Paved with good intentions: rethinking the ethics of ELSI research.

Author:Seltzer, Daniel
Position::Ethical, legal and social implications research - Report
 
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Introduction

Ethical, Legal and Social Implications ("ELSI") research has been a new constant in basic genomic projects for two decades. In the last 10 years, the inclusion of ELSI research as a required component in a wide range of sponsored basic and translational research projects--from medicine to chemistry--has reassured the public that scientists who receive public funding work closely with academic bioethicists, legal scholars and social theorists to carefully explore the implications of new science. These grants have also inspired a generation of bioethics research on genetics, genomics, stem cells, climate change, synthetic biology and nanotechnology. This article, while celebrating this attention to ethics, raises the issue of whether the structure of funding such work creates inadvertent conflicts of interest and commitment. This paper asks: if the Principal Investigator (PI) of the grant controls the funding of the ethics projects, can ethicists undertake serious, objective reflection and make normative suggestions independently and fearlessly, especially in an economic climate in which reductions in ethics and humanities funding jeopardize other employment?

Ethical issues in science research have concerned both scientists and the public for decades. The first formal designation of funding for study of basic research by federal agencies is most clearly linked to biological advances in the 1950s and 1960s that eventually led to the development of recombinant DNA (rDNA) technology in the early 1970s. Paul Berg of Stanford developed a method of joining fragments of monkey virus SV-40 (a tumor gene) and bacteriophage lambda. Further work, however, was halted due to concerns that this rDNA could find its way into E. coil, the most widely used bacterial species in laboratories, also commonly found in human intestine, and risk infection of lab workers. This concern was deepened by the fact that, at that time, researchers working with rDNA increasingly were biochemists not practiced in the standard safety measures used by microbiologists. Due to concern within the field itself, in 1975 a conference was organized at the Asilomar Conference Center in Pacific Grove, California to discuss the potential biohazards and regulation of rDNA. Known as the Asilomar Conference, this meeting of scientists drafted voluntary guidelines to address the concerns of rDNA technology and research (Profiles in Science).

History of ELSI

The history of the specific funding called "ELSI" began in the mid-1980s as the NIH and Department of Energy undertook the task of mapping out the human genome, under what was to become the Human Genome Project (HGP). Harking back to the Asilomar Conference, those in charge of the HGP, as well as researchers, social scientists and lawmakers, understood that exploring uncharted areas of science was likely to raise a number of complex moral issues for individuals and society (Human Genome Project). James Watson was appointed the Director of the HGP in 1988 and determined that the project would set aside funds specifically to study the ELSI issues arising under the HGP, openly explaining that the intent was to reassure a public concerned with the increasing reach and power of science. Each year, between three and five percent of the funds earmarked for HGP was dedicated to ELSI. From the beginning, the HGP's ELSI program has examined a variety of issues, ranging from privacy, to commercialization, to the use of Genetically Modified Organisms (GMOs) as food. While it was initially contemplated to address the potentially harmful consequences of the project, the HGP and ELSI programs shared the common goal of addressing larger moral issues from the outset; thus ELSI, rather than impeding HGP progress, was "viewed as an important adjunct that would facilitate its success" (Everson 2007, p. 124). The expansion of the ELSI program to a variety of emerging technologies provides evidence of its success. Such expansion includes the National Nanotechnology Initiative, which dedicates approximately five percent of its budget to ELSI issues. The emergence and increasing understanding of the importance of, and funding for, ELSI allowed rigorous consideration of essential ethical questions within emerging science projects.

Issues with ELSI Funding

As with many scientific methods, however, continued practice reveals weaknesses embedded in the ELSI programs' strengths. While the intentions of government support of ELSI are to be lauded, unintended consequences have emerged that must be addressed for serious research in ethics to have power and credibility. While a few centers are funded directly and dedicated entirely to ELSI research (Centers of Excellence in Ethics Research, or "CEER" grants), most of the current funding schemes for ELSI projects result in serious structural conflicts of interest. Specifically, when the PI of the larger grant also controls the finances of its ELSI component, the ELSI faculty and staff are placed in the untenable position of evaluating critically the project that pays their salary.

The problem of ethics centers being funded by the labs they "oversee" was most clearly revealed in the case of human genetic intervention trials. In 1999, while participating in a Phase I clinical trial at the University of Pennsylvania, 18 year old Jesse Gelsinger died from an immune reaction to the viral vector containing a potential future gene therapy to correct X-Linked SCIDS, a defect that was, in his case, fully treatable by diet and medication. It was later revealed that the physician leading...

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