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
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).
Number of Human Subjects Projects reported: 1
Project Identifier: CU-95-95EH89658
Project Title:
Ocular Radiation Effects in Chernobyl Liquidators
Principal Investigator:
Dr. Basil V. Worgul
Principal Investigator's Institution: Columbia University
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding began 8/4/95. The actual use of human subjects will not begin until FY97.
Funding Sources:
Human subjects will not be studied until FY97. The monies are for project preparation and start-up.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 12, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
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 cataract. 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.