USDOE Human Subjects Research Database, Fiscal Year 1996

Johns Hopkins University

Public Information Contact:

Dr. David L. Swift
Room 6010, School of Hygiene
615 N. Wolfe Street
Baltimore, MD 21205

Phone: 410-955-3602
Fax: 410-955-9334
Email: dlswift@welchlink.welch.jhu.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Johns Hopkins University.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1090

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

JHU-87-DEFG0288ER60655

Regional Aerosol Deposition in Human Upper Airways

Project Identifier: JHU-87-DEFG0288ER60655

Project Title:

Regional Aerosol Deposition in Human Upper Airways

Principal Investigator: Dr. David L. Swift

Project started in: 1987
This project ended in Fiscal Year 1996.

Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $100,000

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: May 01, 1996
IRB Approval Number: H18760618A

Number of Human Subjects who participated in this project/protocol during 05/01/95 - 05/01/96: 10

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

• Other internal administration of radioactive substances:

  For research

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• Other internal use of chemical substances:

  For research

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])

This research project was carried out to assess the role of particle size, respiratory tract dimensions and breathing properties in the deposition of environmental airborne particles in the human respiratory tract. The human subjects inhaled a cloud of inert particles (di-ethyl-hexyl-sebacate) containing 99m-Technetium radioactive material during the experiment. Subjects performed breathing maneuvers and had a sound measurement made to determine their respiratory tract status. The breathing test required that a modified respirator face mask be worn during the procedure and a pressure tube placed comfortably in the mouth. Measurement of nose dimensions with an acoustic reflection device was performed; this procedure involved placing a metal tube comfortably into one nostril for a period for less than one minute while an undetectable sound pulse was generated. The subjects inhaled a cloud of particles for a period not in excess of two minutes. The inhalation of these particles does not produce noticeable irritation or discomfort except for the possible slight drying of the airway mucosa. Following inhalation the subjects were seated in front of a gamma camera that locates the particles in the airways and their movement. The radiation exposure a subject receives from participating in this study is equivalent to an exposure of 0.02 rems to the whole body. This procedure gives subjects about 4% of the annual limit (excluding medical procedures) of radiation exposure. Female subjects were only allowed to participate in the study if they were certain that they were not pregnant. Di-ethyl-hexyl-sebacate used in this study is inert and is safe for inhalation studies.

The human subjects who participated in the research study read and consented to a statement which described the nature of the study and its risks. The participating subjects are not identified by name and no information of a sensitive nature is needed. The subjects are identified only by a code number in all reports and publications, thus the issue of privacy/confidentiality is of no consequence.