USDOE Human Subjects Research Database, Fiscal Year 2004

Johns Hopkins Bloomberg School of Public Health

Public Information Contact:

Ms. Maureen A. Cadorette
Johns Hopkins Univeristy School of Public Health
615 N. Wolfe Street, Room 7503B
Baltimore, MD 21205

Phone: 410-955-4587
Fax: 410-955-1811
E-mail: mcadoret@jhsph.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

JHUSHP-97-DE-FC03-98SF21541

"Medical Surveillance for Former Department of Energy Workers"

Project Identifier: JHUSHP-97-DE-FC03-98SF21541

"Medical Surveillance for Former Department of Energy Workers"

Principal Investigator: Dr. Brian S. Schwartz, Johns Hopkins Bloomberg School of Public Health

Project started in: 1997

Project Funding Information:

Funding for Human Subjects Research:

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

$599,609.00 for: Other time period:
The above budget is for 1/1/04 through 8/31/04.

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: 03/30/04
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: 11/05/03
IRB approval number: LANL 98-05

Type of Review: Full Board
Approving Institution: DOE Central Beryllium IRB
Most recent approval: 10/16/03
IRB approval number: CBeIRB (02)- 7 LANL

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 231
Reporting period for number of human subjects: Fiscal Year 2004

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• Other. Explain:

Chest x-ray (PA 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. We are no longer recruiting former workers into the program. We are in the process of closing down the program.

Program activities to 9/30/04:
1) As of 9/30/04, 34,369 letters were sent to former workers inviting them to participate in this program.
2) We completed 188 Exposure and Medical History Questionnaires (EQ2) between 10/1/03 and 9/30/04.
3) The total number of EQ2 interviews completed as of 9/30/04 was 2,773.
4) We completed 212 exams between 10/1/03 and 9/30/04.
5) The three sites where exams were performed are:
a) The LANL Occupational Medicine Clinic in Los Alamos, NM completed 18 exams between 10/1/03 and 9/30/04.
b) The LANL Former Workers Program Office in Espanola, NM completed 194 exams between 10/1/03 and 9/30/04. This office closed 6/15/04.
c) The Center for Occupational and Environmental Health (COEH) in Baltimore, MD; this office closed 6/30/03 and no exams were done there this year.
6) We completed a total of 101 medical record reviews to 9/30/04.
7) As of 9/30/04, we have completed 2,329 examinations, including Medical Record Reviews.
8) We developed a two hundred-page book that describes all aspects of this program. This book, titled Medical Exam Program Handbook for Former Workers at LANL, was sent to every former worker who completed an Exposure and Medical History Questionnaire (EQ2).
9) The risks involved with this program were the risks involved with routine medical examinations and testing. The medical tests included spirometry, audiometry, blood tests (complete blood count with differential, blood urea nitrogen, creatinine, thyroid stimulating hormone, beryllium lymphocyte proliferation test [LPT]), a hemocult test of stool, and a chest x-ray. Not all former workers received all these exams and tests. The chest x-ray was one view only and the radiation received was the same as that received during a routine medical chest x-ray.
10) Consent forms were obtained for every former worker who completed a questionnaire, survey, or participated in a focus group. Separate consents were obtained for:
a) surveys or questionnaires
b) focus groups
c) medical exam or the medical record review, and
d) a beryllium lymphocyte proliferation test (BeLPT).
11) The DOE Final Beryllium Guidance was provided on June 2, 2003. The JHBSPH Committees on Human Research (CHR), the LANL IRB, and the Central Beryllium IRB approved consent forms revised to reflect the Final Beryllium Guidance in October 2003.
12) All records, test results, and x-rays are kept 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.
13) 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 these reports.
14) We completed a mailing in early October to all program participants who completed an Exposure and Medical History Questionnaire (EQ2). This mailing included a letter from JHBSPH explaining the closing of the LANL Former Workers Program. The mailing also included a letter from DOE and five options for their program records. Energy Employees Occupational Illness Compensation Program Act (EEOICPA) brochures were also included in the mailing packet.
15) We are in the process of receiving responses from program participants about the options that they have chosen for their records. We expect that it will take six to twelve additional months from September 1, 2004 to complete the closing of this program (including such activities as complete results letters, complete data entry, complete long-term records storage, remove furniture and materials from the clinic, and close down the clinic). We have received a no-cost budget extension from DOE to complete closing activities of the entire program.