USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-93-091-H01

Project Title:

Training and Basic Research Related to Health Effects of Exposure to HZE Particles (see LBL-93-6-59 in 1994 database)

Principle Investigator: Dr. Aloke Chatterjee

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-DOE Federal: National Aeronautics and Space Administration (NSCORT Program)

Amount: $93,000 (Est.)
Comments:

NASA Special Center of Research and Training (NSCORT)

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Protocol/Subproject # 1
Protocol/Subproject Identifier: CPHS 95-4-84

IRB Review:
Type of Review: Full Board
Most Recent Approval: April 25, 1995
IRB Approval Number: CPHS 95-6-112

Number of Human Subjects in the Last Reporting Period for this Project: 347
(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 cells cultured in a laboratory.
• Use of existing bodily materials that were collected for another purpose or project.

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.

(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])

OBJECTIVES

The objective of this study is to provide training in the assessment of risk of carcinogenesis associated with protons and HZE* exposure to humans during extended space missions. This study will benefit space missions personnel, as well as providing a better understanding of the mechanisms underlying carcinogenesis. A novel feature of this project is the utilization of data and discard tissues from patients previously treated for cancer with similar particle beams.
*HZE= particles with high [H] atomic numbers [Z] and high energy [E].

METHODOLOGY

Cell cultures are established from the discarded lenses of patients who developed cataracts subsequent to helium or heavy-ion cancer treatments. The existing medical records of subjects are examined to determine the radiation dose to the lenticular volume (lens of the eye). The cell cultures are then used as an in vitro model for evaluating the effect of heavy-ion exposure on the eye, which provides a better understanding of the potential risks of exposure on the eye, and provides a better understanding of the potential risks of exposure to similar radiation associated with extended manned space missions.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

There are no additional risks associated with this follow-up stage. The subjects were previously treated for cancer with heavy ions under experimental protocols (such as LBL-75-102-H01) and are routinely contacted for medical record follow-up as part of the study. Cataract surgeries are medically necessary procedures performed at the University of California at San Francisco; subjects sign a surgical consent form that informs them that residual tissues from the surgery may be used for medical research.