USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-91-111-H01

Project Title:

Characterization of Particulate-Phase Environmental Tobacco Smoke in Differing Environments (see LBL-93-4-55 in 1994 database)

Principle Investigator: Dr. Richard G. Sextro

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

All human subjects involvement was completed prior to the beginning of FY '95.

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: April 15, 1994
IRB Approval Number: 94-4-58

Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)

Type of Human Subjects Involvement:

Environmental/Human Habitat Studies:

Use of human subjects for environmental studies (e.g., weatherization, energy-efficiency, lighting studies).

(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 investigate the factors affecting the size, distribution, and concentration of environmental tobacco smoke particles indoors with the aim of providing a more accurate means of estimating the lung dose of these pollutants for various exposure settings. In so doing, better regulations and guidelines may be developed around the management of environmental tobacco smoke, which is classified as a Class A carcinogen by the U.S. Environmental Protection Agency (EPA).

METHODOLOGY

Fully informed volunteer smokers are requested to smoke normally in the Indoor Air Quality Research House. Built-in instrumentation is utilized to measure particle concentration and size distribution under controlled but realistic situations. The resulting data is used only to validate a "smoking machine" developed by the research group.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Cigarette smoke is inhaled by the subjects.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

A limited number of subjects who already smoke are being asked to smoke several cigarettes in a test room to serve as a check for the automatic smoking machine developed by this research group. The subjects are already aware of the risks of their smoking habit.