Ms. Ann M. Shirley
PO Box 2008
MS 6103
Oak Ridge, TN 37831-6103
Phone: 865-576-8262
Fax: 865-574-6169
E-mail: shirleyam@ornl.gov
Number of Human Subjects projects reported: 8
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1993
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/00
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 2001
Type(s) of Human Subjects Involvement:
Objectives
The purpose of this study has been to determine the personal exposure to environmental tobacco smoke (ETS) of non-smoking subjects in occupational and away-from-work settings. Exposures have been related to occupational categories, living and working environments, and demographic factors.
Methodology
Individual participants wore one of two personal sampling pumps, one each at work and away-from-work. (For Phase 2, restaurant and tavern servers wore only one sampling system: in their workplace.) Samples of breathing zone air were collected, and analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS), including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, scopoletin, solanesol, nicotine, 3-ethenyl pyridine, and myosmine. In addition, prior- and post-exposure saliva samples were collected by having the subjects chew on a piece of cotton dental dam in order that the smoking status can be assessed through cotinine levels. In the first phase of this study, 1566 subjects participated in the study. The subjects were distributed geographically around the United States, with about 100 subjects in each of 16 urban areas. In the second phase of the study, 165 subjects participated. All were recruited form the Knoxville, TN Standard Metropolitan Statistical Area.
In the course of analyzing the data from the first phase of the study, it was determined that for one of the targeted occupational groups, waiters/waitresses/bartenders, there was an insufficient number of subjects in the study pool to confidently distinguish exposure differences. For that reason, we increased the subject pool by about 165 subjects. This increased the overall study population by about 11%, to approximately 1729 subjects. All of the added subjects were recruited from the aforementioned occupational category in one of the urban areas studied in the first phase: Knoxville, TN. Essentially, the same experimental protocol as that previously employed will be used to judge occupational exposure. Area samplers were also placed in the subjects' place of employment. An extension of Phase I, which began near the beginning of FY98, involved about 270 subjects and have a sampling and subject protocol identical to that of Phase 1. However, subjects were recruited to fill specific demographic categories so that the overall study population was representative of the non-smoking population from which the subjects were recruited.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational or non-occupational routines. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
Two aspects of the study qualify it for human studies consideration. First, a sample of saliva is acquired from each subject upon the entrance into and departure from the study. Depending on timing, sample acquisition could be as little as 24 hours or as much as 72 hours apart. The purpose of the saliva collection is to determine the concentration of a nicotine metabolite (cotinine) present. Salivary cotinine levels are used to confirm the absence of smoking among self reported non-smokers, and to determine the potential efficacy of use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Secondly, a great deal of demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. A contractual requirement of any firm sub-contracted to recruit subjects or assist with field operations is that they make no permanent copies of the written questionnaires. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety.
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, and amounts to having to chew on a sterile piece of cotton dental dam for 60 seconds, and expelling it into a sterile vial. A videotape training film of 20-25 minutes in length is produced for each experimental protocol, and augments the formal human studies consent form.
"Characterization of Components of Fingerprints"
Principal Investigator: Dr. Michelle V. Buchanan, Oak Ridge National Laboratory
Project started in: 1994
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 06/05/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project will chemically characterize the components present on the fingertip skin to determine if information about age, sex, and personal habits can be ascertained. The long-term goal of the project is to obtain methodologies that can be used in forensic applications, but could also lead to non-invasive clinical assays. Samples will be obtained by asking the subject to deposit material from fingertips on glass slides or beads in order to collect the material from the skin. After the sample is returned to the lab, then the materials will be removed from the surface by solvent wash. This protocol will NOT expose the subject to any chemicals (or other hazards). No risks to the subject are involved. We will gather samples from subjects to determine general trends in chemical components present and identify specific compounds that might be useful for distinguishing individuals based on skin components.
Subjects consisted of ORNL staff/visitors who volunteered to participate after having the project explained. Consent forms were given to them to read and sign. The samples were coded and one researcher on the project was the only one who had the code. He kept this along with the consent forms in file cabinets in his office, which is locked when he is not there.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 06/05/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This part of the project looks for drugs of abuse that may be found on fingertip surfaces. The sample collection is similar to subtask 1 Amendment (a), where volunteers provide samples by rubbing a glass bead between their fingertips. The volunteers are never exposed to chemicals or other hazardous material and are not subject to any risk by agreeing to participate in this research. The subjects used in this study will be different than those used in amendment (a). The volunteers for this study are from Davidson County Community Corrections (Nashville) and will have to read and sign an informed consent form in order to participate. The samples are coded with an identifier that is determined by Davidson County Community Corrections. The samples are then re-coded at ORNL to further protect the privacy of the volunteer. The individual results obtained at ORNL are never shared with Davidson County to protect the volunteers' confidentiality.
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces. Phase III"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1998
This project ended in fiscal year 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: 12/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Objectives
The purpose of the study was to document the levels of environmental tobacco smoke ETS in a recently constructed corporate facility where smoking is unregulated, but which employs an advanced HVAC system, and to determine non-smoker personal exposure to ETS within the facility.
Methodology
Experimental protocol was similar to that used in ORNL-93-17, in which subjects wear a small sampling system which collects indoor air samples from their personal breathing zone air. Samples of breathing zone air were analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS) and other combustion derived particles and vapors, including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, solanesol, nicotine, and 3-ethenyl pyridine. Personal breathing zone samples were collected for three consecutive days, usually Tuesday, Wednesday, and Thursday. Fixed location area samples were acquired in the vicinity of the subjects’ work stations. In contrast to the ORNL-93-17 protocol, no saliva samples were collected, since the smoking status (based on observational data acquired in the workplace) was known to the investigatory team.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational routine. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
One aspect of the study qualifies it for human studies consideration. Demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. (Note that since all of the subjects in this protocol were office workers, this was deemed to be a minimal risk.)
Privacy
Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality is protected through the use of pseudo-identifiers. Because of the relatively small number of subjects in this protocol, no videotaped instructions were given. Instead, ORNL staff explained the purpose of the study, trained each subject on the wearing and use of the personal sampling pumps, answered subjects’ questions about the protocol, and obtained witnessed Human Studies consent.
"In-Vehicle Information Integration Study"
Principal Investigator: Dr. Philip F. Spelt, Oak Ridge National Laboratory
Project started in: 1999
This project ended in fiscal year 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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 40
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
A. The purpose of this research is to evaluate different ways of presenting information messages to drivers of automobiles.
B. Methodology: The study will take place in a driving simulator, and will involve simulated messages coming from several different systems, for example: cell phone, pager, and warning system. This study will compare the impact of these separate messages on driving performance, when they are either presented in a prioritized fashion or presented as they are generated by the separate systems.
C. No exposure to harmful substances is involved.
D. Subjects will drive a stationary driving simulator. Because no motion in the simulator is involved, there is no physical danger to subjects. A very few people may become slightly nauseated due to "simulator sickness, and they will be allowed to withdraw with no penalty. Data are strictly confidential, and will not be released or used with any identifying characteristics included. Summary statistics will be reported. Participants in the project must read and sign a consent form prior to the start of the test. In addition, there is a pre-test briefing after which a participant may withdraw if they choose.
See project NIOSH-97-009.
Project Identifier: ORNL-00-NIOSH3_IRB
Project Title: "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation"
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"Industrial Assessment Center Impact Evaluation"
Principal Investigator: Dr. Michaela A. Martin, 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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/00
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 2001
Type(s) of Human Subjects Involvement:
This project is to evaluate the energy and cost savings impacts generated by DOE's Industrial Assessment Center Program. Four surveys shall be conducted with subject populations of industrial firms that have received IAC Program assessments, alumni of university-based IAC programs, and users of IAC-affiliated websites. Two of the surveys shall be by phone and the other two are web-based. Participants in the web-user survey shall receive an ASHRAE Pocket Guides. Although there will be no identifiers on web surveys, personal identifiers shall be maintained on telephone surveys. The identifiers shall be separated from the responses for reporting purposes. Only the ORNL PIs and two UT researchers will have access to the raw data, and at the completion of the project, the PI will maintain the data for several more years.
The consent form was waived by the IRB Chair for this project since the responders have been identified for recruitment from publicly accessible databases or other lists and by responding to recruitment notices are consenting to participate.
"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: 02/08/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 40
Reporting period for number of human subjects:
Fiscal Year 2001
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 session will be video-taped, and the tape will be held by the consultant (who will hold as confident information on the identities of participants) but the participants will be informed that researchers may have access to the videotape.
Participants are informed that they will videotaped when recruited by phone. On-site, they will be 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
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: 02/08/01
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 2001
Type(s) of Human Subjects Involvement:
Public forums are to be used to advance knowledge of the determinants of bioremediation technology acceptability substantively and in terms of communication process. Workshops with voluntary participation of 15-20 individuals solicited by phone will focus on specific questions pertaining to technology acceptability. Will work with community participants and ORNL staff who are not associated with remediation projects. Sub-groups of participants will consider merits and problems of particular situations or options and what advice they hypothetically would give to DOE Records of workshop sessions will be kept through audiotape recordings and notes, but strict confidentiality will be maintained. Participants will be not be identifiable in documents based on the workshops. Interest is in kinds of issues categories of individuals raise in small-group discussion versus individuals.
Participants will be given consent forms briefly describing their activities in the workshop to read and sign prior to the beginning of the workshop.
"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: 04/20/01
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Vanderbilt
Most recent approval: 01/25/01
Type of Review: Full Board
Approving Institution: Boeing
Most recent approval: 01/19/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 952
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This is a cohort mortality study of approximately 55,000 workers employed since 1950 at the 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. 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, thus the Vanderbilt IRB and Boeing's IRB have reviewed and approved the study in January 2001.
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. ORNL/ORAU involvement with the study will focus on radiation dosimetry aspects and retrieval of death certificates for workers who died before 1979.
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, and
-ORISE staff have signed agreement to keep identities 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.