Johns Hopkins Bloomberg School of Public Health

Funding for Human Subjects Research:

DOE: Former Worker Screening Programs (HS-15)

$1,060,500.00 (Est.)
This funding amount was from 7/1/06 through 11/30/07 for both the LANL and SNL Former Workers Programs
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

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: Expedited
Approving Institution: Johns Hopkins Bloomberg School of Public Health
Most recent approval: 09/17/07
IRB approval number: IRB#: 36 (SNL)

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Sandia National Laboratory (SNL)
Most recent approval: 06/19/07
IRB approval number: SNL0644

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 220
Reporting period for number of human subjects: Other: 07/01/06 to 09/30/07
Explanation:

The new Cooperative Agreement started in July of 2006.

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Routine Chest X-ray (PA only)

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.

(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 SNL Former Workers Program

Since the last reporting period, we have started to conduct medical examinations for former Sandia National Laboratory (SNL) workers. We have completed the following:
1) We have completed Exposure and Medical History Interviews on 220 SNL former workers.
2) We have completed 158 new examinations for SNL former workers. SNL former workers are offered examinations and testing for asbestos, beryllium, lead, noise, radiation, solvents, and silica.
3) In the SNL Former Workers program to date, we have completed 134 chest x-rays (PA only) and all of these films have had a B-reading. Of these films, eight x-rays had changes related to asbestos exposure. We have completed 131 spirometry tests and 34 of these tests had restrictive changes. Of 133 former workers who had a beryllium test, five had a single positive test and were eligible for the Department of Labor Energy Employee Occupational Illness Compensation Program. Over 130 former workers had hearing tests and 56 had hearing loss.

All program records are kept in Baltimore, MD 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.

Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Johns Hopkins Bloomberg School of Public Health
Most recent approval: 12/27/06
IRB approval number: H.18.02.03.11.A2

Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Los Alamos National Laboratory (LANL)
Most recent approval: 07/12/07
IRB approval number: LANL 98-05

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 212
Reporting period for number of human subjects: Other: 07/01/06 to 09/30/07
Explanation:

The new Cooperative Agreement started in July of 2006.

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Routine Chest X-ray (PA only).

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.

(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 LANL Former Workers Program

Since the last reporting period, we continue to conduct medical examinations for Los Alamos National Laboratory (LANL) former workers. We have completed the following:
1) We have completed Exposure and Medical History Interviews on 80 new LANL former workers, 132 LANL former workers who are eligible for a re-screening examination due to past exposure to asbestos and/or beryllium.
2) We have completed 149 examinations including 56 new examinations for LANL former workers and 93 re-screening examinations for LANL former workers.
3) In the LANL Former Workers Program to date, we have completed 2,298 chest x-rays (PA only) and all of these films have had a B-reading. Of these films, 202 x-rays had changes related to asbestos exposure. We have completed 1,433 spirometry tests and 244 of these tests had restrictive changes. Of 2,308 former workers who had a beryllium test, 64 had a single positive test and were eligible for the Department of Labor Energy Employee Occupational Illness Compensation Program. Over 2,000 former workers had hearing tests and 1,156 had hearing loss.

All program records are kept in Baltimore, MD 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.