USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-80-63

Project Title:

The U.S. Radiation Accident Registry Follow-Up Program

Principle Investigator: Dr. Ronald E. Goans
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1980

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Occupational Medicine

Amount: $40,000 (Est.)
Comments:

Radiation Medicine and Cytogenetics Program Funding

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: August 05, 1995
IRB Approval Number: 63

Number of Human Subjects in the Last Reporting Period for this Project: 1,505
(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 bodily materials collected from subjects specifically for this project.
• 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 data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or project.

(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])

ORAU - 63 The U.S. Radiation Accident Registry Follow-up Program

The U.S. Radiation Accident Registry is a unique facility containing clinical data, accident descriptions and accident reconstructions for most of the famous radiation accidents occurring since the Los Alamos-1 (LA-1) accident in 1945. In addition, a large number of minor accidents and incidents are described. The REAC/TS Central Registry describes 1505 radiation cases involving 141,384 individuals and, therefore, is a valuable database for researchers interested in the clinical aspects of case management as well as the various human factors involved. The U.S. experience as of June 1995 includes 234 accidents that meet DOE criteria, involving 1309 persons. Of these, there were 779 significant exposures with 30 fatalities. The non-U.S. experience comprises 147 accidents involving 132,037 individuals, with 2106 significant exposures and 82 fatalities. We continue to update the registry as we receive information on accidents, either through professional contacts or through our function as a World Health Organization collaborating center. Risks are limited to those associated with routine health evaluation (e.g. drawing blood) and submission of personal data that, while protected by the Privacy Act, is also subject to access under the Freedom of Information Act.