USDOE Human Subjects Research Database, Fiscal Year 2001

Alaska Department of Environmental Conservation

Public Information Contact:

Mr. Douglas Dasher
Alaska Department of Environmental Conservation
610 University Ave.
Fairbanks, AK 99709

Phone: 907-451-2172
Fax: 907-451-5146
E-mail: ddasher@envircon.state.ak.us

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

ADEC-00-DE-FG08-99NV13726

"Amchitka Island Workers Medical Surveillance Program"

Project Identifier: ADEC-00-DE-FG08-99NV13726

"Amchitka Island Workers Medical Surveillance Program"

Principal Investigator: Dr. Knut Ringen, Alaska State District Council of Laborers

Project started in: 2000

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH-6, Deputy Assistant Secretary for Health Studies

$550,000.00 (Est.) for: Other time period:
Estimate is for funding period State of Alaska Fiscal Year July 01, 2000 - June 30, 2001.

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: Pacific Northwest National Laboratories
Most recent approval: 06/26/01
IRB approval number: 2000-4

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1255
Reporting period for number of human subjects: Fiscal Year 2001

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Medical Surveillance - If the worker history and medical exam indicate that a chest X-ray is needed one will be offered to the participant.

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excretia, etc):

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.
• Using existing data that were collected for other purposes or projects.

(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])

Project objectives are to implement a notification and health evaluation, including medical screening, for workers who worked at the DOE Amchitka Island, Alaska Underground Nuclear Test Site where they may of been exposed to health hazards as a result of their work.

Specific Aims are:

1) Identify and locate former workers who are considered "at risk".
2) Ascertain the health concerns of identified workers.
3) Communicate risk information to the workers and discuss any action taken.
4) Provide medical screening for identified "at risk" workers.
5) Assist in the coordination of referrals, diagnostic work ups, and follow-up treatment and any compensation that may arise from medical findings.
6) Ensure dialogue with local parties concerned with the project.
7) Assess project impact, including workers' satisfaction with the project.

Multiple layers of protection in the data management system minimize the loss of privacy risks to the participants. All personal data is coded and encrypted and maintained in separate databases. Participants are fully informed of the purpose of the program and must consent at different stages within the program. They are notified about all results, and special care is taken to assure that participants have received and understand any information that is important to their health or well being.