USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-91-114

Project Title:

Food Mutagen Metabolism

Principle Investigator: Dr. James S. Felton

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

No human subjects during this period. Project used old, archived samples.

Funding Sources:

Non-DOE Federal: National Cancer Institute (NCI)

Amount: $60,000 (Est.)
Comments:

Used for metabolism of food mutagens. Human liver extracts.

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: January 18, 1995
IRB Approval Number: 91-114

Number of Human Subjects in the Last Reporting Period for this Project: 0
(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 existing bodily materials that were collected for another purpose or project.

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of existing data that were collected for another purpose or project.

Other use of human subjects:

Liver extracts used to metabolize food carcinogens. Project used old, archived samples.

(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 objectives of this work are to understand the metabolic products of heterocyclic amines produced from human liver extracts in a test tube. Samples are acquired in Australia and shipped here as frozen extracts. Samples are primarily normal tissues from cancer dissections taken under normal surgical procedures for removal of cancerous tissues. Researchers at LLNL never know the identification of the individual, but do know the samples are HIV- and Hep B-negative and whether the donor is a smoker or a nonsmoker. The extracts are incubated with carcinogens in a test tube and the metabolites are identified by HPLC and LC/MS. There are no risks imposed by these experiments beyond the required surgery for the cancer.