Ms. Ann M. Murphy
PO Box 2008
MS 6291
Oak Ridge, TN 37831-6291
Phone: 865-576-5641
Fax: 865-576-3392
E-mail: shirleyam@ornl.gov
Number of Human Subjects projects reported: 7
| ORNL-93-17 | " Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces" |
| ORNL-01-62 | "Fuel Economy Information Evaluation/Green Vehicle Ratings" |
| ORNL-01-63 | "The Determination of Social Acceptability of Bioremediation Technologies: Applying the Public Acceptance of Controversial Technologies (PACT) Model to Improve Communication" |
| ORNL-01-64 | "Rocketdyne Worker Health Study" |
| ORNL-02-65 | "Communication, Web, and Exhibit Support Project - DOE's Office of Energy Efficiency and Renewable Energy, Distributed Energy and Electric Reliability Program Audience Market Research Survey" |
| ORNL-02-66 | "Determination of Variability of Personal Exposure to Environmental Tobacco Smoke" |
| ORNL-02-67 | "Increasing Effective Student Use of the Scientific Journal Literature" |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-95-005 | "Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)" |
| NIOSH-95-022 | "Study of Heat Stress and Performance in Carpenters at DOE Sites" |
| NIOSH-95-034 | "Work Histories - Evaluating New Participatory Methods" |
| PACE-96-DE-FC03-96SF21260 | "DOE Gaseous Diffusion Plants K-25, Portsmouth, and Paducah Current and Former Workers Medical Surveillance Program" |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| UOC-96-DE-FC03-96SF21263 | "Medical Surveillance Program for Construction Workers at Oak Ridge, TN : Phase II-LPT" |
| NIOSH-97-009 | "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation" |
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1993
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/01
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 2002
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.
"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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
Reporting period for number of human subjects:
Fiscal Year 2002
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 be videotaped when recruited by phone. On-site, they will be given a consent form to read and sign prior to the session beginning.
There were two focus groups that met during FY 2002. Both involved consumers determining the effectiveness of the web site.
"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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 44
Reporting period for number of human subjects:
Fiscal Year 2002
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 the communication process. Workshops with voluntary participation of 15-20 individuals solicited by phone will focus on specific questions pertaining to technology acceptability. We 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' names will not be used in note-taking. 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: 12/01/01
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Vanderbilt
Most recent approval: 12/06/01
Type of Review: Full Board
Approving Institution: Boeing
Most recent approval: 01/19/01
Explanation of additional approval:
According to the PI for the entire project, Boeing granted approval for the entire life of the study. Because this study is funded with no federal monies, Boeing is
not required to comply with 45CFR46.109(2) which requires continuing annual review.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14142
Reporting period for number of human subjects:
Fiscal Year 2002
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.
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.
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. During FY2002, analysis procedures were formulated to directly access the worker data base. Also, the radiation exposure data was computerized from hard copy records this year. Software to convert exposure measurements into organ doses continues.
"Communication, Web, and Exhibit Support Project - DOE's Office of Energy Efficiency and Renewable Energy, Distributed Energy and Electric Reliability Program Audience Market Research Survey"
Principal Investigator: Ms. Barbara G. Ashdown, Oak Ridge National Laboratory
Project started in: 2002
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: 02/04/02
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 2002
Type(s) of Human Subjects Involvement:
Telephone interviews are to be conducted with individuals in professional and trade organizations, power providers, and large companies and manufacturers, who are involved to some level in the advocacy, use, or delivery of clean energy technologies. Contacts for interviews have been obtained through the DOE's Office of Energy Efficiency and Renewable Energy, Distributed Energy and Electric Reliability Program web site and from program managers and research staff members who work with the Program's portfolio of technologies and systems.
Approximately 250 individuals to be interviewed are to be contacted in advance for appointments. At that time the purpose of the interview will be explained to get initial concurrence. The individuals will then be contacted and interviewed during their appointment time. The interviews will be audio-recorded concurrently with taking notes. Permission for recording interviews will be obtained prior to beginning the interview. If the interviewee denies permission to record, will proceed by taking notes. The audio recordings will be kept with the other survey data. The access to it will be managed with the other survey data in a method described below. All audio recordings will be destroyed after 12 months of retention according to official records practices, which is burning. A report will be produced aggregating results and will be distributed to all interviewees. Names of individuals will be kept confidential and will be retained with survey data for 12 months following completion of the report. This information will be destroyed after retention through official records practices (shredding). Data will be retained for possible project follow-up with respondents for the duration of the Program's Communication and Outreach Plan project. Information collected on respondents and from individuals interviews will be kept locked in a file cabinet, available only through the PI, but shared with the Co-PI through the PI, but will only be viewed or listened to in the PI's office. Information that is shared about particular organizations, such as success stories, will be with the concurrence of the interviewees. All interviewees will receive a copy of the report.
"Determination of Variability of Personal Exposure to Environmental Tobacco Smoke"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 2002
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 06/19/02
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 2002
Type(s) of Human Subjects Involvement:
A total of 64 non-smoking study subjects will be recruited by phone or personal contact, and administered a screening questionnaire to determine eligibility. Eight subjects will be scheduled to participate per week (total 64 subjects recruited for eight weeks of testing). We would like to have a minimum of 60 "qualified" (i.e., non-smoking) subjects, so 64 will be recruited, since we have observed a typical misclassification rate (i.e., the subject says he/she is a non-smoker when he/she is actually a current smoker) of ~4%. On Monday evening, the subject will come to a test coordination center where he/she will be re-screened, watch an instructional videotape, be trained in the use of the sampling pumps, complete a "first visit questionnaire," and be provided with a human studies disclosure and confidentiality statement for his/her consideration and signature. In addition, each subject will be provided with the supplies for the next day's sampling, which will include the sampling pumps, diaries (to record the types of exposures noted, where each subject was for each hour of the day, etc.) , and a "pump performance survey," to let investigators know about any problems the subjects might have had with the sampling unit. Before leaving, the subject will provide a saliva sample that will be used for low-level determination of cotinine and 3-hydroxy cotinine. The entire visit on Monday will take approximately 90 minutes. The first 24-hour sample will be collected as follows. After work on Tuesday, the subject will begin "away-from work" sampling and wear the pump until they arrive at work on Wednesday morning (~16 hour sample). When the subject arrives at work, he/she will switch to a "work pump" and collect a sample for the entire workday (~8 hour sample). The subject will return to the test center after work on Wednesday, having completed one 24-hour sampling period. There they will provide an additional saliva sample, and be provided new sampling systems. The visit to the test coordination site on Wednesday evening will take less than one hour. The process of collecting 16-hour away-from-work and 8-hour work samples will be repeated on Thursday and Friday. On Friday evening, each subject will be given one sampling system, designed to run a full 24 hours, and a special away-from-work diary, designed to cover the 24 hours until Saturday, at approximately 5 pm, when they will return to the test center for their final visit. On Saturday evening, the subject will return the sampling pump, provide a final saliva sample, and complete a final visit questionnaire. Once the entire process is completed, each subject will receive his/her gratuity of $400 for participation. Thus, for each subject, the study will generate data on four sequential 24-hour periods (three of which will be comprised of separate 16 hr and 8 hr samples), one of which is a weekend day. In addition, we will have data on salivary cotinine concentrations for five days, four of which will be sequential.
Potential risks to subjects beyond those involved in everyday activities is very minimal. They will be asked to wear a four pound sampling apparatus at waist level, and a small breathing zone sampler within 25 cm of their mouth, usually on their upper chest. They are encouraged in both the training video and Informed Consent document to remove the sampling system and pump any time that they might engage in activities in which wearing the pump might compromise their safety, such as operation of heavy machinery. The Disclosure and Confidentiality statement lists mild discomfort (for example, minor neck stiffness) as a possible risk. Risks to the subjects providing saliva samples are minimal, since all they need to do is to chew a piece of cotton dental dam and expel it into a tube. Demographic and lifestyle information will be collected from each subject. However, each subject will be provided with an identifying number, and electronic copies of the subjects' names and contact information will be expunged of that information once data coding is completed, since the names are only maintained long enough to track down subjects and resolve questions during the initial data coding process. Hard copies of the original screening questionnaires, which would have subject names, addresses, and phone numbers will be accessible to only the PI and will be stored in Laboratory Records at Oak Ridge National Laboratory. Original data records will be maintained in accordance with DOE practice.
Other than a monetary gratuity, subjects will not directly benefit by their participation in this study. However, the benefits to society are considerable, since this study will be the first to report exposure variability information on a significantly sized group of subjects in a variety of environments. The data will provide risk assessors key information that is currently not available regarding the variability of environmental tobacco smoke exposure in humans, and resulting dose distribution to various organ systems.
"Increasing Effective Student Use of the Scientific Journal Literature"
Principal Investigator: Ms. Randy A. Hoffman, Oak Ridge National Laboratory
Project started in: 2002
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 07/19/02
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 2002
Type(s) of Human Subjects Involvement:
This study, joint research with the University of Tennessee and ORNL, uses focus groups for obtaining the objective to identify desirable features of a science journal article digital collection and testing of added features. The following explains how access to such participants will be gained. The PI, in consultation with the ORNL Research librarians, will identify researchers who are likely participants for this study. The focus group will consist of four or five researchers in the areas of physics, chemistry or engineering. They will meet once at the beginning of the study and once at the end. After the identification of likely participants, ample time will be given to each participant to decide whether he/she wants to participate in the research project. An email notice will be sent to these individuals delineating the scope of the research project. They will be sent a copy of the consent form, and notified about the tape recordings and note taking that will take place at those meetings, and the anonymous questionnaire they will be asked to complete. At the first meeting, consent forms will be distributed. Anyone may choose not to participate and will not be penalized for his or her decision. Focus group meetings will be lead by a facilitator of the project. Focus group participants will be given an outline of topics to be discussed. At the focus group meetings, participants will be encouraged to discuss their suggestions for features of scholarly journals that will make them more useful. The meetings will tape-recorded and a graduate student will take notes. At the conclusion of the meeting, an anonymous questionnaire will be passed out to participants covering their use of journals. Later, a graduate student will transcribe the tape recordings. To ensure anonymity, the transcription and note taking will not identify individuals by name (and participants will be asked to refrain from identifying themselves during their input). Instead, participants will be documented as speaker 1,2,3, etc. The purpose of the audiotapes, notes, and questionnaires are to gather insight into desirable and non-desirable features of scholarly science journals. These, in turn, will help the researchers develop interactive learning modules that increase the usability of a science journal article digital collection. Audiotapes, notes, and questionnaires will be in the safe keeping of the PI's files in her work office. Access will be limited to those directly involved in the project and only granted for transcription or data analysis. They include: the PI, two faculty co-investigators, and graduate students. In addition, researchers will be working closely with personnel from the Office of Scientific and Technical Information, a part of DOE, who will be providing ideas and programming support and will sit in on focus group meetings.
Risks to participants are considered minimal and benefits include a better understanding of how researchers currently use scholarly journals and id of features that encourage the effective use of scholarly materials in the future.