on every former worker who completes a questionnaire, survey, or participates in a focus group. Separate consents are obtained for the medical exam, the medical record review, and for a beryllium lymphocyte proliferation test (LPT).
8) 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.