As policy makers place great hope in health information technology as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect the relationship (...) between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice. (shrink)

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may (...) provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. (shrink)

Discussions of patient-centred care and patient autonomy in bioethics have tended to focus on the decision-making context and the process of obtaining informed consent, leaving open the question of how patients ought to be counselled in the daily maintenance of their health and management of chronic disease. Patient activation is an increasingly prominent counselling approach and measurement tool that aims to improve patients’ confidence and skills in managing their own health conditions. The strategy, which has received little conceptual or ethical (...) analysis, raises important questions about how clinicians ought to foster confidence and a sense of control in their patients without exposing them to blame, stigma and other harms. In this paper, we describe patient activation, discuss its relationship to personal responsibility, autonomy and health disparities, and make recommendations regarding its use and measurement. (shrink)

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge (...) they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected. (shrink)

Eine patientengerechte Versorgung ist ein hohes Ziel. Unangemessene Behandlung wie Unter- oder Überversorgung zu erkennen und zu vermeiden, stellt Ärztinnen/Ärzte und Pflegende am Krankenbett vor schwierige Entscheidungen. Hier ist die Entwicklung von praxistauglichen Orientierungshilfen angezeigt, die wissenschaftlichen Kriterien genügen und nicht allein auf Konsens beruhen. Die vorliegende Arbeit versucht, zentrale Normen zur Vermeidung von Über- und Unterversorgung zu formulieren und theoretisch zu fundieren. Dafür wird auf Basis einer Interessen-basierten Ethik eine Graduierung der Autonomie vorgenommen, indem zwischen schwacher und starker Autonomie (...) unterschieden wird. (shrink)

Eine patientengerechte Versorgung ist ein hohes Ziel. Unangemessene Behandlung wie Unter- oder Überversorgung zu erkennen und zu vermeiden, stellt Ärztinnen/Ärzte und Pflegende am Krankenbett vor schwierige Entscheidungen. Hier ist die Entwicklung von praxistauglichen Orientierungshilfen angezeigt, die wissenschaftlichen Kriterien genügen und nicht allein auf Konsens beruhen. Die vorliegende Arbeit versucht, zentrale Normen zur Vermeidung von Über- und Unterversorgung zu formulieren und theoretisch zu fundieren. Dafür wird auf Basis einer Interessen-basierten Ethik eine Graduierung der Autonomie vorgenommen, indem zwischen schwacher und starker Autonomie (...) unterschieden wird. (shrink)

Objectives. To document the prevalence of ethical requirements in the instructions for authors of journals that published randomized clinical trials in 2005. Design. Using a validated computerized search strategy for retrieving abstracts of RCTs, we retrieved 13 184 references from 2056 journals. These journals were divided into journals that had published > 30 RCTs in 2005, and those that had published fewer. We included all the former and a random sample of the latter journals in the analysis. Measurements. Coders retrieved (...) the instructions for authors for each journal. The coders identified whether 15 ethical requirements were present in each of the instructions, calculated the age of the journal, and determined where it was published. Results. Only 51% of journals required that authors document review by an ethics committee, only 55% required declaration of conflicts of interest, and only 33% required documentation of informed consent. Overall, 48% of instructions required three or fewer of 15 ethics items. Journals publishing many RCTs each year had more ethical requirements, older journals had more requirements, as did journals published in the US. Journals published in Europe had fewer. However, in multiple regression analyses involving the journal's age, location of publication, and number of RCTs published, only publishing many RCTs was associated with having more ethical requirements. Conclusions. Many journals do not require important elements of research ethics in their instructions for authors. Ethical requirements are less common in the many journals that publish few clinical trials each year, journals that have often been overlooked in prior studies of journal ethics. Keywords: Randomized clinical trials, ethical instructions, publication ethics, journal requirements. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped (...) the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (shrink)

In den westlichen Industrienationen gilt das Prinzip der informierten Einwilligung als das Zentralelement medizinischer Forschungsethik. In anderen, stärker die Relationalität als die Individualität von Personen betonenden Kulturen hingegen werden medizinische Entscheidungen traditionell eher durch die Gemeinschaft bzw. ihr Oberhaupt getroffen. Um verschiedenen kulturellen Normen gerecht zu werden, wird international tätigen Forschungsteams häufig empfohlen, den Community Consent und den Informed Consent einzuholen. Ausschlaggebend soll dabei letztlich der Informed Consent des Individuums sein. Es soll die Teilnahme auch dann verweigern können, wenn die (...) Gemeinschaft bzw. ihr Repräsentant dem Vorhaben zugestimmt hat. Der Beitrag diskutiert, ob eine solche Kopplung von Community Consent und Informed Consent tatsächlich geeignet ist, den Ansprüchen beider Prinzipien gerecht zu werden. Es wird argumentiert, dass die Kopplung von Community Consent und Informed Consent ethisch problematisch ist, wenn der Gemeinschaft hierbei ein Vetorecht eingeräumt wird, das geeignet ist, die Realisation konträrer individueller Interessen und damit das Selbstbestimmungsrecht der Betroffenen zu unterlaufen. Um zu gewährleisten, dass in interkulturellen Forschungszusammenhängen sowohl der individuellen als auch der relationalen Autonomie von Personen angemessener Raum gewährt wird, wäre es empfehlenswert, den Informed Consent ausdrücklich mit einer Community Consultation zu koppeln. Hier käme die Entscheidung gegen, aber auch für eine Studienteilnahme in letzter Instanz klar dem Individuum zu, während die Vorzüge einer Einbeziehung der Gemeinschaft in den Entscheidungsfindungsprozess anerkannt und genutzt werden könnten. (shrink)

In den westlichen Industrienationen gilt das Prinzip der informierten Einwilligung als das Zentralelement medizinischer Forschungsethik. In anderen, stärker die Relationalität als die Individualität von Personen betonenden Kulturen hingegen werden medizinische Entscheidungen traditionell eher durch die Gemeinschaft bzw. ihr Oberhaupt getroffen. Um verschiedenen kulturellen Normen gerecht zu werden, wird international tätigen Forschungsteams häufig empfohlen, den Community Consent und den Informed Consent einzuholen. Ausschlaggebend soll dabei letztlich der Informed Consent des Individuums sein. Es soll die Teilnahme auch dann verweigern können, wenn die (...) Gemeinschaft bzw. ihr Repräsentant dem Vorhaben zugestimmt hat. Der Beitrag diskutiert, ob eine solche Kopplung von Community Consent und Informed Consent tatsächlich geeignet ist, den Ansprüchen beider Prinzipien gerecht zu werden. Es wird argumentiert, dass die Kopplung von Community Consent und Informed Consent ethisch problematisch ist, wenn der Gemeinschaft hierbei ein Vetorecht eingeräumt wird, das geeignet ist, die Realisation konträrer individueller Interessen und damit das Selbstbestimmungsrecht der Betroffenen zu unterlaufen. Um zu gewährleisten, dass in interkulturellen Forschungszusammenhängen sowohl der individuellen als auch der relationalen Autonomie von Personen angemessener Raum gewährt wird, wäre es empfehlenswert, den Informed Consent ausdrücklich mit einer Community Consultation zu koppeln. Hier käme die Entscheidung gegen, aber auch für eine Studienteilnahme in letzter Instanz klar dem Individuum zu, während die Vorzüge einer Einbeziehung der Gemeinschaft in den Entscheidungsfindungsprozess anerkannt und genutzt werden könnten. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

Should face transplants be undertaken? This article examines the ethical problems involved from the perspective of the recipient, looking particularly at the question of identity, the donor and the donor’s family, and the disfigured community and society more generally. Concern is expressed that full face transplants are going ahead.

Though much has been written about when paternalistic intervention is justified, and about how it is justified, much less has been written about who may do the intervening. This is a substantial lacuna in our understanding of the nature of justified paternalism. By examining the question of who it is that may most appropriately interfere with the course of our decision-making, we can learn something useful both about paternalism and about the nature of friendship.In this essay I will argue that (...) friendship and paternalistic intervention are linked. Friendship of the close, intimate variety that I will be discussing is in part constituted by the fact that one friend is morally justified in interfering with the other’s decisions. Intimate friendship involves a partial meshing of identities. This meshing of identities manifests itself in part by the liberties that one friend takes in guiding the life of the other. Paternalistic intervention between friends can thus be justified because it expresses the union of the friends, and because it preserves that union. (shrink)

Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require precise definition and documentation, (...) which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening. (shrink)

Among medical researchers and clinicians the dominant view is that it is unethical to deceive patients by prescribing a placebo. This opinion is formalized in a recent policy issued by the American Medical Association (AMA [Chicago, IL]). Although placebos can be shown to be always safe, often effective, and sometimes necessary, doctors are now effectively prohibited from using them in clinical practice. I argue that the deceptive administration of placebos is not subject to the same moral objections that face other (...) forms of deception in clinical practice and medical research. Although deception is normally objectionable on the grounds that it limits autonomy and breaches trust, these grounds do not apply to placebos when they are prescribed within appropriate ethical limits. Patients have reason to prefer that doctors can prescribe placebos in ethically responsible ways. Hence, the AMA has an obligation to endorse and to promote the responsible use of deceptive placebos in clinical practice. (shrink)

This article argues that the study conducted by Facebook in conjunction with Cornell University did not have sufficient ethical oversight, and neglected in particular to obtain necessary informed consent from the participants in the study. It establishes the importance of informed consent in Internet research ethics and suggests that in Facebook’s case, a reasonable shift could be made from traditional medical ethics ‘effective consent’ to a ‘waiver of normative expectations’, although this would require much-needed change to the company’s standard practice. (...) Finally, it gives some practical recommendations for how to implement such consent strategies, and how the ethical oversight gap between university-led research and industry-led research can be bridged, potentially using emerging Responsible Research and Innovation frameworks which are currently gathering momentum in Europe. (shrink)

Even though respect for integrity is hailed in several authoritative legal and ethical documents, and is typically presented as a complement to respect for autonomy, it is largely neglected in many leading works in ethics. Is such neglect warranted, or does it express a prejudice? This article argues that the latter is the case, and that this is due to misplaced conceptual concerns. It offers some proposals as regards the conceptualization of integrity in social ethics in general and in biomedical (...) ethics in particular. Five main directions of interpretation of “integrity” are discerned and shown to be relevant for different areas of biomedical ethics. The defense of respect for integrity is served by a softening of principlism and by greater attention to context among the initial critics of this principle. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

Taking up the notion of engineering as social experimentation, this paper argues that engineering research laboratory directors have a responsibility to inform graduate engineering students who participate in their research projects of the potential broader social dimensions of those projects. Informing engineers-in-the-making of the broader social dimensions of the research they are learning to conduct would help ensure their future capacity to act as ethically responsible social experimenters. The paper also argues that graduate engineers have a right to be informed (...) participants in activities that may have broader social dimensions than are recognized by formal research evaluation or educational processes. The process of obtaining the informed consent of graduate engineering students, if implemented effectively, would thus help ensure both their capacity to act as moral agents and their own moral integrity. Since the eventual outcomes of research can be uncertain, complex, and contested, most traditional institutional frameworks—such as principle-based codes of conduct and risk-benefit frameworks—provide an insufficient basis to inform engineers and citizens. Rather, we recommend an ongoing discursive process that explores a number of different actors, contexts, and scenarios, and that evolves with the social context of the engineering research in question. While this may seem burdensome to the engineering research process, it can be integrated directly into the group research meetings and mentorship activities that typically already go on. Moreover, it can actually be seen to benefit engineering practices. (shrink)

The paper examines the attainment and adequacy of informed consent in an ethnographic–discursive study on gynecological visits involving doctors, patients, and nurses. Starting from a theoretical discussion on informed consent and the principles upon which it relies, the paper highlights the changes and the adjustments that these principle undergo in practice, from the planning of the research till later stages of the researcher’s fieldwork and data recording. Analyses first focus on the informed consent as a written artifact and show how (...) the description of the study indexes the prospective participants’ identity, as well as, it works in favor of the researcher’s (or, other institutional representatives such as the managers of the Hospital) accountability. Then, the authors focus on instances of audio and video recorded doctor–patient–nurse interactions in which information is reformulated by the doctors, in such a way as to anticipate and/or respond to the nurses’ and patients’ concerns with regards the project (such as, the risk of exposure to the public). The analysis of these episodes carry ethical implications, in that they alert that patients, nurses, and doctors may be not equally knowledgeable about the project and that they can be conceded unequal opportunities to have their interpretations and identity performances acknowledged and inscribed on the tape. (shrink)

The ethical principle of respect for autonomy has come into its own In American medicine since World War II as equal in importance to the traditional medicomoral principles of nonmaleficence and beneficence. Respect for autonomy provides the ethical underpinning for the patient's right to exercise an informed choice – whether to consent to or to refuse recommended medical treatment. However, an informed choice demands a certain level of competence. Typical criteria for patient competence to accept or to refuse medical treatments (...) Include ability to make a choice and ability to comprehend the nature of the treatment, as well as the risks and benefits of accepting or refusing the treatment. (shrink)

Bioethical arguments conceal the coercion underlying the choice between poverty and selling ones organsIn mid-May 2006, three Palestinian prisoners detained in Israel applied to the Israeli Prison Service for permission to sell their kidneys in order to send money to their children for food. Whether truly sincere or merely propagandistic, the request was made against the background of Israel’s decision to suspend the transfer of Palestinian tax moneys to the Hamas-led Palestinian Authority, and the subsequent increasing poverty and famine in (...) the Gaza Strip.1An official decision was yet to be made when this paper was written. However, the IPS chief medical officer had already made it clear that the request is likely to be rejected. Aside from emphasising that the cost of the pertinent treatment of the prisoners could not be imposed on the IPS, especially as it would greatly exceed the sum to be obtained by the sellers , he asserted that the IPS “won’t lend a hand to endangering the prisoner”. He also reiterated the official IPS policy, according to which the prisoners’ consent to such transaction could not be valid, since they might have been threatened by people from inside or outside the prison.1This is ironic. While the IPS’ professed concerns for the welfare and best interests of the prisoners are commendable, they conceal and hence reaffirm the real coercion implicit in the dilemma the prisoners face: to sell their kidney or let their children starve. Interestingly, approval of their request would have equally concealed the coercion, this time behind concerns for either their autonomy, or the welfare of their children, or both.At present, it is unlikely that Israel will acknowledge the role of national oppression and poverty in producing this dilemma. Rather, the debate will remain focused on …. (shrink)

Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and (...) Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants. (shrink)

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on (...) the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens. (shrink)

Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and (...) Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants. (shrink)

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life HIV cure research is relatively new, the scientific community has a timely opportunity to (...) examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable. (shrink)

Background Despite recent developments aimed at creating international guidelines for ethical global health research, critical disconnections remain between how global health research is conducted in the field and the institutional ethics frameworks intended to guide research practice. Discussion In this paper we attempt to map out the ethical tensions likely to arise in global health fieldwork as researchers negotiate the challenges of balancing ethics committees’ rules and bureaucracies with actual fieldwork processes in local contexts. Drawing from our research experiences with (...) an implementation and evaluation project in Jamaica, we argue that ethical research is produced through negotiated spaces and reflexivity practices that are centred on relationships between researchers and study participants and which critically examine issues of positionality and power that emerge at multiple levels. In doing so, we position ethical research practice in global health as a dialectical movement between the spoken and unspoken, or, more generally, between operationalized rules and the embodied relational understanding of persons. Summary Global health research ethics should be premised not upon passive accordance with existing guidelines on ethical conduct, but on tactile modes of knowing that rely upon being engaged with, and responsive to, research participants. Rather than focusing on the operationalization of ethical practice through forms and procedures, it is crucial that researchers recognize that each ethical dilemma encountered during fieldwork is unique and rooted in social contexts, interpersonal relationships, and personal narratives. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Various aspects of the concepts of privacy and confidentiality are discussed in relation to health care information in primary health care settings. In addition, findings are presented from patient and nurse practitioner focus groups held to elicit concerns that these two groups have in relation to privacy and confidentiality in their respective primary care settings. The focus groups were held prior to the implementation of the Health Insurance Portability and Accessibility Act in the USA. Implications for advanced practice registered nurses (...) in primary care practices are provided. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

In this dissertation I examine ethical issues that concern fertility preservation (FP) technologies for women from a feminist perspective. FP technologies involve the removal, cryopreservation and subsequent storage of reproductive materials for future use. The aim of these technologies is to preserve the option of future genetic reproduction. FP technologies have been developed in the cancer context because infertility is one of the long-term side-effects of many cancers or cancer therapies. Many FP technologies are still experimental, but some technologies are (...) becoming available to healthy women who wish to guard against age-related infertility. Although FP technologies are expanding women’s reproductive options and benefitting some women by satisfying their desires for genetically-related children, these technologies pose numerous physical, emotional and financial risks to women. I maintain that a feminist examination of choice is necessary for the ethical provision of FP technologies within patriarchal contexts. My analysis begins by demarcating two oppressive social biases from one another: namely pronatalism and biologism. I argue that each of these biases can unduly influence women’s reproductive choices about FP technologies. I then consider how these biases might be identified and challenged in the FP decision-making context. I outline an ethical process of informed choice that is equipped to protect patient autonomy when such autonomy is threatened by these biases. I then consider whether the choice to use FP should be available to both women within and without the cancer contexts. I argue that both disease-related FP and age-related FP can be morally permissible. Finally, I consider whether there should be an upper age limit on women’s access to their stored reproductive materials. I argue that age can be morally relevant to reproduction and thus age limits on access to assisted reproduction are morally permissible. I conclude by suggesting how feminist insights might inform policies on FP technologies and related assisted reproductive technologies. In sum, my dissertation shows that a feminist analysis of choices about FP is essential for ensuring the ethical provision of FP technologies. (shrink)

“Neurodiversity” is associated with the struggle for the civil rights of all those diagnosed with neurological or neurodevelopmental disorders. Two basic approaches in the struggle for what might be described as “neuro-equality” are taken up in the literature: There is a challenge to current nosology that pathologizes all of the phenotypes associated with neurological or neurodevelopmental disorders ); there is a challenge to those extant social institutions that either expressly or inadvertently model a social hierarchy where the interests or needs (...) of individuals are ranked relative to what is regarded as properly functioning cognitive capacities. In this paper, we explore some of the reasons justifying which make it an important tool for achieving greater neuro-equality, while still recognizing its limitations for achieving this goal. Particularly, we explore how an appeal to functionality and neurological diversity can support a re-seeing of at least certain forms of ASD. (shrink)

Drawing on empirical evidence in medicine, economics, law, and anthropology, I argue that a market is uniquely capable of meeting the demand for transplantable kidneys, and that it may be arranged so as to operate safely. The welfare gains, expected to accrue to both vendors and recipients, are sufficient to justify sales. Having spelled out the considerations recommending a kidney market, I address the most forceful objections facing the proposal. Despite its currency, the claim that incentives will crowd out altruistic (...) donors and result in a decrease in supply is empirically unsupported and predicated on an implausible view of donorsâ motives. A host of objections claim vendorsâ will not give informed consent. Many such objections identify easily remediable problems, or impose unreasonable standards â standards that would rule out morally permissible kidney donation. And all presuppose a model of morally transformative consent that, I argue, is deficient. Two further challenges point to harms inflicted on those who do not participate in the market. Some claim that those in poverty will be subject to harmful social and legal pressure to vend. This objection fails to distinguish between being pressured to perform a specific act, and being under general economic pressure and having the option to perform an act. It, moreover, presupposes vending more common than is possible. Others worry that the market will give rise to unfair pecuniary externalities. This objection also presupposes that kidney sales will occur more often than is possible. But more importantly, the normative consideration that is supposed to make such externalities especially objectionable, in fact, recommends allowing sales. I also make a political case for kidney sales. I offer an account of the stateâs proper role in the market. I begin with a conception of democratic equality according to which the state is responsible to secure for its citizens the preconditions for democratic participation. I then show that this end would be promoted were the state to end the current prohibition on sales. (shrink)

This study is a contribution to the bioethical debate about new and possibly emerging reproductive technologies. Its point of departure is the intuition, which many people seem to share, that using such technologies to select non-disease traits – like sex and emotional stability - in yet unborn children is morally problematic, at least more so than using the technologies to avoid giving birth to children with severe genetic diseases, or attempting to shape the non-disease traits of already existing children by (...) environmental means, like education. The study employs philosophical analysis for the purpose of making this intuition intelligible and judging whether it is justified. Different ways in which the moral problems posed by reproductive technologies are often framed in bioethical debates are criticised as inadequate for this task. In particular, it is argued that the intuition cannot fully be made sense of in terms of harm to the children that such technologies help create. The study attempts to elaborate an alternative to that broadly consequentialist approach, by drawing on Martin Heidegger’s philosophy of technology, Hans Jonas’s ethics, and Aristotle’s practical philosophy, as it has been received and developed in the hermeneutical tradition. It is suggested that reproductive choices, unlike decisions for already born children, are characterised by a peculiar one-sidedness: the future child appears to the parents as something wholly theirs to decide about, not as a concrete other with whom they must interact in a responsive and attuned way. This is problematic because it means that such choices cannot call upon the particularised moral understanding only gained in interpersonal encounters. In particular, it makes them easily shaped by various tendencies, to which parents are always susceptible, to relate to children in instrumentalising ways, and at risk of reinforcing such tendencies. However, this does not mean that all uses of reproductive technologies are equally troubling. When selecting against severe disease the parents can rely on a widely shared illness experience to escape the dangers that one-sidedness involves. It is concluded that the intuition under discussion, thus explicated and in some ways qualified, makes sense morally. (shrink)

Severe brain injury is a leading cause of death and disability. Following severe brain injury diagnosis is difficult and errors frequently occur. Recent findings in clinical neuroscience may offer a solution. Neuroimaging has been used to detect preserved cognitive function and awareness in some patients clinically diagnosed as being in a vegetative state. Remarkably, neuroimaging has also been used to communicate with some vegetative patients through a series of yes/no questions. Some have speculated that, one day, this method may allow (...) severely brain-injured patients to make medical decisions. Yet, skepticism is rife, due in part to the inherent difficulty of assessing decision-making capacity through neuroimaging communication. In this thesis, I provide the first systematic analysis of this problem. I present and defend a strategy for assessing decision-making capacity in brain-injured patients who can only communicate through neuroimaging. (shrink)

Package leaflets belong to the complex communication system related to the minimization and prevention of pharmaceutical risk. Their legal nature is not exhausted by safety regulation though: as a privileged form of product instruction, they are also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure. This article presents the results of a doctoral dissertation devoted to the legal and communicative analysis of PL information. After illustrating the articulation of pharmaceutical risk through risk prevention norms, (...) the paper goes on with a discussion of the PL role within the therapeutic decision as a complementary vehicle to doctor’s information. It results that the liability framework in which both information channels are embedded determines a communication model, which far from promoting a shared decision process, radicalizes the two-step communication structure typical of the informed consent model inherited by surgery judicature. The second part investigates PL information as a source of knowledge updating through the methodological tools provided by Bayesian decision theory. Finally, an empirical study conducted over a sample of 55 drug consumers investigates the impact of PL information on drug risk perception and its perceived value to therapeutic decision. (shrink)

To address some questions in global biomedical ethics, three problems about cultural moral differences and alleged differences in Eastern and Western cultures are addressed: The first is whether the East has fundamentally different moral traditions from those in the West. Concentrating on Japan and the United States, it is argued that theses of profound and fundamental East-West differences are dubious because of many forms of shared morality. The second is whether human rights theory is a Western invention with no firm (...) traditions in Eastern moral traditions. It is argued that this thesis is unsupported both historically and in contemporary bioethics. The third problem is whether multiculturalist theory casts doubt on claims of universal principles and rights. It is argued that the reverse is true: multiculturalism is a universalistic theory. The argument throughout supports common morality theory. (shrink)

Respect for autonomy and beneficence are frequently regarded as the two essential principles of medical ethics, and the potential for these two principles to come into conflict is often emphasised as a fundamental problem. On the one hand, we have the value of beneficence, the driving force of medicine, which demands that medical professionals act to protect or promote the wellbeing of patients or research subjects. On the other, we have a principle of respect for autonomy, which demands that we (...) respect the self-regarding decisions of individuals. As well as routinely coming into opposition with the demands of beneficence in medicine, the principle of respect for autonomy in medical ethics is often seen as providing protection against beneficial coercion (i.e. paternalism) in medicine. However, these two values are not as straightforwardly opposed as they may appear on the surface. In fact, the way that we understand autonomy can lead us to implicitly sanction a great deal of paternalistic action, or can smuggle in paternalistic elements under the guise of respect for autonomy. -/- This paper is dedicated to outlining three ways in which the principle of respect for autonomy, depending on how we understand the concept of autonomy, can sanction or smuggle in paternalistic elements. As the specific relationship between respect for autonomy and beneficence will depend on how we conceive of autonomy, I begin by outlining two dominant conceptions of autonomy, both of which have great influence in medical ethics. I then turn to the three ways in which how we understand or employ autonomy can increase or support paternalism: firstly, when we equate respect for autonomy with respect for persons; secondly, when our judgements about what qualifies as an autonomous action contain intersubjective elements; and thirdly, when we expect autonomy to play an instrumental role, that is, when we expect people, when they are acting autonomously, to act in a way that promotes or protects their own wellbeing. I then provide a proposal for how we might work to avoid this. I will suggest that it may be impossible to fully separate paternalistic elements out from judgements about autonomy. Instead, we are better off looking at why we are motivated to use judgements about autonomy as a means of restricting the actions of patients or research subjects. I will argue that this is a result of discomfort about speaking directly about our beneficent motivations in medical ethics. Perhaps we can reduce the incentive to smuggle in these beneficent motivations under the guise of autonomy by talking directly about beneficent motivations in medicine. This will also force us to recognise paternalistic motivations in medicine when they appear, and to justify paternalism where it occurs. (shrink)

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when (...) principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)

A current trend in bioethics considers genetic information as family property. This paper uses a logical approach to critically examine Matthew Liao’s proposal on the familial nature of genetic information as grounds for the duty to share it with relatives and for breach of confidentiality by the geneticist. The authors expand on the topic by examining the relationship between the arguments of probability and the familial nature of genetic information, as well as the concept of harm in the context of (...) genetic risk. Lastly, they examine the concept of harm in relation to the type of situations w the potential recipient of the information is not the person directly affected by the risk. (shrink)

Los avances científicos y su aplicación técnica en el ámbito de la odontología, ha motivado la reflexión bioética de la práctica en esta disciplina planteando las siguientes interrogantes: ¿cómo entender el papel del odontólogo?, ¿cómo se configura el universo bioético del odontólogo?, ¿cómo se posibilita el consentimiento válidamente informado? Para explorar la respuesta a estos cuestionamientos, se tiene como punto de partida la relación odontólogo-paciente, y se transita por aspectos de la bioética del odontólogo y las características del consentimiento informado (...) en la práctica odontológica. La conclusión destaca la importancia de hacer del consentimiento informado el medio por el cual se recupera la dignidad de la persona mediante una relación ética y dialógica en tanto proceso mediante el cual se reconoce la alteridad del paciente durante la relación odontólogo- paciente además de coadyuvar a la educación en salud del paciente promoviendo su responsabilidad frente a la autonomía y sus derechos. Scientific advances and their technical application in the field of Dentistry, have led to a bioethical reflection about practice in this discipline by asking questions like: how to understand the dentist´s role, how to set the dentist´s bioethical universe?, how is the valid informed consent made possible? To answer these questions, the patient-dentist relationship is taken as a starting point, and goes through the dentist´s bioethical aspects and informed consent characteristics in dental practice. The conclusion highlights the importance of the informed consent as a way to recover a person´s dignity by which the otherness of the patient is recognized as well as to contribute to the patient´s health education promoting responsibility towards autonomy and rights. (shrink)