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There will be sharing: population biobanks, the duty to inform and the limitations of the individualistic conception of autonomy.

"'Data! Data! Data!' he cried impatiently. 'I can't make bricks without clay.'"

--Sherlock Holmes (in Arthur Conan Doyle, The Adventure of the Copper Beeches)

INTRODUCTION

The principle of autonomy has been the cornerstone of the physician's duty to inform ever since paternalistic practices receded in the second half of the 20th century. (1) In the past, physicians were authorized to withhold

relevant information in an effort to protect their patients from harm. (2) With the advent of comparative judgment, however, physicians were encouraged to consider whether "withholding [...] information [would] result in less harm on balance than divulging it". (3) Eventually, disclosure became a central feature of the principle of autonomy. Practically speaking, the principle of autonomy in the medical field translated to the right (of a patient) to make an informed decision free from unjustified interference by others. (4) According to one conception, to respect autonomy is:

"[...] to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so". (5)

Based on this principle, the less an individual is expected to benefit therapeutically from a procedure, the higher the duty to inform becomes. This is true for cosmetic surgery, organ donation and non-therapeutic research. (6)

In research, Canadian courts have maintained that participants are entitled to a "full and frank disclosure" (7) and that researchers' duties in that regard are as great, if not greater, than the duties owed by physicians in the clinical setting. (8)

The increasingly longitudinal and international nature of research is challenging the feasibility of maintaining such an expansive duty to inform. (9) As researchers rely less on active human participation, and more on cutting-edge technologies that generate vast amounts of data, (10) the parameters of the traditional duty to inform look increasingly porous. This is particularly true for population biobanks, which aim to study data and samples collected on a large population scale and over a long period of time. (11) In these large-scale projects, participants are informed that their data and samples will be used to establish biobanks as resources for future research in health and genomics. (12) It is very difficult to provide full disclosure in the context of a biorepository for future, unspecified research by as-yet unnamed researchers.

Much ink has been spilled in the last decade on the type of consent required for these population projects. Indeed, many have debated whether or not broad consent--a model increasingly used by population studies satisfies the legal requirements of informed consent. (13) Others have focused on operational matters, examining the governance and practicability of both specific and broad consent approaches to population biobanks. (14) In contrast, this article delves deeper into the reasons why many population biobanks have resorted to broad consent and why the current legal duty to inform requirements might be inimical to such projects (in particular) and research (in general).

As will be detailed later in this text, population biobanks are limited in terms of what information they can provide to research participants during the consent process. On the one hand, they are increasingly encouraged to share their findings by providing access to their repositories, but on the other hand, they are unable to provide participants with full disclosure about the future use of their data and samples at the time of recruitment. This is why many of them have resorted to broad consent.

This text will first discuss the role, main objectives and distinct characteristics of population biobanks (Part A). Secondly, it will provide an overview of international, regional and Canadian normative documents, both legislative and non-legislative, addressing the significance of sharing data and samples, which lie at the heart of why biobanks are using the broad consent approach (Part B). Third, the duty to inform in non-therapeutic research will be outlined through readings of Halushka v University of Saskatchewan and Weiss v Solomon. This analysis will outline the requirements of a heightened intensity of disclosure in research, and will be contrasted with the limited information population biobanks provide to participants on the sharing of their data and samples (Part C). Part C will also examine the cause behind this amplification of researchers' duties, which I assert is an individualistic conception of autonomy, incompatible with the objectives of research (in general) and population biobanks (in particular).

A. Population Biobanks: Definition and raison d'etre

With the recognition that common diseases result from a multitude of interactions between genetic variations, lifestyle and the environment, recent research initiatives have evolved from the study of single genes to

(iv) it receives and supplies materials in an organized manner". (20)

Examples of national population studies include Quebec's CARTaGENE project (20,223 participants aged 40-69 years) (21) and UK Biobank (500,000 participants aged 40-69 years). (22) In both studies, individuals representative of the population at large are randomly selected to participate in the research project. (23) Other population biobanks recruit their participants via clinicians. This is notably the case of the Estonian Biobank (51,535 adults aged 18 years and older) (24) and the Lifelines Project in the Netherlands (165,000 participants, across three generations). (25) Also emergent in recent years is the establishment of infrastructures networking population biobanks together. The Biobanking and Biomolecular Resources Research Infrastructure ("BBMRI") (pan-European, 53 member consortium) (26) and the Canadian Partnership for Tomorrow Project ("CPTP"), a pan-Canadian research study of five cohorts (including CARTaGENE) exploring how genetics, environment, lifestyle and behaviour contribute to the development of cancer and other chronic diseases, (27) are cases in point.

The data and biological samples collected through these various projects will constitute a reference map for local and international researchers, allowing them "to validate, compare, or replicate their studies or use the data and samples as controls". (28) While such cooperation could arguably be considered as a scientific imperative, (29) what do ethical and legal normative documents tell us about the sharing of data and samples? The following section highlights the importance given by international, regional and Canadian norms to this notion of access and international collaboration.

B. Maximizing Collaboration in Population Biobanks

To achieve the statistical significance needed to investigate gene-gene, gene-disease and gene-environment interactions over time, large numbers of samples and data are required. (30) Only collaborative efforts in population studies can achieve such breadth. (31) As will be detailed below, providing access to data and samples is not only seen as a scientific necessity, but is also increasingly supported by ethics norms. This view is consistent at the international, regional and Canadian levels. The documents retrieved and referenced in this section were collected using the PopGen Module (32) of the HumGen International Database, (33) a database of guidelines and policies specific to human genetic research. The PopGen module is a specialized database composed of laws, guidelines and policies addressing the legal and ethical issues in biobanking. These collections of documents are divided into three jurisdictions: international, regional and national. Regional here refers to norms adopted by European organizations. As our discussion will focus on Canada, review of national documents is limited to Canada. The keywords "biobanks", "sharing" and "access" were used. I retained results not necessarily specific to population biobanks, but pertinent to biobanking in general as it concerns the sharing of data and samples. Some of the documents analyzed are legislative in nature, but most are ethics norms emanating from international, regional or Canadian organizations.

1. International Instruments

The issue of access to genomic materials through collaboration has been widely examined in international instruments, often prospective in nature. As early as 1996, the Bermuda Principles (34) recommended that all human genomic sequence information be freely available in the public domain in order to encourage research and development and to maximize its benefit to society." (35) In 1998, the Human Genome Organization's ("HUGO") Ethics Committee's Statement on DNA Sampling: Control and Access (36) stated that research samples obtained with consent may be used for other research if "there is general notification of such a policy, the participant has not objected, and the sample to be used by the researcher has been coded or anonymized". (37) In 2002, the HUGO Ethics Committee's Statement on Human Genomic Databases (38) proposed that "the free flow of data and the fair and equitable distribution of benefits from research using databases should be encouraged". (39)

In 2003, the Bermuda Principles were revisited in the Fort Lauderdale Rules, (40) which recognized that "the scientific community will best be served if the results of community resource projects are made immediately available for free and unrestricted use by the scientific community to engage in the full range of opportunities for creative science". (41) Community projects, like population biobanks, were defined as research projects "specifically devised and implemented to create a set of data, reagents or other material whose primary utility will be as a resource for the broad scientific community". (42) The above-mentioned principles have been reaffirmed by other statements, notably the 2008 Amsterdam Principles, (43) which recommended expanding application to other types of data (e.g. proteomic data), and the 2009 Toronto Prepublication Data Sharing Statement, (44) which reiterated their value for a wider group of stakeholders (e.g. cohorts, tissue banks).

Some guidelines have encouraged a stronger initiative from states, such as UNESCO's International Declaration on Human Genetic Data (45) which upheld the need to regulate "in accordance with their domestic law and international agreements, the cross-border flow of human genetic data, human proteomic data and biological samples so as to foster international medical and scientific cooperation and ensure fair access to these data". (46) In October 2009, the Organization for Economic Co-operation and Development (OECD) published its Guidelines on Human Biobanks and Genetic Research Databases (HBGRD), (47) which expressly address access issues. The Guidelines state that the "operators of the HBGRD [i.e. the biobankers] should strive to make data and materials rapidly and widely available to researchers so as to advance knowledge and understanding". (48) More specifically in regards to access, the Guidelines on HBGRD propose mechanisms to ensure the validity of access procedures and of applications for access. Most importantly, they recommend that access policies be "fair, transparent and [...] not inhibit research". (49)

2. Regional Instruments

At the regional level, access to data and samples has been addressed by the European Society of Human Genetics ("ESHG"). Its recommendations on Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues (50) state that, provided confidentiality is protected, there is an ethical imperative to promote access and exchange of information. Indeed, Recommendation 17 states that "the value of a collection is proportional to the amount and quality of the information attached to it. The full benefits for which the subjects gave their samples will be realized through maximizing collaborative high-quality research". (51)

On a similar note, the Council of Europe's Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin encourages the transborder flow of biological material and associated data if the recipient state can ensure an adequate level of protection. As concerns access, the Recommendation affirms that member states should take appropriate measures to facilitate access by researchers to biological materials and associated data stored in population biobanks". (52) Accordingly, the European Commission recommended in its 2012 report Biobanks for Europe--A Challenge for Governance that "greater investment should be made in the development of e-governance tools to embed 'ELSI [ethical, legal and social issues] by design' solutions, which can be used to augment existing governance structures and facilitate the sharing of samples and information between biobanks and researchers at a meta-level". (53)

3. Canadian Instruments

Canada has guidelines that partially address access and international collaboration. For example, Health Canada, in its 2011 Guidance for Health Canada: Biobanking of Human Biological Materials (54) stresses the importance that requests for access to biobanked samples should be handled in a timely and equitable manner in order to facilitate high quality scientific activities". (55)

Another important Canadian normative document is the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans ("TCPS 2"). (56) This document, while not legislative, has a binding effect on the institutions and its researchers financed by Canada's three federal agencies: the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada. The TCPS 2 addresses genetic research involving communities and has a chapter on Human Biological Materials Including Materials Related to Human Reproduction. The latter underscores the importance of access and collaboration between researchers by highlighting that:

"Access to stored human biological materials--and associated information about individuals whose materials are banked--can be particularly useful in helping researchers understand diseases that result from complex interactions between our genetic makeup, environmental exposure and lifestyles". (57)

Along the same lines, Quebec's Network of Applied Genetic Medicine's Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations (58) promotes open access to biobanks under the principle of freedom of research, subject to certain conditions. It also promotes collaboration between foreign researchers and the dissemination of research results.

These international, regional and Canadian instruments appear to provide an adequate normative basis for the sharing of material embedded in the mission of population biobanks. Data and samples may be shared with the research community in a fair, efficient and ethical way to facilitate high quality science and to maximize the benefits from the participation of altruistic individuals. The remaining issue is determining the degree of completeness of the information provided to the participants regarding the future use of their data and samples. Indeed, given that these projects are built for future unspecified research by as-yet unnamed researchers, population biobanks have resorted to the use of broad consent. (59) The term "broad consent" or "general consent" means "consenting to a framework for future research of certain types" (60) and pertains "to a bank or research infrastructure whose possible uses are not all known at the start". (61)

While no Canadian courts have decided on the legality of this type of consent in research, broad consent's detractors argue that the key element of consent, that it be informed, is not satisfied. (62) They claim that donors only receive "information on general categories of foreseeable problems [...] and benefits [...], but they get no information about the specific research that will be done with their samples [...]". (63) On the other hand, other authors have maintained that as "long as the broad consent is thorough and includes a discussion of the goals and relevant process", (64) such as "the manner in which tissues will be conserved, the mechanisms for the security of data, and the ongoing governance structures for access and ethics monitoring", (65) broad consent could be considered as informed. They add that considering the nature of such an endeavour, this type of consent strikes a useful balance between valuing the rights and interests of donors and promoting research. (66) Most importantly, while a certain degree of openness is favoured in this type of consent, its proponents insist that such openness is not a "carte blanche" (67) and should be accompanied by additional security and governance mechanisms. (68) 69 Moreover, these population cohorts usually recontact the donors for repeat questionnaires and samples, "thereby providing an opportunity for renewing consent and the right to withdraw through participant response over time". (69)

A number of international, regional and national normative documents (non-legislative in the case of Canada) are open to the use of a broader consent approach in projects such as population biobanks (see examples in Table 1), suggesting that a broader disclosure is accepted in practice in certain jurisdictions. In Canada, the question remains: can broad consent be reconciled with the legal requirement set out by Canadian courts of full and frank disclosure for non-therapeutic research? Section C will discuss the jurisprudential requirement of full and frank disclosure and evaluate the shortcomings of the individualistic conception of autonomy that underlies this amplification.

C. From Paternalism to the Principle of Respect for Autonomy: The Evolution of the Medical Duty to Inform in the 20th Century

As mentioned earlier, respect for autonomy is now at the core of the medical duty to inform. Since the second half of the 20th century, patients have become central contributors to the therapeutic decision-making process. For centuries before that, a certain conception of medical beneficence and a pledge from physicians to do their best to protect patients from harm paved the way for paternalistic practices. (70) What are the characteristics of medical paternalism and why did it wane? What made the principle of autonomy rise to prominence, and what consolidates its place in the medical setting? This section will briefly examine the concept of paternalism and highlight its shortcomings in the medical context. It will then discuss the emergence of the principle of autonomy as the basis of the medical duty to inform.

Contemporary commentators have defined paternalism as the "interference of a state or an individual with another person, against their will, and defended or motivated by a claim that the person interfered with will be better off or protected from harm". (71) In other words, to act in a paternalistic manner is to interfere with a person's freedom of action for his or her own good. That said, the concept itself is not monolithic. In fact, the "paternalist" in question and the class of persons being interfered with are important elements to consider. For example, a narrow paternalist is only concerned with "the question of state coercion", (72) while a broad paternalist is concerned with any paternalistic action stemming from the state, the institution or individuals. (73)

Another distinction could be made between pure and impure paternalism. In pure paternalism, "the class being protected is identical with the class being interfered with", (74) i.e., a physician withholding information from a patient for his or her own good. In impure paternalism, "the class of persons interfered with is larger that the class being protected". (75) Dworkin, in his seminal piece on paternalism, gives the example of a state that prevents the manufacturing of cigarettes because it causes harm to the consumers. (76) According to him, the basic reasoning is still paternalistic because the purchaser consents to the harm.

A third differentiation could be made between welfare and moral paternalism. The latter is usually associated with state intervention and seeks to protect a person's moral wellbeing. (77) Welfare paternalism, on the other hand, aims at making a person's life better. (78) Consider, for example, the 1847 Code of Ethics of the American Medical Association (AMA), which reads:

The obedience of a patient to the prescriptions of his physician should be prompt and implicit. He should never permit his own crude opinions as to their fitness, to influence his attention to them A failure in one particular may render an otherwise judicious treatment dangerous, and even fatal". (79)

Similarly, section 5 of the first Chapter of AMA's 1903 Principles of Medical Ethics explains that "[o]rdinarily, the physician should not be forward to make gloomy prognostications, but should not fail, on proper occasions to give timely notice of dangerous manifestations to the friends of the patient; and even to the patient, if absolutely necessary [...]". (80)

In the medical context, physicians have long used pure welfare paternalism to justify withholding information from their patients. (81) Their chief argument can be outlined as follows:

"1. The physician's duty--to which he is bound by the Oath of Hippocrates--is to prevent or at least to minimize harm to his patient.

2. Giving the patient information X will do great harm to him.

3. (Therefore) It is permissible for the physician to withhold information X from the patient". (82)

According to some authors, this logic is flawed as the existence of both the first premise and the second premise does not automatically justify the third premise. (83) Accordingly, another premise needs to be taken into account, which is the following: "on balance, the fact of providing "X" information will result in greater harm than withholding "X" information". (84) This, however, will require the physician to exercise comparative judgment. (85) The use of the word "judgment" infers more than just a simple assessment. As a matter of fact, for a physician to withhold "X" information from a given patient, the comparative judgment required will have to "be founded on a profound knowledge of the most intimate details of the patient's life history, his characteristic ways of coping with personal crises [...] and his attitude toward the completeness or incompleteness of his experience". (86) Such judgment could hardly be well founded if it relies solely on the physician. To do so would amount to what Dworkin characterizes as unjustified paternalism: an action that does not preserve or enhance an individual's ability "to rationally consider and carry out his own decisions". (87) Thus, the major shortcoming of pure welfare paternalism is its lack of respect for autonomy, which involves "attitudes and actions that ignore, insult, demean, or are inattentive to others' rights of autonomous action". (88)

Indeed, respect for autonomy runs deep in common morality. (89) According to the Oxford English Dictionary, the word "autonomous" derives from the Greek words "auto" (self) and "nomos" (law), meaning "having one's own laws". (90) Early use of the word autonomy did not refer to individuals, but to cities that made their own laws. (91) When applied to an individual the word autonomy can refer to a variety of concepts, including: "the capacity of reason for moral self-determination" (92) and the "liberty to follow one's will; control over one's own affairs; freedom from external influence, personal independence". (93) Strictly speaking then, autonomy requires two conditions: liberty and agency. (94) Accordingly, someone in a state of coma or mental incapacity might not be considered autonomous.

Philosophers such as Immanuel Kant and John Stuart Mill have strongly influenced current interpretations of respect for autonomy. (95) In his Foundations of the Metaphysics of Morals, (96) Kant contends that individuals have the capacity to determine their own moral destiny. (97) Based on his recognition that all persons have unconditional worth, he argues that violating a person's autonomy is equivalent to treating that person as a means; "that is, in accordance with others' goals without regard to that person's own goals". (98) As for John Stuart Mill, his essay "On Liberty" (99) focuses on the "individuality" of the autonomous individual. He asserts that nothing should warrant limiting an individual's liberty of action, except self-protection. (100) In other words, individuals should be allowed to develop according to their own beliefs. I will come back to Mill later in section C.2.1.

With the rise of Western individualism (101) and the mounting influence of the civil rights movement in the second half of the last century, (102) the decline of paternalistic practices and the emergence of patient autonomy have become an embodiment of personal freedoms. The principle of respect for autonomy--crystallized by the doctrine of informed consent (103)--has become the main ethos in health care provision. This reality shaped a positive duty for physicians: that of adequately informing their patients prior to and during the delivery of care. It is "positive" because it involves "both respectful treatment in disclosing information and actions that foster autonomous decision making". (104)

The focus on autonomy as a form of self-determination is evident in Canada's Supreme Court decisions since Hopp v Lepp (105) and Reibl v Hughes, (106) two seminal cases involving the physician's duty to inform. Indeed, in its discussion of the notion of informed consent, the Court states in Hopp v Lepp that the "underlying principle is the right of a patient to decide what, if anything, should be done with his body". (107) In the same vein, when discussing the risks that need to be divulged to the patient through the informed consent process in Reibl v Hughes, Judge Laskin alludes to the right of the Patient to know the risks of having or not having an operation or a treatment. (108) As mentioned above, the Supreme Court of Canada has consistently followed this stance. Indeed, in the Ciarlariello case, Judge Cory, on behalf of the Court, writes:

"This concept of individual autonomy is fundamental to the common law and is the basis for the requirement that disclosure be made to a patient. If, during the course of a medical procedure a patient withdraws the consent to that procedure, then the doctors must halt the process. This duty to stop does no more than recognize every individual s basic right to make decisions concerning his or her own body". (109)

That said, what are the characteristics of the medical duty to inform? Are there limitations to what could be provided to the patient/participant? Section C.1 will discuss these two points through an analysis of pertinent Canadian case law addressing both the clinical and the non-therapeutic research settings. As population biobanks fall within the latter category undertaking this comparative analysis will allow for a better appreciation of the legal requirements imposed on biobank researchers. It will also highlight the particular conception of autonomy underlying these same requirements.

1. Medical Duty to Inform: Characteristics in the Clinical and the Non-Therapeutic Research Settings

The essentials of the therapeutic duty to inform in Canada can be characterized as the provision of sufficient information (material risks and, in the common law provinces, special or unusual risks (110)) to patients in order for them to make the best decision possible when consenting to treatment. In the landmark common law case of Reibl v Hughes, Judge Laskin wrote: "What the doctor knows or should know that the particular patient deems relevant to a decision whether to undergo prescribed treatment goes equally to his duty of disclosure as do the material risks recognized as a matter of required medical knowledge". (111) In Hopp v Lepp, the same Court specified the scope of the duty to inform of physicians, which includes answering "any specific questions posed by the patient as to the risks involved [...] [and] [...] without being questioned, disclose to [their patients] the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation". (112) This has since become the minimum standard with which physicians are expected to comply in the common law provinces. In Quebec civil law, however, courts have tended to reject the "reasonable patient" threshold proposed in Reibl v Hughes and upheld a test focused on what a reasonable physician would disclose in the circumstances. (113)

Yet, the amount of information needed to satisfy the requirements of the duty to inform in the clinical setting can be considered quite minimal compared to the requirements for non-therapeutic research. This differential duty stems from two Canadian court decisions, namely Halushka v University of Saskatchewan and Weiss v Solomon. The first case, a 1965 Saskatchewan Court of Appeal decision, involved a student who was paid $50 to be part of an experiment involving the administration of a new anesthetic and the insertion of a catheter at the University Hospital. The participant was informed that the procedure would last a couple of hours and that this was a "perfectly safe test [...] conducted many times before" (114) where "there was nothing to worry about". (115) During the procedure, the participant suffered a complete cardiac arrest and remained unconscious for four days. As a result, the new anesthetic was withdrawn from clinical use in the University Hospital. The participant sued for damages and the court decided that the disclosure of the information in this case was inappropriate, incorrect and in reality a non-disclosure. The Court contrasted the duty to inform in a research project with that in a clinical setting by stating: "the duty imposed upon those engaged in medical research [...] to those who offer themselves as subjects for experimentation, as the respondent did here, is at least as great as, if not greater than, the duty owed by the ordinary physician or surgeon to his patient". (116)

The Court then justified this higher duty to inform by explaining:

"[t]here can be no exceptions to the ordinary requirements of disclosure in the case of research as there may well be in ordinary medical practice. The researcher does not have to balance the probable effect of lack of treatment against the risk involved in the treatment itself. The example of risks being properly hidden from a patient when it is important that he should not worry can have no application in the field of research. The subject of medical experimentation is entitled to a full and frank disclosure of all the facts, probabilities and opinions which a reasonable man might be expected to consider before giving his consent". (117) (our emphasis)

Taking these arguments together, the Court articulated a standard whereby the lower the therapeutic benefit to the individual, the higher the duty to inform becomes.

The Superior Court of Quebec restated this principle of heightened duty to disclose in research in the 1988 Weiss v Solomon decision. In this case a patient who underwent cataract surgery was invited to participate in a research project (distinct from his surgery) involving the administration of opthalmologic drops and a fluorescein angiography. Following the injection of the fluorescein, the patient suffered a ventricular fibrillation and died as a result of this adverse event. (118) It was determined, among other things, that the risks of death or collapse due to the participant's pre-existing heart problem were not sufficiently disclosed. The Court refers to the Halushka case and reiterates the importance of full disclosure in non-therapeutic research by characterising it as the most exacting possible. (119) In other words, it goes beyond the disclosure requirements in the clinical setting.

Although these two decisions represent the state of the law in matters relating to the disclosure of information in research, the standard they set is challenged in an era where non-therapeutic research is increasingly international, collaborative and longitudinal. More specifically, the standard required by these two decisions contains two limitations. The first has to do with research typology. One could argue that the type of research featured in these two decisions is very different than that of population biobanks, where no drug is administered and no toxicity is assessed. At a time where research methodologies are increasingly diversified and research is producing more and more non-interpretable data due to cutting edge technologies (e.g. whole genome sequencing), a one-size-fits-all legal approach becomes problematic.

Consent forms and associated documents from Canadian population biobank studies reveal a balancing approach, in which limited disclosure on future access of data and samples is coupled with rigorous governance and heightened privacy protection (see Table 2). For example, Alberta's Tomorrow Project states that participants' data and samples "may be used, in coded form, by approved researchers from Canada and other countries for research related to cancer, and potentially other health conditions" (120) on the condition that these researchers apply for such access, implying a controlled access governance system. However, some could perceive this balancing approach as failing the strict requirements set out by the Halushka and Weiss decisions. The uncertainty of whether the approach satisfies legal requirements (121) brings us to the case law's second and more substantial shortcoming: its use of individual autonomy to amplify the researcher's duty to inform. While neither Halushka v University of Saskatchewan nor Weiss v Solomon explicitly refers to this principle in their rationale, autonomy underlies the heightened duties of researchers. The following section will examine this matter in more detail and highlight the shortcomings of the conception of autonomy, as advocated in both Halushka and Weiss.

2 Conception of Autonomy in Halushka and Weiss: Origins and Shortcomings

2.1 Origins of the Conception of Autonomy in Halushka and Weiss: John Stuart Mill's Concept of Liberty

As previously discussed, autonomy can refer to a variety of concepts, including: "the capacity of reason for moral self-determination" (122) and the "liberty to follow one's will; control over one's own affairs; freedom from external influence, personal independence". (123) Other conceptions of autonomy require "consistency in decision-making [...] self-sufficient independence in the establishment of personal values and beliefs". (124) In brief, autonomy is used broadly and could also be associated with "dignity, integrity, individuality [...], responsibility, and self-knowledge". (125) This diversity, however, has the misfortune of not providing us with a unique definition Gerald Dworkin thus notes: "[w]hat is more likely is that there is no single conception of autonomy but that we have one concept and many conceptions of autonomy". (126)

One of these various conceptions can be referred to as the traditional conception of autonomy, better known as individual autonomy, (127) which is applied in contemporary bioethics (128) and medical law. (129) To better understand the rationale behind the Halushka and Weiss cases as well as their requirement for full disclosure in the non-therapeutic research setting, one must examine this conception and appreciate its characteristics.

According to Onora O'Neill, individual autonomy "[...] is generally seen as a matter of independence or at least as a capacity for independent decisions and action". (130) This conception has its roots in John Stuart Mill s utilitarian principle of liberty. According to Mill:

"That principle is, that the sole end for which making are warranted, individually or collectively, interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or even right". (131)

Indeed Mill's focus on individuality hails from his belief that it ultimately forms one of the elements of wellbeing. (132) Thus, autonomous expression should not be interfered with, but it should also be actively strengthened. Some authors have labelled this notion as one of liberal individualism. (133) According to Dworkin, it refers more concretely to the:

"[...] right of a patient to make his own decisions about important personal matters and to effectuate those decisions (or have them effectuated). Properly understood this would mean that the patient is entitled to all the information relevant to the decision, including information the patient does not know he wants or needs. To exercise autonomy the patient would have to be fully informed and counseled about what decision to make". (134) (our emphasis)

Much similarity can be drawn between this definition and the requirements set out in both the Halushka and Weiss decisions. Indeed, the amplification of the duty to inform extolled by the two courts appears to have liberal individualism at its core. In Halushka, the court insisted that participants in non-therapeutic research have a right to a "full and frank disclosure of all patients. (145) Dworkin finds the roots of this approach in individual autonomy. (146) Other authors have gone as far as to qualify the resulting patient-physician relationship as one of bioethical paternalism, which leads "some doctors to consider mistakenly that unthinking acquiescence to a requested intervention against their clinical judgment is honouring 'patient autonomy when it is, in fact, an abrogation of their duty as doctors". (147)

The above-mentioned examples reflect a sense of unease towards the relationship created by this individualistic conception of autonomy. Indeed through this "unidirectional" relationship, the role of a physician is limited to that of "a passive information provider". (148) Such an approach puts physicians in a position where they no longer rely on logical or rational persuasion characterized by the use of facts and rationality to make their case. (149) Increasingly, the focus is merely on perfunctorily providing the patient with the required information.

More troublingly, the unilateral approach to autonomy can transcend the clinical setting and have significant implications for non-therapeutic research. As discussed in the Introduction, this is particularly true for population biobanks which rely on participant contribution and public participation. in the context of population biobanks, therefore, the application of a unilateral, unidirectional approach can be detrimental, as it does not sufficiently recognize the involvement of the public or consider the inherent limitations facing the researcher. Each of these two detrimental effects will now be elaborated upon in turn.

2.2 Individual Autonomy and the Public

The traditional conception of autonomy neglects both the contributions made by the public and the fact that the latter remains the ultimate benefactor. Research projects--especially those in population genomics--not only involve contributions from researchers and participants, but also implicate the general public in a very concrete way. (150) In fact, while the clinical setting strives to provide direct benefit to the patient, human genetic research aims at benefiting the general public as well as future generations. Thus, individual autonomy's sole focus on the participant destabilizes the balance created by the various stakeholders involved in population studies (see Figure 1).

By taking part in a population biobank study, the research participant contributes data and samples for purely altruistic reasons. Once these data and samples are stored, there is a scientific imperative for the biobank and its researchers to make them available to the research community. This will increase the statistical power needed to generate useful results, which will then translate into the clinic. The ultimate goal is better health for the population, which in turn, increases public trust in these endeavours. This can be clearly seen in the normative instruments reviewed in section B, where the sharing of data and samples was valued as maximizing benefits to society (151) and "advancing knowledge". (152) This characteristic of human genetic research has stimulated the emergence of new trends in the field of ethics, among them solidarity and universality. (153) Solidarity refers to a common willingness to share information for the benefit of others. (154) Universality, in turn emphasizes that genetic knowledge is beneficial beyond borders and so for other "publics". (155) Both trends highlight the importance of public engagement Indeed, given that genomic research can cover isolated populations or whole countries, it is essential that researchers communicate and consult with policymakers and the public. This engagement could affect decisions relating to the type of consent and access modalities. (156) A narrow view of autonomy through liberal individualism devalues public influence and underestimates public interest in population studies and their sustainability How would a strict access system, which requires that participants explicitly re-consent to every access request to a biobank, efficiently contribute to the orderly translation of knowledge to the clinic? How would such a narrow approach increase public trust in these research endeavours?

The reality is that members of the public play a central role in population research and that this role is fuelled by trust, a shared belief in the common good and thoughtful engagement. These necessities are not captured by individual autonomy because the latter has become shorthand for independence (157) (in this case, participant independence). This has the negative effect of creating an imbalance that will ultimately affect all the different stakeholders involved.

2.3 Individual Autonomy Does Not Consider the Limitations of All the Parties Involved

This pattern of individual autonomy-based neglect (as described above) not only extends to public contributions, but also to individualized researcher-patient dynamics. Individual autonomy and its unidirectional focus on research participants solely as individuals, also creates a general inability to consider the limitations of both parties in the researcher-participant relationship. A good example of this inability is the disclosure of information surrounding future access to data and samples. Here, the unilateral approach focuses only on what needs to be provided to the participant--in this case, everything--without fair consideration of the possible confines in which researchers might find themselves. As reflected in the consent clauses presented in Table 2, population biobanks are clearly limited in what they can divulge. Moreover, it could be too cumbersome for these projects --which usually involve more than 10 000 individuals--to re-consent individuals every time a researcher's request for access is received. (158)

Mill's liberal individualism calls for society to allow individuals to progress according to their own views, as long as they do not interfere with the autonomous expression of others or "unjustifiably harm them". (159) That said, Mill made no mention of the possible limitations that could arise from strengthening autonomous expression. The nature of consent and the specificity of its content are just two examples of such limitations in a field where increasingly cutting-edge technologies are being used to generate vast amounts of non-interpretable data.

The return of individual research results (IRRs) and incidental findings (IFs) is another case in point. It is also one that illustrates the limitations faced by both researchers and participants in genomics and population biobanks. While IRRs pertain to the objectives of a research project, IFs fall outside the scope of the project. (160) In Halushka, the Court explained that the participant is entitled to a full and frank disclosure of all the facts, opinions and probabilities. In Weiss, disclosure was characterized as the most exacting possible. By definition--and if we follow the principle of liberal individualism --both types of findings could fall under a broad duty of disclosure, which is limited in the context of genomics. Indeed, the nature of the information discovered (whether IRRs or IFs) will not necessarily provide the participant with an actionable result. It may even lack analytical validity or any form of clinical significance. (161) The imposition of a stringent duty to return such findings not only creates more harm than benefit, but could also put the researcher in a difficult and unduly onerous position. Indeed, researchers might not always have the required in-house expertise to feed this information back to the participant. Even if they have the requisite expertise, researchers should nevertheless take into consideration the participants situations and constraints (e.g. social, familial, etc.). Disclosure of information and of results in research should be personalized, and should not follow a "one-size-fits-all" approach. Moreover, "return" in population biobanks could be considered to create a therapeutic misconception between research and the clinic or be considered an inducement. (162) Population biobanks could be overwhelmed with obligations that are essentially inimical to genomic research (in general) and population biobanks (in particular). This has the damaging effect of breaking the fabric of trust between all parties involved in population studies (see Figure 2).

Participants trust biobank researchers with their data and samples and expect that any benefits accrued will be achieved through collaborative, high-quality research. The public trusts that any funding of these endeavors will generate benefits for future generations. (163) In turn, the biobank researcher trusts that the research community will use these data and samples according to the agreed-upon terms and conditions and will strive to return derived data back to the biobank to enrich its resources. (164) Through an individualistic conception of autonomy, researchers do not enter into relationships of trust with participants, but rather are forced into unremitting professional accountability. (165) This unidirectional relationship weakens the remaining threads in the joint web of trust.

Through an individualistic conception of autonomy, researchers are forced to be accountable to participants rather than enter in relations of trust with them. (166) This unidirectional relationship will, in turn, weaken the remaining threads in the joint web of trust.

CONCLUSION

The move towards personalized medicine will require the creation of reference maps of whole populations. Indeed, these maps will serve "as controls for replication, comparison, and validation of personalized genomic discoveries and profiles". (167) Population biobanks are at the centres of important undertakings, such as public health planning; the only way they can achieve these goals is to collect, store and share data and samples for future unspecified research. Today, at the international level, the focus is on facilitating such collaborative efforts. In that respect, the Public Population Project in Genomics and Society ([P.sup.3]G) (168)--an international consortium whose members are leading public organizations involved in large-scale genetic epidemiological studies--is developing research tools for effective collaboration between researchers, may they be in ethics, information technology or data harmonization.

To efficiently embark on these activities, however, population biobanks must ensure local legal requirements are met. While this text has depicted the nature, role and characteristics of population biobanks as essential resources for researchers, it has also stressed the limitation of the jurisprudential requirements of disclosure, which affect the manner in which any future collaboration is divulged to research participants in the informed consent process. More specifically, this text has criticized the restrictive nature of the individualistic conception of autonomy--which lies at the heart of the onerous duties imposed on researchers--and demonstrated how its origins are rooted in a unilateral approach incongruous with the nature of genomic research. Given the importance of considering the contribution and limitations of all stakeholders involved, the heightened duty to inform can be considered inimical to the nature and characteristics of population biobanking.

While this text is in no way a repudiation of the concept of autonomy, it represents a call for a complementary principle that could offer a more proportionate approach to the researcher's duty to inform. Proportionality here refers to the imposition of a fair and balanced intensity on the duties of professionals by taking into account the type of services they provide, the multilateral characteristics of their duties and the nature of the research project. The principle should also recognize that the "actual problems of autonomy in the modern state cannot be solved by a model of autonomy as independence in opposition to the collective". (169) It is time for a complementary principle premised on multilateral trust and transparency. This will not only allow data to be shared in an efficient, equitable and ethical way, but will ensure that the bedrock of our scientific innovation remains solid for years to come.

(1) Roger B Dworkin, "Getting What we Should From the Doctors: Rethinking Patient Autonomy and the Doctor-Patient Relationship" (2003) 13 Health Matrix 235 at 235 [Roger Dworkin]; for a detailed account of the concept of paternalism, see Gerald Dworkin, "Paternalism" in Stanford Encyclopedia of Philosophy, 2002, online: <plato.stanford.edu/entries/paternalism/> [Gerald Dworkin]; see also LB McCullough & Stephen Wear, "Respect for Autonomy and Medical Paternalism Reconsidered" (1985) 6:3 Theoretical Medicine and Bioethics 295; Douglas N Husak, "Paternalism and Autonomy" (1981) 10:1 Philosophy & Public Affairs 27; Ranaan Gillon, "Paternalism and Medical Ethics" (1985) 290 Brit Med J 1971; GB Weiss, "Paternalism Modernised" (1985) 11 Journal of Medical Ethics 184 at 184-185 [Weiss] (the author notes that in less than two decades, studies with physicians have shown a shift from a trend of withholding cancer diagnostics (90% of physicians in 1961) to a general preference to disclose them (97% in 1979)); see also James F Childress, Who Should Decide? Paternalism in Health Care (New York: Oxford University Press, 1982) [Childress].

(2) Gerald Dworkin, ibid, at Introduction.

(3) Allen Buchanan. "Medical Paternalism" (1978) 7:4 Philosophy & Public Affairs 370 at 377-78 [Buchanan].

(4) Graeme Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge: Cambridge University Press, 2002) at 186-87 [Laurie].

(5) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978), DHEW Publication No. (OS) 78-0012, Section 1 "Respect for Persons".

(6) Suzanne Philips-Nootens, Pauline Lesage-Jarjoura & Robert P Kouri, Elements de responsabilite civile medicate, 3d ed (Cowansville, QC: Editions Yvon Blais, 2007) at 204-15 [Philips-Nootens, Lesage-Jarjoura & Kouri]; on the topic of research

more specifically, see Ellen I Picard & Gerald B Robertson, Legal Liability of Doctors and Hospitals in Canada, 4th ed (Toronto: Thomson Carswell, 2007) at 176-78 [Picard & Robertson].

(7) Halushka v University of Saskatchewan, (1965) 53 DLR (2d) 436 (Sask CA) at 443-44.

(8) Weiss c Solomon, [1989] RJQ 731, 48 CCLT 280 (Sup Ct) at 743.

(9) Bartha Maria Knoppers & Ma'n H Zawati, "Population Biobanks and Access" in S Rodota and P Zatti, eds, Il Governo del Corpo: Trattato di Biodiritto (Milan: Giuffre Editore, 2011) at 1181.

(10) See Samuel Levy et al, "The Diploid Genome Sequence of an Individual Human" (2007) 5 PLOS Biology e254. doi:10.1371/journal.pbio.0050254.

(11) See Muin J Khoury, The Case for a Global Human Genome Epidemiology Initiative" (2004) 36 Nature Genetics 1027.

(12) See e.g., CARTaGENE (a Quebec-based biobank) Information Brochure for Participants, online: CARTaGENE <www.cartagene.qc.ca/>.

(13) Clarissa Allen, Yann Joly & Palmira Granados Moreno, "Data Sharing, Biobanks and Informed Consent: A Research Paradox?" (2013) 7 McGill JL & Health 85; Timothy Caulfield, "Biobanks and Blanket Consent: The Proper Place of the Public Good and Public Perception Rationales" (2007) 18 King's Law Journal 209.

(14) For a review of this literature, see Bartha Maria Knoppers & Ma'n H Abdul-Rahman (Zawati), "Biobanks in the Literature" in Bernice Eiger et al, eds, Ethical Issues in Governing Biobanks: Global Perspectives (Aldershot, UK: Ashgate, 2008) [Knoppers & Abdul-Rahman (Zawati)].

(15) Susan MC Gibbons et al, "Governing Genetic Databases: Challenges Facing Research Regulation and Practice" (2007) 34 JL & Soc'y 163 at 165-67; Muin J Khoury, The Case for a Global Human Genome Epidemiology Initiative" (2004) 36 Nature Genetics 1027.

(16) See Francis S Collins, Michael Morgan & Aristides Patrinos, "The Human Genome Project: Lessons from Large-Scale Biology" (2003) 300 Science 286.

(17) Bartha Maria Knoppers, Ma n H. Zawati & Emily Kirby. "Sampling Populations of Humans Across the World: ELSI Issues" (2012) 13 Annu Rev Genomics Hum Genet 395 at 397 [Knoppers, Zawati & Kirby].

(18) Ibid.

(19) See Alice K Hawkins, "Biobanks: Importance, Implications and Opportunities for Genetic Counselors" (2010) 19 J Genet Couns 423.

(20) Council of Europe, Recommendation Rec (2006) 4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin (2006), Article 17, online: Council of Europe <https://wcd.coe.int/ViewDoc.jsp?id=977859> [Council of Europe 2006].

(21) For more information, see CARTaGENE's official website, supra note 12.

(22) See UK Biobank's official website, online: UK Biobank <www.ukbiobank.ac.uk>.

(23) Knoppers, Zawati & Kirby, supra note 17.

(24) See Estonian Genome Centre's website, online: University of Tartu <www.geenivaramu.ee/en/>.

(25) See Healthy Ageing, Campus Netherlands (Lifelines Project), online: Healthy Ageing <www.healthyageingcampus.nl/Research/LifeLines.aspx>.

(26) See Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) website, online: <http://bbmri-eric.eu/>.

(27) See Canadian Partnership for Tomorrow Project's (CPTP) website, online. <www.partnershipfortomorrow.ca>.

(28) Knoppers, Zawati & Kirby, supra note 17 at 408.

(29) Bartha Maria Knoppers et al, "Towards a Data Sharing Code of Conduct for International Genomic Research" (2011) 3 Genome Medicine 46 at 46.

(30) See Paul Burton et al, "Size Matters: Just How Big is BIG?" (2009) 38 International Journal of Epidemiology 263.

(31) Ma'n H Zawati, Pascal Borry & Heidi Carmen Howard, "Closure of Population Biobanks and Direct-to-Consumer Genetic Testing Companies" (2011) 130 Hum Genet 425 at 431.

(32) See PopGen Module--International database on the legal and socio-ethical aspects of population genomics, online: PopGen <www.popgen.info/home>.

(33) See HumGen Database--Your resource in ethical, legal and social issues in human genetics, online: HumGen <www.humgen.org>.

(34) Human Genome Organisation (HUGO) (as reported by), Summary of the Principles Agreed at the First International Strategy Meeting on Human Genome Sequencing (1996), online: HUGO <http://cirge.stanford.edu/Classic%20Readings%20 in%20Genetics%20and%20Ethics/Bermuda%20Principles/Bermuda%201&2.pdf> [HUGO 1996].

(35) Ibid at Preamble.

(36) Human Genome Organisation (HUGO) Ethics Committee, Statement on DNA Sampling: Control and Access (1998), online: HUGO <www.hugo-international.org/img/dna_1998.pdf>.

(37) Ibid at para 2 of Recommendations.

(38) Human Genome Organisation (HUGO) Ethics Committee, Statement on Human Genomic Database (2002), online: HUGO <www.hugo-international.org/img/genomic_2002.pdf>.

(39) Ibid at Principle 3.

(40) Human Genome Organisation (HUGO), Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility (2003), online: <www.genome.gov/Pages/Research/WellcomeReport0303.pdf>.

(41) Ibid at 3.

(42) Ibid at 2.

(43) Henry Rodriguez et al, "Recommendations from the 2008 International Summit on Proteomics Data Release and Sharing Policy: The Amsterdam Principles" (2009) 8 Journal of Proteome Research 3689.

(44) Toronto International Data Release Workshop Authors, "Prepublication Data Sharing" (2009) 461 Nature 168.

(45) United Nations Educational, Scientific and Cultural Organization (UNESCO), International Declaration on Human Genetic Data (2003), online: UNESCO <portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL SECTION=201.html>.

(46) Ibid at Art 18.

(47) Organisation for Economic Co-operation and Development, OECD Guidelines on Human Biobanks and Genetic Research Databases (2009), online: OECD <www.oecd.org/science/biotechnologypolicies/44054609.pdf> [OECD 2009].

(48) Ibid at Principle 1.C.

(49) Ibid at Best Practice 7.4.

(50) S Ayme on behalf of European Society of Human Genetics, "Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues (2003) 11 European Journal of Human Genetics 906.

(51) Ibid at 907.

(52) Council of Europe 2006, supra note 20 at Art 20, para 1.

(53) European Commission, Biobanks for Europe--A Challenge for Governance (2012), Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, online: European Commission <www.coe. int/t/dg3/healthbioethic/Activities/10_Biobanks/biobanks_for_Europe.pdf>. at Recommendation 7.

(54) Health Canada, Guidance for Health Canada: Biobanking of Human Biological Material (2011), Ottawa, 14 February 2011.

(55) Ibid at s 2.8.2.4.

(56) Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (December 2010), online: TCPS 2 <www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf> [TCPS 2],

(57) Ibid at Chapter 12, section D.

(58) Network of Applied Genetic Medicine (RMGA), Statement of Principles: Human Genomic Research (2000), online: Reseau de Medecine Genetique Appliquee

du Quebec (RMGA) <www.rmga.qc.ca/fr/documents/ Enoncedeprincipesrechercheengenomiquehumaine_fr_000.pdf>.

(59) Zubin Master, Eric Nelson, Blake Murdoch & Timothy Caulfield, "Biobanks, Consent and Claims of Consensus" (2012) 9 Nature Methods 885 at 885.

(60) Kristin Solum Steinsbekk, Bjorn Kare Myskja & Berge Solberg, "Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?" (2013) 21:9 European Journal of Human Genetics 897.

(61) Fonds de la recherche en sante du Quebec, Final Report--Advisory Group on a Governance Framework for Data Banks and Biobanks Used for Health Research (2006), online: <www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/Rapport_groupe_conseil_anglais.pdf> at 59-60.

(62) Bjorn Hofmann, "Broadening Consent--and Diluting Ethics? (2009) 35 J Med Ethics 125 at 128.

(63) Henry T Greely, "The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks" (2007) 8 Annu Rev Genomics Hum Genet 343 at 358.

(64) Timothy Caulfield & Bartha Maria Knoppers, "Consent, Privacy and Research Biobanks" (2010) Policy Brief No. 1 Genomics, Public Policy, and Society 1 at 5, online: Genome Canada <www.genomecanada.ca/medias/pdf/en/GPS-PolicyDirections-Brief.pdf> [Caulfield & Knoppers] citing Ants Nomper, Open Consent --A New Form of Informed Consent for Population Genetic Databases (Tartu: Tartu ulikooli kirjastus, 2005).

(65) Knoppers & Abdul-Rahman (Zawati), supra note 14 at 14.

(66) Bartha Maria Knoppers & Ma'n H Abdul-Rahman (Zawati), "Health Privacy in Genetic Research: Populations and Persons" (2009) 28 Politics and the Life Sciences 99 at 100.

(67) Bartha Maria Knoppers et al, "Framing Genomics, Public Health Research and Policy: Points to Consider" (2010) 13 Public Health Genomics 224 at 231.

(68) Knoppers & Abdul-Rahman (Zawati), supra note 14.

(69) Caulfield & Knoppers, supra note 64 at 5.

(70) JJ Chin, "Doctor-Patient Relationship: from Medical Paternalism to Enhanced Autonomy" (2002) 43 Singapore Medical Journal 152 at 152 [Chin]; Aaron E Hinkley, "Two Rival Understandings of Autonomy, Paternalism, and Bioethical Principlism" in HT Engelhard! Jr. (ed), Bioethics Critically Reconsidered, Chapter 5 (Netherlands: Springer, 2012) at 87 [AE Hinkley].

(71) Gerald Dworkin, supra note 1. See also: Buchanan, supra note 3; Matthew McCoy, "Autonomy, Consent, and Medical Paternalism: Legal Issues in Medical Intervention" (2008) 14:6 Journal of Alternative and Complementary Medicine 785; Ben A Rich, "Medical Paternalism v. Respect for Patient Autonomy: The More Things Change the More They Remain the Same" (2006) 10 Michigan State University Journal of Medicine and Law 87.

(72) Gerald Dworkin, ibid.

(73) Ibid, see also Carlos A Rodriguez-Osorio & Guillermo Dominguez-Cherit,

"Medical Decision Making: Paternalism versus Patient-centered (Autonomous) Care" (2008) 14 Current Opinion in Critical Care 708 at 709

(74) Ibid.

(75) Ibid, see also NH Stan, "Deconstructing Paternalism--What Serves the Patient Best?" (2002) 43 Singapore Medical Journal 148 at 149.

(76) Gerald Dworkin, "Paternalism" in Richard A. Wasserstrom, ed. Morality and the Aw (Belmont: Wadsworth Publishing Company, 1971) at 183 [Gerald Dworkin 1971].

(77) Gerald Dworkin, supra note 1.

(78) Ibid.

(79) Cited in Chin, supra note 70 at 152.

(80) American Medical Association (AMA), Principles of Medical Ethics (1903) online:

American Medical Association <www.ama-assn.org/resources/doc/amahistory /1903principalsofethi.pdf>.

(81) Weiss, supra note 1 at 184. See also BW Corn, "Medical Paternalism: Who Knows Best?" (2012) 13 Lancet Oncology 123; Gillon, supra note 1; AE Hinkley, supra note 70; LB McCullough & Stephen Wear, supra note 1.

(82) Buchanan, supra note 3 at 377.

(83) Ibid.

(84) Ibid.

(85) Ibid at 378.

(86) Ibid at 381-2.

(87) Gerald Dworkin 1971, supra note 76 at 188.

(88) Tom Beauchamp & James Childress, Principles of Biomedical Ethics, 6th ed (New York: Oxford University Press, 2009) at 103 [Beauchamp & Childress].

(89) Ibid at 99.

(90) Oxford English Dictionary under "autonomous", online: OED <www.oed.com>.

(91) Onora O'Neill, Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press, 2002) at 29 [O'Neill 2002]; Laurie, supra note 4 at 185.

(92) Oxford English Dictionary, supra note 90, under: "autonomy".

(93) Ibid.

(94) Beauchamp & Childress, supra note 88 at 100.

(95) Rebecca L Walker, "Medical Ethics Needs a New View of Autonomy" (2009) 33 Journal of Medicine and Philosophy 594 at 603.

(96) Immanuel Kant, Groundwork for the Metaphysics of Morals in Thomas E Hill Jr., ed, translated by Arnulf Zweig (Oxford: Oxford University Press, 2009) [Kant].

(97) Ibid at 240; see also Barbara Seeker, "The Appearance of Kant's Deontology in Contemporary Kantianism: Concepts of Patient Autonomy in Bioethics" (1999) 24:1 Journal of Medicine and Philosophy 43 [Seeker].

(98) Beauchamp & Childress, supra note 88.

(99) John Stuart Mill, Three Essays: On Liberty, Representative Government, The Subjection of Women (New York: Oxford University Press, 1975) [Mill].

(100) Ibid at 15; see also Douglas N Husak, supra note 1.

(101) Childress, supra note 1 at 66; Lars Oystein Ursin, "Personal Autonomy and Informed Consent" 12 Medicine, Health Care and Philosophy 17 at 20; Arthur Caplan, "Why Autonomy Needs Help" (2014) 40:5 Journal of Medical Ethics 30.

(102) Philips-Nootens, Lesage-Jarjoura & Kouri, supra note 6 at 139; Mark Siegler, "The Progression of Medicine: From Physician Paternalism to Patient Autonomy to Bureaucratic Parsimony" (1985) 145 Archive of Internal Medicine 713 at 714.

(103) Laurie, supra note 4 at 184.

(104) Beauchamp & Childress, supra note 88 at 104.

(105) Hopp v Lepp, [19801 2 SCR 192, 112 DLR (3d) 67.

(106) Reibl v Hughes, [1980] 2 SCR 880, 114 DLR (3d) 1.

(107) Hopp v Lepp, supra note 105 at 196; see also Louise Belanger-Hardy, "La notion de choix eclaire en droit medical canadien" (1997) 5 Health LJ 67

(108) Reibl v Hughes, supra note 106 at 889; see also Gerald Robertson, "Informed Consent Ten Years Later: The Impact of Reibl v Hughes", (1991) 70 Can Bar Rev 423.

(109) Ciarlariello v Schacter, [1993] 2 SCR 119 (SCC) at 135 [Ciarlariello v Schacter].

(110) In Reibl v Hughes, supra note 106, Judge Laskin of the Supreme Court writes at para 4: "The Court in Hopp v. Lepp [...] also pointed out that even if a certain risk is a mere possibility which ordinarily need not be disclosed, yet its occurrence carries serious consequences, as for example, paralysis or even death, it should be regarded as a material risk requiring disclosure". For a detailed discussion of the meaning of "material, special or unusual risk", see also Picard & Robertson, supra note 6 at 134-49. For the requirements of risk disclosure in the civil law jurisdiction, see infra note 174.

(111) Reibl v Hughes, ibid, at para 16.

(112) Ibid, at para 29.

(113) See Pelletier c Roberge, 41 QAC 161, [1991] RRA 726 (Qc CA) at para 51, also, for a critique of Reibl v Hughes in civil law, see the opinion of Justice Lebel in Chouinard c Landry, [1987] RJQ 1954, [1987] RRA 856 (CA). In Quebec, the courts have generally identified the following risks as requiring disclosure to the patient: 1) probable and foreseeable; 2) rare, if serious and particular to the patient- 3) known to all, if particular to the patient; 4) important, if serious and decisive in the decision-making of the patient; and 5) increased, if a choice is possible. For a detailed discussion on this matter, see Philips-Nootens, Lesage-Jarjoura & Kouri, supra note 6 at 149-55.

(114) Halushka v University of Saskatchewan, supra note 7, para 3.

(115) Ibid, at para 2.

(116) Ibid, at para 29.

(117) Ibid.

(118) Weiss v Solomon, supra note 8, para 4.

(119) Ibid, para 89; see also Philips-Nootens, Lesage-Jarjoura & Kouri, supra note 6, at 212

(120) Alberta Tomorrow Project, Consent Form (2011), referenced in Table 2.

(121) Caulfield & Knoppers, supra note 64 at 5.

(122) Oxford English Dictionary, supra note 90, under: "autonomy".

(123) Ibid.

(124) Laurie, supra note 4 at 185.

(125) Gerald Dworkin, The Theory and Practice of Autonomy (Cambridge: Cambridge University Press, 1988) at 6.

(126) Ibid at 9.

(127) O'Neill 2002, supra note 91; GM Stirrat & R Gill, "Autonomy in Medical Ethics after O'Neill" (2005) 31 Journal of Medical Ethics 127 at 127 [Stirrat & Gill].

(128) Laurie, supra note 4 at 184; Belmont Report, supra note 5.

(129) Roger Dworkin, supra note 1 at 239; Ciarlariello v Schacter, supra note 109.

(130) O'Neill 2002, supra note 91 at 23.

(131) Mill, supra note 99 at 15.

(132) Ibid at 69; Onora O'Neill, "Paternalism and Partial Autonomy" (1984) 10 JME 173 at 173.

(133) Roger Dworkin, supra note 1 at 238.

(134) Ibid at 264.

(135) Halushka v University of Saskatchewan, supra note 7, para 29

(136) Roger Dworkin, supra note 1 at 264.

(137) Weiss v Solomon, supra note 8, at para 91.

(138) Picard & Robertson, supra note 6, at 177, see also Philips-Nootens, Lesage-Jarjoura & Kouri, supra note 6, at 213.

(139) See Edmund D Pellegrino, & David C Thomasma, "The Conflict Between Autonomy and Beneficence in Medical Ethics: Proposal for a Resolution" (1987) 3 J Contemp Health L & Pol'y 23.

(140) Laurie, supra note 4, at 184.

(141) Stirrat & Gill, supra note 127, at 127.

(142) Ibid at 129.

(143) Ibid at 128.

(144) Roger Dworkin, supra note 1, at 265-66; see also Ann P Walker "The Practice of Genetic Counseling" in Wendy R Uhlmann, Jane L Schuette & Beverly M Yashar eds, A Guide to Genetic Counseling, 2d ed, (Hoboken, New Jersey: Wiley-Blackwell, 2009); MB Mahowald, MS Verp & RR Anderson, "Genetic Counselling; Clinical and Ethical Challenges" (1998) 32 Annual Review of Genetics 547.

(145) See Elina Rantanen et al, "What is Ideal Genetic Counselling? A Survey of Current International Guidelines" (2008) 16;4 European Journal of Human Genetics 445.

(146) Roger Dworkin, supra note 1 at 265-66.

(147) Stirrat & Gill, supra note 127 at 127

(148) Chin, supra note 70 at 153.

(149) Gary Yukl & John W Michel, "Proactive Influence Tactics and Leader Member Exchange" in Chester A Schriesheim & Linda L Neider, eds, Power and influence in Organizations: New Empirical and Theoretical Perspectives (Greenwich CT: Information Age Publishing, 2001) 87; Barbara JA Eiser, Arnold R Eiser & Michael A Parmer, "Power of Persuasion; Influence Tactics for Health Care Leaders" (2006) 6 Leadership In Action 3 at 3.

(150) LB McCullough & Stephen Wear, supra note 1 at 299: "In the therapeutic setting however, there is no analogous third party whose interests are systematically built into the patient-physician relationship, as they are in the research setting."

(151) HUGO 1996, supra note 34.

(152) OECD 2009, supra note 47.

(153) Bartha Maria Knoppers & Ruth Chadwick. "Human Genetic Research: Emerging Trends in Ethics" (2005) 6 Nature 75 [Knoppers & Chadwick]; see also M Sutrop, How to Avoid a Dichotomy Between Autonomy and Beneficence: From Liberalism to Communitarianism and Beyond" (2011) 269 Journal of Internal Medicine 375.

(154) Knoppers & Chadwick, ibid at 76; Bartha Maria Knoppers, Ma'n H Abdul-Rahman (Zawat.) & Karine Bedard. "Genomic Databases and International Collaboration" (2010) 18 KLJ 291 at 304.

(155) Knoppers & Chadwick, ibid at 77-78.

(156) Over the years, UK Biobank has conducted various public consultations on its policies. For more information, see: <https://www.ukbiobank.ac.uk/public-consultation/>.

(157) Jennifer Nedelsky, Law's Relations: A Relational Theory of Self. Autonomy, and Law (Oxford University Press, 2011) at 8 [Nedelsky].

(158) See Anne Marie Tasse, Isabelle Budin-Ljosne, Bartha Maria Knoppers & Jennifer R Harris. "Retrospective Access to Data: The ENGAGE Consent Experience" (2010) 18 European Journal of Human Genetics 741.

(159) Beauchamp & Childress, supra note 88.

(160) Ma'n H Zawati & Bartha Maria Knoppers, "International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks" (2012) 14:4 Genetics in Medicine 484.

(161) Ma'n H Zawati, "Liability and the Legal Duty to Inform in Research" in Routledge Handbook of Medical Law and Ethics, Yann Joly & Bartha Maria Knoppers, eds (in press).

(162) Bartha Maria Knoppers, Mylene Deschenes, Ma'n H Zawati & Anne Marie

Tasse, "Population Studies: Return of Research Results and Incidental Findings Policy Statement" (2013) 21 European Journal of Human Genetics 245.

(163) Knoppers & Zawati, supra note 9 at 1193.

(164) See for example CARTaGENE's Data and Samples Access Policy, online: <http://cartagene.qc.ca/sites/default/files/politique_dacces_eng_finale_10_janvier_2012_0.pdf, at p. 9-10>.

(165) O'Neill 2002, supra note 91.

(166) Ibid at 39.

(167) Knoppers, Zawati & Kirby, supra note 17 at 408.

(168) See Public Population Project in Genomics and Society ([P.sup.3]G) website: <www.p3g.org/>.

(169) Nedelsky, supra note 155 at 53.

Ma'n H. Zawati, LL.B, LL.M., D.C.L. Candidate, Faculty of Law, McGill University. Ma'n H. Zawati is a Lawyer and Academic Associate at the Centre of Genomics and Policy, Faculty of Medicine, McGill University. The author would like to thank Professors Lara Khoury, Bartha Maria Knoppers and Alana Klein for their insightful comments on an earlier version of this manuscript and Eliza Cohen, Adrian Thorogood, Susannah Dainow as well as Ariane Mallette for their assistance. The author would also like to acknowledge the financial contribution of the Fonds de recherche du Quebec--Societe et Culture (Doctoral Scholarship) and the Canadian Partnership Against Cancer through the Canadian Partnership for Tomorrow Project.

Table 1--Consent Requirements in National Legislations and other
Normative Documents Pertaining to Biobanks

Legislation            Portion of Legislation Addressing the Nature
Pertaining to          of the Required Consent (Competent Adults)
Biobanks

Estonia, Human         "[section] 12. Consent to become gene donor
Genes Research Act,    (1) A person's consent to provide a tissue
RTI 2000, 104, 685     sample, to have a description of the state of
                       health or the genealogy of the person prepared,
                       to entry of the description of the state of
                       health or the genealogy in the Gene Bank in
                       coded form and to use thereof for genetic
                       research, public health research and
                       statistical purposes shall be prepared in
                       writing and shall be signed by the person who
                       becomes a gene donor."

Iceland, Act on        "Article 7--Consent of donor of a biological
Biobanks no.           sample and revocation of consent
110/2000, 13 May       When a biological sample is collected for
2000                   preservation in [a research biobank], the free,
                       informed consent of the person giving the
                       biological sample shall be sought. This consent
                       shall be given freely and in writing after the
                       donor of a biological sample has been informed
                       of the objective of the sample collection, the
                       benefits, risks associated with its collection,
                       and that the biological sample will be
                       permanently stored at [a research biobank] for
                       use under Article 9.

                       Article 9--Access to biobank and use of
                       biological samples
                       [...] The board of the biobank shall make
                       agreements with scientists on access to
                       biological samples. Access to biological
                       samples for scientific studies may not,
                       however, be granted until the permission of the
                       Data Protection Authority has been granted on
                       the basis of the Act on Personal Privacy and
                       Handling of Personal Data, and a research
                       protocol has been approved by the National
                       Bioethics Committee or the ethics committee of
                       the relevant health institution, appointed
                       under the Patients' Rights Act and regulations
                       issued on the basis of the Act."

Norway, Health         "[section] 13. Main rule on consent
Research Act, ACT      Consent must be obtained from participants in
2008-06-20 no. 44      medical and health research, unless otherwise
                       laid down in law. Consent must be informed,
                       voluntary, express and documented. Consent must
                       be based on specific information about a
                       concrete research project, unless there is a
                       case for granting broad consent, cf. Section
                       14. [...]

                       [section] 14. Broad consent
                       Pursuant to Section 13, research participants
                       may consent to human biological material and
                       personal health data being used for specific,
                       broadly defined research purposes.
                       The regional committee for medical and health
                       research ethics may specify conditions for use
                       of broad consent and may order the project
                       manager to obtain new consent if the committee
                       deems it necessary. Participants who have given
                       broad consent are entitled to receive
                       information about the project at regular
                       intervals."

Sweden, Biobanks in    "Chapter 3. Consent and information
Medical Care Act,      Donors
(SFS 2002:297)         Section 1 Apart from cases specified in section
                       2, tissue samples may not be collected and
                       preserved in a biobank without informing the
                       donor of that intention and about the
                       purpose(s) for which the biobank may be used,
                       and obtaining his or her consent.

                       New purpose
                       Section 5 Tissue samples preserved in a biobank
                       may not be used for other purposes than those
                       indicated in information submitted previously
                       for which consent has been granted. In the
                       event of a new purpose, the person who
                       previously granted consent must be informed
                       about the new purpose and grant new consent.
                       [...]

                       If the new purpose is research or clinical
                       trials, the research ethics committee that
                       approves the new purpose shall also determine
                       the requirements concerning the information and
                       consent regulations that shall apply so that
                       the tissue samples in the bank may be used for
                       the new purpose."

Taiwan, Human          "Article 3--Definitions
Biobanks               4. Biobank: For the purpose of biomedical
Management Act,        research, the Biobank contains participants'
Hua-Zong-Yi-Yi-Tzu     biological specimens, natural persons'
No.09900022481         information and other related data and
                       information based on human population or
                       specific groups. These biological specimens,
                       derivatives, or relevant data are stored in the
                       Biobank without delinking websites for the need
                       of follow-up applications."

                       Article 6
                       Collections of biological specimens shall be
                       conducted in compliance with medical and
                       research ethics. Participants shall be informed
                       of related matters in a clearly comprehensible
                       manner. Such matters shall be specified in an
                       agreement of consent. Any collection may only
                       be undertaken after the participant's written
                       consent is obtained [...]

                       Article 7
                       As set forth in the preceding Article, a
                       participant shall be informed of the following
                       matters: [...]
                       6. The purposes of collection and the range and
                       duration of the use of the collected biological
                       specimens; collection methods; types and
                       quantities of specimens to be collected; and
                       regions where specimens are collected."

Other Normative        Portion of Normative Document Addressing the
Documents              Nature of the Required Consent
                       (Competent Adults)

Canadian Institutes    "Chapter 12--Human Biological Materials
of Health Research,    Including Materials Related to Human
Natural Sciences and   Reproduction
Engineering Research
Council of Canada,     B. Collection of Human Biological Materials
and Social Sciences    Human biological materials may be obtained in
and Humanities         different ways: [...]
Research Council of    3. they may be collected for research or
Canada, Tri-Council    medical or diagnostic purposes with some
Policy Statement:      expectation that they may, or will, also be
Ethical Conduct for    used in future research, although the precise
Research Involving     research project(s) may not be known at the
Humans (TCPS 2)        time.
(December 2010)
                       Article 12.2 To seek consent for use of human
                       biological materials in research, researchers
                       shall provide to prospective participants or
                       authorized third parties, applicable
                       information as set out in Article 3.2 as well
                       as the following details: [...]
                       (b) the intended uses of the biological
                       materials, including any commercial use."

European Society       "As it is difficult to foresee all the
of Human Genetics.     potential research applications that a
"Data storage and      collection may be used for, individuals may be
DNA banking for        asked to consent for a broader use. In that
biomedical research:   case, there is no need to recontact individuals
technical, social      although the subjects should be able to
and ethical issues.    communicate should they wish to withdraw"
Recommendations of     (ESHG, S9).
the European Society
of Human Genetics"
(2003) 11 EJHG S8

German National        "2.2 Purpose-restricted use of data
Ethics Council         A question connected to the principle of
(Geschaftsselle       limitation of use to specific purposes is how
des Nationalen         specifically the donor's consent must relate to
Ethikrates), Human     the later use of the sample and data material.
Biobanks for           This question too is not answered by the data
Research (2010)        privacy Acts with sufficient clarity. [...] On
                       the one hand it is pointed out that the donor
                       cannot give informed consent if he does not
                       know exactly what he is consenting to. The
                       purpose "medical research", it is argued, is
                       also not precise enough to show the donor the
                       scope of his consent. This is countered by the
                       argument that it is part of a person's right of
                       self-determination, when he is aware that a
                       situation is uncertain, to be able to accept
                       this very uncertainty. Consequently, the
                       argument continues, it is only necessary for
                       the donor to be informed that the concrete
                       future use is uncertain and to agree to accept
                       this situation. The requirement of a more
                       narrowly expressed consent would call into
                       question the biobank principle as the
                       infrastructure for research purposes which are
                       as yet indefinite."

                       II. Recommendations for a five-pillar concept
                       [...]
                       Biobanks, as a resource for scientific
                       research, cannot be narrowly limited to
                       specific purposes in the use of samples and
                       data. Nor is it usually possible to inform the
                       donors in advance of the precise purposes of
                       use and of the duration of storage and use.
                       Both these deficiencies should be compensated
                       for by legislation that use should be
                       exclusively for scientific research, together
                       with biobank secrecy."

Organisation for       "4. Terms of participation
Economic Co-
operation and          4.6 Where authorised by applicable law and the
Development (OECD),    appropriate authorities, the operators of the
OECD Guidelines        HBGRD could consider obtaining a consent that
on Human Biobanks      will permit human biological specimens and/or
and Genetic Research   data to be used to address unforeseen research
Databases (2009)       questions. Participants should be fully
                       informed of the breadth of such consent and
                       there should be additional safeguards in place
                       to ensure that participants are protected.

                       II. Annotations
                       [...]
                       28. In some situations, where authorised by
                       applicable law and the appropriate authorities,
                       an HBGRD may consider obtaining a relatively
                       broader consent from the participant. For
                       example, the relatively broader consent may be
                       obtained to enable the use of human biological
                       specimens and/or data to address unforeseen
                       research questions. In some jurisdictions,
                       obtaining this broader consent typically will
                       involve that (a) the participant understand and
                       consent to participating on this broader basis;
                       and (b) additional safeguards are in place to
                       ensure that the interests of the participant
                       are protected. For example, the additional
                       safeguards can include the use of oversight
                       mechanisms to verify that access to human
                       biological materials, data and/or information
                       is provided in a manner consistent with the
                       participant's wishes. Where an HBGRD chooses to
                       seek a relatively broader consent from
                       participants, participants should be given a
                       range of possible scopes of consent to choose
                       from and the HBGRD should put in place
                       mechanisms for ensuring that participants'
                       decisions and instructions are respected."

Reseau de Medecine     "Definitions
Genetique Appliquee
(RMGA), Enonce         Individuality: Recognition of the uniqueness of
de principes sur la    the person mandating respect for the autonomy
conduite ethique       of the individual within a given group.
de la recherche en     Universality: Knowledge dissemination and
genetique humaine      international collaboration.
concernant des
populations (2003)     3. Consent
                       Each individual carries a unique copy of the
                       human genome. Yet, genes are shared by all
                       humans as a species, as the common heritage of
                       humanity. Research on any population should
                       neither lose sight of the individuality of the
                       person nor of the universality of the human
                       genome.

                       Implementation--Autonomy of the Person
                       (Individual Consent)
                       Even in a population study, free, informed, and
                       written consent of each individual is required,
                       with legislative exceptions (for the
                       surveillance of disease prevalence in a
                       population, for example). It should be made
                       clear to participants in a population research
                       project that they are considered as a
                       representative of their population. Consent is
                       a continuing process and must be reconfirmed
                       for instance in the case of significant changes
                       to the research protocol, to the conditions of
                       banking, in the research partnerships, and in
                       the management of the bank."

Sweden, Ministry of    Summary--p. 34
Health and Social      "For other purposes, express consent is
Affairs, A New         required, especially when tissue samples are
Biobanks Act (SOU      collected for research, including clinical
2010:81)               trials. In such cases, the provisions of the
                       Act concerning the Ethical Review of Research
                       involving Humans (2003:460, also known as the
                       Ethical Review Act) and the Medicinal Products
                       Act (1992:859) will apply. When samples that
                       have been stored for later use in research are
                       considered for use in a research project, an
                       ethical review board will decide which
                       requirements are to apply regarding information
                       and consent for use of the tissue samples
                       (Section 15 of the Ethical Review Act).

                       Our proposal calls for the collector of tissue
                       samples to be required to inform the donor of
                       the right to self-determination, the reason for
                       collecting and storing the tissue sample and
                       the purpose of the biobank."

                       Section 15 of the Ethical Review Act (SFS
                       2003:460)
                       "In cases where the research concern studies of
                       biological materials that have previously been
                       removed from a living person, if approval is
                       qranted it should be decided which requirements
                       should apply concerning information and consent
                       with respect to the use of the material."

World Medical          "32. For medical research using identifiable
Association,           human material or data, such as research on
Declaration of         material or data contained in biobanks or
Helsinki--Ethical      similar repositories, physicians must seek
Principles for         informed consent for its collection, storage
Medical Research       and/or reuse. There may be exceptional
Involving Human        situations where consent would be impossible or
Subjects, 64th WMA     impracticable to obtain for such research. In
General Assembly,      such situations the research may be done only
Fortaleza, Brazil,     after consideration and approval of a research
October 2013.          ethics committee."

Table 2--Consent Provisions from Selected Canadian Population
Biobanks

Name of         Portion of the Documentation Addressing Access to
the Cohort      Data and Samples as well as Privacy Measures

BC              Consent Form
Generations
Project         "The BC Generations Project expects to receive
(British        requests from Canadian and overseas scientists and
Columbia)       international collaborators to use the information or
                your sample (with your identifying information
                removed).

                All information will be kept under the most stringent
                security conditions at the BC Cancer Research Centre
                in Vancouver. We are currently in contact with another
                BC health research facility at the University of BC
                called Population Data BC which has recently been
                commissioned to construct the most secure data
                protection facility possible for health research
                information. If this facility incorporates even more
                security provisions than the Cancer Research Centre we
                will then consider moving de-identified information to
                that facility. Biological specimens however, will
                continue to be maintained by the BC Cancer Research
                Centre."

The             Consent Form
Tomorrow
Project         "I accept that my data and samples may be used, in
(Alberta)       coded form, by approved researchers from Canada and
                other countries for research related to cancer, and
                potentially other health conditions, and this will
                continue even after my death or if I can no longer
                make decisions."

                Study Booklet

                "Researchers may apply to access the research data and
                samples that are stored by the Tomorrow Project in
                Alberta.

                Applications for access to data or samples may be
                received from, and approved for, researchers working
                in Alberta, other parts of Canada, or international
                locations.

                Most of the blood, urine and saliva samples will be
                stored in Alberta, initially in a secure facility at
                the Holy Cross site in Calgary. The storage area for
                blood, urine and saliva samples may be moved to
                another Alberta Health Services facility within
                Alberta. All data will be stored on secure computer
                servers located in restricted access, high security
                facilities. At first, we will keep all data on secure
                computer servers behind the firewall protection of
                Alberta Health Services, housed in Calgary, Alberta.
                The data will be accessed only by a limited number of
                Tomorrow Project staff. All computers are password
                protected. We will keep paper copies of consent forms
                and questionnaires in the Tomorrow Project offices in
                Edmonton and Calgary. After processing, we will store
                them in a secure off-site facility in Alberta."

Ontario         Consent Form
Health Study
(Ontario)       "I accept that my questionnaire answers [...] may be
                used by researchers from Ontario, Canada (for example,
                as part of larger studies being carried out across
                Canada), and other countries for approved health-
                related projects."

                OHS Website FAQ

                "All data and information that you provide will be
                kept on secure servers at the Ontario Institute for
                Cancer Research, housed in Toronto, Ontario."

CARTaGENE       Information Brochure with Consent Form
(Quebec)
                "The results of the health questionnaire, as well as
                the physical measurements ... and biomedical analyses
                will be coded and transmitted electronically to
                CARTaGENE's database at the Universite de Montreal,
                where they will be stored until the end of CARTaGENE's
                activities.

                I accept that my data and samples, once coded, be used
                by researchers in Quebec, Canada or other countries
                ...

                Researchers from Quebec, the rest of Canada and abroad
                will be able to request access to CARTaGENE data and
                samples. Before access is granted, CARTaGENE will
                ensure that research projects meet scientific criteria
                and have been approved by ethics and science
                committees."

Atlantic Path   Volunteer Pack
(Atlantic
Provinces)      "The samples and all of the information gathered for
                the study will be stored for 30 years, during which
                time they will be made available to researchers and
                may also be stored in a secure national storage
                facility that is being developed by the national
                study. We expect to receive requests and, if approved,
                provide Canadian and International researchers access
                to the data and samples."
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Title Annotation:medical research in Canada
Author:Zawati, Ma'n H.
Publication:Health Law Journal
Date:Jan 1, 2014
Words:13854
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