Ms. Ann
M. Shirley
PO Box 2008
MS 6103
Oak Ridge, TN 37831-6103
Phone: 865-576-8262
Fax: 865-574-4084
E-mail: shirleyam@ornl.gov
Number of Human Subjects projects reported: 8
Project Identifier:
ORNL-93-17
Project Title:
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1993
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/29/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2007
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Objectives
The purpose of this study has been to determine the personal exposure to environmental tobacco smoke (ETS) of non-smoking subjects in occupational and away-from-work settings. Exposures have been related to occupational categories, living and working environments, and demographic factors.
Methodology
Individual participants wore one of two personal sampling pumps, one each at work and away-from-work. (For Phase 2, restaurant and tavern servers wore only one sampling system: in their workplace.) Samples of breathing zone air were collected, and analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS), including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, scopoletin, solanesol, nicotine, 3-ethenyl pyridine, and myosmine. In addition, prior- and post-exposure saliva samples were collected by having the subjects chew on a piece of cotton dental dam in order that the smoking status can be assessed through cotinine levels. In the first phase of this study, 1566 subjects participated in the study. The subjects were distributed geographically around the United States, with about 100 subjects in each of 16 urban areas. In the second phase of the study, 165 subjects participated. All were recruited form the Knoxville, TN Standard Metropolitan Statistical Area.
In the course of analyzing the data from the first phase of the study, it was determined that for one of the targeted occupational groups, waiters/waitresses/bartenders, there was an insufficient number of subjects in the study pool to confidently distinguish exposure differences. For that reason, we increased the subject pool by about 165 subjects. This increased the overall study population by about 11%, to approximately 1729 subjects. All of the added subjects were recruited from the aforementioned occupational category in one of the urban areas studied in the first phase: Knoxville, TN. Essentially, the same experimental protocol as that previously employed will be used to judge occupational exposure. Area samplers were also placed in the subjects' place of employment. An extension of Phase I, which began near the beginning of FY98, involved about 270 subjects and have a sampling and subject protocol identical to that of Phase 1. However, subjects were recruited to fill specific demographic categories so that the overall study population was representative of the non-smoking population from which the subjects were recruited.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational or non-occupational routines. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
Two aspects of the study qualify it for human studies consideration. First, a sample of saliva is acquired from each subject upon the entrance into and departure from the study. Depending on timing, sample acquisition could be as little as 24 hours or as much as 72 hours apart. The purpose of the saliva collection is to determine the concentration of a nicotine metabolite (cotinine) present. Salivary cotinine levels are used to confirm the absence of smoking among self reported non-smokers, and to determine the potential efficacy of use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Secondly, a great deal of demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. A contractual requirement of any firm sub-contracted to recruit subjects or assist with field operations is that they make no permanent copies of the written questionnaires. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality is protected through the use of pseudo-identifiers. Acquisition of saliva samples is minimally invasive, and amounts to having to chew on a sterile piece of cotton dental dam for 60 seconds, and expelling it into a sterile vial. A videotape training film of 20-25 minutes in length is produced for each experimental protocol, and augments the formal human studies consent form.
Project Identifier:
ORNL-94-33
Project Title:
"Characterization of Components of Fingerprints"
Principal Investigator: Dr. Michelle V. Buchanan, Oak Ridge National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
This project will chemically characterize the components present on the fingertip skin to determine if information about age, sex, and personal habits can be ascertained. The long term goal of the project is to obtain methodologies that can be used in forensic applications, but could also lead to non-invasive clinical assays. Samples will be obtained by asking the subject to deposit material from fingertips on glass slides or beads in order to collect the material from the skin. After the sample is returned to the lab, then the materials will be removed from the surface by solvent wash. This protocol will NOT expose the subject to any chemicals (or other hazards). No risks to the subject are involved. During FY 2000, we will gather samples from up to 300 subjects to determine general trends in chemical components present and identify specific compounds that might be useful for distinguishing individuals based on skin components.
Project Identifier:
ORNL-94-38
Project Title:
"Advanced Robotics for Remanufacturing and Aircraft Support Functions"
Principal Investigator: Dr. John V. Draper, Oak Ridge National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/29/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Objectives: This report describes preliminary testing to garner feedback about the heavy lift dexterous manipulator (HDM) arm from experienced fighter load crewmen. The purpose of the testing was to provide preliminary information about control system parameters and to gather feedback from users about manipulator arm functionality. To that end, subjects interacted with the next generation munitions handler (NGMH) in informal testing sessions and provided feedback about the performance of the system. Certain control system parameters were changed during the course of the testing and feedback from the participants was used to make a rough estimate of "good" initial operating parameters. Later, formal testing will concentrate within this range to identify optimal operating parameters.
Ionizing radiation, radioactive substances, chemical substances: Human subjects were not exposed to any ionizing radiation, radioactive substances, or chemical substances during testing.
Methodology: Operational safety was an important concern during this testing program because of the nature of the HDM and its payloads, and because of the relative inexperience of the load crews with the NGMH program. For that reason, the first half-day of the testing program was devoted to a formal briefing on the NGMH project and testing program safety. Subject safety was further safeguarded by: (1) presence of a safety observer, who held a switch enabling him to shut down the manipulator arm in the event of an unplanned incident; (2) presence of a test observer, who monitored control system parameters and manipulator function via computer, and who could shut down the system should a problem appear; and (3) the deadman switch built into the manipulator controller, which shuts down the manipulator if the handle is released.
The testing itself was conducted using an informal format that encouraged the participants to interact with the HDM in a manner that allowed them to become familiar with its capabilities. At the end of each exercise with the NGMH, the participant was briefly questioned about his experience with the machine. Any evaluative comment made by the user was recorded, as were suggestions for improving it. The observer also noted important events or noteworthy differences in operating style during the task, and then briefly questioned the participant about problems with the system and reactions to the control system set-up for that task. Comments were recorded in a logbook for later review and analysis.
Involvement of Human Subjects: Human subjects were involved as described in the preceding paragraphs. In addition, the research subjects received a pre-test briefing outlining the conditions for their participation and testing conditions. The former included receipt of and explanation of the informed consent form reproduced elsewhere in this report. Research subjects also participated in a post-testing debriefing.
Project Identifier:
ORNL-98-17a
Project Title:
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces. Phase III"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/29/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Objectives
The purpose of the study was to document the levels of environmental tobacco smoke ETS in a recently constructed corporate facility where smoking is unregulated, but which employs an advanced HVAC system, and to determine non-smoker personal exposure to ETS within the facility.
Methodology
Experimental protocol was similar to that used in ORNL-93-17, in which subjects wear a small sampling system which collects indoor air samples from their personal breathing zone air. Samples of breathing zone air were analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS) and other combustion derived particles and vapors, including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, solanesol, nicotine, and 3-ethenyl pyridine. Personal breathing zone samples were collected for three consecutive days, usually Tuesday, Wednesday, and Thursday. Fixed location area samples were acquired in the vicinity of the subjects’ work stations. In contrast to the ORNL-93-17 protocol, no saliva samples were collected, since the smoking status (based on observational data acquired in the workplace) was known to the investigatory team.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational routine. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
One aspect of the study qualifies it for human studies consideration. Demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. (Note that since all of the subjects in this protocol were office workers, this was deemed to be a minimal risk.) Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality is protected through the use of pseudo-identifiers. Because of the relatively small number of subjects in this protocol, no videotaped instructions were given. Instead, ORNL staff explained the purpose of the study, trained each subject on the wearing and use of the personal sampling pumps, answered subjects’ questions about the protocol, and obtained witnessed Human Studies consent.
Project Identifier:
ORNL-98-47
Project Title:
"Biomarkers of Magnetic Field Exposure"
Principal Investigator: Dr. Paul C. Gailey, Oak Ridge National Laboratory
Project started in: 1998
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/29/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Other: 05/07/98 to 05/07/99
Explanation:
reactivation of an previously approved protocol
Type(s) of Human Subjects Involvement:
I. Objectives of Study:The goal of this project is to evaluate ornithine decarboxylase (ODC) activity and host immune cells (immunophenotyping of T cells, B cells and NK cells) in a group of 40 male electric utility workers exposed to different levels of magnetic fields. Individual magnetic field exposures will be quantified over three 24 hours work days and divided into work, sleep and other, non-work intervals. ODC activity will be measured in resting peripheral blood lymphocytes and lymphocytes exposed for three days to three different mitogens: PHA, PWM and superantigen. Total and differential blood counts as well as immunophenotyping including: total T and B cells (CE3+ and CD45+), subpopulation counts: T cells (helper/CD4+ and suppressor/cytotoxic/CD8+) and NK cells (CD56+) will be evaluated using the same blood sample.
II. Methods of Procedure: A group of 40 electric utility workers exposed to high fields (linemen, substation workers, power plant operators) and exposed to lower fields (utility maintenance, for example) will be evaluated in this study. Colorado State University will quantify individual magnetic fields over three 24 hours work days. Blood will be collected on the third day, between 4:00 and 6:00 p.m., at the participant's workplace, and then sent via Federal Express directly to Biophage, Inc., where the evaluation shall be conducted. Moreover, blood will be collected from 20 healthy adults from Laval, Quebec (age and sex-matched) at precisely the same time of the day. This population of utility workers is currently being assessed by Drs. Reif and Burch (Colorado State University) under a grant from the National Institutes of Environmental Health Sciences, so there are no additional costs to DOE for the sampling of workers. This work is a follow up to research originally supported by DOE, Office of Program Management.
With the exception of a review of immune parameters based on a consulting physician's guidelines, the participant's records shall be kept strictly confidential. All files will be maintained in a locked and secure manner at the Colorado State University Department of Environmental Health, accessible only to authorized personnel. Neither the participant's name or the results will be released to any private party, employer, or insurance company. The results of this study shall be released as group data only. There will be no means of identifying any particular participant in any results that will be published.
The participant shall be fully informed of the purpose and requirements of the study. Written consent to participate shall be obtained from the participants. The participant shall be given a copy of his/her completed consent form. If the results of the participant's blood test are outside normal ranges, the participant will be contacted by letter from Colorado State University Department of Environmental Health, advising the participant to contact his/her personal physician.
III. Possible Hazards and their Evaluation: Risks associated with blood sampling include possible hematoma (bruise), slight risk of infection, local soreness, and fainting. A certified nurse will be used to collect the sample and all precautions will be taken to insure the participant's safety.
IV: Radioisotopes and New Drugs/Devices: This study involves no use of radioisotopes or new drugs and devices.
Project Identifier:
ORNL-98-56
Project Title:
"Study of Neurotransmitters in Children with ADD or ADHD"
Principal Investigator: Dr. Gary A. Sega, Oak Ridge National Laboratory
Project started in: 1998
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/29/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this research is to investigate the blood levels of the following neurotransmitters: dopamine, serotonin, serotonin to tryptophan ratio and melatonin in children with attention deficit hyperactive disorder (ADHD) diagnosed according to the DSM-III-R criteria and in children diagnosed as being autistic. The blood will be drawn for clinical diagnostic tests and 1 or 2 cc of extra blood will be used for the study of the neurotransmitters. This blood will be centrifuged and the plasma will be stored frozen at -70C until the samples are ready to be analyzed by high performance liquid chromatography.
The specific objective of this project is to gain knowledge on the neurobiological factors leading to the behavioral abnormalities. The long-term goal is to define the metabolic changes and genetic mechanisms involved in the hope that this knowledge may lead to the development of more effective therapeutic interventions.
Project Identifier:
ORNL-99-57
Project Title:
"Driver Research by the Human Systems Research Group"
Principal Investigator: Dr. Dan R. Tufano, Oak Ridge National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/29/99
IRB approval number: M1394
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
a. Objectives
Individuals are invited to participate in evaluating new displays that give messages to drivers of automobiles. In the near future, these messages will come to the driver from a variety of new devices in cars; for example, navigation directions, collision warnings, pager messages. The study will take place in a driving simulator. Two types of displays will be compared in this study. One is a Head-Up Display (HUD) which projects messages onto the windshield of the car. In this study, the HUD will be simulated by projecting the messages onto the same screen as the road scene. The other type of display is a head-down display, similar to a small television, mounted inside the car, to the right of the driver’s seat. We will be measuring how well the participants can drive the simulated car when messages are presented on one or the other display.
b. Methodology
The functioning of the driving simulator, the two displays, the driving scenario, and the task to be performed with the displays will be explained to all participants. We will also describe and explain the series of tests we will ask each participant to do. These tests are to measure the drivers’ general abilities in (for example) short-term memory and reaction time. These tests will be conducted before the driving simulator tests.
c. There will be no exposure of human subjects to ionizing radiation, radioactive substances, or chemical substances.
d. Involvement of Human Subjects
Capability Pre-Tests: Participants will sit in front of a desk-top computer for a series of eight tests, which have been selected to measure abilities related to driving: static visual acuity, dynamic visual acuity, contrast sensitivity, selective attention, manual tracking, simple reaction time, useful field of view, and monocular depth perception. These tests will be administered one after the other. Participants will receive instructions before starting.
Driving Simulator Tests: Before participants begin the simulator tests, we will walk them through the set-up and functioning of the simulator, and they will have a five minute practice run to get the feel of the controls. There will be two test runs: one for the head-up display task and one for the head-down display task. Each of these runs will involve driving the simulated car while keeping track of one of the displays for a target word. Participants will be instructed on what to do in the display tasks before each run, and will be given the opportunity to ask any questions they may have.
Because the tests will be conducted with a desk-top computer and a driving simulator (not an actual vehicle), there is no risk of physical injury to participants. The only possible discomfort might be a sense of nausea, similar to car sickness, caused by driving the simulator, because the computer generated road scene moves, but the cab where they are sitting does not. This disconnect between visual movement and the absence of physical movement may cause a feeling called simulator sickness, in some individuals. If any individuals experience such discomfort, they are free to end the testing without loss of their participation fee.
Participant's identity in this testing will be treated as confidential. The results of this work, including laboratory or other data, may be published for scientific purposes but will not give out names or any identifiable references.
Privacy and the confidentiality of any records or data obtained as a result of participation in this testing will be protected to the extent allowable by law. However, they may be inspected by the sponsor, by any relevant agency with the necessary justification (e.g., Department of Energy), by the ORAU/ORNL Institutional Review Board or by the person conducting the testing.
Project Identifier:
ORNL-99-58
Project Title:
"In-Vehicle Information Integration Study"
Principal Investigator: Dr. Philip F. Spelt, Oak Ridge National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/05/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
A. The purpose of this research is to evaluate different ways of presenting information messages to drivers of automobiles.
B. Methodology: The study will take place in a driving simulator, and will involve simulated messages coming from several different systems, for example: cell phone, pager, and warning system. This study will compare the impact of these separate messages on driving performance, when they are either presented in a prioritized fashion or presented as they are generated by the separate systems.
C. No exposure to harmful substances is involved.
D. Subjects will drive a stationary driving simulator. Because no motion in the simulator is involved, there is no physical danger to subjects. A very few people may become slightly nauseated due to "simulator sickness, and they will be allowed to withdraw with no penalty. Data are strictly confidential, and will not be released or used with any identifying characteristics included. Summary statistics will be reported.