USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-92-106-H03

Project Title:

Metabolic Atherosclerosis Management Clinic and Research Unit (see LBL-94-2-87 in 1994 database)

Principle Investigator: Dr. Ronald M. Krauss

Project started in: 1992

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-Federal: Sequoia Hospital District

Amount: $380,500 (Est.)

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: 95-2-103

Number of Human Subjects in the Last Reporting Period for this Project: 1,695
(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.

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 improve lipoprotein analytical tests developed at Lawrence Berkeley National Laboratory (LBNL) and to perform further research and development involving the clinically applicable benefits of these lipid tests. These tests will contribute to the development of better diagnostic tools for lipoprotein disorders.

METHODOLOGY

Blood samples are obtained and reviewed with other portions of the study at Sequoia Hospital; LBNL involvement is limited to analysis of serum samples from the study.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

LBNL involvement is limited to the analysis of serum samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples.