On May 15, DOE's Office of Biological and Environmental Research (OBER) convened a peer-review panel to consider 23 applications for Ethical, Legal, and Social Implications (ELSI) grants to the Human Genome Program. As detailed in the solicitation published on December 14, 2000, the thrusts of the DOE ELSI program included issues associated with genetics and the workplace, storage (banking) of genetic information and tissue samples, education activities, and complex and multigenic conditions. The aims of this solicitation reflect the recommendations from a workshop convened at the end of September 1999. Although the DOE ELSI program focused on privacy and education activities for 10 years, the relatively new emphasis on complex traits reflects the urgency of addressing these issues now that the draft human genome sequence has been completed. The new grants for FY 2001 are the following.
Regulation of Biobanks: Banking Without Checks or Insured Deposits?
Mark Rothstein (University of Louisville) with a subcontract to Bartha Maria Knoppers (University of Montreal)
Explore ELSI considerations emerging from the banking of human genetic materials and information entailing, in the words of the application, "the solicitation, collection, and storage of human biological materials for purposes that include dissemination for research." The four forms of biobanking to be considered—classical, population, commercial, and virtual—are acutely important topics that are likely to spur legal disputes as well as legislative interest This is particularly timely with the recent completion of draft human genome sequences by the publicly funded consortium and Celera Genomics. Biobanking raises many troublesome issues since biological resources can be solicited for a clearly delineated purpose but saved and, months or years later, used for other purposes. [3 years]
The Age of Genes: The Science of Your Life in the New Genomic Era
Barbara Wold (California Institute of Technology) and Peter Baker (Baker and Simon Productions)
Create, produce, and air four 1-hour programs for public TV. The overarching goal is to contribute to public understanding of science by exploring questions, both scientific and ethical, about the impact of recent developments in genetics and genomics. Additional products will include outreach materials and a Web site to extend the impact of these programs beyond the broadcast dates. Efforts to contribute to public understanding, based on first-rate scientists discussing the realities of genome science have long been a priority of DOE ELSI. [2 years]
Ethical and Legal Issues Arising From Complex Genetic Disorders
Lori Andrews (Chicago-Kent Law School)
Identify and delineate ELSI associated with common complex (multigenic) disorders and traits. Genetic testing for certain single-gene traits and disorders (e.g., Huntington's Disease) has progressed and ethical protocols and procedures have been developed, but for the much more common complex conditions, this has not yet happened. The challenges of genetic testing for common complex conditions and disorders, the ones most people are concerned with (among them heart diseases, mental illnesses, cancers, and numerous others), are challenging and have not received sufficient analysis. [1 year]
Our Genes/Our Choices
Richard Kilberg and Barbara Margolies (Fred Friendly Seminars)
With NGHRI and other funders, support the development and production of three television programs for PBS based on panels of distinquished scientists and ethicists in a moderated discussion format. The three sessions will be "Whose Genome Is It, Anyway?," Making People Better, Making Better People," and "Biology, Destiny, Responsibility." Each of these will address important issued related to genomics, genomic data, and its use. [2 years]
Assessing Models of Public Understanding in ELSI Outreach Programs
Bruce Lewenstein (Cornell University)
Examine and evaluate the overall impact of ELSI on the public understanding of genome science by a retrospective evaluation of selected material produced with ELSI funding. A stated assumption of ELSI has always been that greater access to information will lead to more knowledge about ELSI, which in turn will lead to an enhanced ability by individuals and communities to deal with these issues. It will be very useful to learn more about the effectiveness of ELSI outreach and, more important, to gain insights into ways to increase the value of future efforts. One key benefit will be an assessment of the continued use of materials produced by previous outreach methods. [2 years]
GeneClinics Primer for Clinicians
Roberta Pagon (University of Washington)
Build on the impressive Web-based GeneClinics/GeneTests projects that catalog genetic diseases and genetic testing. This work will provide a basic primer to make the information in GeneClinic accessible to a broader group of professionals. Existing glossaries are inadequate, and this primer is expected to be a useful addition to the existing Web sites, which get more than 2800 "hits" each weekday. Enhancing the usefulness of these sites will aid the medical community in better understanding the impact of the many advances anticipated from HGP progress. [2 years]
Enhancing the DNA Patent Database
Leroy Walters (Georgetown University)
With cofunding from NHGRI, build a robust algorithm that will enable anyone to search a database of patents issued for genes and DNA sequences. The database already exists, but it is difficult to use because searching tools are either poorly designed or proprietary (and therefore unavailable). This work will make a significant contribution to the ability of researchers and others to use an important database. [1 year]
Cynthia Needham (ICAN Productions)
Produce a treatment for a proposed public TV documentary on nanotechnology, especially nanotechnology that involves biology. An additional aim is to incorporate the ELSI of research into nano"bio"technology. This new field, nanotechnology, promises remarkable new developments of which no one, to date, has given much thought to the societal implications. This program will start the thinking process in a timely manner. [1 year]
Creating and Distributing Your World Materials about Microbial Genomics
for 7th to 12th Grade Audiences
Jeffrey Davidson (Biotech Institute)
Produce a 16-page booklet, profusely illustrated and geared for 7th to 12th graders, on recent developments in microbiology, which is undergoing a revolution sparked by genomics and catalyzed by the DOE Microbial Genome Program. Distribute copies to biology teachers in Mid-Atlantic junior high schools and middle schools by early 2002. A teachers' guide also will be produced. [1 year]
The DOE ELSI program made its first awards in Fiscal Year 2000, 11 years ago. At a joint NHGRI-DOE "Decade of ELSI" workshop in January 2001, the remarkable work of both NIH and DOE was on full display. Just as the progress in the Human Genome Project has raced ahead of expectations, ELSI must try to keep pace. This is a daunting challenge. The completion of the draft human sequence by the international Human Genome Sequencing Consortium, in parallel with Celera Genomics, will lead to even greater proliferation of new genetic tests and insights. This, in turn, will heighten the challenges of dealing with the privacy and confidentiality issues these developments already have spotlighted. Thus the aims of ELSI programs (to clarify the science and its implications for physicians, policymakers, courts, and, most important, the general public that pays the bills; and to address the many difficult challenges that arise) remain "unsolved." Perhaps expecting "solutions" is naive; even if ELSI "products" are only clearer perspectives, insights, and definitions of what we face, however, then the programs have been successful.
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.
Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.