Exploring the Key Informational, Ethical and Legal Concerns to the Development of Population Genomic Databases for Pharmacogenomic Research

Introduction As time passes man becomes more sophisticated at unraveling the mysteries and miracles of life. The completion of a high quality comprehensive sequence of the human genome has lead to the discovery of genetic links to complex diseases and the development of target drugs. This field of biotechnology which applies bioinformatics and genomics to the development of pharmaceutical products is known as "pharmacogenomics," literally pharmaco- meaning drug and genomics meaning the study of genes and their function (Binzak, 2003). The digitization of information has moved scientific research from the wet lab to the computer lab. Large scale population based DNA collections, population genetic databases (PGDs), are proving to be particularly useful in sorting through genetic variants and environmental factors in order to discern which permutations are significant contributors to disease. As the scientific and the pharmaceutical communities move forward towards providing "individualized medicines" many legal and ethical issues need to be addressed. The literature that discusses the ethical, legal and social implications (ELSI) of the human genome project (HGP), pharmcogenomics and population genetic databases is vast, ranging from common law rules of ownership and "reach through" agreements to privacy rights and profit sharing. This article focuses on the need to establish a legal structure which creates the proper intellectual property incentives to promote the development of population genetic databases and the ethical standards that must be upheld in creating these databases. This article will describe the database protection laws that impact the development of PGDs together with ethical policies around issues of informed consent can influence the growth of this research. The first section, the Development of the Science of Pharmacogenomics, of this article explains the background of the (HGP), the field of bioinformatics and the main trends in the study of population genetic databases. An Analysis of Intellectual Property in Genomics sets out the intellectual property rules that have been used to create incentives in the development of databases in general and in genomics more particularly. The ethical considerations that are involved in obtaining informed consent are reviewed in the third section, What is Informed Consent: An Ethical Duty and the Conclusion provides an overview of the how policy decisions regarding intellectual property rights and human beneficence can encourage growth in the field of pharmacogenomics. The Development of the Science of Pharmacogenomics The deciphering of the chemical structure of deoxyribonucleic acid (DNA) began with the work of James Watson and Frances Crick in 1953. The study of genomes has been an international project aimed at obtaining a detailed map and complete sequence of a variety of organisms since the late 1980s. Prior to the sequencing of the human genome 20 species' genomes were available for viewing and use on the Internet. The first organisms to be sequenced were viruses. Genetic analysis of sequences of organisms other than Homo Sapiens established a common language of genetics and the similarity of genes meant genetics was being advanced for all species. The HGP is the term used to describe a collective group of projects from around the world organized in 1980 to create an ordered set of DNA sequences from known chromosomal locations and to develop new computational methods for analyzing genetic maps and DNA sequences (Binzak, 2003). In 1988 the Polymerase Chain Reaction (PCR) was devised which greatly increased the rapidity of DNA manipulation. Microarray technology or "lab on a chip" techniques are the more recent biomedical informatics techniques have greatly expanded genome -wide discovery. The data capacity afforded by microarray technology extends the molecular understanding of disease in order to find pathways to modulate it. …