Volume 4, Issue 5

Introduction For everyone involved in the governance and economics of science and technology the subject becomes more and more complicated. Today's scientific news is increasingly faster replaced by even more astonishing news. New science and technology (S&T) fields and new S&T ‘buzzwords’ appear at an ever-increasing speed. ‘Biotech’ and genetic engineering are buzzwords for many decades with 43,000,000 and 2,230,000 Google hits respectively. In the last few years nanotechnology joined the rank of buzzwords with already 16,300,000 Google hits. The nano-visibility increase influenced the appearance of nano-bio fusion terms and vice versa. Nanobiotechnology generates 538,000; nanobiotechnology 603,000 and nanobio-technology 539,000 Google hits. DNA-Nanotechnology produces 35,700 hits. ‘Synthetic biology’ (synbio) stormed onto the scene in the last two years with already 964,000 Google hits. As the popularity of synbio increases one can expect ‘Nano-synthetic biology’, ‘Nano-synbiotechnology’ or similar terms to increasingly appear. In June 2007 a meeting created the ”Ilulissat Statement Synthesizing the Future a vision for the convergence of synthetic biology and nanotechnology”. The increasing appearance of fusion terms fits the increased move towards and discourse about converging different sciences and technologies. One influential event in this regards was the 2001 National Science Foundation and Department of Commerce (USA) workshop ””Nanotechnology, Biotechnology, Information technology and Cognitive science (NBIC): Converging Technologies for Improving Human Performance”. which coined the term NBIC. The workshop stated: ”The integration and synergy of the four technologies (nano-bio-info-cogno) originate from the nanoscale, where the building blocks of matter are established.”

Introduction Some scientific advances can become realities only with the help of vulnerable people who do not have legal capacity to consent to research. When dealing with legally non-competent adults, practitioners now consider the patient's own wishes more than ever before, and so they have pioneered the practice of seeking what has become known as their ‘assent’ before treating them. Assent has been defined as a person's ‘permission or affirmative agreement to something’. People who do not possess sufficient capacity to make a particular decision entirely on their own may nonetheless have certain psychological and cognitive abilities. Including such people in decisions that affect them directly but without necessarily handing the decision over to them completely, has had a certain moral appeal. Indeed, in many national and international guidelines on research using vulnerable populations, we see the widespread use of this new term, one apparently unsullied with the legal heritage of ‘consent’. In particular, the term ‘assent’ now appears separately from ‘consent’ in certain of these guidelines. For example, ‘assent’ has primarily and predominantly been used in research using children although in some significant documents, the term has been applied to any patient lacking capacity. For example, the World Medical Association's 2000 version of the Declaration of Helsinki states in Article 25: ‘When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative.

Introduction The combination of health and lifestyle data with bodily substances and genetic information has led over the last few years to the creation of so-called biobanks. These biobanks are used to research a large number of diseases of modern civilization and their genetic interactions. One of the best-known projects in this respect is without a doubt the Icelandic biobank, operated since 1998 by a private pharmaceutical company, deCode Genetics, and set up with government support. The database contains family histories and medical records, as well as biological samples taken from a large section of Iceland's homogeneous population. The hope is that this data will allow a correlation to be established between genetic predispositions and the onset of widespread diseases. Other examples of population-based biobanks include the Estonian Genome Project, launched in 2001 by the Estonian Government, as well as the UK Biobank in the UK and PopGen in the state of Schleswig-Holstein in Germany.

I. Preamble The obtainment, preservation and utilisation of human biological material for training and research, but also for other purposes, have long been common practice. Important technical innovations, especially in the fields of human genetics and electronic data processing, today make it possible to collect and compare biological material and personal data obtained from it on a large scale. In this way, important new epidemiological, diagnostic and therapeutic knowledge can now be obtained, which was not possible with the research tools available up till now. Biobanks can thus contribute to an important advance in the further development of medical research, particularly in the health-care sector, but also in the whole field of human sciences.

Introduction The potential use of human embryonic stem cells (hESC) as well as the disposable and destruction of human embryos produced for in vitro fertilization (IVF) as a source for these cells, are interrelated scientific and medical procedures currently surrounded worldwide by deep moral objections. For that reason, I would like to start arguing that in the last few years, prior to become indisputable scientific achievements and despite their promising applications in medicine, the research use of hESC and the related technology of the so-called Therapeutic Cloning became (TC) subjects extremely morally controversial.