Ethical and Legal Requirements of Transnational Genetic Research
Published by Hart Publishing
ISBN-10: 1849461287, ISBN-13: 978-1849461283
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First, here is the bad news. Readers attracted by this title are in for a stormy and depressing journey. The writing, both in choice of language and sentence construction, is turgid. The problems of 'plain English' start in the six-page introduction, reach a low point in the ethical chapter and only improve slightly in the legal section.
The importance of international collaboration in research which follows up the Human Genome Project cannot be over-stated; worthwhile benefits could soon be realised. People from diverse communities differ in DNA and disease incidence; these differences give clues to the origin and functions of some genes. What a pity if unclear writing deters enthusiasts!
Let me set the scene. Two to three decades ago the chromosomal locations of genes were being mapped and mutation causing Mendelian (single gene) disorders were then delineated. In most communities the conditions were rare; samples from affected families were therefore collected from international sources. We asked permission from the affected families to take DNA samples and to carry out research 'to help to identify their disease gene'. We said that this work would not bring immediate benefit, but might explain the illness better: 'In the future there might be more options'. If research data indicated benefits for participating families, they would be informed. If they wished to explore possibilities (e.g. carrier or presymptomatic tests) they could ask for repeat testing in a service laboratory (i.e. one with validation and quality control procedures beyond those of research). If, later, samples might be used for other purposes we promised to contact them.
Life is more complex now. DNA studies often screen the whole genome for markers which are associated with complex genetic conditions, including cancer. Patients and other participants need to make informed choices about joining such studies and allowing their DNA data to be stored accessibly for future research. Studies often focus on common familial disorders and the approach is 'blunderbuss', i.e. across the whole genome; thus the findings may not only clarify specific risks, but those of which the subject was unaware. Dilemma! There are good reasons to review topics accurately and completely, to research ethically and to summarise the findings clearly.
The senior authors, Professors Forgo and Kollek, are from the Departments of Law and of Technology Assessment respectively of the University of Hamburg. The others are senior research fellows. Their research was funded with about €11 million from the European Commission 6th Framework and was entitled 'Advancing Clinico-Genomic Trials on cancer' (ACGT). The aim was 'to deliver to the cancer research community an integrated clinico-genomic information and communication technology (ICT) environment enabled by a powerful Grid infrastructure. ACGT's vision is to become a pan-European voluntary network or Grid connecting individuals and institutions to enable the sharing of data and tools'.
To do so, ACGT focussed on how to design experiments and avoid biases and errors, how to develop 'methods for heterogeneous...data source integration, including ontologies that facilitate mapping and information retrieval', how to select, check, 'clean' and pre-process genomic and medical data and how to incorporate collaborative approaches to data analysis. Perhaps you now understand my earlier comments about clarity?
Reading this book, you might think that this project involved no hands-on genetic researchers, no clinicians skilled in enabling patients to make informed decisions and no input from European patient organisations such as the Genetic Alliance! My thoughts wandered to the Greek philosophers who wished to find out how many teeth horses had, debating fiercely without opening the equine mouths and counting. You can look at the ACGT website (1) and get details of the multidisciplinary input; this book does not make it clear how expert sources, such as the Childhood Parent Group, participated.
The first of the two main sections, on ethical requirements, does include a useful discussion of models of consent (specified consent, blanket consent, tiered consent) and comes to a compromise model – 'intermediate scope consent'. This latter model is not too different from the approach I summarised in the third paragraph above, but obviously the authors have accompanied it with written advice, which you can examine most clearly on the ACGT website; not in the book.
The good news is that the legal requirements section does give a comprehensive analysis of the European Data Protection Directive (95/46 EC) and of the ways to apply the data protection framework, including anonymisation of genetic data within genetic research networks, expected period of usage of the consent, how to handle death of the patient and data transfer to third parties or third countries.
My own views were coloured by a fascinating five-year experience in the Sultanate of Oman, where the matter of transnational genetic research was debated not in terms of the transfer of data, but on whether any DNA should be sent out of the Sultanate to help the family by genetic testing, often in an international research laboratory which had the necessary experience. This book will not inspire the Omani academics and ethical committees to allow participation by willing Omani families in global genetic research.
My advice is that you do not waste time or money on the book. Go instead to the web addresses (below) to examine the details of ACGT and pick out the elements that interest you most.
If you prefer to read a supportive review by a research fellow from the Max Planck Institute for Comparative Public Law and International Law in Heidelberg, try 'Ethical and Legal Requirements for Transnational Genetic Research', published in the European Journal of International Law (2).
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