USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-91-068-H03

Project Title:

Red Cell Membrane (see LBL-94-1-65 in 1994 database)

Principle Investigator: Dr. Mohandas Narla

Project started in: 1991

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: $1,315,605 (Est.)
Comments:

Grant Number DK-32094

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2

Protocol/Subproject # 1
Protocol/Subproject Identifier: CPHS 94-1-65

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 17, 1995
IRB Approval Number: 95-2-109

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.

(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 obtain a detailed understanding of the role of selected red cell skeletal proteins in regulating membrane function. Several subprojects approach this through characterization of specific proteins and manipulation of the corresponding cloned genes. These studies will aid in the formation of better diagnostic and treatment tools for patients with sickle cell conditions.

METHODOLOGY

Blood samples for analysis or malarial infection are obtained by venipuncture. Some samples are obtained from blood donors with sickle cell or other thalassemias.

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.

IRB Review:
Type of Review: Full Board
Most Recent Approval: August 18, 1995
IRB Approval Number: 95-8-139

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.

(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 examine the interactions between malarial proteins and proteins of the human red blood cell membrane. These studies will aid in the formation of better diagnostic and treatment tools for patients with sickle cell conditions.

METHODOLOGY

Blood samples for in vitro malarial infection are obtained by venipuncture. Some samples are obtained from blood donors with sickle cell or other thalassemias.

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.