USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge National Laboratory

Project Identifier: ORNL-95-46

Project Title:

Immunogenic Structural Features of a Breast Tumor-Specific Epitope for Cancer Immunotherapy

Principle Investigator: Dr. Robert L. Hettich

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

ORNL received no funding in FY95 to carry out this project. Alternate funding sources are being sought.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: August 03, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of existing bodily materials that were collected for another purpose or 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])

a. To develop a cancer-specific tumor antigen using human tumor tissue, lymph nodes, and white blood cells. The portion of the work to be performed at Oak Ridge National Laboratory (ORNL) involves the use of mass spectrometry for chemical characterization of peptides and proteins associated with normal and tumor cells. Samples of these peptides and proteins will be provided to ORNL by researchers at Harrington Regional Medical Center (HRMC), Amarillo, Texas.

b. This project is a collaborative effort centered at HRMC. The investigators at HRMC are operating under the approval of their local institutional review board. Samples received at ORNL will be coded so that the identity of the human subject is not known to researchers at ORNL. Procedures to be performed at ORNL involve performing mass spectrometric analysis of the samples received from HRMC.

c. None.

d1. No direct interaction involving human subjects will take place at ORNL.

d2. No hazard will result to human subjects from the work to be performed at ORNL. Hazards to human subjects due to work performed at HRMC are described on the HRMC consent forms.