USDOE Human Subjects Research Database, Fiscal Year 1999

Medical University of South Carolina

Public Information Contact:

Ms. Peggy S. Smoak
Medical University of South Carolina
Biometry and Epidemiology
135 Rutledge Ave.
Charleston, SC 29425-

Phone: 843-876-1152
Fax: 843-876-1127
E-mail: smoakpe@musc.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

MUSC-97-DE-FC03-97SF21513

"Savannah River Site Former Production Workers Health Surveillance Program"

Project Identifier: MUSC-97-DE-FC03-97SF21513

"Savannah River Site Former Production Workers Health Surveillance Program"

Principal Investigator: Dr. David G. Hoel, Medical University of South Carolina

Project started in: 1997

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of Occupational Medicine & Medical Surveillance

$784,098.00 for: Fiscal Year 1999

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
Most recent IRB approval: 11/24/98
IRB approval number: HR8047
Explanation of IRB approval:
Savannah River Site IRB human subjects review; September 30, 1999; SRS document# ESH-MED-990058

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 500
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])

A. Objectives: The objective of the project is to provide medical examinations for former SRS workers considered to have been exposed to hazardous agents while working at the SRS.

B. Methodology: Survey former workers for likelihood of hazardous exposures, then invite to a physical examination those workers likely exposed to or whose health was possibly impacted by harmful exposures.

1. The workers at SRS had the potential to be exposed to ionizing radiation, various radionuclides, chemicals such as hydrazine, TCE, hydrogen sulfide and agents such as asbestos.

2. The physical examinations should subject the former workers to little or no usually risks. The former workers have a choice of participating and we attempt to maintain the confidentiality that one expects with medical records.