USDOE Human Subjects Research Database, Fiscal Year 2004

University of Utah Health Sciences Center

Public Information Contact:

Dr. Coralie Alder
201 South Presidents Circle, Room 201
John R. Park Bldg.
University of Utah
Salt Lake City, UT 84132

Phone: 801-581-5180
Fax: 801-585-3350
E-mail: coralie@ucomm.utah.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: University of Utah Health Sciences Center
The approving IRB operates under an OHRP assurance.
OHRP assurance number: FWA 00003745

Human Subject Projects:

Number of Human Subjects projects reported: 1

UUHSC-01-8476-00 "Growth of Human Skin Explants and Cells"


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Project Identifier: UUHSC-01-8476-00

Project Title:
"Growth of Human Skin Explants and Cells"

Principal Investigator: Dr. Raymond L. Warters, University of Utah Health Sciences Center

Project started in: 2001


Project Funding Information:

This project received funding during fiscal year 2004.
This project used human subjects in fiscal year 2004.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$10,000.00 (Est.) for: Fiscal Year 2004

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: 8476-1

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Utah Health Sciences Center
Most recent approval: 01/16/03
IRB approval number: 8476-1
Explanation of IRB approval:
This protocol is an exempt protocol as approved on 1/16/03. It does not expire or require renewal.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 100
Reporting period for number of human subjects: Fiscal Year 2004

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
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. Objectives: The objectives of this project are to determine the response of cultured human skin and cells of the human epidermis to low doses of ionizing radiation (IR). Identification of the mechanism by which human cells recognize and respond to very low IR doses will clarify to what extent human cells respond to the carcinogenic cell damage produced at low IR doses. Our focus will be on post translational modification of cell proteins in response to low dose IR.

b. Methodology: Human neonatal foreskins will be obtained from Latter-Day Saints (LDS) Hospital and University of Utah Hospital in Salt Lake City. Either the neonatal foreskin, dermal cells (fibroblasts), or epidermal cells (i.e., keratinocytes and melanocytes) recovered from the foreskin, will be exposed to increasing IR doses. The stress response of epidermal cells will be characterized either as changes in synthesis or changes in post-translational modification (i.e., phosphorylation) of stress responsive proteins. Cellular response will be quantified both at the microscopic (i.e., indirect immunofluorescence) and biochemical (i.e., western blotting) levels. The magnitude of responses will be compared to IR dose.

c. Ionizing Radiation, Radioactive Substances or Chemical Substances: Not applicable.

d. Involvement of Human Subjects:
1. Foreskins recovered from human neonates during circumcision surgery are collected at the University of Utah or LDS Hospital. Typically between three and four foreskins are available every other day at LDS Hospital. The foreskins are placed into culture medium containing antibiotics and left overnight at 4 degrees C to remove any bacterial and fungal contamination. Foreskins will be cut into small pieces, irradiated with increasing IR doses, and collected at increasing post irradiation times for analysis (either by fixation and immunocytochemical examination, or by homogenization and biochemical analysis by western analysis). Alternatively, foreskins will be dissociated into constituent cells (i.e., fibroblasts, keratinocytes, and melanocytes) that will be selectively cultured, irradiated, and subsequently analyzed in a manner similar to the foreskin as a whole.

2. Human subjects will not be exposed to risks during this research.

3. Since multiple foreskins are combined randomly into a single sample container by the physician during surgery at LDS Hospital, and there is no patient identification associated with the collected foreskins, it will not be possible to associate the human material used with any individual patient. Patient/parental consent for the use of neonatal material for research is not required per the protocol approved on 1/16/03.


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