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: 6
Project Identifier: ANL-90-92005
Project Title:
Two-dimensional Electrophoresis of Proteins from Human Blood Samples
Principle Investigator:
Dr. Carol S. Giometti
Project started in: 1990
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
Human subjects were not involved in FY 1995 because research on other projects took precedence over study of blood cells. Research on blood cells is expected to resume in FY 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 09, 1994
IRB Approval Number: ANL-92/005
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
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-93-93001
Project Title:
Bone Marrow Specimens for Studies of Biochemical Mechanisms of Chemically Induced Health Effects
Principle Investigator:
Dr. Maryka H. Bhattacharyya
Project started in: 1993
Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
Research activities involving the use of human bone marrow samples were completed earlier than anticipated. The project has been terminated.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 09, 1994
IRB Approval Number: ANL-93/001
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
Cadmium exposure has been linked to severe osteoporosis/osteomalacia and renal tubular dysfunction found in persons suffering from Itai-Itai disease. Because the cases involved were predominantly postmenopausal women with a history of multiple childbirths, these epidemiological studies suggested that the effects of cadmium on bone might be enhanced in animals after ovariectomy. Results of our studies have shown that cadmium causes a striking increase in the loss of bone mineral in ovariectomized mice compared to sham-operated controls. An extensive study using dogs as a more appropriate model for humans supported the findings of the mouse study. The dog study further demonstrated that bone resorption was increased in dogs at concentrations of cadmium in blood that are in range of those reported in persons who smoke cigarettes and in workers with low-level exposure to cadmium in industry. In vitro studies using cultured fetal rat limb bones demonstrated a 60%-70% release of 45 Ca from prelabeled bones in response to 10 nanometers (nM) of cadmium compared to a 20-30% release from control bones. Thus the rapid increase in bone resorption in vivo and the direct effects of cadmium in vitro support the hypothesis that cadmium may act primarily on bone, possibly by stimulating the formation of osteoclasts, the cells directly responsible for breakdown of bone mineral and matrix.
Preliminary data demonstrated that 10 nanometers of cadmium caused a fivefold increase in the fraction of multinucleated osteoclast-like (MN-OS) cells present after 14 days in culture of a progenitor-enriched population of mononuclear dog bone marrow cells. In contrast to those in the control cultures, the MN-0S cells formed in the presence of 10 nanometers of cadmium took on osteoclast features, including a highly elaborated ruffled border, centralized nuclei and a clear zone. However, these cells must still be extensively characterized to confirm whether they have the biochemical, immunological and bone-resorbing properties of true osteoclasts. Once this is established, experiments to determine the mechanism of cadmium action on the formation and/or stimulation of osteoclasts will be performed. An investigation of intercellular communication in the bone marrow via cytokines is essential to our understanding of how cadmium exerts its effects. Because many of the probes to study cytokine message and production are directed at human cytokines, human bone marrow is required to do these types of experiments. Antibodies to cytokines will be incubated with the bone marrow cultures to determine which cytokines are working in combination with cadmium to exert its effects. In situ hybridization using probes to these cytokines will be performed to determine which cells are producing the cytokines and thus are influencing osteoclast development.
Bone marrow is obtained from normal human donors at the University of Chicago Hospitals to be used for transplantation into suitable recipients. A small amount of marrow is routinely set aside for laboratory research projects investigating normal bone marrow cells. The donors are not personally identifiable. According to the donor consent form at the University of Chicago, the principal hazard of this procedure is that of the anesthetic. There is a slight risk of infection at the site where the bone marrow is obtained. There will be some soreness at the sites where the marrow is taken and a small amount of bleeding into the skin may occur. The blood loss from obtaining the marrow rarely causes any problem. All of the risks are related to the procedure being performed at the University of Chicago. There is no added risk due to our receipt of a small portion of the bone marrow.
Project Identifier: ANL-95-93002
Project Title:
Analysis of Radiation Sensitive Markers in Normal Human White Blood Cells
Principle Investigator:
Dr. Eliezer Huberman
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
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 09, 1994
IRB Approval Number: ANL-93/002
Number of Human Subjects in the Last Reporting Period for this Project: 5
(Reporting periods vary.)
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
Principle Investigator:
Dr. Eliezer Huberman
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
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 09, 1994
IRB Approval Number: ANL-93/003
Number of Human Subjects in the Last Reporting Period for this Project: 5
(Reporting periods vary.)
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
Principle Investigator:
Dr. Carol S. Giometti
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
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 09, 1994
IRB Approval Number: ANL-93/004
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
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. 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. If serum is needed as a nutrient to grow these cells in culture, 1-2 tubes of blood will be drawn from the donor by venipuncture by ANL Medical Department personnel. 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-95-94001
Project Title:
Virtual Reality and Human Factors Studies
Principle Investigator:
Dr. Stefania A. Brown-VanHoozer
Project started in: 1995
Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Explanation:
DOE approval was received after LDRD funding expired. Management approved a limited study as time permitted.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 09, 1994
IRB Approval Number: ANL-94-001
Number of Human Subjects in the Last Reporting Period for this Project: 6
(Reporting periods vary.)
Type of Human Subjects Involvement:
Objectives:
(1) Develop and evaluate the feasibility of using virtual reality to design
reactor control consoles, panels and equipment (2) Develop virtual reality
models from a user's perspective.
Methodology of the Study and Involvement of Human Subject:
Six reactor operators were asked to participate in a two-phase study involving
interviews and an evaluation of a virtual reality (VR) model of Experimental
Breeder Reactor-II (EBR-II). During phase I, the participants were asked to (1)
complete an "experience background" survey which consisted of personal data,
e.g., name, age, gender, title or position, years of experience as an operator,
etc., and (2) provide verbal description of EBR-II and the fuel-handling
sequence. Phase I was conducted at Argonne National Laboratory in Idaho, and
consisted of one session per subject lasting approximately four hours. In this
phase of the study, a set of communications techniques known as Neuro Linguistic
Programming (NLP) was used to assist the reactor operators in clarifying their
perspective model of the reactor system and process. The subjects were
videotaped to collect accurate information on the subjects' responses to verbal
and non-verbal cues, and to record accurately what was being said. Phase II of
the study required the subjects to evaluate a virtual reality model of EBR-II at
Argonne National Laboratory in Chicago. The subjects were to (1) view the VR
image of the EBR-II model, (2) describe the VR effect, and (3) manipulate the
transfer arm of the reactor using some type of force feedback glove device. A
force feedback glove is an apparatus that returns an output signal to control a
device or system. Change in the output is directly proportional to the pressure
caused by the user. In a virtual environment, it is a glove that returns
signals to the computer showing the user group around an (object) image. This
part of the study was terminated due to lack of funding for trips to and from
Idaho, and for obtaining a force feedback glove device. The risk for physical
injury is similar to that presented by day-to-day activities in an office
environment. However, the study involves the collection of personal information
for research, which requires protection to maintain confidentiality. All
confidential information to include videotapes and surveys are viewed by the
participating researcher only, and videotapes and surveys are locked in a file
cabinet.