USDOE Human Subjects Research Database, Fiscal Year 1997

Argonne National Laboratory

Public Information Contact:

Mr. David M. Baurac
Argonne National Laboratory
9700 S. Cass Avenue
Argonne, IL 60439-4833

Phone: 630-252-5584
Fax: 630-252-5274
Email: dave_baurac@qmgate.anl.gov

Institutional Review Board (IRB):

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).

Human Subjects Projects:

Number of Human Subjects Projects reported: 2

ANL-95-93003
Analysis of Differentiation Markers in Normal and Leukemic Blood Cells
ANL-97-96/001
Validating a Model of the Effect of Operator Information Processing Behavior on Performance

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Project Identification:

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


Fiscal Year 1997 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)
Amount: $35,000 (Est.)
Comments:
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.


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: December 06, 1996
IRB Approval Number: ANL-93/003

Number of Human Subjects who participated in this project/protocol during FY 1997 (10/1/96 - 9/30/97): 6

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

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 20 volunteers will be solicited for participation 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 two-four (2-4) tubes required for a typical experiment. 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.


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Project Identification:

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


Fiscal Year 1997 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.

Explanation:

The initiation of a study involving human subjects is pending the availability of the collaborator at the University of Southern California.

Funding Sources:

DOE: Nuclear Energy
Amount: $0 (Est.)
Comments:
The study is scheduled to be conducted through normal ANL operating funds.


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: December 06, 1996
IRB Approval Number: ANL-96/001

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:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

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 to 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.


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