Ms. Ann M. Murphy
PO Box 2008
MS 6169
Oak Ridge, TN 37831-6291
Phone: 865-576-5641
Fax: 865-576-7926
E-mail: shirleyam@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-04-73 | "Regional Studies Program-Analysis of Administrative Records for the Development of Programmatic Decision Support Tools - Department of Education" |
| ORNL-04-74 | "Voluntary Job Turnover and Firm Agglomeration" |
| ORNL-04-75 | "Enhanced Visualization of Aged Latent Fingerprints by Non-Invasive Chemical Derivatization Technique" |
| ORNL-04-76 | "Enhanced Latent-Print Detection on Human Remains and Non-porous Media" |
| ORNL-04-77 | "Latent-Fingerprint Development in Large Enclosures Using Superglue Fumes and Dye-Sublimate Smoke " |
| ORNL-04-78 | "Improved Extraction Efficiency for Fingerprint Drug Screening and Detection" |
| ORNL-04-79 | "Investigation into the Development of Latent Fingerprints on Fragments Remaining after the Detonation of Improvised Explosive Devices (IEDs) " |
| ORNL-04-80 | "Dynamics of Cardiovascular Responses to Particulate Exposures" |
| ORNL-04-81 | "Sustaining the Landscape: A Comparison of Current and Desired Future Conditions of Forest Ecosystems in the North Cumberland Plateau" |
| 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." |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-95-005 | "Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)" |
| PACE-96-DE-FC03-96SF21260 | "DOE Gaseous Diffusion Plants K-25, Portsmouth, and Paducah Current and Former Workers Medical Surveillance Program" |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| UOC-96-DE-FC03-96SF21263 | "Oak Ridge, Portsmouth GDP & Paducah GDP Building Trades Medical Screening Program, Phase II-LPT" |
| NIOSH-97-009 | "Multi-Site Case-Control Study of Lung Cancer and External Ionizing Radiation" |
"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: No Funding Sources Reported
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: 11/20/03
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 2004
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 a 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 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 of 20 to 25 minutes in length is produced for each experimental protocol and augments the formal human studies consent form.
No work was done on the data evaluation in FY2004.
"Fuel Economy Information Evaluation/Green Vehicle Ratings"
Principal Investigator: Dr. David L. Greene, 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: 11/20/03
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 2004
Type(s) of Human Subjects Involvement:
The objective of the study is to conduct a structured evaluation of DOE and EPA's websites with special attention to measures for conveying the environmental attributes of vehicles, such as air pollutant and greenhouse gas emissions. Focus groups will be led by a moderator through a structured evaluation of the website and alternative environmental rating systems. Participants from the Knoxville, Tennessee and California areas will be recruited by quasi-random telephone methods by a consultant who will also act as a moderator for the session. Adults with a general interest in the environment will be selected. No other criteria for participation are stipulated. The sessions will be video-taped and the tapes held by the consultant (who will hold the identities of participants as confidential information), but the participants will be informed that researchers may have access to the videotape.
Participants are informed when recruited by phone that they will be videotaped at the focus session. On-site, they will be given a consent form to read and sign prior to the session beginning.
There were two focus groups that met during FY2002. Both involved consumers determining the effectiveness of the web site. During FY2003, information from previous years' focus groups was used to make the website more user friendly with simpler language and clarifications of how to read the greenhouse gas emissions ratings and air pollutants.
No work was done on this project in FY2004.
"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
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: 11/20/03
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 2004
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 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 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: 11/20/03
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 retrival 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 2004
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: 11/20/03
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 2004
Type(s) of Human Subjects Involvement:
The objective of this work is to (a) determine daily variation in exposure to environmental tobacco smoke 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 will be 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 environmental tobacco smoke exposure in humans and resulting dose distribution to various organ systems.
"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: No Funding Sources Reported
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: 11/20/03
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 2004
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: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
Several empirical studies have been performed to determine how well dogs can differentiate odors between people; yet very little scientific data has been published with respect to the actual identity of chemical components canines are targeting/smelling. Using human scent to identify an individual assumes that (a) each person has his/her own unique odor, (b) the unique odor remains distinctive over a relatively long time period (several days), and (c) a dog is able to differentiate between odors of different people. In this project, olfactory fingerprints of humans will be analyzed by mass spectrometry and the individual components of the fingerprint identified.
Human involvement will consist of a sampling (non-invasive) period to collect material from the skin using (1) a swab 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 samples will be split and analyzed by mass spectrometry. The results will be analyzed to determine the sources of variation (a) within an individual and (b) between different individuals. A variance component experiment will be statistically designed to estimate different body sources, morning and afternoon time periods, and day-to-day variations. Estimates of these variations will identify those individual compounds that can be used for constant human scent markers. These initial experiments will involve only a few individuals to see if we can identify human scent markers and which ratios of human scent markers can be used for individual identification.
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 FBI sponsor.
In FY2004, we demonstrated that material can be collected onto scent pads using the scent transfer unit (STU, essentially a modified hand-held vacuum cleaner), and that this material can be desorbed off the pads and analyzed by mass spectrometry. Our results also showed that complex mixtures such as colognes, can be sampled, mass analyzed, and the data processed using multivariate analysis to differentiate between the different colognes. When this technique was applied to human subjects, our data showed that there appears to be enough differentiators to distinguish between individuals. However, a much larger data set will be required before any rules can be deduced.
"Regional Studies Program-Analysis of Administrative Records for the Development of Programmatic Decision Support Tools - Department of Defense"
Principal Investigator: Dr. David P. Vogt, 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: 11/26/03
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 2004
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 (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 FY2004, no human subjects research was conducted, only non-generalizable research for the sponsor's need.
"Regional Studies Program-Analysis of Administrative Records for the Development of Programmatic Decision Support Tools - Department of Education"
Principal Investigator: Dr. David P. Vogt, 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: 11/26/03
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 2004
Type(s) of Human Subjects Involvement:
The Department of Education Pell Grant database for all students attending post-secondary schools who have completed Pell Grant application is 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 (e.g., SAS, SPSS) and econometric tools (Limdep) are used to conduct such analyses. Data are used to examine issues that are at the core of policy decisions in the department. An example of this type of analysis is the examination of the age structure in the student data. Of particular concern is examining those schools that report unusually larger numbers of elderly students to see if those schools may be "manufacturing" students as indicated by the multiple uses of SSNs in more than one institution. 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 FY2004, no human subjects research was conducted, only non-generalizable research for the sponsor's needs.
"Voluntary Job Turnover and Firm Agglomeration"
Principal Investigator: Dr. Victoria T. D'Urso, Oak Ridge National Laboratory
Project started in: 2004
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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/03/03
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 2004
Type(s) of Human Subjects Involvement:
This project aims to investigate the relationship between employees' propensity to voluntary quit one job to take another and the agglomeration of relevant firms or potential employers in the employee's job market. The hypothesis tested is: An employee quits one job to take another without exiting the labor force in between employments; this is more likely to occur in labor markets with more employers to choose from.
This study plans to use pre-existing data from the Bureau of Labor Statistics (BLS) National Longitudinal Survey of Youth (NLSY) 79 survey years when respondents were asked about quits from previous jobs and whether a new job was lined up at the time of quitting, indicating previous search activity on the job as well as socioeconomic status of the respondent and avialability of employment as indicated by the public NLSY 79 database. Information about the number of establishments by type of industry will be added from publicly available County Business Patterns data for the corresponding year, industry, and relevant job market for each respondent in the NLSY 79 survey.
An econometric estimation of the impact of firm agglomeration on voluntary job turnover and tenure until quit into another job will be performed. The duration until voluntary quit to take another job and alternatively the number of quits in a given period of time will be empirically modeled as a function of firm agglomeration and a variety of socioeconomic and environmental variables. It will also investigate the differences across the distribution of tenures.
The data used in this study do not contain personal respondent identifiers such as name, SSN, etc. The non-publicly available data as part of the NLSY 79 survey includes Geocodes for county and state of residence. (See the attached NLSY 79 Geocode application to the BLS.) The Geocodes themselves will not be part of the analysis or the published results and only used to match the NLSY database to the corresponding number of firms in the relevant employment area. Thus, the results presented in the paper will be aggregated and the de-identified.
The NLSY 79 Geocodes electronic files will be stored on a desktop computer, laptop computer, and/or server located on the U.S. Department of Energy Oak Ridge National Laboratory (ORNL) network. The ORNL computer network is protected from external intrusion by a filtered gateway router and a firewall. Cyber access in general is protected by a ORNL user identification (uid) and a DOE 205.3 compliant password. ORNL desktops are required to have current virus protection and to be up to date with all security patches for the appropriate operating systems. Password protected screen savers are required at ORNL. The information owner/custodian controls access to information utilizing the above mentioned controls.
The results of this study will be an academic research paper, possibly to be published as a journal article, and/or presented to academic and student audiences. Publication is a validation of completed research.
"Enhanced Visualization of Aged Latent Fingerprints by Non-Invasive Chemical Derivatization Technique"
Principal Investigator: Dr. Reza Dabestani, Oak Ridge National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 04/15/04
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 2004
Type(s) of Human Subjects Involvement:
The objectives of the proposed study are to develop a new technique for lifting aged latent fingerprints from objects that have been used to carry out a crime and typically disposed of after the crime was committed. These objects that may potentially be recovered after a long period of time and after having been exposed to harsh environments will not develop a good print due to loss of some of the ingredients contained in the latent fingerprint. This study will look at the stable components that survive harsh environmental conditions and chemically derivatize these components with fluorescent reagents for visualization using a handheld blacklight. Fingerprints shall be introduced on a variety of surfaces and then exposed to heat, sunlight, and moisture to evaluate the effect of these parameters on developing the prints. The source of fingerprints shall be the researchers' own prints. The fingerprint images will be destroyed after the testing is completing.
Funding was not received from the National Institute of Justice (NIJ), so this project was not initiated.
"Enhanced Latent-Print Detection on Human Remains and Non-porous Media"
Principal Investigator: Dr. Linda A. Lewis, Oak Ridge National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 04/15/04
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 2004
Type(s) of Human Subjects Involvement:
Cyanoacrylate (superglue) fuming is a prominent method of developing latent prints on nonporous surfaces. This method is widely employed by local, state, and federal law-enforcement agencies. Often in fingerprint examinations, only partial latent prints are detected. According to the Federal Bureau of Investigation (FBI), the average print area recovered is approximately 22 percent. Fingerprints deposited on victims of abuse frequently go undetected once the prints age over a few hours. The ability to develop latent fingerprints is influenced by many factors including print-type, humidity, light, surface matrix, etc. Recent research findings revealed methods of enhancing the ability to detect latent fingerprints. In cases where the major initiators had not been photodegraded, treatment of the print with 75 percent acetic acid prior to fuming under humid conditions dramatically enhanced the development. Thus, clean prints that otherwise would not have been detected were developed with excellent visibility and contrast. Further study is needed to better understand these polymerization and enhancement mechanisms and determine the degradation processes of major polymerization initiators on various surfaces including that of a human corpse. By understanding and optimizing this enhancement method, an increase in the average area and quality of developed fingerprints is expected to increase dramatically.
Components in eccrine sweat have been identified as initiators of the cyanoacrylate fuming process. Initially, the proposed study will focus on determining degradation processes associated with the major polymerization initiators under different environmental conditions and on various surfaces including stainless steel, glass, and skin. The degradation products will be analyzed by a combination of analytical techniques including capillary electrophoresis and electrospray ionization mass spectrometry. Once fingerprint degradation is understood in relation to key cyanoacrylate initiators, limiting parameters for print enhancement will be defined. In parallel with the degradation study, an enhanced regeneration method will be optimized in relation to acids and humidity during superglue fuming. The goal is to develop an easily applied and field-applicable method of locating latent fingerprints on non-porous surfaces and skin that otherwise would not be developed with superglue fuming. The method must develop these prints with excellent quality regardless of print type. In addition, polymerization mechanisms will be studied to better understand the enhanced development process. Finally, clean and oily fingerprints on stainless steel, glass, and decomposing bodies will be aged under both dark and sunlit conditions for extended periods of time. At given intervals, prints will be processed and evaluated for quality with and without enhancement.
Involvement of Human Subjects:
The research on human remains will be conducted through the Body Farm at the University of Tennessee. Latent fingerprints will be deposited on metal and glass by the Principal Investigators (PIs). The prints will be developed by superglue fuming and evaluated for quality. The fingerprints deposited on corpses may be deposited by the anthropology students (one per year or the same student both years) at the Body Farm. The student(s) shall be recruited by announcements by Anthropology Department faculty and selected based on the best match with their professional interests and the study. These will be students who are already working at the Body Farm. They will have an opportunity to be a co-author on any publications. Should the students feel apprehensive about depositing fingerprints on corpses, the PIs will deposit the prints in their place.
"Latent-Fingerprint Development in Large Enclosures Using Superglue Fumes and Dye-Sublimate Smoke"
Principal Investigator: Dr. Robert W. Smithwick, Oak Ridge National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 04/14/04
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 2004
Type(s) of Human Subjects Involvement:
Abstract:
The objective of the study is to scale up a method involving the formation of colored smoke which will adhere to the surface of superglue-fumed latent (hidden) fingerprints for the purpose of causing the fingerprints to become visible in a dark color such as blue. The methodology includes fingerprints being introduced onto objects or surfaces within a large enclosure, the researchers vaporizing superglue, producing colored smoke, and evaluating how well those fingerprints become developed in the dark color.
Involvement of human subjects will be limited to the application of the researchers' own fingerprints prior to testing the fingerprint-development procedures. Those fingerprint images will be destroyed after they are no longer useful to the researchers.
Expected outcome is that procedures and methods will be devised to enable developing fingerprints in color within a large enclosure to help law enforcement personnel better perform their work.
Funding was not received from the National Institute of Justice (NIJ), so this project was not initiated.
"Improved Extraction Efficiency for Fingerprint Drug Screening and Detection"
Principal Investigator: Mr. Keiji G. Asano, Oak Ridge National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 04/15/04
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 2004
Type(s) of Human Subjects Involvement:
Abstract:
Current drug testing protocol involves the rapid screening of biological fluids, such as urine or blood, followed by confirmatory testing by gas chromatography/mass spectrometry (GC/MS) when screen results are above a set threshold. Urine or blood collection is an invasive and problematic task. Less invasive sampling techniques are needed and desired, especially for initially screening. The employment of a non-invasive sample collection protocol could alleviate resistance to provide and to adulterate samples. The process of collecting urine and blood specimens also leads to a higher risk of personnel exposure to biohazards. This research proposes to develop a non-invasive sampling method for drug screening/testing. The testing method developed will be targeted toward both clinical and forensic testing needs. We will be teaming with forensic investigators from the Tennessee Bureau of Investigation (TBI) and plan to target those drugs and their metabolites that are currently the most abused substances. The proposed method would detect illicit drugs by analyzing material from a fingerprint using capillary electrophoresis (CE), gas chromatography/mass spectrometry (GC/MS), or electrospray/mass spectrometry (ES/MS). The major drugs or drug classes will be studied as well as the associated metabolites, if available. Detection of the metabolites will be an important factor in distinguishing between drug use and drug contact or contamination.
Fingerprint residue of the Principal Investigators will be evaluated for background peaks that may interfere with the drugs or metabolites of interest.
Funding was not received from the National Institute of Justice (NIJ), so this project was not initiated.
"Investigation into the Development of Latent Fingerprints on Fragments Remaining after the Detonation of Improvised Explosive Devices (IEDs)"
Principal Investigator: Dr. Linda A. Lewis, Oak Ridge National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 04/15/04
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 2004
Type(s) of Human Subjects Involvement:
The objective of this proposal is to study, evaluate, and enhance one of the most critical and basic forensic identification techniques capable of visualizing latent fingerprints on non-porous surfaces. The technique is cyanoacrylate (superglue) fuming, and it facilitates the identification of those responsible for a criminal act, such as the construction and detonation of improvised explosive devices (IEDs). In a previous study, scientists from the Oak Ridge National Laboratory (ORNL) identified a major degradation process associated with a key component within latent fingerprints responsible for initiating polymerization during superglue-fuming. This degradation occurs when a latent fingerprint is deposited on a surface containing iron. ORNL researchers propose to team with a latent-fingerprint examiner certified by the International Association for Identification (IAI) and an employee of the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) to develop an enhancement method for visualizing latent fingerprints on fragments remaining from the detonation of an IED. In addition, ATF explosive experts will be utilized as a knowledge base for understanding and constructing the different types of devices.
A phased approach has been outlined to evaluate the chemical composition and associated degradation of components in fingerprints responsible for superglue development, to evaluate the survivability of those components after IED detonation, to enhance the latent print development techniques targeting surviving components, and finally to apply and evaluate the enhanced development techniques on fingerprints surviving the detonation of IEDs. Capillary electrophoretic (CE) and electrospray ionization mass spectrometric (ESI-MS) methods are ideal analytical techniques for the analysis of biological constituents. These methods will be utilized to identify and quantitate eccrine materials responsible for the visualization of latent fingerprints by superglue fuming and their associated degradation products. Since the major superglue initiators are known to degrade in the presence of iron, novel regeneration processes will be targeted to develop aged latent fingerprints on metallic IEDs. CE and ESI-MS will also be employed to identify chemical changes involving eccrine initiators and associated degradation products due to heat and chemical byproducts encountered during the detonation of an IED. Involvement of human subjects will involve the deposition of fingerprints from two Principal Investigators on the IED devices prior to detonation.
This project never received funding; thus it was never initiated.
"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: 04/19/04
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 2004
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 hypothesize that acute exposure to particles of different species will elicit distinctive cardiorespiratory patterns. Furthermore, we hypothesize 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. In addition, effects of postural changes and other environmental factors on HRV cannot be ignored. We therefore propose two separate controlled studies with the following specific aims:
a) To quantify concentration-dependent physiological responses to particulate exposure of individual species. We will use an environmental chamber to expose volunteers to particles of three origins (environmental tobacco smoke [ETS], cooking oil fumes, and wood smoke), each at three levels of concentration. Each particulate species will be tested separately. Results of this study will discriminate changes in respiration, cardiac, blood pressure, and vascular variabilities produced by ETS from those produced by cooking oil and wood smoke.
b) To quantify physiological responses to particulate exposure of combinations of species, in concentrations representative of environmental exposures. We will use the environmental chamber to expose volunteers to particle combinations modeled from data collected in field studies. The exposure matrices will consist of combinations of cooking oil fumes, wood smoke, and ETS, the most commonly encountered sources of indoor pollution.
Changes in respiratory variability will be used as a co-factor to dissect heart rate and blood pressure variabilities into those secondary to respiration and non-respiratory components. Gender, disease, age, exercise history, body movement, postprandial and circadian influences, all previously shown to have significant effects on HRV, will be controlled in both studies.
The portable cardiovascular, respiratory, particulate monitoring and data logging system (CRPM) to be developed in the proposed study, will be of added benefit in terms of providing platforms for uniform data collection now, and in future field studies that exceed the scope of the proposed study.
We will recruit 20 subjects in Year 1 and 20 subjects in Year 2. There will be 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 will sign an informed consent in the presence of a witness. Evaluation of each individual will include 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 will be brought to the Controlled Experimental Atmosphere facility at ORNL and exposed to commonly encountered aerosols on each of three occasions on separate days. Each complete exposure cycle will be less than three hours in duration. Actual exposures to the test aerosols will likely be less than one hour total duration. All of the maximum concentrations of smoke and fumes encountered by the subjects will be lower than that the mandated Occupational Safety and Health Administration (OSHA) eight-hour permissible exposure limits (PELs) for workers. And, if the subjects do not deliberately expose themselves to high concentrations of aerosols, their exposures for the day should be less that the single day permitted EPA National Ambient Air Quality Standard (outdoor) for respirable suspended particulate matter (RSP).
In both years of the proposed study, we will balance or eliminate age, gender, postprandial, environmental, postural and circadian influences, exercise and smoking histories, disease and activity level. Since it is well documented that each of these factors affect the parameters we are using as non invasive indexes of autonomic regulation, the controlled studies of this proposal are necessary in order to interpret results from true field studies. Use and validation of this system in a controlled environment modeled on real world particulate exposures will then allow us to develop a more detailed assessment of changes in heart rate and blood pressure variability produced by environmental tobacco smoke and other particulates.
In addition to physiological response data collected during the experiments, and cardio-respiratory data obtained as part of the physical exam, each subject will be asked to fill out a brief questionnaire. That questionnaire will collect information concerning what other exposures they may encounter as part of their normal daily life and a small amount of demographic data. Subjects will not be videotaped during the experiments. All data collected as part of this study will be 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.
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.
"Sustaining the Landscape: A Comparison of Current and Desired Future Conditions of Forest Ecosystems in the North Cumberland Plateau"
Principal Investigator: Ms. Sarah Chamberlin, Oak Ridge National Laboratory
Project started in: 2004
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
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 07/19/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
X mumber forest owners in the Tennessee Cumberland area were recruited by telephone for semi-structured interviews. The intent was to learn more about how they manage their forests. These interviews were done to serve as case studies to help better understand private forest management and how this management relates to the forest cover for the whole region. Data from the interviews will be incorporated into Ms. Chamberlin's master's thesis.
Interview questions will include how long the landowner has owned the property; information on past land-use; whether the landowner has a forest management plan and whether he or she follows the plan; what different management activities the landowner current uses on each section of the land; what goals the landowner has for each section of the land; whether the landowner is currently considering any new management activities for certain sections of the land; and whether the landowner would consider new management activities in the future. This information could be useful in relating the landscape-level ecological data generated from satellite imagery to individual landowners and their management constraints.
Each landowner was interviewed once in person in July 2004. The interviews were audiotaped. Data from these interviews will be incorporated in a master's thesis. The audiotapes will be destroyed at completion of the master's project.
"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: 08/24/04
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 2004
Type(s) of Human Subjects Involvement:
An imaging system (Mueller matrix polarization imaging system) being developed at 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 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), and the raw and processed data will be password protected DVD archived at the end of the study.
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.
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.