The Center to Protect Workers' Rights

Funding for Human Subjects Research:

DOE: Former Worker Screening Programs (HS-15)

$3,900,000.00 (Est.) for: Fiscal Year 2007
The funding is used to carry out the Building Trades National Program (see abstract for more details on the program).
Percent of funding associated with the use of human subjects: 81-99

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: The Center to Protect Workers' Rights
Most recent approval: 07/10/07
IRB approval number: 2005-04

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5000
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

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])

CPWR is carrying out a national screening program titled the Building Trades National Medical Screening Program. This program includes continuing screening and re-screening services for sites where the Former Worker Program (FWP) has been on-going for a number of years, as well as at additional DOE sites. DOE sites covered include Hanford, Savannah River, Oak Ridge, Idaho National Laboratory, Fernald, Mound, Amchitka, Kansas City, Pinellas, Rocky Flats, Mallincrodkt, Weldon Spring, GE Evendale, Brush Luckey, Battelle West Jefferson, Battelle King Avenue, Huntington Pilot Plant, and Brookhaven National Laboratory and other miscellaneous DOE sites.

The Program contains the following general components:
Start up planning/Needs Assessment: A modified exposure assessment will be conducted to identify high-risk buildings or areas, primary exposures, and worker populations at risk.

Outreach: CPWR, as the research arm of the Building and Construction Trades Department, AFL-CIO, has direct access to workers. CPWR will rely on direct mailings to lists of former workers, and working through and relying on existing organizations (unions, union pension funds, employers, DOE site administrators, etc.) to reach former workers and "get the word out." CPWR will establish/maintain an outreach office at each site listed above. This office will serve as the face of the Program to workers and their communities.

Communications and intake center: CPWR has two established toll-free phone numbers (1-800-866-9663 and 1-888-464-0009). We will also create a website for the Program. Workers can register with the Program by mail, telephone, or on the website.

Work history: A standardized, structured work history will be administered with modules that accommodate unique exposure scenarios for different occupations and different DOE sites. A work history interview will be administered by a trained program interviewer. The work histories will be used to determine whether a participant is eligible for the medical examination and to interpret the findings from the medical examination.

Medical evaluation: The Program will contract with local medical providers qualified to deliver occupational medical screening services. Providers are credentialed. The Program will contract with a certified national laboratory and with NIOSH certified B-readers to review x-rays. Based on the work history, the participant will be referred to a credentialed medical provider who is located close to the participant's home. If it is not convenient to use a credentialed provider, the Program will make arrangements for the participant to receive a physical exam through the Supplemental Care Program (either through one of the Supplemental Care Program clinics or the individual's personal physician). All eligible participants will receive the same core medical exam (including a Beryllium Lymphocyte Proliferation Test, BeLPT), and in addition, based on their work history, they may be assigned to exposure specific modules for asbestos, silica, lead, noise, cadmium, and chromium. All lab work will be sent to a national laboratory for processing, except the blood samples for the BeLPT, which will be sent to a DOE-approved laboratory for evaluation.

Determination of work-relatedness and follow-up: A letter of findings will be sent to the participant within 60 days of the exam. The letter will be written and/or reviewed by occupational medical health personnel with knowledge of the DOE site(s) where the participant has worked and will include specific follow-up recommendations. Urgent findings will be followed up by the provider without delay.

Evaluation and quality assurance: All data will be entered into the Program Data Management System (DMS). The DMS will be web-based and will rely on electronic submission of results, whenever possible. A de-identified data set on all participants will be available to Duke University Medical Center for evaluation and analysis. Each participant will be asked to complete a satisfaction survey. The DMS will be used for quality assurance purposes and to also report summary data to the DOE.

Reporting: The Program will provide monthly financial and quarterly progress reports on the number of workers served to the DOE on medical findings.