USDOE Human Subjects Research Database, Fiscal Year 1999

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 (DUPLICATE, SEE RFET-96-FWP)"

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

"Medical Monitoring Program for Former Rocky Flats Workers (DUPLICATE, SEE RFET-96-FWP)"

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

$20,000.00 (Est.) for: Fiscal Year 1999
During the reporting period, only feasibility of a screening program was involved.

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: 12/01/99
IRB approval number: 99-688
Explanation of IRB approval:
The protocol for the actual screening program - including clinical exam protocol - went to full review and has just received approval. The Colorado Multiple Institutional Review Board has undergone extensive re-organization due to sanctions by the FDA and the OPRR (Office for the Protection against Research Risks). This action delayed our approval by about 10 weeks. The UCHSC IRB has approved the revised participant consent form for this project on 1/11/00. Dr. Susan Rose, the Protecting Human Subjects Program Manager (Office of Biological and Environmental Research, SC-72), has granted interim approval via letter dated 12/13/99 to this project until the Rocky Flats IRB is reconstituted. National Jewish Medical and Research Center IRB also approved the protocol and revised consent form on January 14, 2000.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 75
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

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 design 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.

To date, this project has not involved human subjects with the exception of verifying the job exposure matrix that was developed to identify exposed individuals. For this purpose, existing plant data along with interviews of workers, conducted under the auspices of another study, were used to construct a matrix of exposures associated with job titles and buildings at RFETS. During the present year, however, screening examinations will begin. These screening examinations will include chest x-rays when indicated according to exposures. In addition, samples of blood and/or urine 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.