Biobanks and the Public. Governing Biomedical Research Resources in Europe

Biobanks and the Public. Governing Biomedical Research Resources in Europe. A Report from the BBMRI Project BBMRI_Master_Galley.indd 3 2013/06/05 19:35 BBMRI_Master_Galley.indd 4 2013/06/05 19:35 Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) BIOBANKS AND THE PUBLIC Governing Biomedical Research Resources in Europe BBMRI Biobanking and Biomolecular Resources Research Infrastructure BBMRI_Master_Galley.indd 5 2013/06/05 19:35 BBMRI_Master_Galley.indd 6 2013/06/05 19:35 THIS REPORT PROVIDES A SUMMARY OF the research undertaken by the Working Group on Ethical, Legal, and Social Issues (ELSI) of the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) project, a major effort funded by the European Commission and aimed at coordinating biomedical resource collections in Europe. The explicit goal of the ELSI sub-project was to provide guid- ance and advice on the governance of biobanks and biomolecular resource collections. The material presented in the following is based on empirical research—in the form of numerous “focus group” interviews—as well as a series of meetings and discus- sions of the experts participating in the BBMRI/ELSI effort. As such, what follows represents perhaps the most comprehensive collection of materials related to the political and social governance of biobanks and biomolecular resource collections in Eu- rope today. This summary guide was written for a very broad audience, including government officials, medical researchers or biobank practitioners, corporate managers, journalists, represen- tatives of NGOs, and members of the informed public. In itself, this report reflects the main conclusion of our research: In order to be successful in the long term, biobanks must engage with the public. 5 BBMRI_Master_Galley.indd 5 2013/06/05 19:35 6 BBMRI_Master_Galley.indd 6 2013/06/05 19:35 Contents 1. Introduction 9 2. From Pathology Collections to Biobanks 11 3. Biobanks as Universal Research Infrastructures 19 4. Public Opinion About Biobanks in Europe 33 5. Ethics for Biobanks: A New Notion of Consent? 47 6. A Legal and Technical Framework for Biobanks 57 7. Governing Biobanks in Europe Today 63 8. Recommendations: From Ethics toward Participation 71 Notes 79 Appendices 1. Bibliography and References 81 2. Relevant Legislation, Regulations, and Guidelines 85 3. BBMRI Member Organizations 87 4. BBMRI Partner Charter 89 7 BBMRI_Master_Galley.indd 7 2013/06/05 19:35 8 BBMRI_Master_Galley.indd 8 2013/06/05 19:35 1. Introduction Over the past two decades, the explosion in biomedical research since the 1950s, together with important technical advances in high-throughput analysis, has resulted in the creation of an increasing number of facilities for the long-term storage of human cell and tissue samples for research. Despite significant differences in approach, purpose, scale, and scope, these facilities are now collectively known as “biomolecular resource collections” or simply “biobanks”. When “biobanks” were first reported in the European science press almost 15 years ago, they were greeted with a healthy dose of scepticism and, on occasion, with outright fear. At least to some, the proposal by the Icelandic biotechnology firm deCODE to build an exhaustive database of genetic linkages between all Icelanders raised fears of a new kind of “big brother”, with access to our family history and genetic make- up and funded by US American venture capitalists. Since then, much has changed. For example, large biobank projects throughout the world are now aiming at sequencing the entire genome of tens of thousands of individuals. At about the time deCODE started its endeavour, the private company Cel- era Genomics raised around US$300 million to assemble the first full sequence of a single human genome, while a parallel public- sector project spent probably billions of US$ on the same task. Over the past years, the cost of genome sequencing has dropped considerably and, if we are to believe the announcements from a number of companies developing new sequencing equipment, in only a few years the cost of sequencing the entire genome of a person will cost less then a few hundred US$. 9 BBMRI_Master_Galley.indd 9 2013/06/05 19:35 But, while inexpensive genome sequencing may well be a nec- essary prerequisite for a new area of genome-informed, personal- ized medical care, cheap sequencing alone is far from sufficient when it comes to extracting real medical benefits from genome research. Thus, apart from a few singular cases, for many years to come the main beneficiaries of inexpensive genome sequencing will not be patients—but, rather, biomedical scientists. In this new world of clinical genomics, where the entire ge- nomes of tens of thousands of individuals will be readily availa- ble, the role and importance of biobanks—which link physiologi- cal samples to medical and biomedical information, such as whole genome sequence data—will become ever more important. But, future biobanks are no longer simply organizations that collect, and store, peripheral blood samples, and then make them avail- able to scientists and, in this fashion, limit the potential risks— ranging from a breach of confidentiality to the violation of a informed consent agreement—that an investigator faces when dealing with human-derived materials or genetic information. Rather, we believe biobanks will increasingly turn into strong and trusted partners of both medical scientists and the public— and, especially, the invisible community of biobank “donors” or “participants”. * In this report we advocate a novel approach toward biobank governance; an approach where biobanks are no more simply service institutions for the scientific community, but active, and reliable partners of both the scientific community and the public in the pursuit of genomic medicine. * Note that, in the case of scientific research there is, strictly speaking, no “donation” to a different patient. Thus, it has been argued that biobank donors should be more appropri- ately termed “source persons”. In what follows we will continue to use the more common term “donor” or “participant” when referring to individuals who have provided blood or tissue samples, or medical information, to biobanks. 10 BBMRI_Master_Galley.indd 10 2013/06/05 19:35 1. From Pathology Collections to "Biobanks" Collections of paraffin embedded tissue samples, built up since the late 18th century by many pathology institutes across Europe, are the predecessors of today’s biobanks. Materials derived from human bodies have been collected at many sites, and with a variety of purposes, for many decades and, in some cases, even centuries. Pathology institutes started to sys- tematically collect, and store, tissue samples at least since the be- ginning of the 19th century. Since then, sites that collect human materials have multiplied tremendously. Today, there exist many different types of organizations collecting a wide variety of human cells and tissues, and for numerous purposes, ranging from diagnostics to law enforcement. Pathological institutes at university hospitals have collected tissue samples for pathological analysis and further research for over two hundred years. While the collection of pathological tissues often started sporadically and out of curiosity, with the ad- vent of public health as a political concern for nation states in the late 18th and early 19th century, collecting pathological tissues took on a broader political significance. In fact, in some European na- tions collecting pathological tissues was obligated by state health authorities. Technological advances also played an important role in ena- bling these first large-scale collections of human tissues. Fixing tissues with formaldehyde and embedding tissue samples in paraffin wax, both methods invented, and perfected, during the first half of the 19th century, provided a simple, low-cost solution to the problem of long-term storage for pathological tissues. 11 BBMRI_Master_Galley.indd 11 2013/06/05 19:35 These innovations, together with advances in light microsco- py, also helped to turn human tissues into objects of controlled scientific investigation within the laboratory. As a result, during the 19th century, pathology turned into a discipline in its own right at the forefront of research and innovation in medicine. Some of the tissue collections that have been assembled by pathology institutes over the past hundred years are enormous. The Institute for Pathology at the Medical University of Graz, Austria, assembled over three million paraffin-embedded tissue samples. Today these samples are stored and managed at Biobank Graz, the central biobank of the university. Collections at other pathology institutes throughout Europe similarly store significant numbers of paraffin embedded tissue samples. Embedding tissues in paraffin remains a preferred method for the long-term storage of pathological tissue samples even today. Paraffin-embedding as a method of long-term storage was very much linked to the dominant culture in pathological research since the late 18th century. For over two hundred years, pathologists have examined tissues mainly through the visual inspection of tissue morphology. Thinly sliced tissue samples are fixed on glass cover slides, stained with various reagents, and examined through standard light mi- croscopy. Inexpensive, accurate, and perfected over more than a century, this approach remains the standard procedure for tissue examination in clinical practice

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