USDOE Human Subjects Research Database, Fiscal Year 2001

Colorado University Health Sciences Center

Public Information Contact:

Dr. A. James Ruttenber
Department of Preventive Medicine and Biometrics
Campus Box C-245
4200 E. Ninth Avenue
Denver, CO 80262

Phone: 303-315-5627
Fax: 303-315-3183
E-mail: jim.ruttenber@uchsc.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

CUHSC-96-DE-FC03-96SF21259

"Medical Monitoring Program for Former Rocky Flats Workers "

Project Identifier: CUHSC-96-DE-FC03-96SF21259

"Medical Monitoring Program for Former Rocky Flats Workers"

Principal Investigator: Dr. A. James Ruttenber, Colorado University Health Sciences Center

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of Occupational Medicine & Medical Surveillance

$500,000.00 (Est.) for: Fiscal Year 2001
During the reporting period, notification and screening activities were performed.

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: Colorado University Health Sciences Center
Most recent approval: 11/29/00
IRB approval number: 99-688
Explanation of IRB approval:
We will be submitting our protocol for continuing review. We are approved through 11/28/01 and this will be extended through 11/28/02 at the completion of our annual review.

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Oak Ridge Associated Universities
Most recent approval: 04/26/01

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1088
Reporting period for number of human subjects: Fiscal Year 2001

Type(s) of Human Subjects Involvement:

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

This project involves the implementation of a clinical screening program for former workers at the Rocky Flats Environmental Technology Site (RFETS). A job exposure matrix is being used to identify workers who were exposed to toxic agents at levels that may lead to health conditions that may be diagnosed through screening exams. The benefits of this program include the potential early diagnoses of health conditions and early treatments that may improve the living conditions of former workers. In addition, patterns of exposure related to health outcomes may possibly be identified.

During the present year, screening examinations continued. These screening examinations include chest x-rays when indicated according to exposures. In addition, samples of blood will be collected from eligible former workers at their screening exams. All specimens and documents containing personally identified data will be kept in locked file cabinets. All computer files will be password protected and transfer of confidential data between the Health Sciences Center and National Jewish Medical and Research Center will occur under conditions when only project personnel will have access to the data.

The risk to individuals associated with their involvement in medical screening will be explained to them and their signed consent forms will be obtained prior to screening.