Ms. Gail
S.
Van Gorp
Argonne National Laboratory
9700 South Cass Ave.
Building 200, Office L162
Lemont, IL 60439
Phone: 630-252-3689
Fax: 630-252-7608
E-mail: gvangorp@anl.gov
Number of Human Subjects projects reported: 3
| ANL-05-UCIRB13968A | "Effects of Cigarette Smoke Cadmium on the Release of Calcium from Bone in Humans" |
| ANL-05-UCIRB14132B | "Focus Groups to Measure the Value of Public Confidence in the Government and Law Enforcement Agencies to Prevent Terrorist Attacks" |
| ANL-07-Protocol #15340B | ""Geospatial Visualization Applications for Critical Infrastructure Analysis"" |
"Effects of Cigarette Smoke Cadmium on the Release of Calcium from Bone in Humans"
Principal Investigator: Dr. Maryka H. Bhattacharyya, Argonne National Laboratory
Project started in: 2005
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Chicago
Most recent approval: 06/05/07
IRB approval number: 13968A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Objectives
Study 1) Characterize cadmium (Cd) exposures due to cigarette smoking in a group of postmenopausal women and age-matched men, and
Study 2) Determine the relationship between cadmium in cigarette smoke and calcium (Ca) release from bones among a subset of postmenopausal women from Study 1.
The proposed project will test the hypothesis that cadmium in cigarette smoke contributes to the etiology of osteoporosis in humans, particularly among postmenopausal women.
Osteoporosis is a disease that critically affects the quality of life of elderly persons. By 90 years of age, one-third of women have broken a hip which can result in a dependent lifestyle. Understanding the extent to which environmental factors, such as Cd in cigarette smoke, contribute to osteoporosis in our aging population is an important undertaking.
Methodology
Study 1) Analyze cadmium concentrations in blood and mainstream smoke (once per month for three months) among postmenopausal females and age-matched males, for smokers vs. non-smoking controls. For a subset, determine time-course of change in blood cadmium concentration after a single smoking session.
Study 2) Using Ca-41 as a marker, analyze Ca-41 and cadmium concentrations in blood during two or three periods for each subject (postmenopausal females only): smoking (three weeks), not smoking (at least three days, preferably three weeks or longer), smoking resumption (for those who decide to resume smoking). Conduct parallel analyses of blood Ca-41 and cadmium concentrations for non-smoking controls.
Radioactive Substances
Ca-41 (intravenous, 100 nCi) Note: This amount of Ca-41 is small enough to be declared non-radioactive by European standards. This project was categorized as low risk during the process of IRB review.
Procedures involving humans
1) Answer screening and study questionnaire
2) Receive intravenous Ca-41
3) Provide samples of blood, cigarettes, saliva, and food
4) Keep diary of cigarette smoking and food intake
5) Bone density ultrasound measurement of heel bone
Identification of Risks (respectively, per 1 to 5 above)
1) Loss of confidentiality
2) Bruising at site of injection, fainting, infection at site of injection, effects of small amount of radiation
3) Bruising at site of injection, fainting, infection at site of blood draw
4) Loss of confidentiality
5) None
Evaluation of Risks for Each Procedure
1) Loss of confidentiality is unlikely (see below).
2) Occurrence of minor bruising is likely, especially in older people.
Fainting or becoming lightheaded during blood drawing is unlikely.
Infection is unlikely. Every care will be taken to avoid these complications. Effects of small amount of radiation from Ca-41 are extremely unlikely. For example, risk is similar to radiation risk from flying a short time in an airplane and one-thousand times less than a set of dental x-rays. The amount of Ca-41 to be administered is declared to be non-radioactive by European standards.
3) Occurrence of minor bruising is likely, especially in older people.
Fainting or becoming lightheaded during injection is unlikely.
Infection is unlikely. Care will be taken to avoid these complications.
4) Loss of confidentiality is unlikely (see below).
5) For this standard diagnostic ultrasound, there are no known harmful effects.
Privacy/confidentiality
All study records that identify individual subjects will be kept completely confidential. Each subject will be identified by a unique study subject number (e.g., A1-0). Only members of the primary research team will have access to the original data. Data for each participant will be stored in a locked file cabinet. All locked file cabinets will be located in Room B321, Building 202 at Argonne National Laboratory. This room will be kept locked at all times when not occupied by one or more team members.
Consent
All subjects will provide written consent to their participation. The consent forms have received final approval by the required IRB review process.
"Focus Groups to Measure the Value of Public Confidence in the Government and Law Enforcement Agencies to Prevent Terrorist Attacks"
Principal Investigator: Dr. Thomas E. Baldwin, Argonne National Laboratory
Project started in: 2005
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Argonne National Laboratory
Most recent approval: 08/20/07
IRB approval number: 14132B
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Objective: To measure the value of public confidence in the government and law-enforcement agencies to prevent terrorist attacks.
Method: Data will be collected from six to fifteen groups comprised of about eight subjects each. Groups will be comprised of the general public, government and law enforcement workers, and private sector business executives. Subjects drawn from the government, law enforcement, and continuity executive communities will realize no direct benefit from their participation in the study; they will not be paid for their participation in the focus groups and there will be no cost to them other than local transportation to the focus group session. Subjects drawn from the general public will be given a $100 honorarium for their participation in a focus group. Each group will be administered a baseline questionnaire about their confidence in the government and law enforcement agencies to prevent four types of terrorist attacks. Each group will then be shown mock videotaped television news coverage for each of the simulated terrorist attack scenarios. After each scenario is presented, each person will be administered a questionnaire similar to the earlier baseline questionnaire. Group averages of pre and post confidence levels will be computed and presented to the group. The group will be solicited for an explanation of their levels of confidence as well as the changes due to viewing the scenarios. The discussion will be audio recorded. This data will be used in facilitated elicitations involving each subject being interviewed by one researcher to determine the trade-off value that the subject would assign to their preference for restoring their confidence in government and law enforcement agencies to prevent terrorist attacks.
The potential risk to participants is not greater than viewing actual media coverage of actual terrorist attacks. After agreeing to be part of the study, a consent form will be sent to participants, the original of which they will be asked to sign and return or bring to their group session. Throughout the focus group process, individuals will be identified and referred to only by a randomly chosen five digit number picked by the person from a lot at the beginning of the session. Each person's pre, post, and valuation questionnaire will also be identified only by the five digit number, and no records will be kept to match that number with the person. Demographic data on age, gender, education level, and occupation will be collected from each participant. Only descriptive and qualitative analysis will be performed on the data.
""Geospatial Visualization Applications for Critical Infrastructure Analysis""
Principal Investigator: Ms. Julie Muzzarelli, Argonne National Laboratory
Project started in: 2007
Status of the Research this Fiscal Year:
Protocol approved, but no funding and no human participants
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: University of Chicago (IRB of record for Argonne National Laboratory)
Most recent approval: 03/19/07
IRB approval number: 15340B
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 2007
Type(s) of Human Subjects Involvement:
The purpose of this research is to study the application of three-dimensional (3D) Geographic Information System (GIS) and geovisualization techniques to critical infrastructure analysis, particularly in the areas of natural gas and petroleum. The project will compare infrastructure analysis/assessment by utilizing current 3D visualization techniques versus traditional 2D methods. The intent of this thesis is to identify the potential favorable qualitative and quantitative benefits of 3D GIS visualization as they relate to energy infrastructure analysis. Traditional 2D GIS methods will be compared with current 3D methods to identify potential favorable results. A baseline project that utilizes existing GIS technology will be developed and deployed in both GIS environments. The methods will be compared using qualitative and quantitative techniques/criteria. Qualitative techniques/criteria will be measured using questions that have Likert-type items. Quantitative techniques/criteria may or may not require the use of human subjects.
The subjects for this research study will be comprised of technical staff from Argonne National Laboratory that are industry knowledge experts or infrastructure report analysts. The subjects are co-workers of the PI, work in the same Argonne division, and are 20 or more years old. The subjects will be recruited through group and individual sessions. During these sessions, subjects will be given a brief project overview and description of what they will be asked to do. They will view different GIS environments in front of a computer and answer a series of questions related to what they are viewing. Email addresses may be used during the recruiting process to announce the group sessions that may be conducted. The text of the recruiting email will include the date, time, meeting place, an agenda, and summary. Subjects will not be paid or compensated for participation in this research.
Potential risks are minimal for this research project. One risk may be that potential subjects feel coerced to participate by other subjects already participating. Another potential risk is the subject's identity being exposed during or after the research is completed. The probability of this is extremely low due to the fact that the only document linking the subject to the study is the signed consent form. In addition during the videotaping of the interview sessions, a full face view of the subject will not be captured but will instead focus on what the subject is viewing on the monitor. The PI will discuss consent in a private setting with each subject who will then be asked to sign a written informed consent form if they agree to participate.
Data collection forms will be identified using a subject ID in place of the subject's actual name. Data collected during this study will be secured in the principal investigator's office in a locked desk drawer when not in use. The list of participating subject names and email addresses will be destroyed within 30 days after the research is approved by the principal investigator's thesis committee.