Dr. Laurence
J.
Fuortes
University of Iowa-Former Worker Program (UI-FWP)
2207 Westlawn
Iowa City, IA 52242-1102
Phone: 319-335-9819
Fax: 319-335-5649
E-mail: laurence-fuortes@uiowa.edu
Number of Human Subjects projects reported: 1
| UOI-00-DE-FC03-00EH00025 | "University of Iowa-Former Worker Program (UI-FWP) for the Burlington Atomic Energy Commission Plant (BAECP) and the Ames Laboratory " |
"University of Iowa-Former Worker Program (UI-FWP) for the Burlington Atomic Energy Commission Plant (BAECP) and the Ames Laboratory"
Principal Investigator: Dr. Laurence J. Fuortes, The University of Iowa
Project started in: 2000
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: The University of Iowa
Most recent approval: 09/26/07
IRB approval number: 200008081
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: Oak Ridge Associated Universities
Most recent approval: 01/29/07
IRB approval number: CBeIRB(02)-3
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: 279
Reporting period for number of human subjects:
Other: 12/01/06 to 11/30/07
Explanation:
The project FY 2006-2007 is from December 1, 2006 through November 30, 2007. From 12/1/06 through 8/1/07, we have screened 126 new participants and re-screened 73 participants; we anticipate screening another 80 participants by 11/30/07.
Type(s) of Human Subjects Involvement:
Since 2000, The University of Iowa-Former Worker Program (UI-FWP) has been conducting a medical surveillance program for individuals who formerly manufactured atomic weapons at the Burlington Atomic Energy Commission Plant (BAECP)/Line 1/Division B near Burlington, Iowa from 1945 through 1975. In addition to radioactive materials, they may have been occupationally exposed to potentially hazardous levels other toxic substances (explosives, solvents, epoxies, heavy metals, and fibrogenic dusts).
The UI-FWP identifies and locates those individuals who worked at the BAECP and offers them free medical screening tests. Health conditions that are screened for include chronic lung diseases (such as emphysema and asbestosis), radiogenic cancers, and sensitization to beryllium. Approximately 2,000 Line 1 former workers, or those in the vicinity of Line 1, will participate to receive the following tests:
1. Spirometry
2. Chest X-ray
3. Beryllium Lymphocyte Proliferation Test (BeLPT)
4. Hemoccult Stool Occult Blood Screen:
5. Blood work: Complete Blood Count, comprehensive metabolic panel and thyroid function test
6. Urinalysis
Written results, appropriate educational materials, and if necessary, a referral to a primary care physician are mailed to the participant. Workers who no longer live near the screening site, or who prefer to be seen by their personal physician, will be referred to the DOE's National Supplemental Screening Program.
For those receiving 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. Although there are no proven harmful effects from the radiation they will receive from this program, long-term effects on their health cannot be ruled out.
The risk of physical injury of participating in this program is minimal. After drawing blood, there is occasionally a small leakage of blood under the skin, which can produce discoloration and/or a small bump.
For women who are pregnant, a chest X-ray may present a small risk of harm to the fetus. Those women who are pregnant will not be allowed to have a chest X-ray until they are no longer pregnant.
There is a risk of the emotional distress that some participants may feel as a result of discussing prior exposures to toxic agents and radiation and possible subsequent health risks. We address this risk by providing clear communication about the nature of the health risks due to working on Line 1 and the ways in which they can protect their health and lessen their likelihood of becoming ill.
Identity and participation and medical records remain confidential, to the extent permitted by law. No information that identifies participants will be shared with anyone other than the parties specified in the informed consent (University of Iowa) and in the Health Insurance Portability and Accountability Act (HIPAA) Authorization form, except as required by law.
It is possible that others may become aware of participants in this project, such as the Federal government regulatory agencies, IRBs, or medical staff who administer the screening tests.
The UI-FWP will protect confidentiality by assigning a unique number identifier that is used for analysis. The code that matches names and numeric identifiers are only known to the UI-FWP staff.
All hard copies of individually identified data are kept in locked file cabinets in offices which house only project staff members at The University of Iowa College of Public Health and only are accessible to the UI-FWP staff for internal use only, others as identified above, or as permissible or required by law. All doors are locked at night and only project staff members have keys (except for custodians). Any waste paper with personal identification will be shredded prior to disposal.
Electronic and de-identified data will be kept at in a database designed for the UI-FWP and accessible only to the UI-FWP staff. Customary safeguards are taken to protect the electronic database against unauthorized intrusion (e.g., password protected, authorization clearance). Participants may request their personal information be removed from this database at any time by contacting the Project Director.
UI-IRB and Central BeIRB consent forms are signed before the medical screening with UI-FWP as witnesses; participants are given copies of the consent forms for their records.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of Iowa
Most recent approval: 09/19/07
IRB approval number: 200509719
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: Central Beryllium IRB
Most recent approval: 02/21/07
IRB approval number: CBeIRB(02)-3 Ammendm
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: 115
Reporting period for number of human subjects:
Other: 12/01/06 to 11/30/07
Explanation:
The project FY 2006-2007 is from December 1, 2006 through November 30, 2007. From 12/1/06 through 8/1/07, we have screened 55 participants and anticipate screening another 60 participants by 11/30/07. Additionally, we have referred 189 participants to the NSSP and anticipate referring an additional 80 participant to the NSSP by 11/30/07.
Type(s) of Human Subjects Involvement:
A medical surveillance program for another DOE site in Iowa, the Ames Laboratory at Iowa State University in Ames, Iowa has been conducted since 2005. In 1939, the U.S. government asked leading scientists to develop atomic energy. In 1942, the Ames Laboratory initiated chemical research and development to accompany the Manhattan Project and developed a process for producing nearly pure uranium, making it possible to cast large ingots of uranium for nuclear reactor purposes. The Ames Project furnished one-third of the uranium metal used in the first successful demonstration of a chain-reacting pile at the University of Chicago.
The UI-FWP identifies and locates those individuals who worked at the Ames Laboratory and offers them free medical screening tests. Health conditions that are screened for include chronic lung diseases (such as emphysema and asbestosis), radiogenic cancers, and sensitization to beryllium. Approximately 9,000 Ames Laboratory former workers, or those in the vicinity of the Ames Laboratory, will participate to receive the following tests:
1. Spirometry
2. Chest X-ray
3. Beryllium Lymphocyte Proliferation Test (BeLPT)
4. Hemoccult Stool Occult Blood Screen:
5. Blood work: Complete Blood Count, comprehensive metabolic panel and thyroid function test
6. Urinalysis
Written results, appropriate educational materials, and if necessary, a referral to a primary care physician are mailed to the participant. Workers who no longer live near the screening site, or who prefer to be seen by their personal physician, will be referred to the DOE's National Supplemental Screening Program.
For those receiving 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. Although there are no proven harmful effects from the radiation they will receive from this program, long-term effects on their health cannot be ruled out.
The risk of physical injury of participating in this program is minimal. After drawing blood, there is occasionally a small leakage of blood under the skin, which can produce discoloration and/or a small bump.
For women who are pregnant, a chest X-ray may present a small risk of harm to the fetus. Those women who are pregnant will not be allowed to have a chest X-ray until they are no longer pregnant.
There is a risk of the emotional distress that some participants may feel as a result of discussing prior exposures to toxic agents and radiation and possible subsequent health risks. We address this risk by providing clear communication about the nature of the health risks due to working on Line 1 and the ways in which they can protect their health and lessen their likelihood of becoming ill.
Identity and participation and medical records remain confidential, to the extent permitted by law. No information that identifies participants will be shared with anyone other than the parties specified in the informed consent (University of Iowa) and in the Health Insurance Portability and Accountability Act (HIPAA) Authorization form, except as required by law.
It is possible that others may become aware of participants in this project, such as the Federal government regulatory agencies, IRBs, or medical staff who administer the screening tests.
The UI-FWP will protect confidentiality by assigning a unique number identifier that is used for analysis. The code that matches names and numeric identifiers are only known to the UI-FWP staff.
All hard copies of individually identified data are kept in locked file cabinets in offices which house only project staff members at The University of Iowa College of Public Health and only are accessible to the UI-FWP staff for internal use only, others as identified above, or as permissible or required by law. All doors are locked at night and only project staff members have keys (except for custodians). Any waste paper with personal identification will be shredded prior to disposal.
Electronic and de-identified data will be kept at in a database designed for the UI-FWP and accessible only to the UI-FWP staff. Customary safeguards are taken to protect the electronic database against unauthorized intrusion (e.g., password protected, authorization clearance). Participants may request their personal information be removed from this database at any time by contacting the Project Director.
UI-IRB and Central BeIRB consent forms are signed before the medical screening with UI-FWP as witnesses; participants are given copies of the consent forms for their records.