Due to modern biochemistry and, in particular, recent developments in genomics, proteomics, and bioinformatics, human samples have become the most important raw materials for advancement in the health sciences. Such material has been at the center of fundamental biomedical research for a long time. What is new is its increased usefulness in research with direct clinical relevance, such as the development of drugs. Because of the larger commercial involvement in such research, this has also led to greater economic interests in (...) human biological material and in the information that can be extracted from it. (shrink)

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only (...) compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

Biobanking activities for genetic research purposes have recently undergone nothing short of a small revolution. Many biobanks have left their traditional home of a small refrigerator in a laboratory to reach the unprecedented proportion of large, sophisticated storage centers containing DNA samples from whole populations. As we turn our attention to research on complex diseases and show great interest in human genetic variation and genetic epidemiology, we need to base our research not only on the DNA of small family cohorts, (...) but on larger sample collections, coupled with geographic location, genealogical information, and environmental and medical data. Population genetic research projects are underway around the world. Setting up such large-scale population biobanks is a challenge for any researcher. Population genetic research projects raise legal, ethical, and social issues that need to be addressed properly in order to maintain the trust of the population, an absolute requirement for the success of such research endeavour. (shrink)

Biobanking activities for genetic research purposes have recently undergone nothing short of a small revolution. Many biobanks have left their traditional home of a small refrigerator in a laboratory to reach the unprecedented proportion of large, sophisticated storage centers containing DNA samples from whole populations. As we turn our attention to research on complex diseases and show great interest in human genetic variation and genetic epidemiology, we need to base our research not only on the DNA of small family cohorts, (...) but on larger sample collections, coupled with geographic location, genealogical information, and environmental and medical data. Population genetic research projects are underway around the world. Setting up such large-scale population biobanks is a challenge for any researcher. Population genetic research projects raise legal, ethical, and social issues that need to be addressed properly in order to maintain the trust of the population, an absolute requirement for the success of such research endeavour. (shrink)

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...) by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science. (shrink)

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...) by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science. (shrink)

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss the (...) difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)

Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.