USDOE Human Subjects Research Database, Fiscal Year 2003

The Center to Protect Workers' Rights

Public Information Contact:

Dr. Knut Ringen
Principal Investigator
2610 SW 151 Place
Seattle, WA 98166

Phone: 206-444-9811
Fax: 206-444-9832
E-mail: knutringen@msn.com

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 2

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"

Project Identifier: CPWR-96-DE-FC03-96SF21262

"The Hanford Building Trades Medical Screening Program"

Principal Investigator: Dr. Knut Ringen, The Center to Protect Workers' Rights

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH-6, Deputy Assistant Secretary for Health Studies

$619,045.00 (Est.) for: Fiscal Year 2003

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: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 05/10/03
IRB approval number: PNNL IRB No. 97-5

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 500
Reporting period for number of human subjects: Fiscal Year 2003

Type(s) of Human Subjects Involvement:

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

• Using cells cultured in a laboratory.
• 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.

(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])

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 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 work history. There are minimal risks to participants in this program. All personal data are coded and 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.

Project Identifier: CPWR-97-DE-FC03-97SF21514

"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

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH-6, Deputy Assistant Secretary for Health Studies

$737,000.00 (Est.) for: Fiscal Year 2003

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: Savannah River Site (WSRC)
Most recent approval: 09/29/03
IRB approval number: ESH-WHS-2001-00001

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 2003

Type(s) of Human Subjects Involvement:

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

• Using cells cultured in a laboratory.
• 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.

(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])

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 result of prior work at SRS.

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 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 work history. There are minimal risks to participants in this program. All personal data are coded and 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.