Chernobyl Research and Service Project

Funding for Human Subjects Research:

DOE: International Health Studies (HS-14)

$4,950,000.00 for: Fiscal Year 2007
Percent of funding associated with the use of human subjects: 100

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: Expedited
Approving Institution: Research Triangle International
Most recent approval: 05/14/07
IRB approval number: 11730

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Research Center for Radiation Medicine (RCRM)
Most recent approval: 05/23/07

Type of Review: Expedited
Approving Institution: Duke University
Most recent approval: 05/21/07
IRB approval number: Pro00000670

Type of Review: Expedited
Approving Institution: University of North Carolina - Asheville
Most recent approval: 02/20/07

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 94
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Other types of human subjects involvement. Explanation:

International Consortium for Applied Radiation Research (ICARR) subjects are applicants for work at Chornobyl Nuclear Power Plant stabilization effort. A blood sample (37 ml) is collected and selected medical exam data are abstracted for the ICARR project. However, all samples and data are de-identified for study use. Medical exams are not conducted for ICARR but as part of worker applicant screening process.

(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])

Objectives:

Research Triangle International, Research Center for Radiation Medicine (RTI, RCRM), Duke University, and University of North Carolina - Asheville founded the Chornobyl Research and Service Project (CRSP) Consortium to serve U.S. interests in learning how to identify and treat early biologic changes that could affect human health from exposure to primarily low doses of radiation. This is done within the context of remediation efforts at the Chornobyl nuclear power plant (ChNPP). Newly hired workers are securing the deteriorating concrete encasement that currently surrounds the reactor that exploded in 1986. Workers are at risk of exposure to primarily low levels of gamma and alpha radiation from external and internal sources (i.e., through inhalation and skin absorption).

Methodology:
RCRM conducts a medical screening/surveillance program (BIOMED) under a subcontract with a construction consortium hired by the European Bank of Reconstruction and Development. This program consists of a two-day medical screening to determine health adequacy for employment. CRSP abstracts selected data from the medical screening process after soliciting informed consent from applicants who pass Day 1 of screening. CRSP collects a blood sample from consenting applicants. Data are keyed into a secure web-based relational database for storage and linkage of medical, biological, and exposure data for research purposes. Blood samples are periodically shipped to RTI for storage and transferred to Duke University for specialised testing to support research hypotheses.

Involvement of Human Subjects:

Consent Procedures
Applicants arrive at RCRM on Day 1 for registration during which RCRM personnel provide a 1 hour introduction to radiation and human health effects. Afterwards, they request signature of "Medical and Biophysical Control" Informed Consent before an applicant can begin the medical screening process. This interaction has nothing to do with the CRSP but explains the potential risks of accepting employment at the power plant.

At the end of day 1, trained RCRM staff present the RTI study to each worker who passes Day 1. Workers stay overnight in hospital to complete Day 2 of the medical screening. The consenting process includes two parts: the translated Participant Information Sheet and RTI Informed Consent. The Information Sheet explains the details of study purpose, procedure, risks, benefits, and compensation. The RTI Informed Consent asks the worker to participate.

Staff provide verbal explanation of the study and explain the RTI Informed Consent and answer questions completely before asking the worker to sign. After the worker reads the documents and states that the content of both documents are understood, staff request their signature. A signed copy of the Informed Consent is left with the worker along with the Participant Information Sheet.

Study Procedures Involving Human Subjects
Since CRSP data are a 100 percent abstraction of existing medical data, there are no additional requests of the subject to provide information. The project does request an additional ~40 mls of blood from the subject, taken at the time of the blood collection for the medical screening exam. Although currently in the enrollment stage, the project intends to include return visits using the same procedures, abstraction of medical screening results, and the additional 40 ml blood draw. Each time a worker provides a blood sample, he/she is given a total compensation in the equivalent of $20 USD. Return visits are scheduled on a routine basis according to the position to which the worker is assigned. Also, if a worker experiences a higher than expected radiation exposure (as determined by badge data and periodic analysis of fecal samples), he/she is brought in to the hospital for closer examination.

Risks
The only risk faced by a participant in CRSP is possible discomfort from the blood draw. All risks that the participants experience are related to work assignment at the power plant. The project is under no obligation to provide counselling on these risks, nor to provide counsel on any possible medical problems that are revealed during the medical exam process. All follow up on worker health is the responsibility of RCRM, the contracting agency that hires the workers and possibly, the Ukrainian government, according to legislative regulations designed to address these issues.

Privacy
Participants in CRSP are assured privacy since no identifying information is included in project databases. Data and samples are de-identified according to U.S. Department of Health and Human Services (DHHS) definitions prior to inclusion. Linkages to the individual remain at RCRM and include: signed consent form; a file that links the Ukrainian Tax ID of the consented applicant to an assigned Subject ID that becomes the identifier in the context of the CRSP project. RTI has no access to these documents that are kept in locked secure areas at the medical facility.