USDOE Human Subjects Research Database, Fiscal Year 2001

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

$757,266.00 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: Medical University of South Carolina
Most recent approval: 10/02/00
IRB approval number: HR8047
Explanation of IRB approval:
Our new MUSC IRB approval is pending as of 10/5/01. We have approvals from the IRB committees at USC and Savannah River Site.

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 08/23/01
IRB approval number: ESH-WHS-2001-00001
Explanation of additional approval:
For one year ending 8/23/02

Type of Review: Expedited
Approving Institution: University of South Carolina
Most recent approval: 08/11/00
IRB approval number: None

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 508
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])

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 risks. The former workers have a choice of participating and we attempt to maintain the confidentiality that one expects with medical records.

3. Privacy/Confidentiality/Consent: All information is placed in secured locations (file cabinets, computer files)with access limited to project investigators. Computer files are stripped of personal identifiers and subjects are identified by use of unique identification code. A master file that links personal identifiers
and unique identification code is kept in a secured computer. Workers are provided information about the project and asked for their consent to participate. Workers also are asked for consent for our obtaining medical and exposure history information.