Ms. Maureen A. Cadorette
615 N. Wolfe Street, Room 7503B
Baltimore, MD 21205
Phone: 410-995-4587
Fax: 410-955-1811
Email: mcadoret@jhsph.edu
Projects are approved by an IRB located at: Los Alamos National Laboratory.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: DOEMPA LANL1996-2000
Number of Human Subjects Projects reported: 1
Project Identifier: LANL-98-98-LANL-E5
Project Title:
Medical Surveillance for Former Department of Energy Workers
Principal Investigator:
Dr. Brian Schwartz
Principal Investigator's Institution: Johns Hopkins University School of Hygiene and Public Health
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 19, 1998
IRB Approval Number: 96-04- 23-01
Number of Human Subjects who participated in this project/protocol during
12/15/97 - 12/15/98: 350
Project began in January 1998
Type of Human Subjects Involvement:
This one-year Needs Assessment at Los Alamos National Laboratory (LANL) involved the use of human subjects in two areas. As stated in the specific aims of the original grant proposal, the investigators pilot tested methods to contact former workers and made an initial determination of the most significant concerns of former workers. The methods for accomplishing these aims are described in detail below. The Institutional Review Board at Johns Hopkins University and LANL reviewed and approved all materials that were used to contact and obtain information from former workers prior to their use.
One specific aim of the Needs Assessment was to develop methods to contact former LANL workers and to pilot test these methods in Phase I of the project. In order to accomplish this task, 400 workers were selected from a roster of LANL Workers. These individuals were employees of either the University of California or Zia Corporation, the main subcontractor to LANL from 1945 to 1986. The criteria for selection included job title, alive in 1990, and a termination date in the record. Job title was chosen as a selection criterion because job title may indicate a previous risk of exposure. A current address and telephone number was located and individuals were telephoned to verify their previous employment at LANL. A project information packet and questionnaire will be sent to those individuals who were located. This packet includes a cover letter explaining the project, an information pamphlet with more detailed project information and telephone numbers of key project personnel, a questionnaire, two informed consent forms - one to be returned with the questionnaire and one for the respondent, and a postcard that an individual can use to refuse to participate or to request the questionnaire in Spanish. The questionnaire will be used to verify demographic information, to collect limited work history, some limited health care information, worker concerns regarding their health related to their previous employment at LANL, and information on how individuals feel health information should be given to them. Over 300 questionnaires will be sent to former LANL workers. Upon return to Hopkins, these questionnaires will be kept in a locked file cabinet and only the project investigator will have access to them.
Another aim of this project was to make an initial determination of the most significant concerns and additional hazardous exposures for former LANL workers. This aim was met though four focus groups that were conducted with former workers in New Mexico. Former workers were recruited through local unions, retirement groups and a list of former LANL machinists. Each focus group lasted one and one-half to two hours. Discussions centered on each former worker's concerns about the workplace exposures that they experience and the health conditions that they are living with today. There were many former workers in these groups who had no exposure or health concerns related to their previous employment at LANL. A questionnaire was completed at the end of the discussion. Informed consent statments were obtained prior to the focus group dicussion and it was made clear to all that participation was completely voluntary. No identifying information was collected on the questionnaire and first names only were used during dicussions, therefore, there are no identifiers on the audiotapes from the meetings. All information is kept in locked file cabinets and there are no identifiers that connect consent forms with questionnaires or audiotapes.