Ms. Ann M. Shirley
PO Box 2008
MS 6260
MS 6103
Oak Ridge, TN Anderson 37831-6103
Phone: 423-576-8022
Fax: 423-574-4084
Email: shirleyam@ornl.gov
Projects are approved by an IRB located at: Oak Ridge National Laboratory.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1394
Number of Human Subjects Projects reported: 10
Project Identifier: ORNL-93-17
Project Title:
Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces
Principal Investigator:
Dr. Roger A. Jenkins
Project started in: 1993
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 1,686
Type 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. 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 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 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 are increasing the subject pool by about 120 subjects. This will increase the overall study population by about 8%, to approximately 1686 subjects. All of the added subjects will be recruited from the aforementioned occupational category in one of the urban areas studied in the first phase. Essentially, the same experimental protocol as that previously employed will be used to judge occupational exposure. Final details of the protocol are being developed, and there is a possibility that area samples of ETS will be acquired, independent of the subjects, in the subjects' work locations.
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 will be acquired from each subject upon the entrance into and departure from the study. Depending on timing, sample acquisition could be as little as 24 hours or as much as 72 hours apart. The purpose of the saliva collection is to determine the concentration of a nicotine metabolite (cotinine) present. Salivary cotinine levels are used to confirm the absence of smoking among self reported non-smokers, and to determine the potential efficacy of use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Secondly, a great deal of demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. the confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. A contractual requirement of any firm sub-contracted to recruit subjects or assist with field operations is that they make no permanent copies of the written questionnaires. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality are 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.
Project Identifier: ORNL-93-28
Project Title:
Relating Ecological Indicators to Societal Values
Principal Investigator:
Dr. Amy K. Wolfe
Project started in: 1993
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Explanation:
This project originally was slated to be a 3-year endeavor. Although the project was not formally cancelled, we received no funds in FY 96. In FY 96 we operated under carry-over funds from FY 94. We are working to acquire new funding.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 5
Type of Human Subjects Involvement:
a. Objectives.
The project aimed to develop elicitation techniques that would allow researchers to determine the degree to which indicators from the U.S. Environmental Protection Agency's (EPA's) Environmental Monitoring and Assessment Program (EMAP) reflect societal values about the environment.
b. Methodology, including total planned or estimated number of human subjects.
We focused on three groups of EMAP indicators (forests, surface waters, and landscapes) and planned to conduct surveys about the Southern Appalachian man and the Biosphere (SAMAB) region in the Nashville vicinity (for logistical and financial reasons). We also were to hold focus groups in the Mid-Atlantic Integrated Assessment (MAIA) region, but were not going to conduct surveys in that region. After one year of the three-year project, EPA discontinued funding for this project. When we stopped work on the project, we were at a cross-roads of deciding how to proceed—for instance, whether to conduct a single, long survey or several shorter surveys. These decisions, in turn, would drive decisions about the number of human subjects needed (a) for focus groups, interviews, or other survey-development procedures and (b) for the survey or surveys we would conduct (the number of respondents needed for statistical reasons). In all cases, respondent confidentiality would be maintained either by not asking names or by removing the list of names from the data collected.
c. Ionizing radiation, radioactive substances, chemical substances. List any chemical or radioactive substances or ionizing radiation to which human subjects are exposed.
None
d. Involvement of Human Subjects.
1. Describe the procedures involving human subjects. If the project involves cell cultures, reproductive studies, or genetic engineering, include a description of these procedures.
Procedures involving human subjects would include interviews (one-on-one or in group settings), formal focus group sessions, and responding to surveys. (We did not get to the point of agreeing definitively on what survey formats would be used. We likely would use written surveys sent through the mail; we were less certain about the potential use of telephone surveys or surveys (written or oral) using video materials conducted in public shopping malls. When we concluded our funded work, we planned for Vanderbilt to conduct all surveys.
2. Explain the risks, if any, to which human subjects are exposed.
There are no risks to human subjects.
Project Identifier: ORNL-94-33
Project Title:
Development of Methods to Obtain Fingerprints from Children for Forensic Applications
Principal Investigator:
Dr. Michelle V. Buchanan
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 31, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 3
Type of Human Subjects Involvement:
The purpose of this project is to identify the chemical components in fingerprints to establish if there is a difference in chemical composition between fingerprints between children and adults. In the upcoming year, we will also look at a variety of adults to determine if we can detect other components that can be used to distinguish individuals for forensic and clinical purposes. Originally, the sampling technique used involved extracting the components directly from the fingertips using drug store rubbing alcohol (70% isopropanol). This solvent was chosen due to its low toxicity. However, it was able only to extract a small portion of the fingerprint components. In this present year (since about July), we have been investigating alternative sampling methods, including having the subject rub a microscope slide and extracting the components from the slide using more appropriate solvents (to which the subjects will not be exposed). During this time period only three subjects were studied. We will soon use the new sampling method to look at a number of individuals--perhaps 100 in the next year (FY 97). They will not be exposed to any harmful substance.
Project Identifier: ORNL-94-38
Project Title:
Advanced Robotics for Remanufacturing and Aircraft Support Functions
Principal Investigator:
Dr. John V. Draper
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 06, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 10
Type of Human Subjects Involvement:
METHODS
A cockpit concept for the robotic system will be developed by human factors professionals at the Oak Ridge National Laboratory's Robotics & Process Systems Division (RPSD). The RPSD has extensive experience developing robotic cockpits. Part of this may require research to compare alternative display or control methods. When it is necessary to perform comparative testing, it will be done in the form of realistic work sample tests, in the context of factorial repeated-measures experiments. The testing tasks will be similar to the everyday work performed by the subjects. This testing will not require manipulation of subjects' behavior and the research will not involve stress to subjects. Subjects for the comparative testing will be volunteers drawn from the population of RPSD telerobot operators (the RPSD has a formal training and certification procedure for telerobot operators). From a population of 6 operators, from 2 to 4 will be required depending on the nature of the testing. Testing sessions will be no longer than 1 hour per subject and no more than 1 session per day per subject will be allowed. It is not possible at this time to identify the total number of sessions required for an experiment, as the specific needs for human factors/ergonomics will identified in the course of the program.
The Principal Investigator is a member in good standing of the Human Factors and Ergonomics Society (HFES) and fully subscribes to the HFES Code of Ethics, particularly Article IVSubject Precautions.
INFORMED CONSENT
The procedure for obtaining informed consent from subjects for this work will be as follows (these are the methods followed at the RPSD by the Principal Investigator for the past 10 years for this type of testing):
1. The telerobot operators' supervisor will contacted and the details of the testing plan discussed with him. At this time, he will schedule a briefing session for the operator population or individual briefing sessions for each member of the population, depending on work schedules.
2. At the briefing sessions, the population of operators will be informed of the nature of the tasks to be performed, and if the hardware is available (controllers, robots, and tasks) it will be shown to them and the task will be demonstrated. The specific hypotheses of the testing will not be described, but the general purpose of the testing will be described. Methods, including number of task repetitions, number of testing sessions, length of testing sessions, and data collection procedures will be explained to the operators at this time.
3. Following the briefing sessions, the operators will be individually contacted by the Principal Investigator to determine whether or not they are willing to participate. The order in which they are contacted will be random, and the process will continue until the required number have volunteered or the population is exhausted. At no time will the operators be pressured to participate, either by the Principal Investigator or their supervisor. Speaking from past experience, this is a highly motivated and professional group of people, and they have always been enthusiastic participants in testing programs.
4. At the end of the testing program, participants will be debriefed individually by the Principal Investigator to explain the purposes and outcomes of the testing program and to solicit participants' reactions to the testing methods.
PROTECTING SUBJECTS
Fatigue During Testing: Article IV of the HFES Code of Ethics states, "Members...determine...that the exposure of human subjects to hazards, stress,...or tedium is commensurate with the significance of the problem being researched" and "Members ensure ethical treatment of human subjects." Teleoperation is a fatiguing task. Therefore, subjects will not be required to participate in testing sessions lasting longer than 1 hour, and no more than 1 session per day per subject will be allowed. Furthermore, Test Observers will inquire into the participants' state of well-being during testing sessions at convenient times. Breaks will be allowed as appropriate. If appropriate, subjects may be limited to 1 testing session per every 2 days.
Confidentiality: It is the practice of the Principal Investigator to maintain the confidentiality of participant's task performance during teleoperation testing, relative to both supervisors and from peers. This is done by assigning coded identifiers to subjects' data, with only the Principal Investigator privy to the code key. In that way, it is not possible for anyone else to associate test scores with any particular subject.
Project Identifier: ORNL-95-45
Project Title:
Physiological Responses to Electric and Magnetic Fields (EMF) in Humans
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 50
Type of Human Subjects Involvement:
Two experiments will be performed to determine if the results of previous DOE-sponsored research can be repeated. One will investigate the effects of intermittent 60-Hz magnetic field exposure on human cardiovascular activity, and the other will investigate exposure effects on EEG activity and human performance. A series of three studies also will be performed to determine if changes in the specific magnetic field characteristics and parameters have a direct influence on brain electrical activity.
Sixty men aged 18-35 will participate in the cardiovascular study. Volunteers will be exposed intermittently to 60-Hz, 200 mG magnetic fields in a 45 minute field on/field off test paradigm. Data obtained before, during and after the exposure test periods will be used to assess: cardiac interbeat interval, the electrocardiogram, pulse transit time (and indirect, continuous indicator of blood pressure), FFT of the heart period, sinus arrhythmia and mental alertness ratings. An additional 18 men and 18 women will participate in a study of possible exposure effects on EEG activity and human performance. Volunteers will be exposed to 60-Hz, 200 mG intermittent magnetic fields for 90 minutes. Data obtained before, during and after exposure will be used to assess effects on: EEG event-related potentials, and a battery of standardized performance tests (e.g., memory, attention, reaction time, etc). Finally, three experiments will be performed to explore the direct effects of alterations in magnetic field characteristics on brain electrical activity and perception. These experiments will include both men and women volunteers. Brain event related potential and spectral analysis techniques will be used to identify possible electrophysiological responses in both the visual processing and magnetite-rich temporal regions of the brain to field exposure at selected frequencies and amplitudes.
No human subjects participating in this project will be exposed to ionizing radiation or radioactive substances.
The risks to human subjects participating in the above experiments is minimal. The intermittent exposure protocol has been used in our laboratory in three previous studies, with no adverse effects. The duration of exposure is brief, and field strength levels are similar to those encountered in the home and work environment. Women also have participated in previous exposure studies conducted in our laboratory. While men and women often differ with regard to pa-rticular study endpoints, we have found that such differences are neither due to nor affected by field exposure. Moreover, we have not seen any evidence of elevated reactivity in women compared to men. We therefore believer that the risks of participating are the same for healthy young women as for healthy young men.
Project Identifier: ORNL-95-47
Project Title:
Melatonin Levels of Electric Utility Workers
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1995
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 03, 955
IRB Approval Number: 94-130H (CSU 7/5/95)
Number of Human Subjects who participated in this project/protocol during
05/01/95 - 04/30/96: 192
Type of Human Subjects Involvement:
This study is designed to test the hypothesis that workers exposed to magnetic fields exhibit a decrease in melatonin biosynthesis. Study participants were selected from the population of employees at the Platte River Power Authority (Fort Collins, CO), the Light and Power Division from the city of Fort Collins and the Poudre Valley Rural Electric Authority (Fort Collins, CO). approximately 100 workers with occupational exposure to magnetic fields and 100 comparison participants from the same utilities were randomly selected without regard to gender, race, or ethnic origin.
Participants' exposure to magnetic fields was assessed with the use of a continuously recording monitor (EMDEX C) over approximately 84 hours. Exposure to light was measured simultaneously with the same device adapted for this purpose. Urine samples were collected for the determination of 6-hydroxy-melatonin sulfate, the primary metabolite of melatonin. Overnight urine was collected on 4 successive mornings and post-workshift samples were collected over a period of three work days. A questionnaire was administered to obtain information about use of medications which may affect melatonin, disease history, home use of electrified equipment, occupational history, and potential confounders. Participants kept a daily log to permit assignment of exposures to specific work activities and definition of sleep, work, and other activity periods each day.
A briefing meeting was held with workers to explain the purposes of the study and study procedures. An approved consent form was provided and read by the subjects. If the subject agreed to participate he/she was asked to sign the consent form and was provided with a signed copy. Subjects were provided with a meter and numerically coded sample containers. Subjects were informed that the results of tests of their urine will be provided upon request.
Human subjects were asked to wear a meter during the day and to place the meter near their bed at night. Subjects were asked to collect urine specimens according to the schedule described above. Subjects completed a self-administered questionnaire and kept a daily activity log as described. Confidentiality was assured by using an identification number for each subject's urine samples and questionnaire. All questionnaires, laboratory data and other records are being maintained in locked cabinets. Statistics derived from confidential data will be reported without inadvertent disclosure of individual subject's identities.
There are no physical risks to participants. Subjects may refuse to answer any question which they find objectionable.
Project Identifier: ORNL-95-50
Project Title:
Development of Recommendations for Personal Exposure Measurement of Electric and Magnetic Fields
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 20
Type of Human Subjects Involvement:
The objectives of this project are to develop recommendations for guidelines for performing personal exposure measurements (PEM) of electric and magnetic field (EMF) exposures. Two pilot studies will be conducted in August and September of 1996 to test and evaluate the recommended guidelines. The investigator performing the pilot studies will design and implement time-activity record-keeping protocols following recommendations in the proposed guidelines. To determine subject locations and activities, the protocols may include: prospective and/or retrospective questionnaires; prospective and/or retrospective interviews; a subject diary or observer log. The first PEM pilot study will be performed in a small electronics manufacturing facility where approximately 10 persons will wear an EMDEX II meter in a pouch at the waist. Different approaches to ascertaining their locations and activities will be evaluated. The second pilot study will be performed with approximately 10 volunteer students from a high school physics class. Various approaches to ascertaining time-activity information in the context EMF PEM will be evaluated. Permission for students to participate will be obtained from parents for subjects under 18 years of age. The Consent Form previously approved by the Human Subjects Committee will be employed in both pilot studies.
No ionizing radiation, radiation, radioactive substances, or chemical substances are involved in these studies. Exposure to these substances will be no different than if subjects did not participate in the studies. No physically invasive procedures are included in this study. No additional hazard or physical stress is expected from wearing the personal magnetic field meters. There are no potential psychological, social, economic, or legal hazards associated with this project.
Project Identifier: ORNL-96-53
Project Title:
Survey of Personal Magnetic Field Exposure
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Work completed in FY96 will involve preparations for measurements. Actual survey involving the 200 subjects will occur in FY97.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
A pilot study shall be performed to validate the survey methodologies.
A sampling strategy shall be developed. A list of 500 randomly selected names, addresses, and phone numbers of individuals throughout the United States shall be compiled. 200 participants from the list shall be contacted and enrolled in the study. A follow-up phone call will answer any questions regarding the use of the meter and administer a short questionnaire. The questionnaire will include questions regarding: age, occupation, residential setting, and basic information on power line configurations outside the residence. They will be sent an Emdex Lite magnetic field meter thought the mail. The participant w ill wear the meter for 24 hours during a weekday and maintain a concurrent diary of the times entering and leaving the following places: bed, home, but not in bed, work or school, and none of these places. After the 24-hour measurement period, the participant will package the meter in a prepaid mailer and send it back for analysis. Upon receipt of the meter, the participant will be paid $50.
Procedures to maintain confidentiality shall be followed. All participants shall be assigned a study identification number upon enrollment in the study. The master code key and the file with personal data shall be kept in a secure place. Information from this file will be released on a per need basis to the technicians performing the measurements and conducting the interviews. Information derived from diaries, interviews, and exposure monitoring shall be added to a computerized data base by study identification number only. Personal identifying information shall not be included in analysis, summary reports, or publications.
The participants shall be fully informed on the purpose and requirements of the study. Written consent to participate shall be obtained from the participants. The participants will be given a copy of their completed consent form, a copy of the Experimental Subject's Bill of Rights, and an information letter regarding the study. At their request, participants will receive a summary of their personal EMF exposure measurements by the meter they wore.
There are no potential human health hazards to human subjects associated with this project. The participants are not being subjected to any additional magnetic fields beyond what is already present in their home. No physically invasive procedures are included in this study. No additional hazard or physical stress is expected from wearing the personal magnetic field meters. There are no potential psychological, social, economic, or legal hazards associated with this project.
Project Identifier: ORNL-96-54
Project Title:
Development of Field Exposure Predictions Models
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
The project is just in the initial planning stage. Human subject involvement will occur in FY97.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
In the past, the majority of theoretical modeling work that has been conducted for field sources may not be used directly to predict the field exposure a person experiences in the environment. Field exposure is determined by both the field sources and by the person's activities in the environment. The objective of the project is to develop a model for estimating EMF personal exposure of individuals or groups within the general population. Use of this model will quantify an individual's total exposure over all time periods or within specific general locations such as home or work. Pilot studies shall be conducted to test the validity of the model. Two pilot studies shall be performed. Each pilot study will focus on a different reference group, and each will involve ten individuals. Twenty volunteers shall be recruited by telephone. They will not be randomly selected. The recruiter shall verify that the potential volunteer is a member of the subject reference group. The study shall be briefly explained and the schedule for the study set. Personal exposure magnetic field meters shall be delivered to the volunteers on the scheduled day. The operations of the meters and the time-activity diary requirements shall be explained. Rules for wearing the meter, such as the location of the meter during sleep periods, shall be described. A questionnaire shall be administered to the participants by an interviewer regarding their lifestyle and activities at home and at work. The interview shall last about one hour. Two days (at least 48 hours) after the meters are distributed, the technician shall return to retrieve the meters and the time-activity diary.
Procedures to maintain confidentiality shall be followed. All participants shall be assigned a unique identifiable number. The identifying information that links subjects to their data shall be accessible only to the principal investigator of the pilot studies. Exposure measurement data and questionnaire data shall be identified by only the study identification number. Upon completion of data analysis, the codes linking subjects to their data will be destroyed. The participants shall be fully informed on the purpose and requirements of the project prior to their participation. Written consent forms and explanatory material will be mailed to participants prior to the first visit. The consent forms shall be collected at the first visit when any questions can be answered before the interview and measurements begin.
There are no potential human health hazards to human subjects associated with this project. The participants are not being subjected to any additional magnetic fields beyond what is already present in their home. No physically invasive procedures are included in this study. No additional hazard or physical stress is expected from wearing the personal magnetic field meters. There are no potential psychological, social, economic, or legal hazards associated with this project.
Project Identifier: ORNL-96-55
Project Title:
Environmental Tobacco Smoke: Composition, Exposure, and Measurement
Principal Investigator:
Dr. Roger A. Jenkins
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
ORNL-55 is a new project. Funding is expected to be received by 08/31/96. Last month of FY96 expected to be devoted to planning.
Funding Sources:
FY96 funding to be used for planning associated with human studies efforts. No subjects are expected to be recruited in FY96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 14, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
Objectives
Task 1. To determine the personal exposure of non-smokers to environmental tobacco smoke in private residences and during sleep periods.
Task 2. To determine the nature of extremely low levels of measured nicotine in natural environments.
Task 3. To determine spousal smoking history for those subjects in the previous 16-Cities study (ORNL-17) living with smoking spouses.
Methodology
Task 1
Subjects will be recruited within a 50 mile radius of ORNL from the general population. Saliva samples will be collected in sterile Salivettes®, and analyzed by radio-immune assay or other appropriate analytical technique for cotinine, a major metabolite of nicotine. Salivary cotinine levels will be employed to determine the accuracy of self-reported smoking status.
Subjects will wear personal sampling pumps to collect an air sample from the subject's breathing zone. Sampler will remain on the subject during waking residential periods, and be placed at his/her bedside during sleep hours. Breathing zone samples will be gathered from the subjects on a daily basis, and analyzed for ETS constituents. Demographic and other personal information will be collected through interviews with ORNL staff, or through direct questionnaires.
Task 2
ORNL non-smoking staff volunteers (approximately 20) who reside in non-smoking homes will be utilized to collect 24-hour time weighted average (TWA) breathing zone samples, using the systems and analytical methods described in Task 1. Subjects will go about their daily routines, avoiding environments where smoking is occurring. Saliva samples will be collected and analyzed as described above. In this case, salivary cotinine will be examined and compared with the observed exposures to ETS nicotine, to determine any potential relationship. Subjects will collect observational information, and will provide information regarding dietary intake of certain foods, which may influence salivary cotinine levels.
Task 3
An attempt will be made to contact all of the participants in the 16-Cities ETS Exposure Study (ORNL-17) who resided with smokers at the time of the study, using name and address information provided by the subjects during that study. This would involve potentially 243 subjects from the previous study. The subjects will be re-interviewed over the telephone regarding the smoking history of their spouses.
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 these studies qualify them for human studies consideration. First, a sample of saliva will be acquired from each subject upon the entrance into and departure from the study. Depending on timing, sample acquisition could be as little as 24 hours or as much as 72 hours apart. The purpose of the saliva collection is to determine the concentration of a nicotine metabolite (cotinine) present. Salivary cotinine levels are used to confirm the absence of smoking among self reported non-smokers, and to determine the potential efficacy of use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Secondly, a great deal of demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. the confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. A contractual requirement of any firm sub-contracted to recruit subjects or assist with field operations is that they make no permanent copies of the written questionnaires. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality are 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.