Mr. David M. Baurac
Argonne National Laboratory
9700 S. Cass Avenue
Argonne, IL 60439-4833
Phone: 708-252-5584
Fax: 708-252-5274
Email: dave_baurac@qmgate.anl.gov
Projects are approved by an IRB located at: Argonne National Laboratory.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
Number of Human Subjects Projects reported: 5
Project Identifier: ANL-90-92005
Project Title:
Two-dimensional Electrophoresis of Proteins from Human Blood Samples
Principal Investigator:
Dr. Carol S. Giometti
Project started in: 1990
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Human subjects were not involved in FY 1996 because research on other projects took precedence over study of blood cells.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 08, 1995
IRB Approval Number: ANL-92/005
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:
Two-dimensional gel electrophoresis (2DE) coupled with computerized image and data analysis can be used to detect changes in protein expression that correlate with exposure of a biological system to chemicals or ionizing radiation. Studies in mice of heritable protein changes demonstrated the types and frequency of mutations that can be detected by 2DE, while toxicology studies defined patterns of protein expression that could serve as indicators of individual exposure. Analysis of protein patterns from blood cells and tissue culture systems will allow extension of our studies to include human samples. Analysis of human samples for protein alternations related to heritable or non-heritable toxic effects first requires an understanding of normal protein expression in similar samples. Therefore, we are accumulating 2DE patterns of proteins from human blood cells (primarily leukocytes) from a random human population to establish the level of background pattern variability and to identify the major proteins observed consistently (i.e., in 85% of the patterns). For these studies, peripheral blood samples are obtained from consenting employees at Argonne National Laboratory (ANL). The samples are drawn by ANL Medical Department personnel at the time of an employee's routine physical, involving use of one additional vacutainer tube during routine venipuncture. Although informed consent forms are used so only those individuals willing to allow the additional tube of blood to be drawn are involved in the study, no identifying code is used. Therefore, a given tube of blood and the resulting 2DE protein patterns cannot be connected to any specific individual. There are no risks to the subjects beyond that experienced during the routine blood draw that is taken as a component of employees normal physical examination. After tubes of blood are obtained by the ANL Medical Department, the tubes are carried to Building 202 and leukocytes are isolated. Universal precautions are followed. (Note: All personnel working with blood samples will be tested for hepatitis antibody titers and vaccinated as deemed necessary by the ANL Medical Department.) The experimental procedures that are used in this study do not include any procedures associated with cell culturing, genetic engineering, or in vitro fertilization.
Project Identifier: ANL-95-93002
Project Title:
Analysis of Radiation Sensitive Markers in Normal Human White Blood Cells
Principal Investigator:
Dr. Eliezer Huberman
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:
Amount above represents the level of funding that was directly associated with the tasks or portion of the project involving the use of human subjects.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 08, 1995
IRB Approval Number: ANL-93/002
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 2
Type of Human Subjects Involvement:
The purpose of the experimental research project is to investigate the usefulness of various cellular markers as indicators of radiation exposure. Various cellular markers such as nucleic acids, proteins, and lipids will be analyzed to determine their response to ionizing radiation exposure. The experimental procedure involves the collection of blood samples from healthy human volunteers and exposure of a portion of the sample to ionizing radiation. White blood cells are isolated from the samples and various markers analyzed for differences between the control and radiation-treated samples using standard molecular biology techniques. The goal is to examine differences in the radiation sensitivity of various molecular markers among individuals and determine if these markers can provide an indication of the biological consequences of exposure to ionizing radiation. Approximately 15-30 individuals will be asked to participate in the study, which will be conducted over a 24-month period. Peripheral blood will be obtained by venipuncture using the medical staff at the ANL medical department. Blood will be collected in 10 milliliter vacutainer tubes with four (4) tubes required for a typical experiment. Each individual will be asked to provide a maximum of three (3) 40 milliliter blood samples during the 12-month period in which they are participating in the study. Written informed consent from the donor will be obtained in all cases where blood samples are requested. The volunteers will be informed prior to the collection of the sample that there may be some discomfort during the drawing of the blood with the possibility of a bruise or soreness at the site of the venipuncture. The protocols used in this study do not include any procedures associated with cell cloning, genetic engineering, or in vitro fertilization.
Project Identifier: ANL-95-93003
Project Title:
Analysis of Differentiation Markers in Normal and Leukemic Blood Cells
Principal Investigator:
Dr. Eliezer Huberman
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Amount above represents the level of funding that was directly associated with the tasks or portion of the project involving the use of human subjects.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 08, 1995
IRB Approval Number: ANL-93/003
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 the experimental research project is to investigate the usefulness of various cellular markers as indicators of the differentiation state of normal and leukemic blood cells. With appropriate markers, we hope to be able to distinguish normal blood cells from tumor cells. In our laboratory, the normal and leukemic blood cells will be analyzed for various critical cellular markers such as nucleic acids, proteins, and lipids to determine if the marker is preferentially expressed in normal or tumor cells. The sensitivity of the techniques is determined by examination of various mixtures of normal and leukemic cells. The goal is to develop a procedure to detect leukemic cells while they still represent a relatively small fraction of the total cell population. Approximately 5-10 individuals will be asked to participate in the study during the time remaining in the study period. Peripheral blood will be obtained by venipuncture using the medical staff at the ANL medical department. Blood will be collected in 10 milliliter vacutainer tubes with four (4) tubes required for a typical experiment. Each individual will be asked to provide a maximum of three (3) 40 milliliter blood samples during the 12-month period in which they are participating in the study. Written informed consent from the donor will be obtained in all cases where blood samples are requested. The volunteers will be informed prior to the collection of the sample that there may be some discomfort during the drawing of the blood with the possibility of a bruise or soreness at the site of the venipuncture. The protocols used in this study do not include any procedures associated with cell cloning, genetic engineering, or in vitro fertilization.
Project Identifier: ANL-95-93004
Project Title:
Analysis of Cells Found in Human Milk
Principal Investigator:
Dr. Carol S. Giometti
Project started in: 1995
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
There was sufficient samples left from donors who participated in FY95 for the studies needed in FY96 without recruiting additional donors.
Funding Sources:
Amount above represents the level of funding that was directly associated with the tasks or portion of the project involving the use of human subjects.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 08, 1995
IRB Approval Number: ANL-93/004
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:
Two-dimensional gel electrophoresis (2DE) coupled with computerized image and data analysis can be used to study protein expression in a variety of cell types. As part of the protein mapping effort using 2DE at Argonne National Laboratory, differences in protein expression have been demonstrated in comparisons of cell cultures originally established using cells isolated from patients with breast adenocarcinoma. Thorough characterization of the observed differences is contingent on comparison with breast cells from healthy individuals. One source of breast cells is the milk produced by nursing mothers. For this study, milk samples will be collected by the donor using a breast pump, and an identification number will be assigned to the milk sample upon receipt in the laboratory. No connection between that number and the identity of the donor will be made, thus ensuring that no milk sample will be traceable back to a specific donor. After receipt at the laboratory, cells will be isolated from the milk by centrifugation. The breast cells will be separated from macrophages and then placed in tissue culture media. Successful short-term culturing of the cells from human milk may require the addition of donor serum to the tissue culture media. To study this requirement for human serum, donors will be asked to provide one or two tubes of peripheral blood to be drawn by venipuncture by ANL Medical Department personnel. (Note: All ANL personnel handling blood or milk samples will be tested for hepatitis antibody titers and provided with vaccination against hepatitis if deemed necessary by the ANL Medical Department.) After short-term tissue culture, milk samples will be prepared for examination by microscopy and by 2DE of proteins. Nursing mothers who are ANL employees, family members of ANL employees, or friends of ANL employees who agree to be donors for this study will provide written informed consent. If only milk is donated, there is no risk to the donor. If blood is taken, the donor risks only the discomfort normally associated with routine venipuncture.
Project Identifier: ANL-97-96/001
Project Title:
Validating a Model of the Effect of Operator Information Processing Behavior on Performance
Principal Investigator:
Dr. Stefania A. Brown-VanHoozer
Project started in: 1997
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
The initiation of a study involving human subjects was pending the receipt of DOE approval, which was received 10/2/96.
Funding Sources:
The study is scheduled to be conducted through normal ANL operating funds, following receipt of DOE approval.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 21, 1996
IRB Approval Number: ANL-96/001
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. Objective of the study - The objective of this study is to examine or evaluate different types of control room interfaces that would effectively support the monitoring and control of complex systems being developed at Argonne National Laboratory. The study will be supported through normal operating funds, and will be evaluated and analyzed with the assistance of Dr. Najemdin Meshkati from the University of Southern California.
B. Methodology of the Study and Involvement of Human Subject - Up to 40 operators and supervisors at the Experimental Breeder Reactor II (EBR-II) plant will be asked to participate as subjects. The study will consist of five factor factorial design examining the effects of Operator Decision Style, Degree of Cognitive complexity, Operator level, user interface type and event complexity on a number of dependent measures of operator preference and performance. Operators will be asked to select appropriate responses to specific tasks based on computer simulated reactor scenarios using ecological and traditional graphic displays. Responses are to be recorded by a computer and two video cameras for analysis of operator and team performances. The cameras are to be used to gather and record accurate non-verbal and verbal information. A computer-scored paper and pencils based test will be used to determine the Driver Decision Style Exercise which will be examined at both the individual and team level. The Driver Decision Style suggests that each individual has acquired at least one dominant decision style that is normally exhibited under moderate environmental load, and a second style under extreme environmental load conditions. The Neuro-Linguistic programming methodology will also be used to identify the dominate representational system (decision style) based on the "test-operate, test-exit (TOTE)" technique. The TOTE suggests that an individual tests and operates a decision, and when satisfied of a successful outcome, the individual tests the decision and exits the task. The strategic cues accessed during the performance of the TOTE will be compared to the individual's representational system preference and how successful the individual was in solving the problems posed. The data will then be compared to the results of the Driver Decision Style. The results will be used to model how reactor operators make decisions based on computer simulated scenarios, how information is recalled and understand how differences in interface design can contribute to or alleviate task uncertainty or complexity with unfamiliar plant transients that may be posed during operation.
C. List any chemical or radioactive substances or ionizing radiation to which human subjects are exposed - N/A.
D. Risks to the Subjects - Risk factors to the subjects are minimal. The risk for physical injury is similar to that presented by day-to-day activities in an office environment. The subjects will not be asked to participate in any type of task that would cause them potential harm or discomfort. The subjects will be sitting at computer terminals selecting answers to problems presented to them using a computer mouse or the computer keyboard. Video cameras to be used are standard "home" video cameras. If a subject finds that she/he is not comfortable with the study she/he has the option to leave at any time during the study. However, the study involves the collection of personal information, which requires protection to maintain confidentially. The information will be maintained by the researchers in a locked area. This information can not be used in any personal performance evaluation.