University of Cincinnati

Funding for Human Subjects Research:

DOE: EH-5 Office of Health

$0.00 for: Other time period
The Be-LPT test is the only item of IRB interest. Funding for the Be-LPT test has been provided to the ORISE laboratory directly by DOE; it is not part of our project budget.
Percent of funding associated with the use of human subjects: 0

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 Cincinnati
Most recent approval: 12/07/04

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: DOE-wide Central Beryllium IRB (CBeIRB)
Most recent approval: 12/07/04

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 496
Reporting period for number of human subjects: Fiscal Year 2005

Type(s) of Human Subjects Involvement:

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.

(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])

A. General Objectives: To implement a notification, health evaluation (including medical screening), and intervention program for former building and construction trades workers at the DOE Portsmouth GDP and Paducah GDP sites who may have been exposed to health hazards as a result of prior work at these DOE sites.

Specific Objectives:
1 - Identify and locate those former construction workers who, based on their actual or probable exposure history, are "at risk" for occupational health conditions related to exposure incurred at Portsmouth or Paducah Gaseous Diffusion Plants.
2 - Ascertain the health concerns of these workers.
3 - Provide medical screening exams to former workers based on their exposure histories.
4 - Assist in coordination of referrals, diagnostic work-up, and follow-up treatment.
5 - Communicate risk information to former workers regarding the nature of their health risks and discuss recommended actions.
6 - Ensure dialogue with local parties concerned with the project.
7 - Evaluate project impact, including former workers' satisfaction with the project.

B. Methodology:
1 - Current addresses of workers will be sought through a variety of means.
2 - To ascertain risks and health concerns, information will be gathered on employment and occupational exposure history. Health risks will be conveyed to workers.
3 - Medical examinations will be provided by pre-approved community medical providers.
4 - The examining physician will recommend and assist in making referral decisions.
5 - Dialogue with interested parties will be accomplished by open communications.
6 - Systems have been developed to assure participant satisfaction.

C. Ionizing Radiation, etc.: Not applicable.

D. Involvement of Human Subjects: Will include Be-LPT testing of participants' blood. There are minimal risks to participants and many potential benefits. Worker data will be kept secure at all times. There will be no sharing of identifiable data. Only group statistics will be presented; personal identifiers will not be used in any data sets available for analysis. Informed consent forms approved by Oak Ridge Site-wide IRB and Central Beryllium IRB are employed.