The history of ELSI can be broken down into two major periods, the first goes through the founding of the agency under Jim Watson the second under Francis Collins.
In the first half, 1989-1993, the number of awards to men numbered 51, to women 27. In the second half 1994-1998, men received 36 grants and women 48. The high number of men in the first half is due to an unusual year in 1991 when there were 25 grants given to men, half of the total for that period. A second unusual year was 1994, when women received 18 awards. During the other eight years the differnces are small, although the trend beginning in 1994 is skewed towards women PIs and Social Implications related studies. The male dominated Ethical area has been virtually eliminated from consideration.
Pre-1994 most awards resulted in publication of some kind (video, books, journal articles). From 1994 on the publication production drops off. To some degree this can be associated with long term studies funded in 1994 in the Social Implications area, but there is a clear consequence of the shift in priorities for 1994. The Ethical Implications grants, although a much lower number after 1994, still kept up the level of publication while the Legal Implications area dropped somewhat. The Social Implications area dropped off significantly.
Looking at the general patterns, it is obvious that from 1989 to 1993 we have one direction that emphasized ethics, and cystic fibrosis and counseling (including screening & testing) related awards. Beginning in 1994, the money shifts to women's issues and education. The loss of support for the original areas is dramatic, both in the number of awards and the amount of total dollars, but it follows the five year plans quite closely (see Appendix D for the plans).
The large number of studies and the high level of funding for women's issue's in 1994 subsided the following year, then dropped to zero in 1996. More awards were made each year since, but at lower levels. Cancer related awards, other than breast cancer, follows the same pattern as breast cancer related awards, a sudden appearance in 1994 with an immediate drop off the following year. Breast cancer related funding is about four times the amount of all other cancers.
Education related awards peaked in funding volume in 1994 and 1996 but the number of awards has stayed within a small range over the ten year period.
The number of ethical studies is 26 in the first period and 5 in the second. Ethics lost out in the transition and did not recover, a bit disconcerting since ethics had been the main focus in the beginning of ELSI.
Legal studies appear 20 times in the first period, drop to zero in 1994, but then averages almost 4 per year after (15 in 4 years), giving the appearance of a restoration of funds to an area that had been cut out.
The money granted to conferences (including workshops and seminars) shows a similar pattern, peaking in 1991, steadily decreasing to zero in 1993, with diminished restoration in 1994. Video production peaked in 1991, dropping off to zero in 1995, with only a few awards after that.
There can be no doubt that ELSI has evolved its goals and practices during the first ten years. Beyond the data are the ELSI goals as stated in the Five Year Plans.
At the first meeting of the ELSI working group in September 1989 a set of goals was established as a list of nine "topics of relevance." [Human Genome News, May 1990; 2(1)] The full list is in Appendix A, but seven of the nine topics were concerned with the consequences of newly produced genetic information. The eighth was the issue of commercialization, which later became an unsolvable difference of opinion between James Watson and NIH director Bernadine Healy resulting in his departure. [Cook-Deegan, Robert. The Gene Wars. p340] The last topic was what most of us associate with ELSI, the conceptual and philosophical questions raised by the human genome project.
Genetic information concerns are distributed across areas, such as the discovery and use of the information (privacy and discrimination), and the impact on individuals, for example in genetic counseling, reproduction, and mainstream medical practice. The identification of these areas was reflected in the criteria used to fund the various projects over the years. As policy shifted, the goals shifted and the funding priorities shifted.
The Joint Working Group held first workshop on February 5-6, 1990, at Williamsburg, Virginia, after then Senator Al Gore held hearings about ELSI [Cook-Deegan, Robert. The Gene Wars. p256], four priority areas were established by the participants:
- Cystic Fibrosis Experience
- Insurance Coverage
- Education, Outreach
- Confidentiality Guidelines.
Only the addition of cystic fibrosis was a notable modification with the funding following and then disappearing as the priority was dropped.
By the time May 1990 rolled around, NIH and DOE announced that grant applications were being accepted with a list of five goals of the working group. These five goals showed some changes in thinking in about six months. The first was a generic "stimulate bioethics research and assist DOE and NIH in refining their respective research activities," which was consistent with the original intentions. The second was to "identify issues ... promote public discussion ... and develop policy options to deal with them," still consistent, but with the growth of "issues" to policy development.
The third "reach out to groups likely to be affected by genome research, such as those organized around specific diseases or disabilities" seems to solidify the commitment to Cystic Fibrosis that arose at the February workshop. The fourth goal was aimed as education of professionals and lay groups.
The most interesting change was the new goal "to collaborate with international groups such as the Human Genome Organisation (HUGO); United Nations Educational, Scientific, and Cultural Organization (UNESCO); and the European Economic Community (EEC)"that recognized the importance of the worldwide implications of the Human Genome Project.
In 1991, the first real Five Year Plan was released for the Human Genome Project incorporating ELSI's five year goal: "Develop programs addressed at understanding the ethical, legal and social implications of the human genome project. Identify and define the major issues and develop initial policy options to address them." The wording of the plan carries a subtle, but clear focus: " The purpose of the ethics component of the human genome program is to:
- address and anticipate the implications for individuals and society of mapping and sequencing the human genome
- examine the ethical, legal, and social sequelae of mapping and sequencing the human genome
- stimulate public discussion of the issues
- develop policy options that would assure that the information is used for the benefit of the individual and society."
This put a stake in the ground which moved the focus away from the Joint Working Group to the "ethics component," keeping some of the earlier ideas and ignoring others. The emphasis seems to fall on the implications for people in almost any arena with the development of public discussion and policy. Missing were the mention of specific diseases and international cooperation
The anticipation of problems was desired to head off major negative affects. In order to do this, a set of objectives was presented in addition to the above goals. The first two were for academics, to provide research grants and to support conferences and workshops. The issue of conferences soon raised complaints concerning the value of the expenditures of funds that resulted in severe cutbacks in conference support. The last three were oriented towards the public, the gathering of public testimony, the development of educational materials and the fostering of international cooperation.
The Five Year Plan 1995-1998 had a dramatic impact on ELSI's funding awards. Tables shown later will show the impact clearly. The hints of change are in the text: "Initial policy options for genetic family studies, clinical genetic services, and health care coverage have been developed and reports on a range of urgent issues are expected by 1995." The work that had been underway was over.
"As the genome project progresses, the need to prepare for broad public impact becomes increasingly important. Policies are needed to anticipate the potential consequences of widespread use of genetic tests for common conditions, such as genetic predisposition to certain cancers or genetic susceptibility to certain environmental agents. The new direction has been announced. In fact the actual funding policies had already been changed, as evidenced by the sudden, large increase in funding for breast cancer related projects in 1994.
The new set of goals were a bit more general in nature;
- Continue to identify and define issues and develop policy options to address them
- Develop and disseminate policy options regarding genetic testing services with widespread potential use
- Foster greater acceptance of human genetic variation
- Enhance and expand public and professional education that is sensitive to sociocultural and psychological issues
Policy is now two of the four goals, education is still there and the concept of human variation is introduced as a goal. The missing parts now include ethics. The sudden drop of ethics related funding will be shown with tables and graphs later. These changes reflect the change of the personnel in the most influential positions in both the Human Genome Project and within ELSI.
This research has independently documented the NIH ELSI awards, with a Web accessible database of the abstracts, with information on finding, publications, gender distribution and other analysis. The door is now open for further research in topics such as the evaluation of the publications and perhaps an insider's view of the actual awarding of funding that would explain events like 1994. A review of the Department of Energy's role in ELSI is another important topic that should be researched. There is no question in the author's mind that ELSI itself is of great importance for everyone. The knowledge of the human genome is bringing great promise and great threats. The discussion of how we handle this knowledge means everything to our species.