USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-80-58

Project Title:

Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization

Principle Investigator: Dr. L. G. Littlefield
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1980

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-DOE Federal: National Cancer Institute (RO-1 Grant)

Amount: $100,000
Comments:

These are approximate total dollars for projects that require in vitro irradiations of human cells for which this consent form is used.

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: August 03, 1995
IRB Approval Number: 58

Number of Human Subjects in the Last Reporting Period for this Project: 15
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

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

• Use of cells cultured in a laboratory.
• Use of bodily materials collected from subjects 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])

Objectives of studies using human blood are to conduct in vitro exposures of cells to radiation or chemicals to learn how genotoxic agents cause damage to human chromosomes. In other studies, cells are used to test experimental variables that affect culture or freezing of material. Standard laboratory techniques are applied to expose cells in vitro. The only "procedure" involving the blood donor is the venipuncture to collect the blood samples. As explained on the consent form, the only anticipated risks are the minor discomfort associated with the needle stick or, in very rare instances, minor bleeding at the site of venipuncture.