Medical University of South Carolina

Funding for Human Subjects Research:

DOE: Former Worker Screening Programs (HS-15)

$321,000.00 (Est.) for: Fiscal Year 2007
Percent of funding associated with the use of human subjects: 41-60

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: 04/23/07
IRB approval number: HR8047

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Westinghouse Savannah River Company (WSRC IRB)
Most recent approval: 10/03/07
Explanation of additional approval:
IRB approved Phase II, Phase 5

Type of Review: Expedited
Approving Institution: Medical Univ. of S. Carolina
Most recent approval: 04/23/07
IRB approval number: HR# 8047
Explanation of additional approval:
The research was reviewed in August 2000 and determined to be exempt from ongoing review by the IRB.

Type of Review: Full Board
Approving Institution: Central Beryllium
Most recent approval: 09/19/05
Explanation of additional approval:
The registry said we would no longer need approval from them unless we changed our Beryllium protocol.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 130
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, 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 Savannah River Site (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, trichloroethylene (TCE), hydrogen sulfide, and other 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 codes. A master file that links personal identifiers and unique identification codes 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 to our obtaining medical and exposure history information.