ELSI
Related Terms
CEER, Centers of Excellence in ELSI Research, ELSI, HGP, Human Genome Project, National Human Genome Research Institute, NHGRI.
Background
The National Human Genome Research Institute (NHGRI) established the Ethical, Legal and Social Implications (ELSI) Research Program in 1990 as part of the Human Genome Project. The purpose of the ELSI Program is to promote research on the ethical, legal, and social implications of genetic and genomic research by funding and managing studies and supporting workshops, research consortia, and policy-related conferences on these topics.
In a related initiative, the NHGRI, the US Department of Energy, and the National Institute of Child Health and Human Development (NICHD) launched the Centers of Excellence in ELSI Research (CEER) in 2003. The CEER are intended to bring together experts in many fields to address important ethical, legal, and social issues related to research in genetics and genomics.
A continuing challenge to ELSI Program is to explore ways in which to maintain the balance between the acquisition of information and the acknowledgement of important ethical, legal, and social issues, such as the protection of individual privacy.
Methods
The ELSI Program is to promote research on the ethical, legal, and social implications of genetic and genomic research by funding and managing studies and supporting workshops, research consortia, and policy-related conferences on these topics.
Research
As part of its mission, the Ethical, Legal and Social Implications (ELSI) Research Program of the National Human Genome Research Institute (NHGRI) is charged to conduct projects in the following areas:
Intellectual property issues of access to and use of genetic information: These projects will provide a forum for debate about the effects of laws, regulations, and practices regarding intellectual property on the development and promotion of genomic technologies and related products, as well as public access to this information.
Ethical, legal, and social factors influencing use of genetic information to improve health outcomes: These projects relate to access to and use of new genetic information and technologies for the improvement of human health. Current understanding of how genetic factors influence health remain limited in many areas, and more research is needed in order to provide guidance on how to use genomic information to improve individual or public health. This methodology relies on two lines of inquiry. One relates to the examination of the theoretical steps by which genetic risk information can lead to improved health. The second line of research will determine the value of new genetics tests and interventions in light of cost and access.
Conduct of genetic research: These projects relate to the development of policies for the application of genomics in medical and nonmedical settings, and should address the public's desire for more sophisticated scientifically based methods on improving health but also the possible misuse of these techniques. This process will involve research and policy development from individuals outside the medical industry.
Use of genetic information and technologies in non-healthcare settings: These projects look at the ethical, legal, and social implications of applying genetic information and technology in non-healthcare settings. Such settings may include the workplace, the insurance industry, education, adoption agencies, the criminal justice system, and civil courts.
Impact of genomics on concepts such as race, ethnicity, kinship, and identity: These projects deal with the integration of genomics research with the complex notions of race, ethnicity, kinship, and individual and group identity. The use of genetic information to define biological traits is often subject to misinterpretation. Research is needed in order to determine how race is perceived by different individuals and cultures, and how these groups view the role of biology and genetics in determining racial traits.
Finding genomic contributions to human traits and behaviors: Projects in this area will conduct scientifically based research to investigate the implications of revealing information on genomic contributions to diseases, nondisease traits, and behavioral traits such as cognitive functioning, mental illness, and aging. This research will work to understand the social implications of genomics-based research conducted to examine human traits and behaviors.
How different individuals, cultures, and religious traditions view the ethical boundaries for the application of genomics: Projects in this area will require surveillance and an ongoing dialogue to determine perceptions of the ethical boundaries of genomics research in various subgroups and the population at large.
Implications
Various fields of scientific study have raised unique ethical, legal, and social implications (ELSIs) in obtaining and using genetic information. As the various scientific fields and applications utilizing genomics information expand, additional ELSIs may become apparent.
Patients: As individual and population-based genetic information becomes more widely available, individuals will have to be alert to the ethical considerations of genomics-based research and how they might personally be affected. In addition, public policy governing how such research will be conducted and be funded and what information will be available to the general public must be closely monitored to prevent abuse.
Healthcare professionals: Similarly, health professionals will need to consider the implications of genomic research and how they integrate these findings into patient care. In addition, it will be important to communicate with patients what the new information means and how it can be used.
Researchers: Additionally, there are considerations for the research community as well. In communicating this information to the public, it will be important to note not only how these findings are reported within scientific circles but also how they are interpreted and described in the popular press. It will also be important to address the ethical obligations of these various entities in ensuring that communication is thorough and unbiased.
The ways in which information is gathered from individuals and groups will also become a key consideration. Questions include how surveys will be conducted, how individuals will be motivated to participate in them, and how the risks and benefits of such participation will be communicated.
Other: Various other entities may have access to this information, including insurance companies, pharmaceutical companies, employers, healthcare policymakers, environmental policymakers, educational institutions, courts, adoption agencies, and the military. There are laws in place (e.g., the Genetic Information Nondiscrimination Act) that protect Americans against discrimination based on their genetic information, particularly in regard to health insurance and employment. These laws are intended to allow Americans to take advantage of personalized medicine without fear of discrimination. However, this does not necessarily apply to individuals or populations outside the United States and therefore, genetics-based discrimination may very well still be a concern. This information may affect how individuals behave, how they make decisions, how they interact with other entities, and how they are received by other entities. Questions regarding the responsible handling of communicating these messages by the mass media also remain.
Limitations
Not applicable.
Future research
Future research in the area of ethical, legal, and social implications (ELSIs) includes the development of national policies that encourage communication and collaboration among government entities, educational institutions, and industry.
Existing guidelines may serve as a template for how individuals and various groups can deal with the availability of information related to genetics and health and disease. However, future research in the area of privacy of genetic information and the appropriate ways in which this information should be used will be required. Although the Genetic Information Nondiscrimination Act has been signed into law, it protects the interests of Americans and does not extend to individuals in other countries. Furthermore, the ELSIs are not static: issues will change over time as new genomics-based technologies and tests are developed. Law and policy will likely have to evolve with the changing landscape of genetic understanding and application.
Author information
This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).
Bibliography
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The ELSI Research Program Abstracts and Activities Database.
The Ethical, Legal and Social Implications (ELSI) Research Program.