Colorado University Health Sciences Center

Funding for Human Subjects Research:

DOE: EH/Office of Occupational Medicine & Medical Surveillance

$79,977.00 (Est.) for: Fiscal Year 2007
During the reporting period, notification and screening activities were performed. No new funds were awarded during FY2007. Funds were available through instrument DE-FC02-96SF21259, but this project ended 6/30/06, prior to FY 2007. Earlier in FY 2006, the project was transferred from DOE's Chicago Office to DOE Headquarters in Washington, DC. With the change in adminstrative oversight offices, an additional $100,029 was awarded under instrument number DE-FC01-06EH06005. These funds were available in FY 2007 and the data in the report is based on this project. In FY 2007, $79,977.29 was spent and associated with use of human subjects.
Percent of funding associated with the use of human subjects: 100

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: 09/11/07
IRB approval number: 99-688

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 200
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

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])

This project involves the 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.

Screening was provided for asbestos-exposed workers, and notification about the availability of a free medical screening exam through the National Supplemental Screening Program (NSSP) was prepared for former workers who reside outside the Denver metropolitan area and were not able to travel to Denver in previous years. Notification letters regarding project closure were prepared for all previously contacted workers. 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.