USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-88-107-H07

Project Title:

Lipoprotein Subfractions and Coronary Heart Disease During 25-Year Follow-Up (see LBL-93-2-73 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1988

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

Funding completed for study

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: 95-2-116

Number of Human Subjects in the Last Reporting Period for this Project: 400
(Reporting periods vary.)

Type of Human Subjects Involvement:

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])

The objective of this study is to investigate the relationships of fatal and nonfatal coronary heart disease and stroke to lipoprotein subfractions and other risk factors.

This is an epidemiological study of 1,961 men and 423 women whose plasma total cholesterol, blood pressure, height, weight, tobacco use and lipoprotein profiles were studied between 1954 and 1957. The vital status and history of coronary heart disease and stroke in this cohort will be evaluated through state and national mortality surveillance systems, public records, medical reports, hospital records, autopsy reports, and telephone interviews with cohort members.

The total living cohort numbers approximately 2,100; in FY 95-96, emphasis is being placed on recontacting the approximately 400 surviving female members of the cohort. The subjects had blood samples drawn at Lawrence Livermore Laboratory between 1954-1957. The current involvement of all members of the cohort is limited to periodic questionnaires and follow-up of medical records. Each new access to medical records requires fresh consent from the subjects.