USDOE Human Subjects Research Database, Fiscal Year 1998

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
Email: smoakpe@musc.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Medical University of South Carolina.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1012

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

MUSC-98-DG-FC03-97SF21513: Savannah River Site Former Production Workers Health Surveillance Program

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Project Identification:

Project Identifier: MUSC-98-DG-FC03-97SF21513

Project Title:

Savannah River Site Former Production Workers Health Surveillance Program

Principal Investigator: Dr. David G. Hoel

Project started in: 1998

Fiscal Year 1998 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.

Funding Sources:

DOE: EH/Off. of Occupational Medicine & Medical Surveillance: Amount: $555,351

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: July 07, 1998
IRB Approval Number: HR7750

Number of Human Subjects who participated in this project/protocol during FY 1998 (10/1/97 - 9/30/98): 1,000

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Use of data collected from subjects specifically for this project.
Use of existing data that were collected for another purpose or project.

Abstract:

(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 identify the need for a medical surveillance program for former SRS workers. This is to be based upon occupational exposures to hazardous agents while working at the SRS.

B. Methodology: Medical records and industrial hygiene data were reviewed in order to assess the likelihood of hazardous occupational exposures and the potential medical effects of these exposures.

C. 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.

1. Lists of former workers were obtained. Mail questionnaires were sent to a subset of them to ask about their exposures, health and interest in a medical surveillance program. A few workers were spoken to over the phone about these issues. Also, a public meeting was held to discuss the medical surveillance project.

2. We did not subject the workers to any known risks.

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

Go to list of projects at Medical University of South Carolina