USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-91-C14

Project Title:

UAW-Ford/BNL-IPAG Information System Research Demonstration Project: Phase I

Principle Investigator: Dr. Jerome Barancik

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Funding of $45,000 was received, but did not involve the human studies of the project.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: April 05, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 0
(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 existing data that were collected for another purpose or project.

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Environmental/Human Habitat Studies:

Use of human subjects for environmental studies (e.g., weatherization, energy-efficiency, lighting studies).

(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 overall objective of this project is to introduce and demonstrate the efficacy of a safety and injury control information system designed to measure process and injury patterns systematically before and after introduction of injury countermeasures. Using BNL developed epidemiologic research and surveillance methodology, existing human data from two selected Ford plants will be acquired and analyzed. BNL expects to identify 4,000 to 6,000 subjects for both plants combined from the existing computerized databases. The data will be representative of a period not exceeding 12 months. The data will be aggregated into grouped numerical format for scientific presentations and reports. All records are maintained in strict confidence and are stored in accordance with Clinical Record storage at BNL. Data items include age, sex, job/process codes and descriptions, length of employment on job, nature, type and severity of injury, outcomes including workdays lost, and time and place of event. There are no risks to subjects.