Chapter 6: Emerging Technology: Informatics, Biobanks, Nanotechnology, Neuroethics

 

INTRODUCTION

This is the second chapter of this book devoted to new and emerging technologies. An examination of some emerging technologies at either end of a spectrum will be made: at one end is the imminent technology of informatics in the digital age; at the other end are technologies that are, to a large extent, yet to be actualized.

Medical information in the digital age is changing. The nature of the information is the same but the storage, manipulation and sharing of information is undergoing great change and keeping pace with the ever more rapid enhancements in information technology. The shift from the paper chart to digital record keeping is afoot, and it is inevitable. The discussion will start with the benefits and pitfalls of the Electronic Health Record (EHRs), the ethical issues that attach to this technology, and the policies and legislation that is in place in Canada to manage these issues. Next from information databases to portable informatics and implantable chips, the Canadian perspective and experience will be revealed. Carrying on in the theme of data banking, discussion will turn to biobanking and some of the Canadian initiatives in this field.

At the other end of the spectrum, from the known and evolving technology, discussion turns to the theoretical, the unknown and the sometimes scary, nano-world. Nanotechnology is difficult to define but some of the ethical concerns are clear. While this technology is not yet fully realized in the world, the Canadian perspective and the initiatives to prepare for it are discussed. The new millennium has been described as the age of the brain; rapid advances in neuroscience have opened strange doors and given us a glimpse into what makes us—“us”. Our consciousness is our defining trait and new neuroimaging techniques give us insight into the process of thinking itself. Furthermore, manipulation of brain and mind through surgical and stimulation techniques threatens to change our consciousness, how we define ourselves, and what we can become. While neuroethics problems are, by and large, yet to be seen, it will repay any society to ponder and prepare for these issues before they arise.

MEDICAL INFORMATICS

We live in a digital age. Our lives have been forever changed and shaped by computing and information technology. The record of our lives is increasingly being rendered into 1’s and 0’s and stored, possibly beyond our own ends, potentially forever. Seekers of the Holy Grail likely did not conceive of immortality along these lines, but it will be left to philosophers to discuss these weighty issues. This discourse will concern itself with the records of the living, and the impact that these recordings have on their lives and on the greater society. For better or for worse, the information age is here to stay and the issues of the emerging digital technologies in health care must be confronted.

Computers are an integral part of any health care facility. Where once they were a luxury, they are now indispensible and, indeed, access to databases, medical references, and the World Wide Web are now the standard of care in the industrialized world. The incoming generation of health care workers will not remember a time without IT in the workplace. Electronic Health Records (EHR) and Electronic Medical Records (EMR) are becoming a firmly entrenched part of that landscape. In defining these terms this discussion will adopt the terminology set forth by the American Institute of Medicine.1 Electronic Health Records are generally understood to be a more comprehensive health record of a person’s life; a record of many aspects of the person’s health and wellbeing  which could potentially contain demographic, environmental, familial, social data etc., in addition to a record of evolving health issues. An Electronic Medical Record, on the other hand, is a narrower construction of an individual’s medical history; a typical example is a patient chart found at a hospital or a doctor’s office.

More and more health care practitioners and institutions are adopting EMRs as a practical way of storing and using patient medical information. There are, however some very significant barriers to the adoption of EMRs and EHRs in the industrialized world. These include, first and foremost, practical logistic and financial barriers, as well as difficulties in digitizing existing records and converting clinics and institutions to a completely new system. There are also great difficulties encountered due to a paucity of practical standards to adhere to in implementing these changes, and it is here that some of the ethical problems arise.2

Canadians are firm defenders of their beloved universal health care system. But while they enjoy the single payer model of health care, the adoption of universal health care standards, and the portability of their health care coverage throughout Canada, there is, nonetheless, a certain apprehension about the keeping of comprehensive databases of personal information. Canadians have perceived an erosion of their personal privacy over the last 20 years but remain firm and vocal about their privacy rights, and the confidentiality of their information.3

Despite these concerns, a very comprehensive report on the status of health care in Canada, undertaken by former member of parliament and cabinet minister Roy Romanow in 2002, strongly urged the creation of an EHR system in Canada4, and indeed developments are underway.5 In 2001 Infoways was set up by Canada’s first ministers to facilitate and enhance the adoption of electronic health (“eHealth”) endeavours including national adoption of EHRs. Despite Infoway’s goal of having 50% of Canadians accessing HER’s by 20106, Canada still lagged behind much of the industrialized nations on eHealth matters, ranking 21st of 159 nations worldwide.7, 8 This poor showing has been attributed to weak federal initiatives, poorly crafted policy, and a lack of accountability.7

One concern with digitized health records is with privacy issues (digitized information being more easily copied, shared or stolen than paper records). Increasing concern with privacy has led to an increase in legislation. The Office of the Privacy Commissioner of Canada is a Government office that helped forge the Personal Information Protection and Electronic Documents Act (PIPEDA).9 While this act is comprehensive and well-structured to protect the privacy of Canadians, (especially in areas such as EHR’s), it has many shortcomings. As an act, it is largely untested in the law, it likely does not cover activities undertaken in health institutions such as hospitals, and it is vague in the issue of consent for treatment.5 In addition, by and large, it is provincial legislatures that oversee the delivery of health care and the administration of EHR’s, and PIPEDA is national legislation. A lack of uniformity between provinces (despite the PIPEDA), has added further confusion as to the nuts and bolts practicalities of EHR implementation and oversight.10 Nevertheless, the notion of EHR’s is still a palatable concept for Canadians and seemingly in line with their adherence to a universal health care model. The Canadian Medical Association, seemingly in anticipation of such emerging innovations and changes, established a Health Information Privacy Code to guide practitioners.11 Although penned in 1998, it seems prophetic in its ability to accommodate issues in the brave new world of digitized patient information. Finally guidance is given to researchers and Research Ethics Boards with the Tri-Council Policy Statement which stipulates the correct storage, usage, and retrieval of data from electronic records in research endeavours. Now in its 2nd edition the TCPS2 recognizes the importance of electronic records but privacy or anonymity of information remains of paramount importance in any research protocol.12

On an international note, an inquiry into the state of legislation in this field is instructive to locating the Canadian perspective. The UK and Australia have strict privacy laws and strict oversight of EHR’s. In the US, the monumental Health Insurance Portability and Accountability Act (HIPAA) of 1996, predated the Canadian PIPEDA by 4 years. And yet, there is no strict legislation for EHR’s in the US, the exception being a proposal by President Bush in 2004 that suggested a voluntary national EHR program; several initiatives exist but there is, as yet, no national program.10 The US, the European Union (EU), and Canada have very different privacy laws and very different policies on how to manage privacy. Canada and the EU are very government oriented, controlled, and supervised. In the US, privacy is equated with protection of liberty, whereas in Canada privacy is equated with autonomy over personal information.13

Some of these differences are instructive as to some of the other bioethical concerns that attach to EHR’s in an era of increasing globalization. The HIPAA, and PIPEDA, are acts in individual nations— for individuals in those nations—but their jurisdiction is, at best, dubious outside their respective borders. The US PATRIOT Act14 is one example of legislation that overrides individual confidentiality and privacy concerns. Such legislation has potential application that extends well beyond international boundaries and could impinge on Canadians and their EHR’s.15

Finally, with an eye toward considerations of global justice, there are other bioethical issues with electronic record keeping. Even if the wrinkles of privacy and autonomy have been worked out, there is still the issue of ensuring distribution of the benefits of this technology. There is an increasing gap in the world between the “haves” (who, in addition to all of the other “have” items, also possess more IT resources), and the “have-nots”. EHR’s pose a threat of increasing this disparity and in identifying, isolating, or discriminating against the already marginalized or vulnerable populations.16 This issue, while it is introduced here as an international one, can play out on the national, and local level; the marginalized and impoverished within nations and within communities will feel these effects as well.

A separate but related issue involves not data storage but data portability. It is possible for people to carry huge databases of personal information in formats that are getting ever smaller. Implantable data chips are one example of such technology and these have garnered global attention with much consideration of the risks and benefits that they may hold. The concept is relatively simple: encode personal medical (or other) information in a small microchip and implant it in a person’s tissue, usually just under the skin. With the proper “reader,” this information can be transmitted to health care providers instantly and accurately.

The technology involves the increasingly ubiquitous Radiofrequency Identification (RFID) tag. These tags are placed on retail items to be scanned at checkouts, and in parcels that can be scanned and tracked by courier companies; their usefulness is indisputable in those applications. Information can be encoded on a chip or tag the size of a grain of rice and taken anywhere, or implanted into tissue and taken anywhere. This has proved a tremendous boon to pet owners in finding and recovering lost or stolen pets who have implanted chips. The first time the application was created for human use was by the Applied Digital Solutions Corporation of the US which is now the VeriChip Corporation. The VeriChip received approval by the Food and Drug Administration (FDA) in October of 2004.17, 18 It later received the approval of the American Medical Association in summer 2007.19

Despite this American endorsement, Canadians and the Canadian Medical Association have been lukewarm to the idea.19 Canada has been proactive in regulating RFID technology through the Office of Consumer Affairs, a subsidiary of Industry Canada, but Health Canada does not consider the VeriChip as a medical device. Without the recognition by Health Canada’s Therapeutic Drug Directorate, this device would be unlicensed and unregulated. So while this technology is excellent in the checkout stand and fine for (non-human) animals, the widespread adoption of this technology is a long way off in Canada, and significantly lagging the American initiatives.

Ignoring, for a moment, the possible adverse medical consequences that are possible with such technology (infections at implantation sites, unwelcome migration of the chip once implanted, interference with other medical devices etc.), we must still confront the significant ethical implications of this technology. One must at first recognize the gap in precise legislative and policy directives as the source from which some of these issues will emanate. On either side of the gap clear and uncontroversial applications are possible. On one side, being able to scan and call up an unconscious, or incompetent, or otherwise vulnerable patient’s data would be of enormous value to an emergency room doctor. On the other hand, the surreptitious and covert scanning of private and sensitive data unbeknownst to the chip bearer, is an obvious and potentially harmful abuse. Consider for a moment the person of ill intent using a pirated chip reader, trolling through crowded areas finding those with HIV, or single mothers, or the visitor from out of country. In the grey zone between the extremes, strict oversight, policy, and legislation are called for, none of which exists in Canada.

Abuses of such sensitive information as could be contained on an implanted chip are breaches of privacy and confidentiality that border on international human rights violations. As widespread adoption of this technology is instituted, there may be increasingly coercive means to encourage people to be “chipped”.20 It is not known how implementation of such a system, a system which remains a private sector affair with VeriChip corporation overseeing the distribution and oversight of its product, could be integrated into a single payer universal health care system such as Canada’s. This opens up the range of bioethical problems where business meets government. In this issue specifically, the sustained quality assurance and reliability of this technology has been questioned even for American users21, in Canada, where big business and health care are like oil and water, and where any such minglings are closely scrutinized, it is hard to imagine such a technology without more direct government control.

To fail to mention issues at the other end of the argument would be a disservice to this innovative technology; that is to say, there are staunch advocates of this technology as well. For example, advocates for patients with dementia and for the disabled with communication deficits see implantable chips as a godsend, and any legislation or lobbying to suppress them is tantamount to discrimination against  already vulnerable populations.22

Despite what the Canadian stance will ultimately be on this technology and other forms or portable data technologies in health care, progress in this field will not be undone and VeriChips, or something very nearly like them, are certainly here to stay. Moreover, despite its slow adoption in Canada, Canadians will soon be forced to confront and resolve the questions and issues that attach to these emerging technologies.

BIOBANKS

Storing medical information has a diverse set of problems—as seen in the above discussion—withdrawing information from repositories poses another set of diverse ethical problems. There are, and will continue to be, a growing number of biobanks and information registries as our world moves through new frontiers in data storage, management, and manipulation. It is now possible to store enormous banks of tissue and blood samples for use in research, and staggering amounts of data pertaining to persons and populations. While disease specific and pathology based tissue banks have been in existence for decades, there is a new phenomenon that takes this further with dedicated and concerted efforts to broadly sample large sections of the population for the purposes of current or future research. These programs—called biobanks—are relatively new but are something which Canada has ventured into with bold initiatives and proposals.23

Research in the industrialized (and increasingly digitized) world is moving away from tightly defined research questions that involve temporally isolated applications—it is moving toward work with large population samples and more prospective work that requires the creation and maintenance of biobanks and data registries. The information and samples can be called up and analysed and reanalysed according to the problem du jour, or to query the importance of new information or a new theory on the given sample set. Research, in this way, is moving more toward the linking or unlinking of diseases to genetics and the environment (or any external factor), or perhaps more significantly, to tease out the influences of these parameters independently. Important research is being done on whole populations (geographic populations, disease populations, cohorts etc.) over very long periods of time. Very large sets of data are being drilled down to yield important insights and generalizable knowledge that can potentially influence whole societies. These are research initiatives that go beyond traditional research into therapeutic interventions or narrow inquiries into the nature of particular diseases.

These new directions would not be possible without technological innovation—a new toolset—which permits linking and manipulating datasets. This powerful toolset comes with significant risk to the user and the society it is being used in. There is often a lag in the normative ethical theory about how to manage the issues that arise from new technologies as issues arise unexpectedly. Predicting and resolving these ethical issues is beyond the scope of this text, but certain of these known or foreseeable issues are evident and have practical bearing on Canada, Canadians, and the research environment as it moves into new frontiers. Chapter 8 will pick up and examine some of these issues further.

An example of an evolving biobanking phenomenon is in the collection of umbilical cord blood (UCB). Banked UCB samples can potentially be used for transplants of blood diseases, but the stem cells contained in the cord blood can also be used in stem cell research. Research on the ever growing number of cord blood samples in the two government funded UCB banks (and the many private banks) is an example of biobanking without a clear view of the implications, and without principled guidance in research initiatives. It is simply not clear what the value of banked UCB will hold in the future (neither for research, nor as a supply of stem cells for transplant), nor is it clear what role the Canadian government or the individual provincial health insurance plans should take in directing, funding, or overseeing these ventures.24

In addition to UCB there are other types of banked specimens. There are an ever increasing number of repositories of archived blood and tissue samples in research and teaching institutions for educational purposes and left over from completed research initiatives, and these are now being eyed as rich fodder for future research. Even more importantly there are several biobanking initiatives throughout Canada that aim to acquire broad sample bases prospectively, specifically for unspecified future research endeavours.

The overarching and most stark ethical consideration involves consent. As discussed in Chapter 2, autonomy is a value of primacy in Canadian society, and respect for autonomy of paramount concern to researchers and all the stakeholders in the scientific enterprise. Consent for treatment, and informed consent to participate in research, is woven into the fabric of the principle of respect for autonomy. Biobanks and data registries must acknowledge these concerns and balance the potential good of research with the potential for abuse of an individual’s privacy and confidentiality. They must consider how anonymous the banked samples or data are, and consider how, and to what degree, to link new information with the donors of the samples. While donors must have full disclosure before donating, to what extent this will impact their lives personally and for how long their donations will be used etc., are important yet poorly defined concerns.25 Further bioethical concerns are for the populations of extraordinary, or diseased, or in some way unique persons that bear the brunt of such enduring scrutiny and investigation. Be it for better or for worse, the benefits and the costs that attach to scientific investigation should, in a just society, be bestowed and borne by all members of society, not the populations of the select fortunate or unfortunate few. Research on biobanked specimens has the potential to elevate, alienate, discriminate, or ingratiate several minority groups in society; research must protect the vulnerable and marginalized not provide means of more sharply separating them.

It is these issues the Canadian Institute of Health Research has taken to heart in considering monumental undertakings such as the “Canadian Lifelong Health Initiative” (CLHI) which was proposed in 2004 as a long term (multigenerational) research platform looking at the health of Canadians. A significant component of this study would involve data registries and biobanking. While there is some guidance from the WHO and other international health organizations on these matters, Canada has a dearth of specific policy and legislation in this regard. This is not to say that there is a dearth of case law to inform policy makers and legislators; there are a great many cases that involve all aspects of informed consent that are relevant to prospective research. And Canadians take such matters as genetic testing and future use of tissue samples very seriously.23 The year the CLHI was proposed saw a dip in public opinion toward the banking of things such as genetic material.  In a Government of Canada sponsored survey, Canadians saw merit in banking genetic material, but willingness to contribute was less than 40%; cited concerns were a perceived lack of regulation and oversight.26 The regulations concerning privacy, anonymous data and linking data to biobank donors, have been derived not in the courts as much as in policy statements such as the Tri-Council Policy Statement (TCPS2), Canada’s collaborative document to guide research ethics.12 This document as well as its place in research ethics issues will be discussed in Chapter 8, but an introduction to the issues is particularly relevant here.

While the TCPS was originally designed to guide Research Ethics Boards (REBs)27 in managing protocols for research involving humans, REBs remained largely perplexed and disunited in precisely how to manage protocols and issues that involve biobanks and data registries. Fortunately, the TCPS2 was released in 2010 and provided more guidance on the use of banked specimens.12 As noted above, there has been a shift in research paradigms from the individual research protocol (which sets out to test or illuminate one issue), to research that involves reworking banked information.  REBs have been called upon to answer procedural and policy questions in the creation of such banks and have been thrust into the role of gatekeeper of the information because any proposed research that requires access to the bank must first pass through them. These boards vary in their perceived role in this matter and have found themselves ill equipped to take on this gatekeeper role; the presumption has been that the scrupulous stewardship of biobanks and registries should be left to the administrators of these services, members of REBs have been left wondering just how it has come to be that they are now minding the shop.28 Nevertheless, it has been proposed that until firm legislation is enacted, or government policy established, REBs are the only alternative to safeguard public privacy and confidentiality.29

An innovative and proactive approach to the principled and ethical creation and oversight of biobanks was trialed in British Columbia in 2007 (and a subsequent deliberation was held in 2009). Dr. Michael Burgess of the Maurice Young Centre for Applied Ethics at the University of British Columbia engaged members of the public in a deliberative process, the aim of which was to provide meaningful input into the oversight of current and future biobank projects preserving the values and responding to the concerns of the society in general.30,31 The acronym GE3LS has been used to capture the scope of considerations in this realm: the Ethical, Environmental, Economic, Legal, and Social considerations of Genomic Research.  Public input was felt to be informed, pertinent, and relevant to biobank projects.32 As biobanks and data registries represent an increasing trend and an emerging technology in our digital age, the input of the Canadian public is necessary and legitimate as these technologies will have an ever increasing impact on society, both in terms of their financial costs and potential benefits.

NANOTECHNOLOGY

One of the biggest problems facing any scholarly approach to this subject is to first pin it down and precisely define just what nanotechnology (nanotech) is. Strictly speaking, nanotechnology is the technology involving things smaller than 100 nanometres (a nanometre is a billionth of a metre). A broad definition to be sure, and consequently, since the adoption of the term in the 1980’s, seemingly any (perhaps every) technology that deals with anything small is contained within its purview, at times giving the term dubious credibility as an authentic branch of science. Materials scientists and even microbiologists have at times been recast as nano-scientists and nano-technicians, but it is questionable just how this semantic shift represents a true scientific shift in exploration of a truly new phenomenon. Despite earnest attempts, this slippery subject so far eludes enduring precise understanding of its scope and dimensions; it defies attempts at elucidating a precise taxonomy and the adoption of a uniform lexicon. And as with anything that is largely unknown, fear—and optimism—abound.

Discussion of nanotech in the biomedical arena often involves the notion of “convergence”. The nano-realm is frequently identified as the place where nanotechnology will merge and become indistinguishable from biotechnology. Furthermore, it is thought that this will be the realm of convergence of biotechnology and information technology, and by short extension of this logic, also of cognitive science. Hence the acronym NBIC (nano, bio, info, cogno) convergence. This gives an insight into the sheer magnitude and scope of this technology if fully realized, and a glimpse at just how broad the ethical ripple effect could be for humanity as we know it. This concern is captured by another acronym NE3LM; the ethical, environmental, economic, legal and social issues of nanotechnology.33

Despite what is not known about nanotech, much is known about the nano world and it is here that the foundation for abundant speculation and innovation are found. In the world of the small the subjectively experienced macro level natural forces give way to other stranger forces. Gravity, a well-known and significant force in our experience of the world, gives way to forces we are unfamiliar with such as the surface tension of water.  At the nano level there is a new thermodynamic rule book, there are new and bizarre catalytic capabilities for elements, and new electrostatic properties. Breaking into the nano world is breaking new ground, and this has yielded strange and powerful objects like ultra-strong carbon nanotubules, novel semiconductor materials and a wealth of ideas (some rational, some not) about just what could come next. These ideas and musings are well beyond the scope of this discourse but this introduction is necessary to a discussion of just where these concepts intersect with bioethics and Canadians.

To start with the known and the extant, consider popular existing nanotech applications such as zinc oxide in sunscreen and silver based particles to repel odour in clothing. While these remain rather uncontroversial, they do point up the potential for big nano-problems (a perfect oxymoron). The first place these novel innovations intersect with bioethics is a consideration of how nano-particles, even ones as seemingly innocuous as those above, will interact with human health and the environment. These are legitimate concerns, not because they have been found to be problematic in their application, but because it is entirely plausible that they will be absorbed by and ingested by people and diffused into the environment, and it simply is not known what can happen when this inevitably occurs. There is no data, but with a nod to the first rule of anthropologists, absence of evidence is not evidence of absence.

It is heartening to see that there are genuine and rigorous attempts to fill this void. In the US the National Institute of Safety and Health (NIOSH) is leading the charge in methodically dealing with such questions.34 In Canada, nanotechnology is overseen by Health Canada but authority has largely devolved to various research and teaching institutions that have an interest in developing nanotechnology. Where this technology specifically involves health concerns and health research, the Canadian Institutes of Health Research is involved, but clear leadership and dedicated oversight is absent.35 Unfortunately there is a paucity of research into the NE3LS concerns discussed above.36 Furthermore, with respect to research into nanotech involving humans there is little guidance for Research Ethics Boards (REBs); the first edition of the TCPS (the REB’s guidebook) sheds little light on this area,37 and there is no specific mention of nanotechnology in the TCPS2.12 While there is a lack of explicit and firm leadership in this emerging technological sphere, public opinion has been demanding clearer leadership. BioPortal38, a Government Canada program, is devoted to conducting research on opinions and concerns in biotech related industries. A 2006 survey revealed that most Canadians have a high degree of uncertainty about the leadership and oversight of biotechnology endeavours.39 Nevertheless, as the nanotech industry grows, leadership seems to be taking shape, at least in the institutions responsible for nanotech research in Canada.40

It is estimated that nanotech will represent a $2 trillion industry in the next generation.41 It may have far reaching applications on improved pharmaceutical products, better medical imaging techniques, more precise surgical tools and many unforeseen medical advances.37 But these advances may only be fully realized in nations with trillion dollar budgets and GDPs, and the stage may be set to widen the gap between the industrialized and developing world. If nanotech has the capacity to enhance individuals and societies, what national and international oversight exists to ensure a fair distribution of the benefits, and indeed the risks (as alluded to above) to the citizens of the global village? These are some of the issues UNESCO (United Nations Educational Scientific and Cultural Organization) attempted to tackle in its congress in 2007. One of the main concerns was the creation of a “nano-gap” (and another oxymoron) between the developed and developing world.42

On the issue of enhancement we begin to leave the realm of the relatively understood benefits and pitfalls of nanotech, and enter into a realm of speculation. It will be left to science fiction writers, philosophers and others to fully develop these hopes and fears, but there are considerations relevant to the Canadian public in this realm.  At the fringes of nanotech debates and controversies we often encounter the trans-humanists; those who contemplate that being which would result from a successful convergence of nano, bio, info, and cognitive technologies; those who see nanotech as the passport to the next level beyond human to, perhaps, superhuman. Even if these trans-humanist endeavours are not realized, it is of significant concern that these progressive thinkers are, in many ways, influencing the direction of Canadian research and the allocation of funding.43 Furthermore, even if nano does not turn out to be the Holy Grail, bioethicists must spare a thought for the potentially dangerous core principles driving this research agenda. Worshipping at the altar of trans-humanism leads to a certain type of “ought-ism” reminiscent of other bioethical conundrums that attach to tech-laden innovations: just because it can be done does not necessarily mean it should be done, and not everything that is broken must necessarily be fixed. The CIHR is in fact moving in some of these bold (reckless) directions. 43 But this has not gone unnoticed by the public, and public sentiment does, after all, hold sway in a democracy.

While the research moves in one direction, it is possible that public opinion may in fact derail nanotech before it really gets off the ground. The swirling interest in nanotech has been compared to the hype and panic surrounding Genetically Modified Foods.33 This hype was largely based on dubious science, but in an arena where public opinion holds sway, empirical evidence can often matter less than popularised conspiratorial panic. It is for this reason that Health Canada must take bold steps in disseminating public knowledge and securing public support of nanotechnology if it is to survive.44 A poll in 2006 found that only half of Canadians endorsed GM foods but sadly, and perhaps worryingly, most Canadians did not know enough about nanotech to even comment.39 While there is strong support for nanotech among the tech savvy, there is significant pushback from several groups concerned about the unknown consequences. The ETC Group (Erosion Technology and Concentration) is a Canadian organization (having started in Winnipeg, it is now based in Ottawa with international offices abroad) which has as its mandate, the implementation of a moratorium on all nanotech research until the full impact of such can be fully and completely elucidated. It lobbies governments, performs its own research, and works with civic societies. It has put forward many strong warnings backed by cogent arguments meticulously laid out in its publications.45 So while strong opinions reside on either side of the debate, these opinions are, as yet, largely uninformed. Whether pro or anti-nanotech, advocates on both sides would agree that the way forward is a better understanding of the issues, transparent funding, strong and effective governance, open discussion of ethical issues, consideration of justice and equity, and disclosure of intents and possible applications of the fruits of the research.33

Nanotechnology in Canada does hold great promise, but Canadians and the rest of the world must be educated and informed and must separate fact from fancy. The nano world may reveal powerful new tools and capabilities; Canadians would do well to ponder these even before they reach fruition.

NEUROETHICS

Neuroethics is a term that has only recently, and necessarily, come into existence owing to rapid advance in the neurosciences. Neuroscience, as a term, in turn, is very difficult to capture owing to the breadth and scope of the technologies it encompasses. Neurology, neuropharmacology, neurophysiology, psychology, psychiatry, psychopharmacology: one could add a “neuro” or a “psych” to almost any “-ology” and there would likely be a field of research, and a body of empirical data that is being rapidly generated. As scientists and scholars of the humanities increasingly identify mind with brain, neuroscience takes on an increasingly important role in how we define ourselves ontologically and socially, how we define our health and wellbeing, and how we define our goals values and beliefs. In many ways, we are our brains, and our meaningful world is our “brainscape”.  As the brain becomes less of a “black box” and more understood, how we treat that insight and to what use we put this new knowledge is of the utmost importance both individually and socially. Just what to do with these neuroscientific advances and just how to do it, is the intriguing intersection of science and philosophy; it is neuroethics.

In contemplating neuroethics, we are leaving the realm of the extant and imminent, and entering into the realms of the theoretical and the speculative. Nonetheless, the world seems on a trajectory to realize many of these now potential issues in the not too distant future and for that reason an understanding of the role of Canada and Canadians in this realm must first be an examination of what some of the neuroethical issues, in fact, are. This discussion will briefly introduce issues pertaining to neuroimaging, psychosurgery, deep brain stimulation, and psychopharmacology before turning to a discussion of neuroethics in Canada.46 Once again, the deeper discussion of the issues per se, and the debates that attach, will be left for other bioethics texts, and the focus will remain on the Canadian perspective.

Neuroimaging has advanced significantly in the past two decades from the first computed tomography (CT) scans to the increasing use of magnetic resonance imaging (MRI) in diagnostics, and onward to the functional MRI (fMRI), positron emission tomography (PET) scans, and single photon emission computed tomography (SPECT) scans that not only show structure but brain function. We have the first glimpses into the actual function of brains, a glimpse at not just where the thinking occurs in our brains, but how and, perhaps someday, even what we think. Peering into the minds of our fellow humans is indeed an ethically charged notion; such neuroimaging impinges on privacy and rights every human holds dear. To get from here to there – from our crude imaging techniques which we now employ, to the brave new world of invasive “mind reading” – will not happen overnight and begs for a principled approach to the application and oversight of these technologies as they do emerge in order to protect privacy and dignity. Definitions of “normal” and “abnormal” will be changed and informed by functional neuroimaging. While this may be a boon to treatment, it may deeply offend ones sense of personal identity, open one up to discrimination, or limit access to employment or insurance. Furthermore, recognition of the lag between the data that imaging provides, and the clinical and ethical interpretation is requisite; the scientist and social scientist must tread carefully over the bridge between observation and interpretation.47 A related issue is found in confusion over what to do with incidental findings. 48 The adage: “no one is ‘normal’… just under-investigated,” takes on a much greater meaning in the new neuroethics.

Modern psychosurgery is a giant leap and a welcome departure from the crude beginnings that brought the world the frontal lobotomy. Modern neurosurgical techniques with the use of MRI’s are proving useful in extreme cases of disorders such as OCD (obsessive compulsive disorder) and epilepsy.49 But while society eschews the gross personality changes that accompanied lobotomies, and favours positive changes in curing OCD, there is a vast middle ground that remains very unclear. Just how permissible such surgery is and how it should be administered and regulated, is a topic that is, and will be, earnestly debated by bioethicists. Similarly for deep brain stimulation (DBS): while it holds promise for patients with Parkinson’s disease and OCD, it also holds the potential to change or enhance persons without disease. While it may be a boon to the deeply and chronically depressed patient, now is the time to consider the application of this technology to those who have a desire to feel “good” as opposed to those who have an urgent need to just feel “better”.

It is on these issues of elective enhancement that imminent neuroethical issues are encountered. Presently these concerns pertain not to the invasive procedures noted above, but rather there is growing concern with neuropharmaceuticals, some of which are being used and abused even today. Modafinil50 is a classic example: originally intended for narcolepsy, it has been increasingly being used for “off label” indications by shift workers, truck drivers, students, or anyone that needs to stay awake.49 It is a short leap from the use of mood stabilizers and stimulants for those who “need” them to those who “like” them. Neuropharmaceuticals stand a real chance of increasing use and abuse and threaten to widen gaps between those who can afford them, and those who cannot. Gaps will open between developed nations that can fund their use, and underdeveloped nations that cannot. Gaps will develop between those willing to accept the risk of such drugs, and those who will not. For example, professional sports are filled with the elite who can afford to (or can’t afford not to) take these drugs and afford to elude the anti-doping committees. And gaps will also develop in the way humans see themselves, where once a whole person was composed of a body and a mind we risk being left with only cognitive criteria as the legitimately human. Bioethicists have a heavy burden to shoulder in filling these gaps and answering emerging questions—but that must be left for another discussion.

Many of the ethical problems in neuroscience alluded to above, can be boiled down to a few core issues identified by Canadian neuroethicist, Judy Illes.51 Illes has identified four key areas of ethical concern in this emerging technology:

1. Implications for notions of the self, agency, and responsibility;

2. Social policy related to topics such as brain imaging, cognitive enhancement, and direct-to-consumer marking;

3. Implications for clinical practice;

4. Public discourse and training.52

 

But more than all this, one concern that is particularly relevant to Canadians requires revisiting some of the issues from Chapter 1. Canada has a universal single payer health care system. “Necessary” treatments are insured by provincial health care plans. It is, perhaps, in neuroethics more than the other topics of this chapter that questions in this arena will be raised and issues will need to be confronted. The other topics of this chapter involve existing ubiquitous technology (for example, computer technology), or things that remain in the realm of biotech research (such as nano-technology). But CT scanners and MRI machines and neuropharmaceuticals are a part of everyday health care in Canada. A growing reliance on their increased use will heighten and amplify all of the issues voiced in Chapter 1 with respect to the right to health care, improving access to health care, and also with respect to resolving a means by which Medicare can absorb the tremendous cost entailed by this new technology. As these innovations become less “elective” and more “essential”—as they become less of an option and more of a standard of care—reconciling their implementation with the existing model of health care will become more challenging. Furthermore, neuroenhancement (as distinct from just treatment) has the potential to impinge on arguments, and agitate proponents on either side of debates on public versus private financing and delivery of health care.

In Canada, things “neuro” remain, for the present, more firmly in the realm of science than in the realm of ethics. But with an eye to the future this is changing. At present fully 20% of the Canadian Institutes for Health Research (CIHR) budget is devoted to neuroscience. Furthermore, there has been a strong recognition of the need for collaboration between neuroscience and behavioural science in issues of addiction and mental illness. This has led to the establishment of the Institute for Neuroscience, Mental Health and Addiction (INMHA) and this, in turn, has naturally led to a focus on the marginalized and vulnerable (Aboriginal populations, the addicted and those afflicted with mental illness).53 Neuroscientific advance, and neuroethical concerns, will first be realized in the treatment of existing neuropsychiatric issues: Canada is not alone among developed nations in its overwhelming burden of mental illness and addiction issues and a growing number of neuro-cognitive diseases facing an aging population. Canada has shown a strong international leadership role in neuroscience research and this has incorporated a proactive role for neuroethics. Presently, one of the greatest hurdles in neuroethics is the dearth of public input and understanding. Knowledge translation and dissemination, not just of the science, but of the attendant implications, has been a clear objective of Canadian neuroethics researchers.52-54

Canada is poised to take a leadership role in neuroethics and neuroethics research. There are now several well established institutions that will confront the coming “age of the brain”. The Institute of Neurosciences Mental Health and Addiction (INMHA) of the CIHR has aligned itself with the International Network on Neuroethics (INN) ensuring Canada’s place at the table of international neuroethics activities. The CIHR established a research chair in neuroethics in 2006 to oversee research across Canada. In 2007 the National Core for Neuroethics was established at the University of British Columbia to complement neuroscience advances with neuroethical input.55 Canadian researchers are also aligned with the Neuroethics Society based in Washington, DC.  An initiative funded by the CIHR, the NeuroethicsNET, focuses on neuroethical issues around neuroimaging in the paediatric population, but it also endorses knowledge translation that extends to the whole of this emerging technology.56

Neuroethical input is critical to the wave of neuroscientific advance that the world is now witness to. Unlike any scientific epoch before, the developments in neuroscience will have not only a profound impact on our health and well-being, but will revolutionize our very conception of our species. Moving forward, scientists and philosophers contemplate the integration of neural integration with computers and artificial intelligence; the mind-machine interface poses challenges to our identity and the concept of life. While these interfaces have not been realized, and one can quickly get lost in mere contemplation of such things, these issues will take shape in the years and decades to come. It is on this note that neuroethicists must be at the ready to manage the advances, and face the perils that this technology brings. Canadians have a proactive stance and are well poised to face such challenges.

SUMMARY

This concludes a short walk through a very long and complex topic. This chapter on emerging technology has been an examination of some of the innovations that are with us now, and some of the things we have yet to fully realize in our world.

Management of data is a growing concern in the digital age. Canada is launching into an age of electronic record keeping, and Canadians are keenly aware that this poses issues with privacy and security. While government agencies such as that of the Privacy Commissioner, and laws such as the Personal Information Protection and Electronic Documents Act do much, there are shortcomings. Questions about the ability of these measures to apply meaningfully on a national level (as health care is largely a provincially managed affair), and to what degree these things will both benefit and protect all Canadians (including the marginalized), are questions that remain unanswered. Banking data is one thing, but the portability of data is another related topic. Discussion turned to some of the new phenomena in data access and portability, such as implantable chips that can convey health information. While these have so far met with only lukewarm reception in Canada, it is certain that Canadians will be confronted with new technologies and new issues in the realm of personal data management in the not so distant future.

From data banking to biobanking, the world is entering a new age of scientific investigation. The world is moving away from probing specific problems and specific interventions, and medical research is more and more looking at broader questions of the interaction of genetics and environment, and more and more examining large populations and cohorts—all this relies on large biobanks and manipulation of data derived from them. But forming large repositories of people’s tissue samples and data sets means necessarily facing questions about privacy, autonomy, and protection of the individuals. And it also means consideration of the proper way new data and information is to be transmitted to society, as well as whether and how this information is to be bestowed on the individuals that contribute to the banks. Canada has been at the forefront of these research initiatives, and continues to forge new means of ethically using and managing these new research tools.

Discussion then turned from the known to the unknown with, first, an examination of nanotechnology. A broad and difficult technology to define, its potential dangers and benefits may be equally broad and difficult to define. Canadians lack a complete understanding of nanotechnology, but are rightly concerned about an uninformed and reckless foray into such technology (even if the fruits of such endeavours pay off). There is a sound base of scientific oversight of research and development in these fields; the ethical concerns are not so much for how to manage the existing technology, but rather concern that there will be sound oversight and regulation in place for future development and application.

Canadians have been proactive in contemplation of the implications of another emerging technology, neuroscience. Neuroethics has a secure foothold in Canada, and for good reason, the bioethical issues that attach to potential advances in this field have the potential to reshape our values, our identities and our very being. The implications of new neurotechnology on Canada, and on Canadians, are largely unknown. Neuroscience has the potential to benefit some of the most marginalized Canadians (such as the addicted and the mentally ill), so once more, Canadians must confront precisely how these new and costly endeavours will fit into the Medicare system—that is, identifying just who will be allowed access to them—as the potential for unfair and inequitable distribution looms. Nonetheless, in this and the other topics of this chapter, it can be seen that Canada seems well poised, in the march of progress, to discern the benefits and risks that attach to emerging technologies, and it seems that it has forward thinking and progressive infrastructure to begin to address bioethical concerns as they arise.

 

REFERENCES

1. The IOM deals more with the use of EHR’s than with the nomenclature and definitions, but the definitions and lexicon put in use by the IOM (can be found at http://www.iom.edu/) is largely accepted by scholars in this field.

2. Anderson JG. Social, ethical and legal barriers to e-health. Int J Med Inform. May-Jun 2007;76(5-6):480-483.

3. A large survey conducted by the Office of the Privacy Commissioner of Canada in 2005 confirms and elaborates on many of these sentiments. It is widely available on the internet or on the Government of Canada, Office of the Privacy Commissioner website at http://www.priv.gc.ca/information/survey/2005/ekos_e.cfm

4. Romanow R. Building on values: The future of health care in Canada- Final report. In: Canada H, ed2002.

5. Ries M. Patient privacy in a wired (wireless) world: Approaches to consent in the context of electronic health records. Alberta Law Review. 2006;43(Special Issue: Privacy Law:):681-712.

6. Canada Health Infoway. Annual Report 2009-20102010: https://www.infoway-inforoute.ca/flash/lang-en/ar2009-2010/docs/CHI_AnnualReport_2009-2010_ENG.pdf. Accessed 28 February 2011.

7. Webster PC. Experts call for health infoway “watchdog”. CMAJ. February 22, 2011 2011;183(3):298-299.

8. World Health Organization. Atlas eHealth Country Profiles: World Health Organization; 2011: http://www.who.int/goe/publications/goe_atlas_2010.pdf. Accessed 28 February 2011.

9. Personal Information Protection and Electronic Documents Act.2000.

10. Ries NM, Moysa G. Legal protections of electronic health records: issues of consent and security. Health Law Rev. 2005;14(1):18-25.

11. Canadian Medical Association Health Information Privacy Code can be viewed at CMA website http://www.cma.ca/index.cfm/ci_id/3216/la_id/1.htm1998.

12. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2nd ed2010: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/. Accessed 28 February 2011.

13. Levin A. Privacy law in the United States, the EU and Canada: The allure of the middle ground. University of Ottawa Law and Technology Journal. 2005;2(2):1-43.

14. Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, designed to ease restrictions on the gathering and use of information domestically and internationally, ostensibly to combat terrorism (loosely defined).

15. Kluge EH. Secure e-Health: managing risks to patient health data. Int J Med Inform. May-Jun 2007;76(5-6):402-406.

16. Schrecker T. It’s not (just) about privacy: A new perspective on health databases. Health Law Rev. 2006;12(2):11-17.

17. Barclay L. FDA approves implantable chip used to access medical records. Medscape Medical News. 2004. http://www.medscape.com/viewarticle/491994. Accessed 28 February 2011.

18. Tanne JH. FDA approves implantable chip to access medical records. BMJ. 2004;329:1064.

19. Kondro W. American Medical Association boards implantable chip wagon. CMAJ. Aug 14 2007;177(4):331-332.

20. Foster KR, Jaeger J. Ethical implications of implantable radiofrequency identification (RFID) tags in humans. Am J Bioeth. Aug 2008;8(8):44-48.

21. Sharpe VA. Ethics and indemnification regarding the VeriChip. Am J Bioeth. Aug 2008;8(8):49-50.

22. Niemeijer A, Hertogh C. Implantable tags: don’t close the door for aunt Millie! Am J Bioeth. Aug 2008;8(8):50-52.

23. Caulfield TR, N. Consent, privacy and confidentiality in longitudinal, population health research: The Canadian legal context. Health Law Journal – Health Law Institute, University of Alberta. 2004;65(Supplement):1-47.

24. Plant M, Knoppers BM. Umbilical cord blood banking in Canada: socio-ethical and legal issues. Health Law J. 2005;13:187-212.

25. Boulton M, Parker M. Informed consent in a changing environment. Soc Sci Med. Dec 2007;65(11):2187-2198.

26. Decima Research. Public Opinion Research on Biotechnology: Canada-U.S. Tracking Survey. 2004. http://www.bioportal.gc.ca/ENGLISH/view.asp?x=588. Accessed 28 February 2011.

27. There are various acronyms used for these boards. In the US they are Institutional Review Boards (IRB’s), in the UK they are Research Ethics Committees (REC’s) and in Canada they are Research Ethics Board’s (REB’s).

28. Gibson E, Brazil K, Coughlin MD, et al. Who’s minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks. BMC Med Ethics. 2008;9:17.

29. Auray-Blais C, Patenaude J. A biobank management model applicable to biomedical research. BMC Med Ethics. 2006;7:E4.

30. Secko DM, Preto N, Niemeyer S, Burgess MM. Informed consent in biobank research: a deliberative approach to the debate. Soc Sci Med. Feb 2009;68(4):781-789.

31. The working papers for this project can be found at the Maurice Young Centre for Applied Ethics, GE3LS ARCH website http://gels.ethics.ubc.ca:8213/ge3ls-arch/ge3ls-arch-working-papers/working-papers-face-to-face .

32. MacLean S, Burgess MM. Biobanks: Informing the public through expert and stakeholder presentations. Health Law Rev. 2008;16(4):6-8.

33. Sheremeta L, Daar AS. The case for publicly funded research on the ethical, environmental, economic, legal and social issues raised by nanoscience and nanotechnology (NE3LS). Health Law Rev. 2004;12(3):74-77.

34. NIOSH. Approaches to safe nanotechnology. 2009. http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf. Accessed 28 February 2011.

35. Unfortunately nothing so concrete as the US NIOSH document exists in Canada but information about the involvement of Health Canada can be found at their website http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/nt_factsheet_fichedocumentaire-eng.php and a useful fact sheet published by Health Canada that describes the tree of oversight can be found at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/nt_factsheet_fichedocumentaire-eng.pdf .

36. Mnyusiwalla A, Abdallah SD, Singer PA. ‘Mind the gap’: Science and ethics in nanotechnology. Nanotechnology. 2003;14:R9- R13.

37. Sheremeta L. Nanotechnology and the ethical conduct of research involving human subjects. Health Law Rev. 2004;12(3):47-56.

38. Government of Canada. BioPortal.  http://www.bioportal.gc.ca/english/BioPortalHome.asp.

39. Decima Research. Emerging Technologies Tracking Research. 2006. http://www.ic.gc.ca/eic/site/ic1.nsf/eng/04275.html. Accessed 28 February 2011.

40. The Royal Society of the UK undertook a monumental project investigating the meaning and impact of nanotechnologies in the UK and the world. It resulted in an informative publication, Nanoscience and nanotechnologies: opportunities and uncertainties which was published on 29 July 2004 and can be viewed at http://www.nanotec.org.uk/finalReport.htm . Part of the society’s research involved investigative inquiries into education and government institutions around the globe, one part of this involved a very thorough compilation of the then extant organizations using, overseeing and developing nanotech in Canada, the results of the questionnaire can be viewed at http://www.nanotec.org.uk/evidence/Canada.htm .

41. Canadian workshop on multidisciplinary research on nanotechnology: Gaps, opportunities, and priorities. Paper presented at: Canadian workshop on multidisciplinary research on nanotechnology (Edmonton, Alberta); January 22-24, 2008.

42. Have H. Nanotechnologies, ethics and politics. Paris, France: UNESCO Pub.; 2007.

43. Kerr I, Wishart J. “A tsunami wave of science”: How the technologies of Transhumanist Medicine are shifting Canada’s health research agenda. Health Law Journal – Health Law Institute, University of Alberta. 2008(Special Edition):13-40.

44. Stang C, Sheremeta L. Nanotechnology–a lot of hype over almost nothing? Health Law Rev. 2006;15(1):53-55.

45. ETCGroup. the Big Down- Atomtech: Technologies converging at the Nano-scale: etc Group; 2003: http://www.etcgroup.org/en/materials/publications.html?pub_id=171. Accessed 28 February 2011.

46. This brief list is no way meant to represent a comprehensive treatment of this broad field but is an introduction to some of the salient issues imminently facing bioethicists in the emerging field of neuroscience. The layout of the issues is derived from an excellent introduction to the subject by Walter Glannon (Glannon W. Neuroethics. Bioethics. Feb 2006;20(1):37-52).

47. Fins JJ, Shapiro ZE. Neuroimaging and neuroethics: clinical and policy considerations. Curr Opin Neurol. Dec 2007;20(6):650-654.

48. Racine E, Illes J. Neuroethical responsibilities. Can J Neurol Sci. Aug 2006;33(3):269-277, 260-268.

49. Glannon W. Neuroethics. Bioethics. Feb 2006;20(1):37-52.

50. Modafinil is a stimulant medication that has many trade names. It was originally approved for use in narcolepsy but is seeing an increasing number of approved indications for example, shift workers who need to be alert at off hours, or people with daytime drowsiness associated with sleep apnea. It is also seeing many new and broader “off label” uses by people doing prolonged shifts of work (ex truck drivers), or people who just want to be more awake or alert (ex students), and it is here that the issue of unregulated enhancement makes its thorny appearance as a bioethical issue.

51. Illes J, Bird SJ. Neuroethics: a modern context for ethics in neuroscience. Trends Neurosci. Sep 2006;29(9):511-517.

52. Secko DM, Burgess M, O’Doherty K. Perspectives on engaging the public in the ethics of emerging biotechnologies: from salmon to biobanks to neuroethics. Account Res. Oct-Dec 2008;15(4):283-302.

53. Illes J. Perspectives and Future Directions: Neuroethics in Canada. Findings Presented to the CIHR. 2009. http://www.neuroethics.ubc.ca/National_Core_for_Neuroethics/INN_Resources_files/Perspectives%20and%20Future%20Directions-%20Neuroethics%20in%20Canada%20090209NC-1.pdf. Accessed 28 February 2011.

54. Illes J, Lau PW, Giacino JT. Neuroimaging, impaired states of consciousness, and public outreach. Nat Clin Pract Neurol. Oct 2008;4(10):542-543.

55. University of British Columbia. National Core for Neuroethics. 2007; http://neuroethics.ubc.ca/index.html. Accessed 28 February 2011.

56. Neuroethics New Emerging Team. NeuroethicsNET. 2003; http://www.neuroethics.ca/cmp_text/?TargetID=2&strCompname=Welcome. Accessed 28 February 2011.

 

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