USDOE Human Subjects Research Database, fiscal year 1995

Sandia National Laboratories

Project Identifier: SNL-93-06

Project Title:

Mathematical Modeling Approach to Quantitative Retrospective Exposure Assessment of Potential Occupational Exposures to Mixed Organic Solvents at Sandia National Laboratories, NM.

Principle Investigator: Ms. Lisa Hooper

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

Project is an in-house dissertation research project; Principal Investigator is employee with no specific funding for human subjects work.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: June 09, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 900
(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.

(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])

Study to develop a mathematical retrospective exposure modeling method appropriate for the variables at Sandia National Laboratories, New Mexico (SNL/NM) and apply it to potential occupational organic solvent exposures. Hypothesis is that in a diverse work environment with limited historical air monitoring data, a mathematical exposure model can be developed to perform retrospective exposure assessments resulting in significantly less misclassification of study subjects, with respect to airborne exposure, than semi-quantitative and qualitative models. The study will include development and application of three models that provide qualitative, semi-quantitative, and quantitative assessments of occupational exposure to neurotoxic organic solvents. The exposure intensity values generated by all three models will be used to establish cumulative exposures for the SNL/NM worker study population. The data used to complete the models are existing aggregate data that were collected for other purposes such as compliance air monitoring (exposure data for groups of people, for example, those working in a certain laboratory during a certain period). The cumulative exposures values will be compared to similar values from published epidemiology studies that look at sub-clinical neurotoxic effects. There are no risks to human subjects from actions taken in support of this project.