USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-94-112

Project Title:

Micropower Impulse Radar Human Organ Motion Studies

Principle Investigator: Mr. Thomas E. McEwan

Project started in: 1994

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:

DOE: Laboratory-Directed Research Development (LDRD)

Amount: $200,000 (Est.)

Non-DOE Federal: Department of Defense

Amount: $50,000 (Est.)

Total Funding: $250,000

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: July 19, 1995
IRB Approval Number: 94-112

Number of Human Subjects in the Last Reporting Period for this Project: 9
(Reporting periods vary.)

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

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])

A. Objectives

This research primarily focuses on hardware development of a new class of biomedical sensor-micropower impulse radar (MIR). MIR shows extremely good promise as a heart muscle motion sensor that can be used with ECG equipment to provide, for the first time, an easily obtainable stimulus-response pair. Cardiologists have indicated that this information would save thousands of lives yearly, particularly for cardiac arrest victims. Additional studies on respiration sensing may lead to a low-cost SIDS detector for home use.

Our work with MIR includes testing a novel, stealthy burglar alarm, and testing a computerized speech recognition system based on direct sensing of vocal cord vibrations with MIR.

B. Methodology

The methodology to date has been non-existent since all activities and subjects involve the Principal Investigator (PI) and immediate staff of professionals experimenting on themselves for the sole purpose of improving the hardware. A defined methodology may be implemented next year as work progresses from hardware development to structured data taken on subjects.

C. Ionizing radiation, radioactive sources, and chemicals: NONE

D. Involvement of Human Subjects

1. The procedure involves holding a small plastic box containing a MIR near, or in contact to one's fully clothed body, such as over the heart or Adams Apple, and adjusting the equipment or recording electronic waveforms for computer processing. At this stage subject identification is not required or used.

2. Tests by LLNL Hazards group show that the non-ionizing microwave radiation from MIR is more than 1000 times lower than US IEEE standards for continuous exposure of microwave radiation to a general population. There are no risks, even in the most extreme equipment malfunction scenario.