USDOE Human Subjects Research Database, Fiscal Year 2001

Rocky Flats Environmental Technology Site.

Public Information Contact:

Dr. John R. McInerney
10808 Highway 93
Unit B, Building 122
Golden, CO 80403-8200

Phone: 303-966-8377
Fax: 303-966-2873
E-mail: john.mcinerney@rfets.gov

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

RFET-91-RF-94-06

"Rocky Flats Beryllium Health Surveillance Program: Current Workers"

Project Identifier: RFET-91-RF-94-06

"Rocky Flats Beryllium Health Surveillance Program: Current Workers"

Principal Investigator: Dr. Lee S. Newman, National Jewish Medical and Research Center

Project started in: 1991

Project Funding Information:

Funding for Human Subjects Research:

Other: Dyncorp of Colorado, Inc.

$1,414,000.00 for: Fiscal Year 2001

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: Rocky Flats Environmental Technology Site
Most recent approval: 04/06/01
IRB approval number: N/A

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1490
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 cells cultured in a laboratory.
• 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 Rocky Flats Beryllium Health Surveillance Program: Current Workers (RFBHSPCW) was designed to identify new cases of chronic beryllium disease (CBD), and beryllium sensitization in individuals who have had the potential for exposure to beryllium while employed at the Rocky Flats Environmental Technology Site.

This program continues the surveillance of workers currently employed at the Rocky Flats Environmental Technology Site. The RFBHSPCW is composed of 5 interrelated tasks which are the identification, notification, scheduling, testing, and retesting of current employees of Rocky Flats who believe they were exposed to beryllium during their employment at the Site. All individuals indicating a desire to participate are tested for sensitivity to beryllium using the peripheral blood Lymphocyte Proliferation Test, and given a chest x-ray. The only risk to human subjects from the beryllium sensitivity screening is the venipuncture, as used for regular medical laboratory testing, and therefore, there is very little risk from this procedure. Further medical evaluation to determine the presence of CBD is offered to those identified as beryllium sensitized or found to have suspicious lung pathology on chest x-ray B-Reader examination. Risks to human subjects from additional procedures undertaken by two leading medical centers for the clinical evaluation of CBD (bronchoalveolar lavage, bronchoalveolar lung biopsy) are on a voluntary basis. Retesting is offered every year to individuals who had a positive blood test for sensitivity to beryllium that was not confirmed or who had an abnormal chest x-ray possibly associated with CBD.

All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.

During fiscal year 2001, there were 3 current workers who were found to have Chronic Beryllium Disease. There were an additional 6 current workers who were found to be sensitized on 2 separate LPT blood tests.

At the present time, there are 18 current workers with CBD and 58 current workers who are sensitized to Beryllium.