Medical College of Wisconsin

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$450,000.00 for: Other time period
2/15/2006 to 2/14/2007
Percent of funding associated with the use of human subjects: 1-20

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: Expedited
Approving Institution: Medical College of Wisconsin
Most recent approval: 11/10/05
IRB approval number: 510-03

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 412
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

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])

Developing Ethical Practices for Genetics Testing in the Workplace:
An Evidence-Based Approach

ABSTRACT

Over 139 million people are employed in the United States, and careful efforts to protect and promote the health of these workers are crucial to our society's well being and our country's economic stability. In the near future, advances in biomedical science will lead to the development of genetic tests that may be very useful in identifying, monitoring, and preventing many genetically-based health conditions of workers. These tests will not only clarify the presence of disease, but also will help to determine whether individuals have increased susceptibility to health conditions that are linked directly to occupational exposures (e.g., asbestosis, chronic beryllium disease, radiation-related cancers, and lung disease), as well as to other illnesses that often influence worker productivity or performance (e.g., diabetes, heart disease, depression, and substance dependence). Because of these extraordinary potential benefits, it is expected that within the next ten years or so, employment-related genetic testing will be introduced widely in both private and government work settings. Although the importance of such testing is clear, the ethical, legal, and social issues (ELSI) encountered in obtaining, handling, and using confidential genetic information are profound. These ethical concerns have yet to be examined using evidence-based methods.

In a preliminary study funded by the DOE ELSI Program, our research team developed, tested, and administered a written survey and structured interview to assess employee attitudes, preferences, concerns, and decision-making regarding genetic testing in the workplace in a sample of 63 workers at Sandia National Laboratories (SNL) and at the University of New Mexico Health Sciences Center (UNMHSC). Results show that workers expressed serious concerns about the possible consequences of genetic testing in the workplace for themselves in four areas: (1) informed consent for genetic testing, (2) handling and retention of genetic samples by employers, (3) safeguards for confidentiality of genetic information gathered in the workplace, and (4) uses of genetic information by employers in decision-making. Two manuscripts are under review reporting these data and several others are being developed.

Guided by findings from our preliminary study, this proposed study will implement a survey on a website to assesses the attitudes, preferences, concerns, and decision-making about ELSI concerning genetic testing in the workplace of Sandia National Laboratories (N = 250), Los Alamos National Laboratory (N = 250), and the University of New Mexico Health Sciences Center (N = 250) employees. The samples at each site will be stratified by five broad job categories to be sure that we assess workers with different responsibilities and potentially different exposure risks. We will then randomly select 25 workers (five per broad work category) from among the respondents at each site to be personally interviewed with questions similar to those used in the interview of the preliminary study.

The proposed study will generate several work products: (1) a survey instrument and a structured interview instrument that assesses workers' views of ELSI in genetics testing in the workplace; (2) comprehensive data (approximately 300 questions) from three sites (N = 750) that have diverse types of workers of differing responsibilities and exposure risks; (3) manuscripts based on survey and interview results that reflect the perceptions of workers concerning ELSI in the workplace; (4) an annotated bibliography concerning empirical and conceptual publications about genetics issues in the workplace; (5) a day-long conference about ELSI surrounding genetics testing in the workplace; (6) best practices guidelines for genetics testing in the workplace that are derived jointly from the survey data, the annotated bibliography, community and expert consultation, and the conference; and (7) a summary report for the Department of Energy and others that provides an overview of all the work products. We will strive to develop these products to be of immediate practical value to DOE, as well as to other public and private sector employers, occupational health physicians, genetic scientists, and experts in health ethics, policy, and law.