USDOE Human Subjects Research Database, Fiscal Year 1998

The Center to Protect Workers' Rights

Public Information Contact:

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

Phone: 206-444-9811
Fax: 206-444-9832
Email: kringen@compuserve.com

Institutional Review Board (IRB):

Projects are approved by an IRB located at: United Brotherhood of Carpenters.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

CPWR-98-001

The Augusta Building Trades Medical Screening Program for Savannah River

Project Identifier: CPWR-98-001

Project Title:

The Augusta Building Trades Medical Screening Program for Savannah River

Principal Investigator: Dr. Knut Ringen

Project started in: 1998

Fiscal Year 1998 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.

Funding Sources:

DOE: EH/Off. of Occupational Medicine & Medical Surveillance

Amount: $455,559 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1999
IRB Approval Number: ESH-MED-990004

Number of Human Subjects who participated in this project/protocol during FY 1998 (10/1/97 - 9/30/98): 30,000

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of existing data that were collected for another purpose or 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, health evaluation (including medical screening) and intervention program for former building and construction trades workers at the DOE Savannah River Site who may have been exposed to health hazards as a result of prior work at SRS. Specific aims include:

1. Identify and locate former workers who are considered "at risk"

2. Ascertain the health concerns of workers indentified

3. Communicate risk information to the workers and discuss actions to be taken

4. Provide medical screenings

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 saticfaction with the project.

Risks to 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 encryped and maintained in separate databases. Subjects will be well informed of the purpose of the program and will be consented at various phases of the program.