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
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: 07/24/02
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: 271
Reporting period for number of human subjects:
Fiscal Year 2002
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. 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).
Former Workers will receive an occupational and health history questionnaire. This questionnaire is 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:
• General health review
• Spirometry
• Chest x-ray
• Hearing test
• Complete blood count
• Urine test
• Thyroid function test
• Comprehensive metabolic panel,
• Beryllium lymphocyte transformation testing (Be-LPT), and for those who screen positive on the Be-LPT,
• A chest CT scan.
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.
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.
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. Your identity in this program will be treated as confidential. However, privacy and confidentiality of your medical records cannot be guaranteed. 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.
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 a successful worker compensation claim.
Identity in this program will be treated as confidential. However, privacy and confidentiality of your medical records cannot be guaranteed. They 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. It would also be available as the Freedom of Information Act or Privacy Act provide, such as to Congress, or to an individual upon a showing of compelling circumstances affecting the health and safety of an individual. The results of tests and examinations may be published in reports or presented at meetings, but will not identify any individuals by name.
The results of the screenings tests will be made available to the former workers, and upon request, to a personal physician. 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. Oak Ridge Institute for Science and Education (ORISE) staff members and their consultants, who will review beryllium program information including results of medical tests.
5. Department of Labor staff who review the claims submitted to the Energy Employees Occupational Illness Compensation Program.
6. The University of Iowa Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this project. It is possible that these records could contain information that personally identifies an individual.
7. Researchers who are studying beryllium-related disease may have access to the records after receiving approval from an Institutional Review Board.
8. 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. All individually identified data will be kept in locked file cabinets at the University of Iowa, and will only be accessible to Burlington Atomic Energy Commission Plant-Former Worker Program staff, others as identified above, or as permissible or required by law. Any waste paper with personal identification will be shredded prior to disposal.
Information regarding medical and project information will be maintained in a database by the University of Iowa project staff for internal use only. 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. This information will be kept on file so that a worker could be contacted in the future regarding this project if necessary.
Results of medical screenings for the entire group will be reported back to the community in order to provide information on health outcomes of the workforce, which may have implications for an individual’s future risks, recommended medical surveillance, and to address concerns regarding the work-relatedness of the outcomes. These results will only be reported in the aggregate; no personal identifiers will be used in analysis or reporting. These aggregate results will be shared with other Former Worker Programs and related health or governmental agencies on a periodic basis. If these results suggest an historical or ongoing public health risk they will be shared with the public health community.