USDOE Human Subjects Research Database, Fiscal Year 2007

Drexel University

Public Information Contact:

Dr. Arthur L. Frank
Department of Environmental and Occupational Health
Drexel University School ofr Public Health
1505 Race Street, 13th Floor
Philadelphia, PA 19102

Phone: 215-762-3930
Fax: 215-762-8846
E-mail: alf13@drexel.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Drexel University
The approving IRB operates under an OHRP assurance.
OHRP assurance number: FWA00005917

Human Subject Projects:

Number of Human Subjects projects reported: 1

DU-05-30366 "Former Pantex Worker Medical Surveillance Program"

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Project Identifier: DU-05-30366

Project Title:

"Former Pantex Worker Medical Surveillance Program"

Principal Investigator: Dr. Arthur L. Frank, Drexel University

Project started in: 2005

Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Deputy Assistant Secretary for the Office of Health
$1,142,183.00 for: Fiscal Year 2007
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Drexel University
Most recent approval: 03/13/07
IRB approval number: 911-03P

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 104
Reporting period for number of human subjects: Fiscal Year 2007
Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

For diagnostic research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

Using data collected from subjects specifically for this project.

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])

The objective of this research is to conduct medical exams using a standard protocol on former workers at the Pantex facility, and if potential work-related illnesses are noted, to so inform participants.The exam consists of standardized medical questionnaires, job history, exposure history, physical exam, and battery of laboratory tests. The exposure to ionizing radiation comes from use of x-ray equipment to do standard pulmonary area (PA) view of the chest. Participants are recruited from all identified former workers at the plant with an emphasis on those expected to have had the most significant exposures. The risks are the same as for any standard medical examination and laboratory testing. Each person signs a consent form and has the right to refuse any or all parts of the evaluation. Data are segregated and not shared with anyone by identifier other than the individual participants who receive a letter regarding their exam results and a copy, if requested in writing, to the regular caregiver.

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