Johns Hopkins Bloomberg School of Public Health

Funding for Human Subjects Research:

DOE: Deputy Assistant Secretary for the Office of Health

$140,936.00 for: Other time period
The above budget is for 4/1/05 through 11/30/05.
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: Full Board
Approving Institution: Johns Hopkins Bloomberg School of Public Health
Most recent approval: 01/26/05
IRB approval number: H.18.02.03.11.A2

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 09/07/05
IRB approval number: LANL 98-05

Type of Review: Full Board
Approving Institution: DOE Central Beryllium IRB
Most recent approval: 04/26/05
IRB approval number: CBeIRB (02)- 7 LANL

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2005

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Chest x-ray (pulmonary area only) for medical screening.

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.

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

• Using data collected from subjects specifically for this project.

Other types of human subjects involvement. Explanation:

Focus Groups with former LANL workers.

(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])

Abstract

The Medical Exam Program for Former Workers at Los Alamos National Laboratory closed on August 31, 2004. At the request of DOE, we will re-start this program around 12/1/05. We will recruit former workers through newspaper ads and union mailings. We plan to complete 50 examinations in our Espanola Office in 2006. Some of these examinations will include former workers who were previously screened for asbestos and beryllium exposure. We will follow the medical screening protocols developed for the DOE Former Workers Program. Former workers who are unable to travel to New Mexico but would like an examination will be referred to the DOE National Supplemental Screening Program.

All records, test results, and x-rays are kept at Johns Hopkins in Baltimore in locked files. Access to these files is limited to the Principal Investigator and selected members of the program team. Reports sent to DOE contain group data. No individual is identified in these reports. A unique identification number identifies the participant and is used on all blood samples and tests. No personal identifiers are used. Program records and data are maintained in locked files and password protected databases. No information is given to anyone without the written permission of the former worker. Certain laws or a subpoena may alter the confidentiality of these records. This information is in all of the program consent forms.

Program records will be kept for 10 years, or longer if necessary or required, after the program ends. After that time, we will remove all personal identifiers from the data and destroy any links that will connect an individual to the records. We will analyze this data as group data only. Any published reports will be reported as group data only. No individual will be identified in reports of data.