Ms. Trish
Quinn
8484 Georgia Avenue
Silver Spring, MD 20910
Phone: 301-495-8521
Fax: 301-578-8572
E-mail: pquinn@cpwr.com
Number of Human Subjects projects reported: 3
| CPWR-96-DE-FC03-96SF21262 | "The Hanford Building Trades Medical Screening Program " |
| CPWR-97-DE-FC03-97SF21514 | "The Augusta Building Trades Medical Screening Program for the Savannah River Site " |
| CPWR-05-96SF21262 | "The Building Trades National Medical Screening Program" |
"The Hanford Building Trades Medical Screening Program"
Principal Investigator: Dr. Knut Ringen, The Center to Protect Workers' Rights
Project started in: 1996
This project ended in fiscal year 2005.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: The Center to Protect Workers' Rights
Most recent approval: 07/04/05
IRB approval number: PNNL IRB No. 97-5
Explanation of IRB approval:
Effective April 2005 this program rolled into the Building Trades National Medical Screening Program. The PNNL IRB is the IRB of record for this project.
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 2005
Type(s) of Human Subjects Involvement:
A. Objective: To implement a notification, health evaluation, including medical screening, and intervention program for former building and construction trades workers at the DOE Hanford Site who may have been exposed to health hazards as a result of working at Hanford.
Specific objectives:
1. Identify and locate former workers who are consider "at risk."
2. Ascertain the health concerns of workers identified.
3. Communicate risk information to the workers and discuss actions to be taken.
4. Provide medical screening.
5. Assist in coordination of referrals, diagnostic work up, and follow-up treatment.
6. Ensure dialogue with local parties concerned with the project.
7. Evaluate project impact, including former workers satisfaction with the project.
B. Methodology:
1. To identify and locate workers, review contractor records, various outreach techniques will
be implemented. Current addresses of workers will be sought through a variety of avenues.
2. To ascertain risks and health concerns, information will be gathered on employment and
occupational exposure history through an interview.
3. Medical examinations will be provided by pre-approved medical providers.
4. The examining physician will recommend and assist in making referral decisions.
5. An evaluation system has been developed and implemented to assure participant satisfaction.
C. Ionizing radiation: Not applicable.
D. Involvement of human subjects:
A work history interview is conducted with all participants. A database questionnaire is used to collect information about a worker's history. There are minimal risks to participants in this program. All personal data are coded, encrypted, and maintained in separate data bases and kept strictly confidential. Participants are fully informed of the purpose of the program and are consented at various stages of the program.
This program has rolled into the Building Trades National Medical Screening Program. It will continue to provide screening services to construction workers at Hanford.
"The Augusta Building Trades Medical Screening Program for the Savannah River Site"
Principal Investigator: Dr. Knut Ringen, The Center to Protect Workers' Rights
Project started in: 1997
This project ended in fiscal year 2005.
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: The Center to Protect Workers' Rights
Most recent approval: 07/04/05
IRB approval number: PNNL 2005-04
Explanation of IRB approval:
Effective 9/25/05 this program rolled into the Building Trades National Medical Screening Program (project no. 96SF211262). The PNNL IRB now is the IRB of record for this program (IRB No. 2005-04).
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 09/19/05
IRB approval number: ESH-WHS-2004-00101
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 550
Reporting period for number of human subjects:
Fiscal Year 2005
Type(s) of Human Subjects Involvement:
A. Objective: To implement a notification, health evaluation, including medical screening, and intervention program for former building and construction trades workers at the DOE Savannah River Site (SRS) who may have been exposed to health hazards as a result of prior work at SRS.
Specific objectives:
1. Identify and locate former workers who are considered "at risk."
2. Ascertain the health concerns of workers identified.
3. Communicate risk information to the workers and discuss actions to be taken.
4. Provide medical screening.
5. Assist in coordination of referrals, diagnostic work up, and follow-up treatment.
6. Ensure dialogue with local parties concerned with the project.
7. Evaluate project impact, including former workers satisfaction with the project.
B. Methodology:
1. To identify and locate workers, review of contractor records, various outreach techniques will
be implemented. Current addresses of workers will be sought through a variety of avenues.
2. To ascertain risks and health concerns, information will be gathered on employment and
occupational exposure history through an interview.
3. Medical examinations will be provided by pre-approved medical providers.
4. The examining physician will recommend and assist in making referral decisions.
5. An evaluation system has been developed and implemented to assure participant satisfaction.
C. Ionizing radiation: Not applicable.
D. Involvement of human subjects:
A work history interview is conducted with all participants. A database questionnaire is used to collect information about a worker's history. There are minimal risks to participants in this program. All personal data are coded, encrypted, and maintained in separate data bases and kept strictly confidential. Participants are fully informed of the purpose of the program and are consented at various stages of the program.
Effective September 25, 2005 this program rolled into the Building Trades National Medical Screening Program. It will continue to provide services to SRS construction workers.
"The Building Trades National Medical Screening Program"
Principal Investigator: Dr. Knut Ringen, The Center to Protect Workers' Rights
Project started in: 2005
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: The Center to Protect Workers' Rights
Most recent approval: 08/24/05
IRB approval number: 2005-04
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 2005
Type(s) of Human Subjects Involvement:
CPWR is carrying out the Building Trades National Medical Screening Program that will include continuing screening services for sites where Former Worker Programs (FWP) have been on-going for a number of years, as well as adding five construction former worker programs. DOE sites covered include Hanford, Savannah River, Oak Ridge, Idaho National Laboratory, Fernald, Mound, Amchitka, Kansas City, Pinellas, and Brookhaven National Laboratory.
The Program will contain 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 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 medicine 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 and annual reports to the DOE on medical findings.