USDOE Human Subjects Research Database, Fiscal Year 2001

Radiation Effects Research Foundation

Public Information Contact:

Dr. Dale L. Preston
5-2 Hijiyama Koen
Minami ku
Hiroshima, 732-0815
Japan

Phone: 82-264-7219
Fax: 82-262-9768
E-mail: preston@rerf.or.jp

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Radiation Effects Research Foundation
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 Subject Projects:

Number of Human Subjects projects reported: 1

RERF-01-DE-AI01-01-01EH01010
"Development of a Unified Research Database for the Mayak Worker and Ozyorsk Population Studies "
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Project Identifier: RERF-01-DE-AI01-01-01EH01010

Project Title:
"Development of a Unified Research Database for the Mayak Worker and Ozyorsk Population Studies"

Principal Investigator: Dr. Dale L. Preston, Radiation Effects Research Foundation

Project started in: 2001

Project Funding Information:

This project received funding during fiscal year 2001.
This project used human subjects in fiscal year 2001.
Explanation: This project is intended to develop a database to support epidemiologial and dosiemtric studies at the Mayak Production Association in Russia. It is a records based study.

Funding for Human Subjects Research:

DOE: EH-6, Deputy Assistant Secretary for Health Studies
$0.00 (Est.) for: Fiscal Year 2001

Information on Use of Human Subjects:

This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Identifier or number: 1

Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Radiation Effects Research Foundation
Most recent approval: 02/13/01

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50000
Reporting period for number of human subjects: Fiscal Year 2001

Type(s) of Human Subjects Involvement:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
Abstract:
(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: Creation of a unified database containing information needed to conduct epidemiological, dosimetric, and clinical studies on the Mayak worker cohort and related populations.

Methodology: The database is a distributed relational database with the primary information stored on servers at the location responsible for collection of specific types of data.

The populations in this study have had internal and external exposures to ionizing radiation due to their occupation or their place of residence. However, this project involves no contact with the members of the study cohorts.

The database is being designed to protect the privacy and confidentiality of information on people included in the study cohorts. In particular, access to the database will be restricted to those involved and access to tables containting confidential information will be further restricted.

There are no risks to human subjects as a result of this project.

Go to list of projects at Radiation Effects Research Foundation