USDOE Human Subjects Research Database, Fiscal Year 1999

Columbia University - Eye Research

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
E-mail: bvw1@columbia.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

CU-95-95EH89658

"Ocular Radiation Effects in Chernobyl Liquidators"

Project Identifier: CU-95-95EH89658

"Ocular Radiation Effects in Chernobyl Liquidators"

Principal Investigator: Dr. Basil V. Worgul, Columbia University

Project started in: 1995

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of International Health Programs

$400,000.00 (Est.) for: Fiscal Year 1999

Information on Use of Human Subjects:

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

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/14/99
IRB approval number: o264-11

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11368
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

Other types of human subjects involvement. Explanation:

Ophthalmic Examination

(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 ocular radiation protection standards formulated by National Council on Radiation Protection (NCRP) and the International Council on Radiation Protection (ICRP) are all predicated on the assumption that radiation cataracts are deterministic and only appear when a high dose threshold is exceeded. However, several lines of evidence from experimental and epidemiologic studies strongly suggest a stochastic basis for radiation cataracts. If this is the case then the radiation safety standards set for workers as well as the general population may be inadequate. Furthermore, if radiation cataract is proven to be stochastic -- implying that some fraction of a population will develop them at even low doses -- its utility for dose reconstruction will be enhanced. Therefore it is important for the risk assessment community to know whether cataract formation is indeed a stochastic response to radiation, a question which can be resolved by studying a dose-defined subset of the Chernobyl population, the clean-up workers or so-called "Liquidators".

In collaboration with the Ukrainian Ministry of Health, three Institutes in Kiev, and six sites outside of Kiev, we plan a 12,000-subject cohort study with a nested case-control analysis of the April 26, 1986-February, 1987 Liquidators to assess the distribution of radiation cataracts as a function of dose. The follow-up involves biennial non-invasive slit-examinations of the lens for cataract development. The methodology does not deviate from that which ordinarily would be applied during a standard ophthalmological examination. A questionnaire will be used to attempt to document the existence of potential confounders to cataract development.

The Chernobyl population, by its size, dose distribution and accessibility presents the first real opportunity to address fully the question of whether or not radiation cataract should continue to be viewed as deterministic. For the same reasons it will permit the determination of risk for cataract development from radiation exposure. In addition, it can supply the data necessary to determine the true potential for using cataract development as a tool to assess populations at risk and help reduce uncertainties in retrospective dose reconstructions across populations.