USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-95-83

Project Title:

Identification and Abstraction of Death Certificates for National Registry of Persons Exposed to Hazardous Substances

Principle Investigator: Dr. Elizabeth A. Dupree
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1995

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:

Non-DOE Federal: Agency for Toxic Substances and Diseases Registry (ATSDR)

Amount: $41,550

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 03, 1995
IRB Approval Number: 83

Number of Human Subjects in the Last Reporting Period for this Project: 118
(Reporting periods vary.)

Type of Human Subjects Involvement:

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.

Other use of human subjects:

Data is collected by ATSDR (see d above). We only retrieve death certificates and code questionnaire data.

(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 objective of this work is to retrieve and verify the death certificate (DC) and code all causes of death on the death certificate for individuals identified by the Agency for Toxic Substances and Diseases Registry (ATSDR). In addition, information from questionnaires administered by ATSDR personnel will be coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD9-CM) codes for the individual's disease conditions and Bureau of Census occupation and industry codes for his or her work history. These data will be maintained by ATSDR as part of The National Exposure Registry.

All records are sent to The Oak Ridge Associated Universities (ORAU) in hard-copy and machine-readable form by ATSDR. If retrieval of DCs is requested, records will be submitted to the National Death Index (NDI) for identification of the deceased individual. Attempts will be made to retrieve a DC for each person identified as dead. A DC request will be made to the state in which the person died. The DC returned by the state will be verified as belonging to the person for whom it was requested. Once the DC has been verified, it will be de-identified and sent to Medical Coding and Consultation Services, Inc. (MCCS) located in Rolesville, N.C. for nosologic coding of all causes of death to the ICD9. The codes returned from MCCS along with selected information from the DC will be computerized. All records will be returned to ATSDR as work is completed.

Human subjects are not exposed to ionizing radiation, radioactive substances or chemical substances as a result of this research.

There is no risk to human subjects.