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: 9
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-17
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 1,729
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. (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 are increasing the subject pool by about 165 subjects. This will increase the overall study population by about 11%, to approximately 1729 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: 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. Phase 3, planned to begin near the beginning of FY98, will involve about 240 subjects and have a sampling and subject protocol identical to that of Phase 1. However, subjects will be recruited to fill specific demographic categories so that the overall study population will be 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 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 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 15-20 minutes in length is produced for each experimental protocol, and augments the formal human studies consent form.
Project Identifier: ORNL-94-33
Project Title:
Characterization of Components of Fingerprints (new title). (old 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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-33
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 24
Type of Human Subjects Involvement:
The objective of this project is to determine if basic components present in skin (amino acids, etc.) show person-to-person changes we have previously observed for fatty acids and esters. We are particularly interested in obtaining samples from individuals who are taking medications for colds, allergies, etc. to establish whether we can identify the presence of the compounds. There is precedence to suggest that this may be possible and this information could lead to applications in clinical testing, which is of importance to our current sponsor. As part of this project, this past year we evaluated a new means of taking samples from individuals that did not require the use of any solvent. The individual was asked to wipe fingertips across a clean microscope slide or inside a plastic Petri dish. Once the samples were taken, the collected materials were washed from the surface with appropriate solvents for analysis. The subjects were therefore NOT exposed to any chemicals and therefore no risks to the subject were involved. The project was conducted through the fall of 1996 by an undergraduate working closely with two ORNL staff members, although we only worked with human samples for about two weeks before the student had to return to his home institution. The project was put on hold while we identified a full-time graduate student to work on the project. She is expected to work on the project starting in FY 1998. We anticipate working with up to 100 individuals in FY 1998, using the same sampling protocols used this past year.
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-38
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 4
Type of Human Subjects Involvement:
Objectives: This report describes preliminary testing to garner feedback about the heavylift dexterous manipulator (HDM) arm from experienced fighter load crewmen. The purpose of the testing was to provide preliminary information about control system parameters and to gather feedback from users about manipulator arm functionality. To that end, subjects interacted with the next generation munitions handler (NGMH) in informal testing sessions and provided feedback about the performance of the system. Certain control system parameters were changed during the course of the testing and feedback from the participants was used to make a rough estimate of "good" initial operating parameters. Later, formal testing will concentrate within this range to identify optimal operating parameters.
Ionizing radiation, radioactive substances, chemical substances: Human subjects were not exposed to any ionizing radiation, radioactive substances, or chemical substances during testing.
Methodology: Operational safety was an important concern during this testing program because of the nature of the HDM and its payloads, and because of the relative inexperience of the load crews with the NGMH program. For that reason, the first half-day of the testing program was devoted to a formal briefing on the NGMH project and testing program safety. Subject safety was further safeguarded by: (1) presence of a safety observer, who held a switch enabling him to shut down the manipulator arm in the event of an unplanned incident; (2) presence of a test observer, who monitored control system parameters and manipulator function via computer, and who could shut down the system should a problem appear; and (3) the deadman switch built into the manipulator controller, which shuts down the manipulator if the handle is released.
The testing itself was conducted using an informal format that encouraged the participants to interact with the HDM in a manner that allowed them to become familiar with its capabilities. At the end of each exercise with the NGMH, the participant was briefly questioned about his experience with the machine. Any evaluative comment made by the user was recorded, as were suggestions for improving it. The observer also noted important events or noteworthy differences in operating style during the task, and then briefly questioned the participant about problems with the system and reactions to the control system set-up for that task. Comments were recorded in a logbook for later review and analysis.
Involvement of Human Subjects: Human subjects were involved as described in the preceding paragraphs. In addition, the research subjects received a pre-test briefing outlining the conditions for their participation and testing conditions. The former included receipt of and explanation of the informed consent form reproduced elsewhere in this report. Research subjects also participated in a post-testing debriefing.
Project Identifier: ORNL-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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-45
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 40
Type of Human Subjects Involvement:
This research is investigating the possible effects of exposure to power-frequency magnetic fields on established measures of human physiology and performance. The aim of the current task is to determine whether changes in magnetic field characteristics have a direct influence on human biological systems. In a previous study of 13 volunteers, the direct effects of variations in selected magnetic field amplitudes and frequencies on measures of brain electrical activity (EEG) was investigated. Exposure appeared to have differential effects on the EEG recorded from the visual areas of the brain, compared to the same measures obtained from scalp sites over the temporal areas. Additional studies are underway with 40 subjects. The volunteers are exposed to 60-Hz, 200mG intermittent magnetic fields for 90 minutes. Sensors are attached to standard scalp sites to record the EEG activity. No human subjects participating in this project will be exposed to ionizing radiation or radioactive substances. The risks to human subjects participating is minimal. The intermittent exposure protocol has been used in the laboratory in many previous studies with no adverse effects. The duration of the exposure is brief, and field strength levels are similar to those encountered in the home and work environment.
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
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 29, 1996
IRB Approval Number: ORNL-50
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 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 were conducted to test and evaluate the recommended guidelines. The investigator performing the pilot studies designed and implemented time-activity record-keeping protocols following recommendations in the proposed guidelines. To determine subject locations and activities, the protocols included: prospective and/or retrospective questionnaires; prospective and/or retrospective interviews; and a subject diary or observer log. The first PEM pilot study was performed in a small electronics manufacturing facility where 10 persons wore an EMDEX lI meter in a pouch at the waist. Different approaches to ascertaining their locations and activities were evaluated. The second pilot study was performed with 10 volunteer students from a high school physics class. Various approaches to ascertaining time-activity information in the context EMF PEM were evaluated. Permission for students to participate were obtained from parents for subjects under 18 years of age.
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-53
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 200
Type of Human Subjects Involvement:
The objective of the pilot study (Phase I) of the project was to develop survey methodologies to characterize magnetic field exposures of the general population. Phase II will then implement these methodologies for a larger nationwide general population. In the pilot study, 200 randomly selected people were recruited by telephone. A follow-up phone call answered any questions about using the meter and administered a questionnaire. The questionnaire included questions regarding: age, occupation, residential setting, and basic information on power line configurations outside the residence. The participants were sent a consent form and a magnetic field meter through the mail. They wore the meter for 24 hours during a weekday and maintained 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 participants packaged the meter and other data in a prepaid mailer and sent it back for analysis. Upon receipt of the meter, the participant was paid $50. In Phase II the procedures followed will be very similar to Phase I, but the subject number will be increased to 1000. The participants will also be recruited by telephone. The sample design will incorporate a list-assisted random digit dialing method. An introductory letter will be sent to all potential subjects and will be followed up by a telephone interview. To all the people that agree to participate, a consent form and a letter that describes the study will be mailed out. The magnetic field meter, activity diary, a questionnaire, a UPS envelope with prepaid label to be used to return the meter, a $50 check for compensation for participation, and further instructions will be mailed out to the participants upon receipt of the consent form. The magnetic meter is the size of a pager and can be clipped to a belt or placed in a pocket. For infants or toddlers, the meter will be placed inside a soft toy that should be kept near them.
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 the 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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-54
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 61
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 electric and magnetic fields (EMF) personal exposures 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. The pilot studies were conducted to test the validity of the model.
Two pilot studies were conducted. One pilot study involved 50 high school students from three classes at two schools. The other study involved l professional and production employees at an instrumentation manufacturing plant. For the pilot study involving the high school students, the PI met with the class one week before the study to solicit volunteers. The volunteer nature and confidentiality of the project was emphasized and parental consent forms were distributed. The participants wore magnetic field meters for either a 24 or 48-hour period. Other data collected was: activity diary, prospective and retrospective questionnaire forms (school grade, age, gender, residence type, job description during study period, primary method of travel during study period, and location).
The selection of the participants for the pilot study involving the manufacturing plant was by convenience and interest. One week prior to the study, the PI met with the potential participants. The voluntary nature and confidentiality of the project was emphasized. Consent forms were reviewed and handed out for signature. The participants wore the magnetic field meters for either a 1.5 hour period or for a one day workday. Other data collected was: activity diary and questionnaires.
Procedures to maintain confidentiality was followed. All participants were assigned a unique identifiable number. The identifying information that links subjects to their data was accessible only to the PI of the pilot studies. Exposure measurement data and questionnaire data was identified by only the study identification number. Upon completion of the data analysis, the codes linking subjects to their data will be destroyed. The participants were fully informed of the purpose and requirements of the project prior to their participation, and written consent forms and explanatory material were presented to them.
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, school, or work. No physically invasive procedures were included in the 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 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
ORNL-55 is a new project. Sponsor asked us instead to focus on an extension of ORNL-17 (Phase 2) and begin to plan Phase 3. Planning work is being initiated on Task 3 (see abstract) in FY97, but is unlikely to be initiated till FY98.
Funding Sources:
FY97 funding to be used for planning associated with human studies efforts. No subjects are expected to be recruited in FY97.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-55
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 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. The 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.
Project Identifier: ORNL-97-ORNL-52
Project Title:
Physiological Responses to Electric and Magnetic Fields in Humans
Principal Investigator:
Dr. Paul C. Gailey
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Protocol/Subproject # 1
Protocol/Subproject Identifier: Task 5
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-52
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 32
Type of Human Subjects Involvement:
Task 5: Adaptation of Heart Rate Variation (HRV) Over Multiple Exposures
The objective is to perform a human exposure study to determine: (1) whether multiple nights of exposure result in adaptation of HRV; and whether measures of heart rate taken during the day show altered variability as a function of night-time exposure.
Thirty-two healthy young men aged 21-35 will participate in the study. Volunteers will be recruited from local colleges, universities, and research institutes. They will be screened to assure that they are in good health (not on medication, no chronic disease or disability, no recent serious acute illness, regular sleep habits, no night work). After receiving a complete explanation of the procedures, risks and benefits of participation, they will provide written informed consent. Subjects will be matched on age and body size, and one member of each matched pair will be randomly assigned to the exposure condition; the other will be assigned to the sham control condition (16 men in each condition). Exposure will be to the same intermittent, 200 mG, circularly polarized magnetic field used in the previous studies. Under the intermittent exposure protocol, the field is presented from 11 PM to 7 am in alternating 1-hr field-off and field-on periods. During field-off periods, the equipment is not energized. During field-on periods, the field cycles on and off at 15-seconds intervals. The study will be performed double-blind to control for the effects of expectation. Each subject will sleep in the exposure facility at Midwest Research Institute (MRI) on four consecutive nights. During the days surrounding the exposure nights, the subject will wear two small portable monitors (Holter and Emdex II) to measure heart rate and ambient magnetic field exposure while he goes about his daily activities. Urine samples will be obtained before and after each night sleep period, and blood samples (14 mL each) will be obtained via venipuncture before and after each night sleep periods. As in the previous studies, recording sensors attached to the chest will be used to measure cardiac interbeat interval. Heart rate data collected during the day will be downloaded from the portable monitors. Magnetic field exposure data collected during the day also will be downloaded from the monitors.
Risks to subjects in this study are minimal. Bruising and soreness sometimes occur with venipuncture; this will be prevented in so far as possible by using a highly trained, experienced phlebotomist/medical technologist to perform the venipuncture. Repeated application of recording sensors to the chest for measuring heart rate can sometimes result in skin irritation. To reduce this possibility, potential volunteers with known allergies to tape or other adhesives will not be included in the study. Furthermore, the sensors will not be applied to identical sites on sequential days or nights. It is feasible to do this, as the Lead II electrocardiogram we will collect as basic data can be obtained from several site configurations. Wearing a Holter monitor to record heart activity while going about one's daily activities is a standard medical practice and presents no health risk. Similarly, wearing an Emdex meter to record magnetic field exposure during daily activities is a widely used technique in occupational studies within the electric utility industry and in residential studies and presents no health risk.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-52
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 12
Type of Human Subjects Involvement:
Task 6: Heart Rate Variation (HRV) in Women During Magnetic Field Exposure
Twelve healthy young women aged 21-35 will participate in the study. They will be recruited and screened as in Task 5. Additional screening criteria for women volunteers will include: regular and predictable menstrual cycle (26-32 days), not on hormonal birth control, and not pregnant. Informed consent will follow those of Task 5. Subjects will be matched on age, and body size, and one member of each matched pair will be randomly assigned to the Task 5 exposure condition; the other will be assigned to the sham control condition (6 women in each condition). All women will be tested between days 2 and 8 of the menstrual cycle to control for hormonal effects, and the study will be performed double-blind to control for the effects of expectation. Each subject will sleep in the exposure facility at Midwest Research Institute (MRI) on four consecutive nights. During the days surrounding the exposure nights, the subject will wear the portable monitors to measure heart rate and ambient magnetic field exposure. Urine samples will be obtained before and after each night sleep period, and blood samples (14 mL each) will be obtained via venipuncture before and after the first and last sleep periods. As in Task 5, recording sensors attached to the chest area will be used to measure cardiac interbeat interval. We believe the risks to subjects in this task are minimal. The possible hazards are the same as in Task 5, and the same precautions will be taken to minimize possible problems.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-52
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 24
Type of Human Subjects Involvement:
Task 7: Heart Rate Variation (HRV) In Middle-Aged Men During Magnetic Field Exposure
The objective is to study the effects of nocturnal magnetic field exposure on HRV using a sample of men 40-60 years old. Twenty-four men aged 40-60 yrs will participate in the study. Subjects will be recruited from local civic organizations, colleges, universities, research institutes, and the general community. They will be screened to assure that they do not have known cardiovascular disease, that they are taking no medications that might alter heart rate variability, and that they are not suffering from any chronic disease. Informed consent will follow those described for Task 5. Each subject will sleep in the MRI exposure facility two nights approximately one week apart. On one night, the subject will be exposed to the intermittent, 200 mG, circularly polarized field described above; on the other night, he will be sham exposed. Order of sham and exposure conditions will be counter balanced. Blood samples ( 14 mL each) will be obtained before and after each sleep period. Analysis of heart rate data will follow the same procedures described for Task 5.
The risks to subjects in this task are minimal. The study design is identical to that used in our previous three studies of magnetic field exposure effects on HRV in younger men. Potential risks associated with venipuncture, sensor application, etc. will be further minimized as described for Task 5.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: ORNL-52
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 18
Type of Human Subjects Involvement:
Task 8: Exposure Frequency and Heart Rate Variability (HRV)
In previous research conducted at MRI, measures of heart rate variability (HRV) were influenced by magnetic field exposure at one amplitude (200 mG), but not at a lower amplitude (10 mG), suggesting that the underlying mechanisms involved in this interaction may be threshold dependent. The objective is to determine whether measures of HRV show threshold sensitivity in relation to variations in magnetic field exposure frequency. Eighteen male volunteers aged 21-35 will participate in a study to evaluate the effects of magnetic field exposure at three frequencies (A= 1 6Hz, B= 40Hz, C=60Hz) compared to sham control conditions. Volunteers will be recruited from local colleges, universities, and research institutes, and screened to assure that they are in good health (not on medication, no chronic disease or disability, no recent serious acute illness, regular sleep habits, no night work). Each volunteer will provide written informed consent. Subjects will sleep overnight In the MRI exposure test facility. Between midnight and 6 am, the intermittent 200 mG magnetic field used in previous MRI studies of HRV will be presented in alternating l-hr field-on and field-off periods. Nine of the 18 subjects selected at random will be exposed to the 16Hz test frequency during all field-on hours; the remaining nine subjects will be exposed to the 40Hz test frequency during the field-on hours. The study will be performed double-blind to control for expectation effects. Risks to subject in this task are minimal. Potential risks associated with sensor application will be further minimized as described for Task 5.