Ms. Leigh
G.
Greeley
Oak Ridge National Laboratory
P.O. Box 2008
MS 6291
Oak Ridge, TN 37831-6291
Phone: 865-576-1367
Fax: 865-576-3392
E-mail: greeleylg@ornl.gov
Number of Human Subjects projects reported: 18
| ORNL-93-17 | "Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces" |
| ORNL-01-62 | "Fuel Economy Information Evaluation/Green Vehicle Ratings" |
| ORNL-01-63 | "The Determination of Social Acceptability of Bioremediation Technologies: Applying the Public Acceptance of Controversial Technologies (PACT) Model to Improve Communication" |
| ORNL-01-64 | "Rocketdyne Worker Health Study" |
| ORNL-03-66 | "Determination of Variability of Personal Exposure to Environmental Tobacco Smoke" |
| ORNL-03-71 | "Statistical Analysis of Finger and Palm Impressions in Relation to Individualization" |
| ORNL-04-70 | "Identification of Human Scent Components" |
| ORNL-04-72 | "Regional Studies Program-Analysis of Administrative Records for the Development of Programmatic Decision Support Tools - Department of Defense" |
| ORNL-04-80 | "Dynamics of Cardiovascular Responses to Particulate Exposures" |
| ORNL-04-82 | "Development of a Multi-mode and Multi-spectral Automated Mueller Matrix Polarization Imaging System for Non-Invasive Skin Cancer Detection and Diagnosis" |
| ORNL-04-84 | "Alzheimer's Disease Detection via Nonlinear Analysis of EEG" |
| ORNL-05-83 | "Network Interference of Human B Cells Using Biospace" |
| ORNL-05-86 | "Epileptic Seizure Prediction" |
| ORNL-05-88 | "EESD Future Technology and Scientific Creativity" |
| ORNL-06-89 | "Post Exposure Injury Assessment Tools" |
| ORNL-06-90 | "Latent Print Detection by Macro-Raman Imaging" |
| ORNL-06-91 | "Commercial Driver's License Program Evaluation, Phase II" |
| ORNL-06-92 | "ORNL Healthy Lifestyle Research Study" |
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1993
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/23/05
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 2006
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
In Phase 1, 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 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 nicotine metabolite (cotinine) levels. In the first phase, 1,566 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, Tennessee 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 percent, to approximately 1,729 subjects. All of the added subjects were recruited from the aforementioned occupational category in one of the urban areas (Knoxville, Tennessee) studied in the first phase. 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 1, which began near the beginning of FY1998, involved about 270 subjects and had 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 exposure to naturally occuring 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 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 the use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Second, 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 the Oak Ridge National Laboratory (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.
Privacy
Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access or ORNL Laboratory Records). Subject confidentiality is protected through the use of pseudo-identifiers. Acquisition of saliva samples is minimally invasive; it 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 20 to 25 minutes in length is produced for each experimental protocol and augments the formal human studies consent form.
Only minimal work on data evaluation was conducted in FY2006.
"Fuel Economy Information Evaluation/Green Vehicle Ratings"
Principal Investigator: Mr. James W. Saulsbury, Oak Ridge National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Identifier or number: ORNL(01)-62
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 08/03/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The objective of the study is to conduct a structured evaluation of the DOE/EPA website www.fueleconomy.gov with special attention to methods for conveying information about fuel economy. Two focus groups of nine participants each are led by a moderator through a structured evaluation of the website. Participants are recruited in the study area by quasi-random telephone methods by a contractor (The Looking Glass Group) who also acts as the moderator for the sessions. Adults who have recently purchased a vehicle or who plan to purchase a vehicle in the near future, and who use the internet to gather information on vehicles, are selected. No other criteria for participation are stipulated. The sessions are video-taped and the tapes are held by the contractor (who holds the identities of participants as confidential information), but the participants are informed that researchers may have access to the videotape. The participants are informed when recruited by phone that they will be videotaped at the focus group session. On-site, they are given a consent form to read and sign prior to the session beginning.
"The Determination of Social Acceptability of Bioremediation Technologies: Applying the Public Acceptance of Controversial Technologies (PACT) Model to Improve Communication"
Principal Investigator: Dr. Amy K. Wolfe, Oak Ridge National Laboratory
Project started in: 2001
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
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 2006
Type(s) of Human Subjects Involvement:
Public forums were used to advance knowledge of the determinants of bioremediation technology acceptability substantively and in terms of the communication process. Workshops with voluntary participation of 15 to 20 individuals solicited by phone focused on specific questions pertaining to technology acceptability. We worked with community participants and Oak Ridge National Laboratory (ORNL) staff who are not associated with remediation projects. Sub-groups of participants considered merits and problems of particular situations or options and what advice they hypothetically would give to DOE or a fictitious federal agency. Records of workshop sessions were kept through audiotape recordings and notes, but strict confidentiality will be maintained. Participants' names were not used in note-taking. Participants will be not be identifiable in documents based on the workshops. Interest is in the kinds of issue categories raised in small-group discussion versus individuals. Participants were given consent forms briefly describing their activities in the workshop to read and sign prior to the beginning of the workshop.
During FY2003, all six workshops were completed. Data analysis, article writing, and presentations at professional societies took place in FY2004 and will be completed with carryover funding starting in FY2005.
"Rocketdyne Worker Health Study"
Principal Investigator: Dr. Keith F. Eckerman, Oak Ridge National Laboratory
Project started in: 2001
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 09/17/06
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: Vanderbilt
Most recent approval: 10/07/04
Explanation of additional approval:
The first sets in the project were initiated to judge the completeness of data retrieval prior to seeking IRB approval.
Type of Review:
Full Board
Approving Institution: Boeing
Most recent approval: 01/19/01
Explanation of additional approval:
According to the PI for the entire project, Boeing granted approval for the entire life of the study. Because this study is funded with no federal monies, Boeing is
not required to comply with 45CFR46.109(2) which requires continuing annual review.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14142
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This is a cohort mortality study of approximately 55,000 workers employed since 1950 at Rocketdyne (now owned by Boeing) in California to determine if excess health risks are associated with work at these facilities. Risks for specific cancers and other diseases in relationship to quantitative estimates of both radiation and chemical exposures will be determined. The lead researcher on the project is John Boice at the International Epidemiology Institute in Rockville, MD. Since he is an adjunct faculty member at Vanderbilt University, the Vanderbilt IRB and Boeing's IRB have reviewed and approved the study.
Vital status of the Rocketdyne workforce employed since 1950 shall be determined using a variety of sources including the California Death Index, Social Security Administration records, Pension Benefit Information, and the National Death Index Plus; then death certificates shall be obtained for those deceased. These individuals shall be classified according to specific chemical exposure groups based on their work history using information from interviews of ~100 past and current employees with a variety of job titles. No identifying information shall be attached to the subjects' interviews so that reported responses will not be related to specific individuals.
Radiation exposure information shall be obtained from radiation work histories and biological measures of exposures in addition to data from DOE databases. Oak Ridge National Laboratory/Oak Ridge Institute for Science and Education (ORNL/ORISE) involvement with the study will focus on radiation dosimetry aspects.
Since there are no identifiers to be associated with the interviews, risks should be considered less than minimal for these subjects. Those subjects for whom personal information is stored in electronic files that shall be developed from the information in other databases shall have the following protections:
-Precautions will be taken to protect any data containing identifiable information that is mailed or sent electronically.
-Media containing identifying information will be kept in a locked cabinet when not in use.
-All computer files shall be password protected.
-Access will be on a need-to-know basis.
-ORISE staff have signed agreements to keep identities of subjects confidential.
During FY2001, procedures were developed to create an electronic data base of individual worker internal and external radiation monitoring data from scanned hard copy records. During FY2002, analysis procedures were formulated to directly access the worker data base. Also, the radiation exposure data were computerized from hard copy records this year. Software development to convert exposure measurements into organ doses continues. During FY2003, the algorithm for reconstruction of the organ doses from radiation bioassays was completed. Also, a database containing external readings for selected workers was constructed. During FY2004, calculations of the radiation dose to the subjects in the databases were completed.
"Determination of Variability of Personal Exposure to Environmental Tobacco Smoke"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 2003
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 67
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The objective of this work is to (a) determine daily variation in exposure to environmental tobacco smoke (ETS) and (b) determine the extent to which exposure on a weekend day compares with that on a "normal" work day. Such data are critical in estimating organ dose distributions.
A total of 67 non-smoking study subjects were recruited by phone or personal contact and administered a screening questionnaire to determine eligibility. Approximately eight subjects were scheduled to participate per week, although exact numbers varied from week to week. On Monday evening, each subject came to a test coordination center where he/she was re-screened, watched an instructional video on DVD, was trained in the use of the sampling pumps, completed a "first visit questionnaire," and was provided with a human studies disclosure and confidentiality statement for his/her consideration and signature. In addition, each subject was provided with the supplies for the next day's sampling, which included the sampling pump, diary (to record the types of exposures noted, where each subject was for each hour of the day, etc.), and a "pump performance survey" to let investigators know about any problems the subjects might have had with the sampling unit. Before leaving, the subject provided a saliva sample that will be used for low-level determination of cotinine and 3-hydroxy cotinine. The entire visit on Monday typically required 100 minutes.
The first 24-hour sample was collected as follows. After work on Tuesday, the subject began "away-from-work" sampling and wore the pump until he/she arrived at work on Wednesday morning (~16 hour sample). When the subject arrived at work, he/she switched to a "work pump" and collected a sample for the entire workday (~8 hour sample). The subject returned to the test center after work on Wednesday, having completed one 24-hour sampling period. There they provided an additional saliva sample and were provided new sampling systems. The visit to the test coordination site on Wednesday evening was usually less than 30 minutes. The process of collecting 16-hour away-from-work and 8-hour work samples was repeated on Thursdays and Fridays. On Friday evening, each subject was given one sampling system, designed to run a full 24 hours, and a special away-from-work diary, designed to cover the 24 hours until Saturday, at approximately 5 pm, when they will return to the test center for their final visit. On Saturday evening, the subject returned the sampling pump, provided a final saliva sample, and completed a final visit questionnaire. Once the entire process was completed, each subject received his/her gratuity of $575 for participation. Thus, for each subject, the study generated data on four sequential 24-hour periods (three of which will be comprised of separate 16-hour and 8-hour samples), one of which was a weekend day. In addition, we have data on salivary cotinine concentrations for five days, four of which will be sequential.
Potential risks to subjects beyond those involved in everyday activities were very minimal. They were asked to wear a four pound sampling apparatus at waist level and a small breathing zone sampler within 25 cm of their mouth, usually on their upper chest. They were encouraged in both the training video and informed consent document to remove the sampling system and pump any time that they might engage in activities in which wearing the pump might compromise their safety, such as operation of heavy machinery. The disclosure and confidentiality statement listed mild discomfort (for example, minor neck stiffness) as a possible risk. Risks to the subjects providing saliva samples were minimal, since all they needed to do was to chew a piece of cotton dental dam and expel it into a tube. Demographic and lifestyle information were collected from each subject. However, each subject was provided with an identifying number, and electronic copies of the subject's name and contact information will be expunged once data coding is completed, since the names are only maintained long enough to track down subjects and resolve questions during the initial data coding process. Hard copies of the original screening questionnaires, which would have subject names, addresses, and phone numbers are accessible to only the Principal Investigator and will be stored in Laboratory Records at Oak Ridge National Laboratory. Original data records will be maintained in accordance with DOE practice.
Other than a monetary gratuity, subjects did not directly benefit by their participation in this study. However, the benefits to society are considerable, since this study will be the first to report exposure variability information on a significantly sized group of subjects in a variety of environments. The data will provide risk assessors with key information that is currently not available regarding the variability of ETS exposure in humans and resulting dose distribution to various organ systems.
Initial findings from the study indicate that individual variations of away-from-work ETS levels were in the range of 40 percent to 80 percent. These compare with much larger exposure variations estimated for examination of exposures for a broader population where exposures were only measured for a single day. We found that weekend concentrations of ETS were not dramatically higher than weekday concentrations for those subjects living in smoking homes. Individuals from non-smoking homes appear to be exposed to lower levels of ETS in smoking workplaces than individuals from smoking homes. Salivary cotinine levels, by themselves, are quantitatively related to ETS nicotine exposures in only a marginal fashion.
"Statistical Analysis of Finger and Palm Impressions in Relation to Individualization"
Principal Investigator: Dr. Linda A. Lewis, Oak Ridge National Laboratory
Project started in: 2003
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/17/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 210000
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Fingerprint (300,000), lower joint (100,000), and palm images (100,000) from a law enforcement database will be supplied by the Federal Bureau of Investigation (FBI) for analysis of similarity using multiple Automated Fingerprint Identification System (AFIS) algorithms. The uniqueness of these three different hand regions will be statistically assessed with regards to individualization. Processing of data sets by the AFIS systems will produce finger/palm feature and comparison data. The feature data will consist of finger/palm minutiae, which are the data used by all AFIS systems. Comparison data will be in the form of similarity scores generated by the different AFIS algorithms. These data will be evaluated using a particular statistical model to estimate probabilistic measures describing the individualization capabilities of finger/palm characteristics as employed by AFIS systems. Human Subjects are not required. Finger/palm prints obtained from the FBI were supplied to ORNL with blind identifiers.
There is a cross-reference number for each fingerprint image, but no links to identifiers will be given to the ORNL researcher. However, in the case of a very high similarity score for two different fingerprints, the FBI will be able to pull the images and conduct an analysis for those images with a very high similarity score. This in turn will be used to determine the root cause for generating high similarity scores in order to evaluate uniqueness or nonuniqueness of two different prints.
"Identification of Human Scent Components"
Principal Investigator: Dr. Gary Van Berkel, Oak Ridge National Laboratory
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 70
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Objectives:
Previous results from this project identified areas in sample collection, desorption, and analysis where changes could improve the performance of the STU (scent transfer unit) in the field as well as benefit the instrumental investigation of human scent. The proposed modifications in the sampling and desorption units will improve the ability to detect the low level components associated with human scent. Utilizing a time-of-flight mass spectrometer with a resolving power of about 10,000 will expand the number of m/z data points (analogous to odor receptors) by a factor of 10 over our prior studies providing greater scent discriminating power. Implementation of the proposed improvements and continued collection and statistical analysis of human scent profiles will lead to a better understanding of canine scent tracking, provide the basis for an instrumental method of individual identification on the basis of scent, and may lead to the identification of scent discriminators that can be used to determine the age, gender, race, etc. from a scent sample.
Methodology:
Human sampling (non-invasive) will involve collecting material from the skin using (1) a swab or scent pad to wipe the skin surface, (2) a vacuum device with a sorbent trap to collect material, or (3) a swab of an object handled by an individual. There are no known risks associated with this method. The swabs (collection material) will be analyzed by thermal desorption atmospheric pressure chemical ionization.
Involvement of Human Subjects:
The study population shall consist of volunteers from the researcher's division at the Oak Ridge National Laboratory. Volunteers will be selected to represent a sample of the adult population. Potential subjects will be given an explanation of the research and what their participation would entail. They will be given an informed consent form to read and sign and a questionnaire to fill out. The questionnaire will be coded to protect the volunteers' confidentiality. These forms will be kept separately in locked cabinets. Non-invasive sampling (by one of the investigators) will be used to collect samples after the consent forms and questionnaires have been completed. The samples will be coded with the same code used on the volunteer's questionnaire. Investigators will have access to the data and codes, and a summary statistical result will be presented to the Federal Bureau of Investigation who is the sponsor.
"Regional Studies Program-Analysis of Administrative Records for the Development of Programmatic Decision Support Tools - Department of Defense"
Principal Investigator: Ms. Colleen G. Rizy, Oak Ridge National Laboratory
Project started in: 2004
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 350000
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Three databases on the Army National Guard (all members as of date of file, starting in September, 2002; applicants and accessions to the military, starting in October 2003; and personnel data on all members of all U.S. Military Reserve components) are combined with other information such as Census, Bureau of Labor, and Bureau of Economic Analysis data. Analysis is performed on the data to understand how individuals respond to the sponsor's initiatives within the context of the broader socio/economic context. Statistical software (e.g., SAS, SPSS) and econometric tools (Limdep) are used to conduct such analyses. Data are used to conduct correlation/regression analysis to gain insight on issues of interest to the sponsors that are reported back as a project service product. Retention and the impact of mobilization on the rate of recruitment are examples of questions that might be studied. Such analysis activities are conducted in cooperation with and by request from the sponsor to meet an urgent concern. However, after the basic analysis is conducted, it is desirable to develop a more formal presentation of the analysis for presentation/publication which increases the credibility of the process for the sponsor's policy needs. Any reported research to validate/establish credibility uses aggregated individual data. The data are de-identified, and the reported research cannot be traced back to specific individuals.
For FY2006, no human subjects research was conducted, only non-generalizable research for the sponsor's need.
"Dynamics of Cardiovascular Responses to Particulate Exposures"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 2004
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 22
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The overall aim of this project is to identify mechanistic pathways underlying changes in heart rate variability (HRV) associated with airborne particulate exposures. The study is being conducted by the University of Kentucky's Center for Biomedical Engineering and the Chemical Sciences Division of Oak Ridge National Laboratory (ORNL). Our approach to determining mechanistic behavior will use correlation analysis to link cardiorespiratory responses to particulate exposures. We have hypothesized that acute exposure to particles of different species will elicit distinctive cardiorespiratory patterns. Furthermore, we have hypothesized that, because the stimulus is signaled via afferent lung pathways, changes in respiratory variability will influence HRV and must be taken into account when assessing the influence of airborne particulate exposures. We expose volunteers in an environmental chamber to inhalable particles at concentrations modeled from data collected in field studies. The exposure matrices consist of of cooking oil fumes, wood smoke, and environmental tobacco smoke (ETS), the most commonly encountered sources of indoor pollution.
We recruited and tested 18 subjects in Year 1 and 22 subjects in Year 2. There were approximately equal numbers of nonsmoking men and women, aged 25 to 45 years, without symptoms of cardiovascular or lung disease. All volunteers willing to participate in the study signed an informed consent in the presence of a witness. Evaluation of each individual included clinical history, cardiologic and pulmonary examinations, and a pregnancy test for the women. Subjects will receive a gratuity for their participation in this study.
The subjects were brought to the Controlled Experimental Atmosphere facility at ORNL and exposed to commonly encountered aerosols on each of three occasions on three consecutive days. Each complete exposure cycle was less than three hours in duration. All of the maximum concentrations of smoke and fumes encountered by the subjects were lower than that the mandated Occupational Safety and Health Administration (OSHA) eight-hour permissible exposure limits (PELs) for workers. And, if the subjects did not deliberately expose themselves to high concentrations of aerosols, their exposures for the day should have been less that the single day permitted EPA National Ambient Air Quality Standard (outdoor) for respirable suspended particulate (RSP) matter.
In addition to physiological response data collected during the experiments and cardio-respiratory data obtained as part of the physical exam, each subject was asked to fill out a brief questionnaire. That questionnaire collected information concerning what other exposures they may have encountered as part of their normal daily life and a small amount of demographic data and physical data. Subjects are not videotaped during the experiments. All data collected as part of this study are linked through an identifying number. Once subjects complete participation in the study, their name, address, and phone number will be separated from the remainder of the data, and the identifying codes will be kept only by the Principal Investigator and ultimately placed into long-term storage within Laboratory Records at ORNL. De-identified data on particle concentrations and individual subject cardio-pulmonary responses will be maintained by both institutions involved in this study but will not be used for any purposes other than those explicitly stated in this study. Ultimately, work from this study will be published in the scientific literature. Both institutions will maintain the de-identified data according to their standard practice.
Preliminary results from the studies suggest the following: Effects of respiration may have a non-negligible effect on low frequency spectral power of respiration rate interval and blood pressure in response to environmental particulate exposures. The responses to particulates of different species display a differentiated autonomic response with cooking oil and wood smoke eliciting a more pronounced sympathetic acute response (increased low frequency power in systolic pressure) post exposure while ETS affected tidal volumes more during exposure. It should be noted that these analyses have not been normalized for differences in inhaled dose of particles. Such will be performed in the fall of 2006.
It is anticipated that these experiments will provide initial data as to the magnitude of cardio-pulmonary responses to exposures to commonly encounter aerosols, and whether such responses, when compared with commonly encountered concentrations, are sufficient to be detectable with current instrumental capability. If they are, it is likely that new, wearable instrumentation will be developed (outside the scope of this study) that will permit study of the importance of this phenomenon under real world exposure conditions.
"Development of a Multi-mode and Multi-spectral Automated Mueller Matrix Polarization Imaging System for Non-Invasive Skin Cancer Detection and Diagnosis"
Principal Investigator: Dr. Justin S. Baba, Oak Ridge National Laboratory
Project started in: 2004
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
An imaging system (Mueller matrix polarization imaging system) being developed at the Oak Ridge National Laboratory (ORNL) will be used to test the hypothesis that it has sufficient sensitivity to accurately discriminate human cancerous and non-cancerous lesions non-invasively, in vivo, enabling early and accurate differentiation of skin cancers. Data will be acquired by the lead ORNL Principal Investigator (PI) in conjunction with the clinician, at MD Anderson Cancer Center, on twenty consenting patients over a period of six months. They will be selected based on their prognosis at the time of their skin clinical examination irrespective of age, gender, race, or color. The goal of this study is to acquire supporting preliminary data for pursuing further National Institutes of Health (NIH) funding to test the hypothesis with a more in-depth clinical study.
The imaging system is a non-contact procedure that utilizes a low power non-ionizing light source. The identity of the patients will be protected by data coding that omits personal identification information; after assigning an ID number, all subsequent patient-generated data such as histological results, will be stored by the patient identifying number. Only the clinician will have access to personal information. All data will be password protected and DVD archived throughout the study. The multi-mode data will be processed at ORNL, and the results validated by the histology of the biopsies obtained from the clinician (biopsies will only be available for the cases that the clinician had already pre-determined, based on the patient skin clinical examination). The raw data and processed data will be password protected and DVD archived at the end of the study. Therefore, patient confidentiality will be protected because only the physician will have access to the key, which will be used strictly for clinical care purposes. The only information that the PI will have on the patients is a number that contains no identifying information.
No subjects were used in FY2004 due to delays in building the imaging system.
"Alzheimer's Disease Detection via Nonlinear Analysis of EEG"
Principal Investigator: Dr. Nancy B. Munro, Oak Ridge National Laboratory
Project started in: 2004
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/23/05
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: University of Kentucky
Most recent approval: 08/17/06
IRB approval number: 04-0120-FIV
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Early detection of progressive brain disorders will provide clues about the origin of those diseases and would enable pre-symptomatic diagnosis and early treatment. Toward this end, we will undertake innovative computational analysis of human scalp electroencephalogram (EEG) data involving: (1) a carefully-chosen subset of the 66 available EEG channels in (2) a multi-channel extension of Oak Ridge National Laboratory's (ORNL's) patented approach for phase-space dissimilarity measures (PSDM). A third innovation uses PSDM analysis across the patient population rather than comparison of the data segments from the same patient. A fourth innovation will use advanced network statistical analyses as a complementary approach to the PSDM analysis. The objective is determination of unique signatures to distinguish among the following four groups of aged patients: (i) normal, (ii) mildly cognitively impaired (MCI), (iii) early Alzheimer's disease (AD), and (iv) diffuse Lewy body disease (DLB). Collaborators at the University of Kentucky (UK) will acquire EEG data from up to eighty patients under standard clinical protocols with twenty patients in each of the groups (possibly less in the DLB group). Half of the data (ten datasets from each group) will be analyzed by ORNL's algorithms to train the methodology. ORNL will be blind to the characterizations of the other half, which will be analyzed as a validation test of the methodology. The work will create a new, more powerful technology that will further expand and strengthen the analysis of complex biomedical data for diverse clinical applications.
"Network Interference of Human B Cells Using Biospace"
Principal Investigator: Dr. Michael L. Simpson, Oak Ridge National Laboratory
Project started in: 2005
This project ended in fiscal year 2006.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/17/04
Explanation of IRB approval:
At the request of the Vanderbilt PI, the IRB reviewed the change in protocol to use previously collected and de-identified/delinked samples from the Red Cross and changed status to exempt on November 8, 2005. The Vanderbilt IRB had already determined that this project no longer qualified as human subjects research.
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: Vanderbilt University
Most recent approval: 06/28/05
IRB approval number: 8675
Explanation of additional approval:
At the request of the Vanderbilt PI, the IRB reviewed the change in protocol to use previously collected and de-identified/delinked samples from the Red Cross and changed status to exempt on November 8, 2005. The Vanderbilt IRB had already determined that this project no longer qualified as human subjects research.
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 2006
Type(s) of Human Subjects Involvement:
Human B cells produce antibodies in response to the presence of antigens. The B cells of infants are known to produce antibodies in smaller quantities and of poorer quality than adults. Apparently, infant B cells possess an intrinsic mechanism to down regulate antibody production in response to antibodies. As a result, children's vaccines are not as effective as they could be. If the down regulation mechanism could be suppressed in the presence of vaccines, immunization could be made more effective. Using samples collected by Vanderbilt researchers under a separate NIH-funded project, we seek to understand the differences between the regulatory networks that control antibody formation in infant and adult B cells. We seek to use computational tools to infer the regulatory networks associated with each type of receptor and how the signaling network of one receptor interacts with that of another.
FY2005 Status: Researchers were still finalizing the laboratory procedures; therefore, they had not recruited the first subject at the end of last year while completing the validation of the laboratory tests was completed.
FY2006 Update: We are still finalizing the laboratory procedures; therefore, we are about to recruit the first subject. We have not attempted to recruit a subject yet, until the validation of the laboratory tests was completed.
"Epileptic Seizure Prediction"
Principal Investigator: Dr. Lee M. Hively, Oak Ridge National Laboratory
Project started in: 2005
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 05/18/06
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 2006
Type(s) of Human Subjects Involvement:
Collaborators at various institutions where electroencephalogram (EEG) monitoring studies are conducted for the diagnosis and treatment of seizure disorders will furnish data sets of temporal lobe epilepsy to Oak Ridge National Laboratory (ORNL) for analysis by our patented nonlinear methods. Phase I of this work will involve obtaining 300 data sets from patients (or nearly as many); half will be event and half non-event data sets. These will be analyzed to determine the total true rate and false positives rate per hour for comparison with results based on the current 60 data sets obtained in a previous cooperative research and development agreement (CRADA) project with a different sponsor. These CRADA data were completely de-identified. We have no access to their coding or data files. There were no constraints on reuse or reanalysis of data sets from the previous CRADA; this was put in writing in the CRADA. The 300 data sets in this study will potentially be reused or reanalyzed, and we will inform medical collaborators of the need to include this in the informed consent. Mechanisms will also be put in place to collect up to a total of 1,000 data sets for future stages of work, although the actual collection may be deferred to a later stage depending on the cost. The initial institutions are the University of Kentucky Medical Center and Vanderbilt University Medical Center.
An amendment to the protocol after the initial approval referenced obtaining EEG data from the Cleveland Clinic Foundation (CCF). Cleveland Clinic will furnish data from 39 subjects obtained over two to three days or more in their epilepsy monitoring unit (EMU) for analysis. The de-identified data will be sent to computers located in their EMU but programmed with ORNL codes for analysis. The results will be sent back to the CCF computers and validated by means identified by CCF biostatisticians.
"EESD Future Technology and Scientific Creativity"
Principal Investigator: Dr. Amy K. Wolfe, Oak Ridge National Laboratory
Project started in: 2005
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/10/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This work does not constitute a hypothesis-based research activity. Exploratory, open-ended interviews will be conducted with some members of up to five Energy and Engineering Science Directorate (EESD) groups. Once groups are selected, interviews will be conducted according to the type of research problem on which they focus as well as the nature of their technology orientation. This project is intended to address concerns about the unevenness in technological and scientific creativity across the EESD. The product of the activity will be white papers that provide insights into factors that are contributing to or inhibiting creativity within EESD groups. As a program development effort, activities undertaken are exploratory rather than research oriented.
"Post Exposure Injury Assessment Tools"
Principal Investigator: Dr. Clay E. Easterly, Oak Ridge National Laboratory
Project started in: 2006
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 10/03/05
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 2006
Type(s) of Human Subjects Involvement:
Abstract:
Purpose of this collaborative study is to determine proof of principle that teeth can be used as dosimeters for radiation exposure. This would provide one potential method by which an estimate of radiation dose could be made immediately upon presentation to a first responder or medical emergency personnel in the event of a terrorist event or other potential exposure scenario. The experimental focus is characterization of the luminescent dosimetry of teeth, the relation of tooth luminescence to whole body radiation dose, and the instrument development needed to interrogate intact teeth. Study efforts at Oak Ridge National Laboratory (ORNL) will involve development of dose-response curves in order to provide the basis for relating luminescence intensity measurements to whole-body radiation dose to people using the Optical Stimulation of Luminescence (OSL) method for detecting radiation exposure using teeth. While porcine teeth will primarily be used, it is desired to determine the range in variability in dose response according to age, gender, and race for human teeth. Participants are recruited by University of Tennessee dental surgeons who will record age, gender, race, and tooth location. No coding link will be maintained tying these teeth back to the subject and ORNL researchers will not come in contact with any of the subjects from whom the teeth are provided.
"Latent Print Detection by Macro-Raman Imaging"
Principal Investigator: Dr. Linda A. Lewis, Oak Ridge National Laboratory
Project started in: 2006
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 10/07/05
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 2006
Type(s) of Human Subjects Involvement:
Objective of study is to develop a method for locating latent fingerprints in the field without prior treatment. This is a collaborative study with ChemImage Corporation which is developing a Raman-based imaging system. Efforts will be directed toward gaining a better understanding of fingerprint and fingerprint degradation chemistry, employing methods to enhance Raman-based latent-print visualization, and utilizing the enhacement methods to modify the ChemImage system for field applications. Fingerprints are to be collected on a variety of surfaces in order to study methods of visualizing the prints using Raman Spectroscopy. The goal is to increase the Raman-signal sensitivity in order to reduce the laser power requirements. This will allow researchers to develop a smaller, field portable fingerprint imaging system. Fingerprints will be deposited on a variety of surfaces and are to only come from researchers assigned to the project and who have consented to depositing fingerprints. Images from the fingerprint data will be be maintained on the PI's computer which is password and firewall protected according to institution requirements.
"Commercial Driver's License Program Evaluation, Phase II"
Principal Investigator: Dr. Lorena Truett, Oak Ridge National Laboratory
Project started in: 2006
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/14/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 51
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The Federal Motor Carrier Safety Administration is sponsoring a program review by Oak Ridge National Laboratory (ORNL) of the Federal Commerical Driver's License Program in order to determine the effectiveness of the their program. Two sets of participants are to be surveyed using a secure web-based survey instrument. The full population of the State Commerical Driver's License Coordinators and Division Administrators for the Federal Motor Carrier Safety Administration Division or their delegates will be surveyed. Responses will be tied to particular states and not individuals. Only project personnel will have access to the database for the purposes of analyzing data. At the end of the project, data will be deleted from the secure computer. Waiver of a consent form was documented in the approval letter from the IRB, but there is a screen at the beginning of the web-based survey which explains the use of the data and who will have access.
"ORNL Healthy Lifestyle Research Study"
Principal Investigator: Ms. Joan Lawson, Oak Ridge National Laboratory
Project started in: 2006
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 06/23/06
IRB approval number: (06)-92
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 2006
Type(s) of Human Subjects Involvement:
This project, a collaborative study with Emory University, was designed to explore potential success with weight management through an affordabale and easily accessible service of telephone-based counseling and self-help materials. A total of 1,500 participants is desired with 700 to 800 from Oak Ridge National Laboratory (ORNL). ORNL participants will be recruited via flyers and notices in the facility electronic newsletter. Prospective participants are to contact the American Cancer Society (ACS) for a screening to determine if they meet the study criteria (over 18, no eating disorders, not pregnant or nursing, and willing to make behavioral changes). Participants are assigned to either a group receiving self-help materials and nine telephone counseling contacts over six months or only self-help materials via electronic randomization. Participants have the option to weigh-in three times over the next 12 months. The consent process will occur by phone with a script. Although the ACS database will contain names in order to mail materials to participants, datasets will contain unique ID numbers in order to protect the privacy of the participants. An optional activity of the study is three weigh-ins during the first six months. Participants who chose to do the weigh-ins will receive $20 compensation.