Ms. Kristina Venzke
Department of Occupational and Environmental Health
2115 Westlawn
Iowa City, IA 52242
Phone: 319-335-8494
Fax: 319-353-5649
E-mail: kristina-venzke@uiowa.edu
Number of Human Subjects projects reported: 1
| UI-00-DE-FC03-00EH00025 | "Burlington Atomic Energy Commission Plant Former Worker Program" |
"Burlington Atomic Energy Commission Plant Former Worker Program"
Principal Investigator: Dr. Laurence J. Fuortes, University of Iowa
Project started in: 2000
Funding for Human Subjects Research:
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: 07/18/03
IRB approval number: 200008081
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Oak Ridge Associated Universities
Most recent approval: 05/07/02
Explanation of additional approval:
This project is also reviewed by a Central Beryllium Institutional Review Board, located at Oak Ridge Associated Universities. The purpose of this IRB is to review protocols and educational materials pertaining specifically to beryllium.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2277
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The University of Iowa College of Public Health will conduct a medical surveillance program for individuals formerly employed at the Iowa Army Ammunition Plant (IAAP) near Burlington, Iowa, 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. 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).
Former workers will receive an occupational and health history questionnaire designed to collect general information on occupational duties and hazards at IAAP. Those who are determined to be eligible participants will be invited to receive a medical screening at no cost. Based on the work history, workers may receive some or all of the following procedures:
a. Spirometry:
b. Laboratory tests: Blood and urine samples will be obtained for a series of screening tests which will include blood counts; liver, kidney and thyroid functions; blood sugar; and a urinalysis.
c. Hemoccult fecal blood test (“stool card” kit) to screen for colon cancer.
d. Beryllium Lymphocyte Proliferation Test (Be-LPT)
e. Chest X-Ray: For those workers who receive chest x-rays, the amount of radiation involved is 6 mrem, or approximately equal to the amount of natural background radiation that the average American receives in one week.
Former workers will receive a written report of the results, appropriate educational materials, and if necessary, a referral to a primary care physician. The medical screenings will be done at one of or a combination of the following facilities in Iowa: Machinists’ Union Hall in Middletown, Henry County Health Center in Mt. Pleasant, Great River Medical Center in Burlington, or the University of Iowa Hospitals and Clinics.
There may be no personal benefit for participating in this project. However, it is hoped that in the future society could benefit from this project by learning more about the relationship between workplace hazards and human health both at IAAP and in other settings. Individuals may benefit from detection of early stages of treatable disease and furthermore may benefit from diagnostic information supporting and leading to successful worker compensation claims.
There is a risk of the emotional distress that some former workers may feel as a result of recalling and discussing prior exposures to toxic agents and possible subsequent health risks during the evaluations. An additional risk in this study is violation of confidentiality. Identity in this program will be treated as confidential. Although it is unlikely, confidential records may be disclosed only as provided by in the Privacy Act of 1974, the American with Disabilities Act (ADA), or as required by a court order or under other law.
The results of the examinations may be available to the people listed below. Some of these people may require access to records that identify workers by name:
1. The clinic staff members who provide the medical testing and who do the lab work.
2. Medical specialists who provide or arrange for additional medical treatment or tests, if necessary.
3. Staff from the University of Iowa who work for the Burlington Atomic Energy Commission Plant—Former Worker Medical Screening Program.
4. Department of Labor staff who review the claims submitted to the Energy Employees Occupational Illness Compensation Program.
5. The University of Iowa Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this project.
6. Others as required by the Americans with Disabilities Act, the Privacy Act of 1974, or as required by court order or under another law.
The University of Iowa project will protect confidentiality by assigning a unique number identifier that will be used in analyzing the information that we obtain. The code that matches names and numeric identifiers will be known only to the program’s staff. Individually identified data will be kept in locked file cabinets at the University of Iowa. Any reports published as part of this research will refer to results only in the aggregate.
Information regarding medical and project information will be maintained in a database by the University of Iowa project staff for internal use only for the length of the project. This database will contain information such as name, social security number, address, age, work history, and diagnosis. Workers may request that personal information be removed from this database at any time by contacting the investigator or project coordinator.