USDOE Human Subjects Research Database, Fiscal Year 2001

University of Iowa

Public Information Contact:

Ms. Kristina Venzke
Department of Occupational and Environmental Health
100 Oakdale Campus
222 IREH
Iowa City, IA 52242-5000

Phone: 319-335-4109
Fax: 319-335-4290
E-mail: kristina-venzke@uiowa.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: University of Iowa
The approving IRB operates under a Multiple Project Assurance (MPA), Single Project Assurance (SPA), or Cooperative Project Assurance (CPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1080

Human Subject Projects:

Number of Human Subjects projects reported: 1

UI-00-DE-FC03-00EH00025
"Burlington Atomic Energy Commision Plant Former Worker Program"

Go to Human Subjects Research 2001 main page

Project Identifier: UI-00-DE-FC03-00EH00025

Project Title:
"Burlington Atomic Energy Commision Plant Former Worker Program"

Principal Investigator: Dr. Laurence J. Fuortes, University of Iowa

Project started in: 2000


Project Funding Information:

This project received funding during fiscal year 2001.
This project used human subjects in fiscal year 2001.
Explanation: Project Started August 15,2000 and no subjects have been contacted to date. As of 09/17/01, the project is very close to being ready to send out a medical history/occupational history questionnaire to 1400 former workers. Based on the results of the questionnaires, former workers will be invited to participate in medical screenings later in the fall of 2001.

Funding for Human Subjects Research:

DOE: EH, Office of Occupational Medicine and Medical Surveillance
$1,304,677.00 (Est.) for: Fiscal Year 2001

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: University of Iowa
Most recent approval: 10/05/00
IRB approval number: 200008081
Explanation of IRB approval:
latest date

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3000
Reporting period for number of human subjects: Fiscal Year 2001

Type(s) of Human Subjects Involvement:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
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 University of Iowa College of Public Health will conduct a Needs Assessment for a medical surveillance program for individuals formerly employed at the Middletown, Iowa, Iowa Army Ammunition Plant, (IAAP), who worked in atomic weapons manufacture on what was known as Line 1. The Line 1 operations consisted primarily of atomic weapons assembly and disassembly and was functional from 1945 through 1975. This site is somewhat unique among Department of Energy, DOE, sites in that the facility was historically shared with the Department of Defense, DOD, and much of the production work done on site involved high explosives formulations, manipulation and testing. In addition to fissionable or radioactive materials these workers may have been occupationally exposed to potentially hazardous levels of a number of other toxic substances, (explosives, solvents, epoxies, heavy metals and fibrogenic dusts).

The Needs Assessment will entail the identification, collection and interpretation of existing historical exposure assessment and medical surveillance data for the Line 1 work sites and employees. A focus group of workers and supervisors will be queried regarding job site and job title specific tasks and exposures as an essential step in the exposure assessment. These same workers will be queried regarding risk perceptions and concerns. Using the historic exposure records and focus group information we will develop exposure algorithms for work sites and job titles and develop recommendations for relevant risk communication and medical surveillance. We will collect and collate available employment, medical, and union membership and benefit records and link these to available secondary data sets such as Iowa death tapes, Iowa drivers' license and HCFA data tapes and in order to identify the scope and enable future location and contact of the Line 1 exposed cohort.

Records of participation in this project will be kept confidential to the extent permitted by law. All papers, electronic records and storage media will be maintained in either secured facilities under physical lock and key or password protection on a secured personal computer. In the event of any report or publication from this study, participant identities will not be disclosed.


Go to list of projects at University of Iowa