USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-90-068-H01

Project Title:

Red Cell Deformability In Vitro and Survival In Vivo (see LBL-94-1-66 in 1994 database)

Principle Investigator: Dr. Mohandas Narla

Project started in: 1990

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 Institutes of Health (NIH)

Amount: $244,375 (Est.)
Comments:

Grant Number DK26263

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: February 17, 1995
IRB Approval Number: 95-2-108

Number of Human Subjects in the Last Reporting Period for this Project: 10
(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 bodily materials collected from subjects specifically for this project.
• 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.

(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 clarify the contributions of reduced cellular deformability to increased red cell destruction in various human hemolytic disorders and to define the biochemical and structural basis for the deformability changes. Another objective is to develop a detailed understanding of red cell membrane physiology as it relates to red cell function in vivo through biophysical characterization of normal and pathologic red cells. In so doing, a greater understanding of sickle cell disease and potential treatment regimes may be developed.

METHODOLOGY

Blood samples for analysis are obtained by venipuncture. Some samples are obtained from blood donors with sickle cell or other thalassemias. The samples are then analyzed.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

None.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

Human subject involvement is limited to the donation of blood for analysis via routine clinical venipuncture, which carries with it small risks of bruising or bleeding and a remote risk of infection.