Johns Hopkins Bloomberg School of Public Health

Funding for Human Subjects Research:

DOE: Office of Health Studies (EH-51)

$81,136.00 for: Other time period
8/10/06 through 12/30/06.
Percent of funding associated with the use of human subjects: 100

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
Approving Institution: Johns Hopkins Bloomberg School of Public Health
Most recent approval: 01/19/06
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: 07/12/06
IRB approval number: LANL 98-05

Type of Review: Full Board
Approving Institution: DOE Central Beryllium IRB
Most recent approval: 03/29/06
IRB approval number: CBeIRB (02)- 7 LANL

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 91
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Chest x-ray (posterior view only) for medical screening.

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, 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.

(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])

Abstract LANL Former Workers Program Phase III Year 1

Since re-opening the program in March 2006, we have completed 91 examinations of former Los Alamos National Laboratory (LANL) workers. Since 2000, we have conducted 2,420 medical examinations.

The protocol for this program is as follows:
1) Select former workers from P2Y1 through P2Y5 who had reported working with and around asbestos at LANL.
2) Contact former workers offering these individuals a re-examination and testing for asbestosis including a chest x-ray (PA only), spirometry, physical examination, stool for occult blood, and a B-read for the x-ray.
3) Contact former workers with a previous borderline abnormal beryllium lymphocyte proliferation test (BeLPT); offer these individuals a re-examination and BeLPT. Select former workers with negative BeLPT tests but who reported working with beryllium or in buildings where beryllium was used. Offer these individuals a re-examination and beryllium lymphocyte proliferation test. A chest x-ray is repeated if indicated.
4) Offer any former worker who has not been through the program a free health examination and testing based on possible exposures to asbestos, beryllium, lead, noise, radiation, and solvents.
5) Complete an Exposure and Medical History Questionnaire #2 (EQ2) interview to determine the exposures for which former workers should be examined.
6) Schedule former workers for an examination in the Espaņola clinic. Former workers are given written instructions about any preparations that are needed for the day of examination. Former workers are called the day before the examination to remind them of their appointment.
7) Complete the examination.
8) Abnormal laboratory results requiring immediate attention are faxed to the former worker's primary care physicians (PCP) for follow-up; former workers with immediate health concerns are referred to their PCP or to local clinics.
9) At the end of the examination and testing, former workers are asked to complete the exit satisfaction survey.
10) Collect all results over the next 8 to 10 weeks in Baltimore.
11) Have chest x-rays receive a B-reading using the International Labor Organization (ILO) method, by a certified B-reader).
12) Enter examination information (date completed and types of exams done) and all test and exam results into our databases in Baltimore.
13) Completed results packets are sent to the former workers, with copies of all test results and our recommendations for follow-up to the primary care provider.
14) Former workers with borderline abnormal or uninterpretable LPTs will be offered repeat testing at the next examination session. Former workers with an abnormal LPT will be referred to the Espanola Resource Center to file a claim with Energy Employees Occupational Illness Compensation Program Act (EEOICPA).
15) Former workers are requested to submit a 15-day notification letter to their former employer, if a work-related disease is suspected.

All program records are kept in Baltimore, MD 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.

Program records will be kept for 10 years, or longer if necessary or required, after the program ends. After that time, we will remove all personal identifiers from the data and destroy any links that will connect an individual to the records. We will analyze this data as group data only. Any published reports will be reported as group data only. No individual will be identified in reports of data.