Mr. Brad P. Buggar
U.S. Department of Energy
Idaho Operations Office
Idaho Falls, ID 83401-1562
Phone: 208-526-0833
Fax: 208-526-8789
Email: buggarbp@inel.gov
Projects are approved by an IRB located at: Idaho National Engineering Laboratory.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
Number of Human Subjects Projects reported: 5
Project Identifier: INEL-90-95-001
Project Title:
Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project
Principle Investigator:
Mr. Ronald A. Larson
Project started in: 1990
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 27, 1995
IRB Approval Number: INEL-IRB-001
Number of Human Subjects in the Last Reporting Period for this Project: 8
(Reporting periods vary.)
Type of Human Subjects Involvement:
a. Objective: The purpose of the testing is to determine if trace amounts of explosives can be detected from a thumbprint after touching secondary explosives.
b. Methodology/human subject involvement: Two types of tests will be conducted to determine if explosives are transferred to other materials by touching. One test will involve a subject touching the explosive with the thumb and then depositing thumbprints on various materials (plastics, aluminum foil, glass, etc.). The second test will involve building simulated explosive threat devices and placing the devices into an electronic system (phone, radio, computer) and then swiping the surface to determine if trace amounts of explosives are transferred to the outside surface. The thumbprint and swipes will be analyzed by gas chromatograph to determine the amount of explosive present.
c. Risks to human subjects: Human subjects are exposed to trace amounts of three secondary explosives (proprietary). Toxicity of explosives is through ingestion. There is a minimal risk of minor skin irritation from touching the explosives. The explosives used are secondary explosives and no detonators are used in the experiments. Human subjects used in testing are trained in the use of explosives as part of their job. Appropriate safety analysis was performed and safety precautions are adhered to during the testing. The risk to human subjects is minimal.
Project Identifier: INEL-94-95-002
Project Title:
Retractable Spiked Barrier Strip
Principle Investigator:
Ms. Donna J. Marts
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Total funding for the project was $95 K. The focus of the task was to design and fabricate a prototype device. Human subject testing evaluated the performance of the prototype.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 27, 1995
IRB Approval Number: INEL-IRB-002
Number of Human Subjects in the Last Reporting Period for this Project: 1
(Reporting periods vary.)
Type of Human Subjects Involvement:
A. Objective:
This project included design, fabrication, testing, and evaluation of a
prototype retractable spiked barrier strip. The device is an enhancement to a
technology that is currently being used by law enforcement to stop fleeing
vehicles. The devices used today typically use a series of hollow spikes
mounted in a portable strip holding device. The strip is deployed across the
roadway just prior to intercept of a fleeing vehicle. When the vehicle drives
over the strip, the hollow spikes are embedded in the tires resulting in a
controlled air leak. This type of barrier strip must be removed immediately from
the roadway to allow other vehicles to pass without puncturing their tires. The
retractable spiked barrier strip provides the same results, hollow spikes
embedded in the tires for a controllable leak. However, the strip can be
deployed safely at any time and left in place for as long as needed. This is
accomplished by designing the strip such that the hollow spikes can be recessed
into a housing where they pose no danger to vehicle tires. The hollow spikes
can be manually rotated vertically so that they can puncture tires when
required. The retractable spike feature of this strip provides for a safer
deployment and is easy to operate.
B. Methodology:
Pre-test brief: Prior to the start of the test procedure, the participant will
be provided with a briefing to explain how the barrier strip is deployed along
with the predicted results of the test. In addition to the briefing, a video
will be shown to the participant of previous barrier strip tests. The
participant will be familiarized with the barrier strip mechanism, test
location, and test procedure prior to the start of the test. If the participant
feels uncomfortable in conducting the test, he or she is under no obligation to
continue.
Participant Requirements: The participant must meet and comply with the
following requirements:
1) Possess a valid driver's license without restrictions except for corrective
lenses
2) Must not be taking medications that would prevent the participant from
operating motorized vehicles or cause impairment in reactions or judgment
3) Must be an INEL employee associated with the project
4) Read consent form and sign prior to the start of the test
Test Requirements:
1) Test surface must consist of a paved surface
2) Area must be free of obstructions and all accesses must be secured during
the test
3) Only the test vehicle will have access to the test area during the actual
test runs
4) At least 200 yards of straight road surface must be provided
5) Test surface must be free of wet or icy conditions
6) At least 200 ft. of stopping distance after the barrier strip must be
available
7) Road surface must be a minimum of 20 ft wide with no obstacles or physical
dangers such as steep embankments, ditches, etc. within 5 ft of the outer edges
of the test surface
8) An individual identified by the Principal Investigator as being familiar
with the barrier strip will operate the strip during the test and maintain
visual contact with the participant at all times during the test
C. Ionizing Radiation, Radioactive Substances, or Chemical Substances: none
D. Involvement of Human Subjects:
Test Procedure: A step-by-step procedure for conducting the barrier strip test
is contained below. Each step must be verified complete by the test director
prior to moving on to the next step. The test director or participant has the
right to end the test at any time if deemed necessary.
1) Position the test vehicle at the start position.
2) Ensure that participant is comfortable in driver's position with seat belt
fastened.
3) First test run: The vehicle will be driven over the course without the
barrier strip.
4) After the first test run, reposition the test vehicle at the start position
and ensure that participant driver is ready to begin step six.
5) Position the barrier strip at least 300 ft. from the vehicle start position.
Ensure that at least 200 ft. of stopping distance remains after the barrier
strip location.
6) Second test run: The vehicle will be driven over the barrier strip with the
spikes in the retracted (down) position at a speed of 35 mph +/- 5 mph. [Note:
Effect will be comparable to driving over a traffic counter strip]
7) After the second test run, reposition the test vehicle at the start position
and ensure that participant driver is ready to begin step 8.
8) Third test run: The vehicle will be driven over the barrier strip with the
spikes in a deployed (up) position at a speed of 35 mph +/- 5 mph.
WARNING: The tires will be punctured during test step #8. Ensure that driver
is prepared for the effects associated with deflating tires on a moving vehicle.
[NOTE: requires approximately 30 seconds from puncture to full loss of air]
End of Test
At any time during the test the participant is free to provide input as to how the device performs, and a record of this input may be made.
Possible Risks, Discomforts:
The risks associated with these tests are the same risks inherent in driving a
motorized vehicle. When the spikes are in the retracted state, driving over the
strip is similar to driving over a traffic counter cable. Driving over the
strip when the spikes are in the up (deployed) position results in flat tires on
the vehicle in approximately 30 seconds. Tire deflation is symmetrical so the
risks associated with a blowout do not occur. The vehicle will experience
degradation of steering control along with a harsh ride. If the participant is
in any way uncomfortable with these risks, he or she should not participate in
the test.
Project Identifier: INEL-94-95-003
Project Title:
Air Bag Restraint System
Principle Investigator:
Ms. Donna J. Marts
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
$155K funding to design and fabricate a prototype device. Human subjects were used to evaluate the performance of the prototype.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 27, 1995
IRB Approval Number: INEL-IRB-003
Number of Human Subjects in the Last Reporting Period for this Project: 2
(Reporting periods vary.)
Type of Human Subjects Involvement:
A. Objective:
This project included the design, fabrication, testing, and evaluation of a
prototype air bag restraint device. The device was designed for use by law
enforcement officers to restrain individuals who become violent while being
transported in patrol vehicles without using immediate physical contact by the
law enforcement officer. At the discretion of the law enforcement officer, a
large, low pressure bag inflates in approximately 5 seconds and fills the volume
of the rear seat of the vehicle. The bag is constructed of air permeable
surfaces to avoid suffocation. Since the bag is low pressure, the individual is
not exposed to a large amount of force at any time during deployment of the air
bag.
B. Methodology:
Pre-test Brief:
Prior to the start of the test procedure, the participant will be provided with
a briefing to explain how the air bag restraint device is deployed along with
the predicted results. The participant will be familiarized with the air bag
device, the test setup, and the test procedure prior to the start of the test.
If the participant feels uncomfortable in conducting the test, he or she is
under no obligation to continue.
Participant requirements:
The participant must meet and comply with the following requirements:
1) The participant must not exhibit the following risk factors:
a. respiratory or heart conditions
b. fear of confined spaces
2) Safety glasses must be worn during the testing.
3) The participant must be an INEL employee associated with the project.
4) Read consent form and sign prior to the start of the test.
Test Location Requirements:
1) Demonstrate deployment of air bag with no one in the vehicle. Passenger
door will be left open for observation by the participant. Air bag pressure and
air flow pressure will be checked, and emergency "OFF" switch will be tested to
ensure that power to the blowers is cut off when emergency "OFF" switch is
depressed.
2) Repack air bag. Participant will be situated in the rear seat of the
vehicle. Seat belt is optional. Partcipant eyeglasses will be removed if
applicable.
3) Ensure that participant has hold of emergency "OFF" switch and check to
ensure that participant understands how the switch is operated to cut off air
supply to the air bag restraint.
4) Test Number One: With passenger door open, ensure that participant is ready
as indicated by a thumbs "UP" signal, deploy the air bag for ten seconds +/- 2
seconds.
5) Test Number Two: Repack air bag. Repeat test number one with passenger
door open, increase air bag deployment time to 20 seconds +/- 2 seconds.
6) Test Number Three: Repack air bag. Repeat test number one with passenger
door open, increase air bag deployment time to 30 seconds +/- 2 seconds.
7) Test Number Four: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 10 seconds +/- 2 seconds.
8) Test Number Five: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 20 seconds +/- 2 seconds.
9) Test Number Six: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 30 seconds +/- 2 seconds.
10)Test Number Seven: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 10 seconds +/- 2 seconds.
11)Test Number Eight: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 20 seconds +/- 2 seconds.
12)Test Number Nine: Repack air bag. Close passenger door with window rolled
down. Ensure that participant is ready as indicated by thumbs "UP" signal,
deploy the air bag for 30 seconds +/- 2 seconds.
End of Test
Possible risks/discomforts to human subjects: The participant will be surrounded by a low pressure bag. Air will pass through the bag so that breathing will not be affected. However, the bag will be pushing against the participant's body. Possible discomfort to the eyes due to air flow or remote possibility of corneal abrasion exists. Therefore, safety glasses are required during the testing. Anyone who feels uncomfortable in confined spaces (such as a claustrophobic) should not participate. The low pressure of the air bag will not cause any excessive force to the participant's body.
Project Identifier: INEL-95-004
Project Title:
Concealed Weapons Detection System
Principle Investigator:
Mr. Philip M. Rice
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
Design and assembly activities were conducted in FY 95. Human subjects will be tested during FY 96.
Funding Sources:
Funded in mid 1995. Carryover into FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 28, 1995
IRB Approval Number: INEL-IRB-004
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
Type of Human Subjects Involvement:
a. Objective: To design, build, and demonstrate a system based on magnetic field sensing technology that can quickly and inexpensively be deployed to accommodate the weapons detection needs of a courthouse environment.
b. Methodology: The proposed technology uses magnetic gradiometers that detect aberrations in the earth's magnetic field to detect the presence of ferromagnetic objects such as guns and knives. A stand alone unit much like an airport scanner system is being developed. The scanner consists of an electronic threshold unit, several magnetic gradiometer devices, and a computer system that will generate magnetic profiles of the individuals who pass through the systems. Computer analysis will provide information about the presence, location, and type of weapon concealed by a person passing through the scanner.
c. No exposure to ionizing radiation, chemical substances, or radioactive substances will occur during the testing.
d. Involvement of human subjects: Magnetic profiles will be generated of persons carrying a variety of weapons and non-weapon personal artifacts through the system to establish a catalog of magnetic signatures. The flux gate magnetometers used to detect the presence of a weapon are passive instruments that do not generate an electromagnetic field, or a radio frequency field, or produce ionizing radiation as an active instrument might. The magnetometers will not affect the use of any electrical equipment brought in close proximity to them, including pacemakers or other medical devices. There are no known risks associated with the human subject testing.
Project Identifier: INEL-95-005
Project Title:
Population Stereotypes for Crane Controls
Principle Investigator:
Ms. Nancy G. Makey
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
Preliminary preparation was conducted in FY 95. Human subject testing will be done in FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 27, 1995
IRB Approval Number: INEL-IRB-005
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
a. Objectives: The Idaho Chemical Processing Plan (ICPP) at the INEL has nearly 80 cranes with almost as many configurations of controls for the operation of those cranes. In order to increase efficiency and operator versatility, and most importantly, to decrease operator error, a standard will be developed. Little current existing research has been located that could provide the necessary information for developing this standard. Population stereotype and user expectation information may not be the same for every population. Specific populations may be influenced by local experiences and standards.
b. Methodology/Human Subject Involvement: There will be three phases of experiments. Two subject groups will be used for the experiments: ICPP trained crane operator volunteers and local college students (who will provide information as to whether the results from the first group can be generalized to a larger, more global population). Phase I will be used to determine the population stereotypes for control/movement expectations of the trained ICPP operators who will be required to manipulate a designated control to provide an expected response from a crane. The manipulation responses will be recorded. In Phase II, optimum control console layouts will be developed based on information from phase I. A new group of ICPP volunteers will be required to manipulate the controls on designated consoles to provide an expected response from a crane. Phase III will repeat the trials conducted in phases I and II using college student volunteers in order to determine if the results can be generalized.
The information that will be obtained as a result of this experiment will be control/movement relational expectations for buttons, knobs, and switches mounted in various configurations. This information will be used to develop a design guideline/standard for crane control design at ICPP and possibly INEL wide. In addition to developing a guideline/standard, prototype consoles will have been tested to verify the applicability of the control/movement relational expectations used in this design/guideline standard.
If the results indicate that the information can be generalized to a larger population, this information may be applicable in many areas of control design, in addition to cranes, that use similar control/movement relationships.
Risks: Through advantageous and consistent application of control relational expectations in design of crane controls, efficiency and safety can be increased while operator error can be reduced. No known risks are associated with the human subject testing conducted in this project.