USDOE Human Subjects Research Database, Fiscal Year 2001
National Institutes of Health
Public Information Contact:
Dr. Albert J. Fornace
37 Convent Dr
Bldg 37, Rm 6144
Bethesda, MD 20892
Phone: 301-402-0744
Fax: 301-480-2514
E-mail: fornace@nih.gov
Institutional Review Board (IRB):
Projects are approved by an IRB located at:
University of Pittsburgh
The approving IRB operates under a Multiple Project Assurance (MPA), Single Project Assurance (SPA), or Cooperative Project Assurance (CPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M1259
Number of Human Subjects projects reported: 1
- NIH-01-950450
- "A functional genomics approach using radiation-induced changes in gene expression to study low dose radiation effects in vitro and in vivo."
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Project Title: "A functional genomics approach using radiation-induced changes in gene expression to study low dose radiation effects in vitro and in vivo."
Principal Investigator:
Dr. Albert J. Fornace,
National Institutes of Health
Project started in: 2001
Project Funding Information:
This project received funding during fiscal year 2001.
This project did not use human subjects in fiscal year 2001.
Explanation: Funding began in late September of 2001 for fiscal year 2002. As of the end of fiscal 2001, no patients had been enrolled in the study.
Funding for Human Subjects Research:
- DOE: Office of Biological and Environmental Research (OBER)
- $0.00
for:
Fiscal Year 2001
Although funding technically began at the end of FY2001, the project is only getting underway in FY2002.
Information on Use of Human Subjects:
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 Pittsburgh
Most recent approval: 03/13/01
IRB approval number: 950450
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 2001
Type(s) of Human Subjects Involvement:
- External use of ionizing radiation on human subjects:
- Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excretia, etc):
- Using bodily materials collected specifically for this project.
- Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
- Using existing data that were collected for other purposes or projects.
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 aspect of this study involving human subjects is to characterize the changes in gene expression occurring in vivo following external irradiation. The patients enrolled in this study are undergoing 1.5 Gy fractions of total body irradiation in preparation for bone marrow transplant. Blood is drawn before commencement of treatment, and at specified time intervals following the first several fractions. RNA is extracted and gene expression is then compared using microarray hybridization. Drawing blood exposes the patients to a risk of slight discomfort and local bruising. Informed consent is obtained from patients before enrollment in the study, and all samples and information collected are coded to break the connection with the individual patient, and kept confidential.
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