USDOE Human Subjects Research Database, Fiscal Year 1999

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: kringen@compuserve.com

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 2

CPWR-96-DE-FC03-96SF21262

"Hanford Building Trades Medical Screening Project (DUPLICATE, SEE PNNL-97-5)"

CPWR-97-DE-FC03-97SF21514

"The Augusta Building Trades Medical Screening Program for the Savannah River Site"

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

"Hanford Building Trades Medical Screening Project (DUPLICATE, SEE PNNL-97-5)"

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/Office of Occupational Medicine & Medical Surveillance

$790,000.00 (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: 05/18/99
Explanation of IRB approval:
Above Institutional Review Board(IRB) Review information supplied pertains to the Pacific Northwest National Laboratory IRB.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1000
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

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

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.
• Using existing specimens or samples of bodily materials collected for another purpose.

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])

The objective of this project is to implement the notification, and health evaluation, including medical screening, for former building and construction trades workers at the DOE Hanford site who may have been exposed to health hazards as result of prior work at Hanford.

Specific aims for Phase II are:

1. Identify and locate former workers who are consider "at risk".
2. Ascertain the health concerns of workers identified in Phase I.
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. Evaluation project impact, including former workers satisfaction with the project.

Risks to the subjects, such as possible loss of privacy is minimized by coding and multiple layers of protection to the data. All personal data is coded and encrypted and maintained in separate data bases. Participants are well 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/Office of Occupational Medicine & Medical Surveillance

$790,000.00 (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: 01/13/99
IRB approval number: ESH-MED-990004
Explanation of IRB approval:
Above Institutional Review Board(IRB) Review information supplied pertains to the Savannah River Site IRB.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1500
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

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

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.
• Using existing specimens or samples of bodily materials collected for another purpose.

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])

The objective of this project is to implement the notification and health evaluation, including medical screening, for former building and construction trades workers at the DOE Savannah River Site who may have been exposed to health hazards as result of prior work at Savannah River.

Specific aims for Phase II are:

1. Identify and locate former workers who are consider "at risk".
2. Ascertain the health concerns of workers identified in Phase I.
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. Evaluation project impact, including former workers satisfaction with the project.

Risks to the subjects, such as possible loss of privacy is minimized by coding and multiple layers of protection to the data. All personal data is coded and encrypted and maintained in separate data bases. Participants are well informed of the purpose of the program and are consented at various stages of the program.