USDOE Human Subjects Research Database, Fiscal Year 2004

University of Washington

Public Information Contact:

Dr. Timothy K. Takaro
Harborview Medical Center
325 Ninth Avenue, Box 359739
Seattle, WA 98104

Phone: 206-616-7458
Fax: 206-616-4875
E-mail: ttakaro@u.washington.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

UOW-96-DE-FC03-96SF21258

"Medical Surveillance Program/Former DOE Hanford Production Workers"

Project Identifier: UOW-96-DE-FC03-96SF21258

"Medical Surveillance Program/Former DOE Hanford Production Workers"

Principal Investigator: Dr. Timothy K. Takaro, University of Washington

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

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

$806,363.00 for: Other time period:
Funding period is for 1/1/04 to 7/31/04.

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: University of Washington
Most recent approval: 01/08/04
IRB approval number: 96-3368-C08

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: PNNL/Hanford Site
Most recent approval: 02/25/04
IRB approval number: 97-2

Type of Review: Expedited
Approving Institution: CBeIRB/DOE
Most recent approval: 02/25/04
IRB approval number: (02)-08

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 54141
Reporting period for number of human subjects: Other: 05/01/98 to 03/31/04
Explanation:

Period from initiation of Phase II until latest quarterly report to DOE.

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

One-view chest x-ray as part of screening examination for effects of exposure to asbestos and/or beryllium.

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.
• 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 focus of the Needs Assessment phase (Phase I) of this project was to identify former Hanford workers who may be at significant risk for disease based on workplace exposure to radioactive or other hazardous substances and to establish contact with the workers. Based on the information collected, the project teams made recommendations to DOE concerning the need for medical monitoring. Phase II is the implementation of medical monitoring programs for targeted groups of former workers. These programs seek to benefit workers by helping to prevent or minimize illnesses related to exposures in years past and to improve the health of the former worker.

Risk to subjects is minimal. Codes will be used to protect personal data. Medical records are protected in compliance with HIPAA. Informed consent will be obtained as necessary at each stage of the project.