The Ethical, Legal, and Social Implications Program of the National Human Genome Research Institute: Reflections on an Ongoing Experiment

Abstract

For more than 20 years, the Ethical, Legal, and Social Implications (ELSI) Program of the National Human Genome Research Institute has supported empirical and conceptual research to anticipate and address the ethical, legal, and social implications of genomics. As a component of the agency that funds much of the underlying science, the program has always been an experiment. The ever-expanding number of issues the program addresses and the relatively low level of commitment on the part of other funding agencies to support such research make setting priorities especially challenging. Program-supported studies have had a significant impact on the conduct of genomics research, the implementation of genomic medicine, and broader public policies. The program's influence is likely to grow as ELSI research, genomics research, and policy development activities become increasingly integrated. Achieving the benefits of increased integration while preserving the autonomy, objectivity, and intellectual independence of ELSI investigators presents ongoing challenges and new opportunities.

Human Genome Project: Twenty-five years of big biology

“…The HGP thus became the first large-scale research project to include a component dedicated to examining broader societal issues, such as how to protect people's privacy and prevent discrimination. This arm of the project -known as ELSI (ethical, legal and social implications) research -was supported by about 5% of the NIH budget for the HGP 7 . It was the largest ever investment in bioethics research.…”

Ethical and legal challenges of personalized medicine: Paradigmatic examples of research, prevention, diagnosis and treatment

“…Much has been written about the advent of genomics and, particularly, about its ethical and legal implications. 3 The conclusions intertwine with developments in other scientific areas and with broader socioeconomic transformations, which involve complex issues such as privacy, liberty, discrimination and market economics. Therefore, this article can only aim to offer a general analysis on this topic.…”

“…Of these, the Human Genome Project (HGP), due to its massive dimension and the unprecedented attention it received from outside the scientific community has polarized most discussions. 2,3 However, irrespective of how enthusiastic or skeptical we are about the progress that the HGP has already forged, we must not isolate this project from other workpast, present and future. 4 A global analysis of the advances in the area of genetics and genomics highlights one trend that is common to most scientific and technological progress -exponential progression.…”

Aftermath of the Human Genome Project: an era of struggle and discovery

“…Such lack bred concern regarding a number of ethical and legal implications which the ELSI, the Ethical, Legal and Social Implications, program addressed. Of the web of apprehension built around the project, the ELSI program addressed four main areas: the privacy and protection of use of obtained genetic information, the ethicality of methods in transferring knowledge extracted in the lab to the clinic, the endeavor to ensure that all those involved in the project understand the benefits and shortcomings before consenting to participate, and the dedication to educate the public and professional sectors on the matter (Collins and McKusick, 2001;Collins et al, 2003;McEwen et al, 2014).…”