USDOE Human Subjects Research Database, Fiscal Year 1998

Columbia University - Chernobyl workers study

Public Information Contact:

Dr. Basil V. Worgul
630 W. 168th St.
ERERL- Eye Research
New York, NY 10032

Phone: 212-305-6748
Fax: 212-305-6749
Email: bvw1@columbia.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Institute of Occupational Health (Kiev, Ukraine).
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).

Human Subjects Projects:

Number of Human Subjects Projects reported: 2

CU-98-ES09484

A Long-Term Stable Bioindicator for Radiation Exposure

Project Identifier: CU-98-ES09484

Project Title:

A Long-Term Stable Bioindicator for Radiation Exposure

Principal Investigator: Dr. Basil V. Worgul
Principal Investigator's Institution: Columbia University - Eye Research

Project started in: 1998

Fiscal Year 1998 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.

Funding Sources:

Non-DOE Federal: Nat. Institute of Environmental Health Sciences (NIEHS)

Amount: $187,543

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: April 16, 1998
IRB Approval Number: 5049

Number of Human Subjects who participated in this project/protocol during the Last Reporting Period for this Project: 42

Type of Human Subjects Involvement:

Other use of human subjects:

Lens material removed during routine cataract extraction and a sample of the blood workup routinely done. The patient is identified only by coded ID and is not identifiable to investigators.

(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 goal of this project is to standardize the Micronucleus (MN) Assay in the eye lens to permit its utilization as a means to evaluate low level radiation exposure of individuals. The method has the potential to provide first approximations or corroborating estimates of exposure levels. Thus it can be used to justify a more robust epidemiological follow-up. Based on the highly regarded MN test typically employing blood cells to quantify exposure to genotoxins, the lens MN assay would be applied to lens epithelial fragments (tags) removed from surgical cataract patients who had resided near, or worked in, locales in which there existed a potential for radiation exposure. The unique biology of the lens complements the test by dramatically extending the duration (up to a working lifetime) over which MNs can express and can provide a cumulative record over that time-frame. In order to optimize the utility of the method, a dose-response calibration is required in a dose-defined population. We propose to calibrate the Lens MN Assay against dose by using tags removed from an epidemiologically and dosimetrically well-defined subset of workers at the Chernobyl site, the clean-up crews or "Liquidators". The study will involve 600 of the 130,000 Liquidators who worked on site during the period from the time of the accident (April, 1986) through February, 1987. Lymphocytes from a subset of the 600 will be also be assessed by the FISH-translocation assay to confirm the overall dosimetry and allow the comparison of the Lens MN assay against another, more established, bioindicator.

The lens MN test imposes little burden on individuals in populations being surveyed since cataract extraction is a necessary, and extremely common surgical procedure. The recovery and proper handling of the tissue does not require additional expertise on the part of the surgeon nor does it extend the length of the operation. In addition, its relatively low cost, speed, and quantitative, long-term integrative capability, all recommend this biomarker for primary dose reconstruction in individuals, as well as communities in the United States, at risk from radiation hazards. Finally, it can serve to validate whether or not the cataracts which occasion the tag removal are the result of radiation exposure either in the workplace or from environmental sources.

The patients are informed of the fact that tissues routinely removed during their surgical procedures will be studied if they agree. The investigators are not privy to the identities of the patients and receive only coded data on the subjects.