USDOE Human Subjects Research Database, Fiscal Year 2002

University of Utah Health Sciences Center

Public Information Contact:

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

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

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

UUHSC-01-UUHSC-01-8476-00

"Growth of Human Skin Explants and Cells"

Project Identifier: UUHSC-01-UUHSC-01-8476-00

"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:

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$25,000.00 (Est.) for: Fiscal Year 2002

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: 01/16/02
IRB approval number: 8476-1

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 300
Reporting period for number of human subjects: Fiscal Year 2002

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.

(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 cells of the human epidermis to low doses of ionizing radiation (IR), and to determine which, if any, of the responses constitute "bystander effects". 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.

b. Methodology. Human neonatal foreskins will be obtained from LDS Hospital in Salt Lake City. Either the neonatal foreskin, 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 LDS Hospital in Salt Lake City. Typically between 3 and 4 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 treat 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 it's constituent cells (i.e., 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. Parental consent for the use of neonatal material for research is required before the foreskins are collected and used.