USDOE Human Subjects Research Database, Fiscal Year 2001

Medical University of South Carolina, Environmental Biosciences Program

Public Information Contact:

Dr. Janardan P. Pandey
Dept. of Microbiology and Immunology
Med. Univ. of SC
173 Ashley Ave.
Charleston, SC 29425

Phone: 843 792 4360
Fax: 843 792 2464
E-mail: pandeyj@musc.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

MUSCBP-95-6241

"Trichloroethylene Exposure and Host Genetic Factors in Autoimmune Diseases"

Project Identifier: MUSCBP-95-6241

"Trichloroethylene Exposure and Host Genetic Factors in Autoimmune Diseases"

Principal Investigator: Dr. Janardan P. Pandey, Medical University of South Carolina, Environmental Biosciences Program

Project started in: 1995

Project Funding Information:

Funding for Human Subjects Research:

DOE: Environmental Management (EM)

$149,000.00 (Est.) 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, Environmental Biosciences Program
Most recent approval: 12/19/00
IRB approval number: 6241

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 378
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 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.

(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 aim of this study is to test the hypothesis that exposure to organic solvents increases the risk of certain autoimmune diseases and the host genetic factors—either through their effect on the immune system or by mediating the bioactivation of solvents—modify this risk. The primary focus of this project is to determine the role of TCE and the host genetic factors in susceptibility to systemic sclerosis (scleroderma, SSc); however, subjects with three other environmentally-associated autoimmune disorders—systemic lupus erythematosus, fasciitis, and polymyositis—are added to the protocol as they become available. Ongoing studies seek to resolve the main and interactive contributions of organic solvents, host genetic factors (HLA, TNF, GM, KM, and cytochrome P450IIE1 genes), and several autoantibodies to the pathogenesis of SSc and other autoimmune diseases.
Following informed consent, subjects (all adults) are interviewed about their residential, occupational, and medical histories and 15 ml of blood is drawn from a vein in the arm during a single visit. Blood is used for determining autoantibodies and genetic markers. There is no subsequent contact with the subjects and they are not informed of the results of the study. Blood drawing (venipuncture) involves following risks: (1) There may be a slight pain when the arm is stuck with the needle (2) A bruise may be left temporarily at the spot where the arm is stuck (3) There is a slight risk of inflammation of the vein and/or blood clot formation; this is extremely rare. No direct benefit to the subjects is expected. In general, the results of these studies may benefit medical science by elucidating the role of immunogenetic markers and organic solvents exposure in autoimmune diseases.
Participant's records of participation in this study are not accessible to the general public and every effort is made to maintain confidentiality. However, all records in S.C. may be subject to subpoena by a court of law. Information gained from this study is used only for research and educational purposes. Information is published in medical journals, but the participant's identity is not revealed. However, identifying information will be available to monitors from the MUSC IRB for Human Research and the U.S. Food and Drug Administration.