Despite calls by some commentators for disclosing incidental fndings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior (...) contact. Past practice is also relevant; genetics researchers historically have chosen not to disclose incidental fndings, of which misattributed paternity and pleiotropic alleles such as ApoE have been the most common. Many people choose not to have genetic tests when given a choice. It may be desirable to discuss the topic of incidental fndings when consent for research is obtained, but given the risk of unwanted surprise when there has been no prior discussion, the potential utility of incidental fndings should be very high before they are even ofered to individuals. (shrink)

There are countless variations on this theme. The call can come from one of your own physicians who was called by the investigator. Your physician may or may not be well informed on what the reported finding about Disease Y means or how to respond. DNA testing can reveal more than susceptibility to disease. People can learn that they do not have the biological connections — parentage or evidence of ethnic origin — that they thought they did.Colleagues who serve on (...) the Institutional Review Board in my institution tell me that they currently do not permit “cold calls” of the type portrayed in the opening paragraph. Such direct contacts have, however, occurred in the past, with or without the blessing of an IRB. Sharing findings with the individual’s physician, who is then supposed to serve as a learned and wise intermediary, is not without problems either, given that many physicians understand little about complex genetics. Yet the very existence of this project on managing incidental findings in research demonstrates that some people believe that some research findings ought to be available to participants. (shrink)

Whole-genome analysis and whole-exome analysis generate many more clinically actionable findings than traditional targeted genetic analysis. These findings may be relevant to research participants themselves as well as for members of their families. Though researchers performing genomic analyses are likely to find medically significant genetic variations for nearly every research participant, what they will find for any given participant is unpredictable. The ubiquity and diversity of these findings complicate questions about disclosing individual genetic test results. We outline an approach for (...) disclosing a select range of genetic results to the relatives of research participants who have died, developed in response to relatives? requests during a pilot study of large-scale medical genetic sequencing. We also argue that studies that disclose individual research results to participants should, at a minimum, passively disclose individual results to deceased participants? relatives. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

ABSTRACT This paper examines some arguments which deny the existence of an individual right to remain ignorant about genetic information relating to oneself – often referred to as ‘a right to genetic ignorance’ or, more generically, as ‘a right not to know’. Such arguments fall broadly into two categories: 1) those which accept that individuals have a right to remain ignorant in self‐regarding matters, but deny that this right can be extended to genetic ignorance, since such ignorance may be harmful (...) to others, particularly those to whom one is genetically related (the ‘harm to others objection’) and 2) those which contend that, even if genetic ignorance is only self harming, it is not something to which individuals can rationally or morally claim to have a ‘right’ at all, since they defend their claims on autonomy‐respecting grounds and ignorance is inimical to autonomy (the ‘incoherence objection’). I argue that defenders of a right not to know have some plausible responses to the ‘harm to others objection’, but that in trying to respond to the ‘incoherence objection’, they and their opponents reach an impasse in which both sides are left voicing concerns about the paternalistic implications of the other's point of view. I conclude that defenders of a right not to know would, therefore, advance their position further by analysing it in terms of values other than those of autonomy and rights. (shrink)

One of the much debated issues around the evolving human genetics is the question of the right to know versus the right not to know. The core question of this theme is whether an individual has the right to know about her own genetic constitution and further, does she also have the right to remain in ignorance. Within liberal traditions it is usually held that people, if they so wish, have the right to all the knowledge available about themselves. This (...) right is based on the value of autonomy or on the right of self‐determination, and it is sometimes partly justified as a countermeasure to the authorities' control over people. I do not wish to deny the right to genetic knowledge (about oneself). I think that its existence is self‐evident. The argument I want to put forth in this paper is that in liberal societies we should acknowledge people’s right to remain in ignorance as well. The only reason for not doing this would be that grave harm to others would follow if people were allowed to make these seemingly self‐regarding decisions. Arguments presented against the right to ignorance are twofold. First there are those arguing against the right to ignorance on the grounds of harm to others, that is, philosophers who do not deny people’s right to ignorance in self‐related matters but wish to state that genetic ignorance causes harm to others, and this is one of the most commonly accepted reason for restricting people’s freedom. The other line of argument flows from the Kantian view that not even merely self‐regarding foolishness (in the eyes of others) should be allowed. (shrink)

The unknown nature of tomorrow’s research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is ‘broad’ or ‘narrow’, the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework—a framework which covers aims, core conditions for acceptable (...) use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large. (shrink)

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples (...) means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. (shrink)

Currently, some of the most significant moral issues involving genetic links relate to genetic knowledge. In this paper, instead of looking at the frequently addressed issues of responsibilities professionals or institutions have to individuals, I take up the question of what responsibilities individuals have to one another with respect to genetic knowledge. I address the questions of whether individuals have a moral right to pursue their own goals without contributing to society's knowledge of population genetics, without adding to their family's (...) knowledge of its genetic history, and without discovering genetic information about themselves and their offspring. These questions lead to an examination of the presumed right to genetic ignorance and an exploration of a variety of social bonds. Analyzing cases in light of these considerations leads to a surprising conclusion about a widely accepted precept of genetic counseling, to some ethical insights into typical problems, and to some further unanswered questions about personal responsibility in the face of genetic knowledge. (shrink)

The article discusses the relationship between the notion of a moral right to personal self‐determination, the notion of a moral right to know and the notion of a moral right not to know. In particular, the author asks under what conditions, if any, the right to self‐determination implies a right to have information or a right not to have information. The conclusions he defends are theoretical in character rather than concrete norms and directions, and they are intended to be relevant (...) in many contexts, not only in the context of information concerning, say, medical decisions. Yet the author restates the question concerning the right to have and especially the right not to have genetic knowledge about one's own genes on the basis of a right to self‐determination. He argues that a right (not) to have genetic information can be defended on the ground of a right to self‐determination, but that this kind of defense presupposes several normative, and controversial, arguments. (shrink)

The emerging international biomedical law tends to recognise the right not to know one’s genetic status. However, the basis and conditions for the exercise of this right remain unclear in domestic laws. In addition to this, such a right has been criticised at the theoretical level as being in contradiction with patient’s autonomy, with doctors’ duty to inform patients, and with solidarity with family members. This happens especially when non-disclosure poses a risk of serious harm to the patient’s relatives who, (...) without that vital information, could be deprived of preventive or therapeutic measures. This paper argues, firstly, that individuals may have a legitimate interest in not knowing their genetic make up to avoid serious psychological consequences; secondly, that this interest, far from being contrary to autonomy, may constitute an enhancement of autonomy; thirdly, that the right not to know cannot be presumed, but must be “activated” by the individual’s explicit choice, and fourthly, that this is not an absolute right, in the sense that it may be restricted when disclosure to the patient is necessary in order to avoid a risk of serious harm to third persons. (shrink)

The article discusses the relationship between the notion of a moral right to personal self‐determination, the notion of a moral right to know and the notion of a moral right not to know. In particular, the author asks under what conditions, if any, the right to self‐determination implies a right to have information or a right not to have information. The conclusions he defends are theoretical in character rather than concrete norms and directions, and they are intended to be relevant (...) in many contexts, not only in the context of information concerning, say, medical decisions. Yet the author restates the question concerning the right to have and especially the right not to have genetic knowledge about one's own genes on the basis of a right to self‐determination. He argues that a right (not) to have genetic information can be defended on the ground of a right to self‐determination, but that this kind of defense presupposes several normative, and controversial, arguments. (shrink)

There is a common view in medical ethics that the patient's right to be informed entails, as well, a correlative right not to be informed, i.e., to waive one's right to information. This paper argues, from a consideration of the concept of autonomy as the foundation for rights, that there can be no such ‘right’ to refuse relevant information, and that the claims for such a right are inconsistent with both deontological and utilitarian ethics. Further, the right to be informed (...) is shown to be a mandatory right (though not a welfare right); persons are thus seen to have both a right and a duty to be informed. Finally, the consequences of this view are addressed: since the way in which we conceptualize our problems tends to determine the actions we take to resolve them, it is important properly to conceptualize patients' requests not to be informed. There may be many reasons for acting in accord with such a request, but it is a mistake to conceptualize one's act as ‘respecting a right possessed by persons’. Keywords: medical ethics, informed consent, autonomy, information-waivers, rights, obligations CiteULike Connotea Del.icio.us What's this? (shrink)

Rights, autonomy, privacy, and confidentialityare concepts commonly used in discussionsconcerning genetic information. When theseconcepts are thought of as denoting absolutenorms and values which cannot be overriden byother considerations, conflicts among themnaturally occur.In this paper, these and related notions areexamined in terms of the duties and obligationsmedical professionals and their clients canhave regarding genetic knowledge. It issuggested that while the prevailing idea ofautonomy is unhelpful in the analysis of theseduties, and the ensuing rights, an alternativereading of personal self-determination canprovide a firmer (...) basis for ethical guidelinesand policies in this field. (shrink)

People have a powerful interest in geneticprivacy and its associated claim to ignorance,and some equally powerful desires to beshielded from disturbing information are oftenvoiced. We argue, however, that there is nosuch thing as a right to remain in ignorance,where a right is understood as an entitlementthat trumps competing claims. This doesnot of course mean that information must alwaysbe forced upon unwilling recipients, only thatthere is no prima facie entitlement to beprotected from true or honest information aboutoneself. Any claims to be (...) shielded frominformation about the self must compete onequal terms with claims based in the rights andinterests of others. In balancing the weightand importance of rival considerations aboutgiving or withholding information, if rightsclaims have any place, rights are more likelyto be defensible on the side of honestcommunication of information rather than indefence of ignorance. The right to free speechand the right to decline to acceptresponsibility to take decisions for othersimposed by those others seem to us moreplausible candidates for fully fledged rightsin this field than any purported right toignorance. Finally, and most importantly, ifthe right to autonomy is invoked, a properunderstanding of the distinction between claimsto liberty and claims to autonomy show that theprinciple of autonomy, as it is understood incontemporary social ethics and English law,supports the giving rather than the withholdingof information in most circumstances. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

In lieu of an abstract, here is a brief excerpt of the content:President’s Council on BioethicsEdmund D. Pellegrino (bio) and F. Daniel Davis (bio)Approximately two weeks before what was to have been its final meeting, the White House dissolved the President’s Council on Bioethics by terminating the appointments of its 18 members. The letters of dismissal, dated 10 June 2009, informed the members that their service on the Council would end with the close of business the next day.The Council’s term (...) was set to expire on 30 September 2009. After President Obama’s election in November and during the transition, we were advised to proceed on the assumption that the Council would be permitted to cease on that date. Reasons for the abrupt move to disband the Council are unknown. We have accepted the fact that we Council members served at the pleasure of the President and that he simply exercised his rightful prerogative. No explanation is therefore required.Some observers have speculated that the action was retaliatory. They related to the fact that several members of the Council disagreed with the President’s stem cell policy in a signed statement published in the Hastings Center’s Bioethics Forum. Others have speculated that the move was pre-emptive. At its final meeting, scheduled for 25–26 June, the Council was set to sign-off on two of its final publications. One was a comprehensive report on the ethics of organ transplantation, and the other a white paper entitled Health Care and the Common Good. The aim was immediately to release the latter as a contribution to the intensifying debate about health care reform. Health Care and the Common Good could well have aided rather than impeded the President’s drive to better control health care costs and achieve universal coverage. The Council report attempted to ground both goals in the ethical framework of, as the title indicates, the common good of all Americans.In his letter terminating the members’ appointments, Assistant to the President for Presidential Personnel Don Gips said that the President “recognizes the values of having a commission of experts in bioethical issues to provide objective and non-ideological bioethics advice to his administration.” Gips went on to say that the President is “currently rethinking the purposes and goals of such a bioethics commission, and is carefully considering a revitalized mission and mandate.” And, [End Page 309] responding to media enquiries, White House press officer Reid Cherlin explained that the President’s Council was terminated because it was a “philosophically leaning advisory group” and, according to a New York Times account by Nicholas Wade, “because it favored discussion over developing a shared consensus.” As for the ultimate outcome of the President’s “rethinking,” Cherlin indicated that President Obama will appoint a new commission with the mandate of offering “practical policy options” in bioethics.In the light of our experiences with the Council, we leave it with hopes that certain questions of national importance will be addressed. In light of the nature of federal advisory commissions, what is or are the proper roles of a national bioethics commission? If the aim is to provide advice and counsel to the President or, perhaps to the U. S. Congress, is that advice best rendered as a group consensus or as an in-depth exploration of the inevitably conflicting ethical perspectives on a given issue? How should such a commission be constituted—with what sorts of individuals? And what is the nature of the expertise that they individually and collectively bring to the commission’s functions? If the commission is to promote public debate and discussion, how exactly should it go about that task? And how is the efficacy of a commission to be assessed? Such questions inevitably lead us deep into contested territory, as the experience of this Council has shown: into the intersections of politics, religion, and science and into the relations between practice and theory—between policy and what some seem to deride as “philosophy.” Indeed, policy without an underlying philosophy is an edifice without a foundation; philosophy without policy is a foundation without an edifice.At the last meeting of the Council in March 2009, we launched a discussion of these questions with the... (shrink)

This volume contains essays which cover a range of aspects in the debate over genetic testing. It looks at both the advantages and disadvantages involved in knowing or not knowing whether one is a carrier of certain genetic traits.

In a community that takes rights seriously, consent features pervasively in both moral and legal discourse as a justifying reason: stated simply, where there is consent, there can be no complaint. However, without a clear appreciation of the nature of a consent-based justification, its integrity, both in principle and in practice, is liable to be compromised. This book examines the role of consent as a procedural justification, discussing the prerequisites for an adequate consent -- in particular, that an agent with (...) the relevant capacity has made an unforced and informed choice, that the consent has been clearly signalled, and that the scope of the authorisation covers the act in question. It goes on to highlight both the Fallacy of Necessity (where there is no consent, there must be a wrong) and the Fallacy of Sufficiency (where there is consent, there cannot be a wrong). Finally, the extent to which the authority of law itself rests on consent is considered. If the familiarity of consent-based justification engenders confusion and contempt, the analysis in this book acts as a corrective, identifying a range of abusive or misguided practices that variously under-value or over-value consent, that fictionalise it or that are fixated by it, and that treat it too casually or too cautiously. In short, the analysis in Consent in the Law points the way towards recognising an important procedural justification for precisely what it is as well as giving it a more coherent application. (shrink)

Why has autonomy been a leading idea in philosophical writing on bioethics, and why has trust been marginal? In this important book, Onora O'Neill suggests that the conceptions of individual autonomy so widely relied on in bioethics are philosophically and ethically inadequate, and that they undermine rather than support relations of trust. She shows how Kant's non-individualistic view of autonomy provides a stronger basis for an approach to medicine, science and biotechnology, and does not marginalize untrustworthiness, while also explaining why (...) trustworthy individuals and institutions are often undeservingly mistrusted. Her arguments are illustrated with issues raised by practices such as the use of genetic information by the police or insurers, research using human tissues, uses of new reproductive technologies, and media practices for reporting on medicine, science and technology. Autonomy and Trust in Bioethics will appeal to a wide range of readers in ethics, bioethics and related disciplines. (shrink)

The authors of this book engage in essay form in a lively debate over the fundamental characteristics of legal and moral rights. They examine whether rights fundamentally protect individuals' interests or whether they instead fundamentally enable individuals to make choices. In the course of this debate the authors address many questions through which they clarify, though not finally resolve, a number of controversial present-day political debates, including those over abortion, euthanasia, and animal rights.