USDOE Human Subjects Research Database, Fiscal Year 1999

Johns Hopkins University School of Hygiene and Public Health

Public Information Contact:

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

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

JHUSHP-97-DE-FC03-98SF21541

"Medical Surveillance for Former Department of Energy Workers (DUPLICATE, SEE LANL-98-98-LANL-E5)"

Project Identifier: JHUSHP-97-DE-FC03-98SF21541

"Medical Surveillance for Former Department of Energy Workers (DUPLICATE, SEE LANL-98-98-LANL-E5)"

Principal Investigator: Dr. Brian Schwartz, Johns Hopkins University School of Hygiene and Public Health

Project started in: 1997

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of Occupational Medicine & Medical Surveillance

$580,000.00 (Est.) for: Fiscal Year 1999

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/11/99
IRB approval number: RPN #96-04-23-01
Explanation of IRB approval:
Los Alamos National Laboratory IRB/HSR, Full-board, 10/1/99, 98-LANL-05

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 162
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Chest x-ray for medical screening

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excretia, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.
• Using existing data that were collected for other purposes or projects.

Other types of human subjects involvement. Explanation:

Focus Groups with former LANL workers.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

18. Abstract

Four focus groups were conducted on 9/30/98 and 10/1/98. Thirty former (30) LANL workers participated in the focus groups. The focus groups were discussed in detail in the abstract of the Human Subjects report filed in 1998. The data from the focus groups were compiled and included in the Final Needs Assessment Report submitted to DOE in February 1999.

A mailing to former LANL workers was conducted in November of 1998. Two hundred and ninety-nine packets that included a questionnaire, two consent forms, and a postcard were mailed to former LANL workers. One hundred and thirty-one questionnaires (87) and postcards (44) were returned. Sixty-four individuals completed the questionnaire. Twenty-three individuals returned the questionnaire partially completed and stated that they were never employed at LANL. Forty-one individuals returned the postcard marked that they had worked at LANL but were not interested in participating in the project. Three individuals returned the postcard marked that they had never worked at LANL. Twenty-five packets were returned undelivered. One hundred and forty-three individuals did not respond to the mailing. The data from the mailing to former workers were compiled and included in the Final Needs Assessment Report submitted to DOE in February 1999.

Phase II of this project began in August 1999. Phase II is a four-year project that will develop and implement a medical screening program for former LANL workers who had significant exposure to asbestos, beryllium, ionizing radiation, lead, noise, and chlorinated solvents. This program will offer these former workers a one-time free screening examination with tests or a review of their medical records by an occupational physician. The types of tests that a former worker will be offered include a chest x-ray, spirometry, audiometry, selected laboratory tests, and clinical evaluations. The tests that are chosen will be based on previous work-related exposure to the agents listed above. Information about work-related exposures and medical history will be collected via self-administered and interview administered questionnaires. Informed consent will be obtained prior to screening examination and testing. Consent forms will be mailed with questionnaires.

In the first year of the program, we are proposing to screen four hundred and fifty former Los Alamos workers. Former workers will be offered screening examinations and testing at two sites. The Los Alamos Occupational Medicine Clinic with screening examinations and testing performed by LANL personnel and a to-be-determined site in northern New Mexico with screening examinations and testing performed by occupational medicine physicians from Johns Hopkins and University of New Mexico. Record review will be offered to those former workers who desire that option. No follow-up examinations or tests will be covered by the program. Individuals will receive written notification of their test results. Former workers who choose to enter the program will be given a unique identification number. Records with personal identifiers will be kept in locked file cabinets. No personal identifiers will appear on any reports. All Phase II records will be kept at Johns Hopkins University.