Consent's capacity to legitimise actions and claims is limited by conditions such as coercion, which render consent ineffective. A better understanding of the limits to consent's capacity to legitimise can shed light on a variety of applied debates, in political philosophy, bioethics, economics and law. I show that traditional paternalist explanations for limits to consent's capacity to legitimise cannot explain the central intuition that consent is often rendered ineffective when brought about by a rights violation or threatened rights (...) violation. I argue that this intuition is an expression of the same principles of corrective justice that underlie norms of compensation and rectification. I show how these principles can explain and clarify core intuitions about conditions which render consent ineffective, including those concerned with the consenting agent's option set, his mental competence, and available information. (shrink)

There is currently intense debate about the significance of user consent to data practices. Consent is often taken to legitimate virtually any data practice, no matter how invasive. Many scholars argue, however, that user consent is typically so defective as to be ‘meaningless’ and that user privacy should thus be protected by substantive legislation that does not rely (or does not rely heavily) on consent. I argue that both views rest on serious mistakes about the validity conditions for consent. User (...) consent is sufficiently impoverished that it does not guarantee legitimacy but is not so impoverished as to be ‘meaningless’; it can legitimate data practices that are independently reasonable but not those that are exploitative. Since many valuable data practices must be consented to if they are to be legitimate (or so I argue), our privacy legislation should continue emphasizing the importance of user consent, even if auxiliary protections are also desirable. (shrink)

There are two distinct ways for someone to place conditions on their morally valid consent. The first is to place conditions on the moral scope of their consent—whereby they waive some moral claim rights but not others. The second is to conditionally token consent—whereby the condition affects whether they waive any moral claim rights at all. Understanding this distinction helps make progress with debates about so-called “conditional consent” to sexual intercourse in English law, and with understanding how individuals (...) place conditions on their morally valid consent in other contexts. (shrink)

Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient’s consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions. -/- What could morally justify the physician’s special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties (...) directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians’ special duties from an argument in Kant’s political philosophy. Kant argues that pre- legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as “consent” in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard. (shrink)

Consent that is voluntary, informed and given by a competent person sometimes transforms a wrong into a right act. How does consent that meets these requirements change the moral property of an act, namely that of being a wronging of a person? This is the question this paper will deal with. Some authors argue that valid consent changes the moral property of an act by changing the reasons which speak against the act. This account of the normative force of consent (...) will be critically examined and rejected. An alternative model will then be put forward and defended according to which consent changes the moral property of an act if and only if the wrong‐making property of the act is that it is not consented to. The upshot will be that consent does not eliminate the wrong‐making property if the unconsented act is wrong for other reasons than not being consented to. (shrink)

Social media data hold considerable potential for predicting health-related conditions. Recent studies suggest that machine-learning models may accurately predict depression and other mental health-related conditions based on Instagram photos and Tweets. In this article, it is argued that individuals should have a sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. The article (1) develops three basic arguments for a right to protection of personal data trading on the notions (...) of social control and stigmatization, (2) argues that a number of features of AI profiling make individuals more exposed to social control and stigmatization than other types of data processing (the exceptionalism of AI profiling), (3) considers a series of other reasons for and against protecting individuals against AI profiling based on publicly available data, and finally (4) argues that the EU General Data Protection Regulation does not ensure that individuals have a right not to be AI profiled based on publicly available data. (shrink)

Background: The concept of the right to health includes decent conditions of work, housing, and leisure. It can be assessed through the evaluation of access to health services and programs. The creation of the Brazilian Unified Health System expanded access to healthcare for the entire Brazilian population. Aim: This study aimed to understand the use of the Brazilian Unified Health System by pregnant women who live on the Brazil–Paraguay border, whose residents are known as Braziguayans. Methods: We conducted 16 semi-structured (...) interviews with users of prenatal services at Unified Health System units located at the border of the municipalities of Ponta Porã and Pedro Juan Caballero. Ethical considerations: The Research Ethics Committee of the Federal University of Mato Grosso do Sul approved of this research. All participants were provided with project information and signed an informed consent form. Findings: Through content analysis of the interviews, “right to health” and “autonomy, pathways, and access” were two recurrent themes that have arisen. These suggested that Braziguayan women live in conditions of social vulnerability. They do not fully experience the right to healthcare, despite sufficient knowledge about the Brazilian and Paraguayan healthcare systems from which to choose prenatal care. The interviewees acknowledged that Unified Health System use is a right of Brazilian citizens and considered its units to be safe environments. These women also understand the structuring of Unified Health System and the mechanisms of accessing healthcare programs. Conclusion: We can conclude that, despite widely known difficulties, Unified Health System represents, for Braziguayan women, potential access to reliable health services for adequate prenatal and childbirth assistance. (shrink)

Over 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained. We have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We demonstrate that (...) the practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures. To end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners. (shrink)

John Locke affirms a right to revolt against tyranny, but he denies that a minority of citizens is at liberty to exercise it unless a majority of their fellow citizens concurs in their judgment that the government is a tyranny. In a recent article, Massimo Renzo takes an equivalent position, on which a revolutionary vanguard requires the consent of the domestic majority before being permitted to revolt. Against Locke and Renzo, I argue that a minority of citizens can have a (...) liberty to revolt, whatever the domestic majority may hold. My argument concentrates on the moral force of majority rule, which turns out to presuppose the satisfaction of a number of background conditions. When any of these conditions fails to obtain, no domestic majority can justifiably block a minority’s liberty to revolt against tyranny. For the purposes of the theory of revolution, this minority has to be large enough to have a reasonable prospect of (military) success. Without that prospect, the minority will be anyhow forbidden to revolt, on grounds familiar from just war theory. However, for the purposes of the theory of political legitimacy, prospects of success are irrelevant. All that matters are the conditions under which any citizen is released from their ordinary duty not to overthrow the government. (shrink)

It is widely accepted among medical ethicists that competence is a necessary condition for informed consent. In this view, if a patient is incompetent to make a particular treatment decision, the decision must be based on an advance directive or made by a substitute decision-maker on behalf of the patient. We call this the competence model. According to a recent report of the United Nations (UN) High Commissioner for Human Rights, article 12 of the UN Convention on the (...) class='Hi'>Rights of Persons with Disabilities (CRPD) presents a wholesale rejection of the competence model. The High Commissioner here adopts the interpretation of article 12 proposed by the Committee on the Rights of Persons with Disabilities. On this interpretation, CRPD article 12 renders it impermissible to deny persons with mental disabilities the right to make treatment decisions on the basis of impaired decision-making capacity and demands the replacement of all regimes of substitute decision-making by supported decision-making. In this paper, we explicate six adverse consequences of CRPD article 12 for persons with mental disabilities and propose an alternative way forward. The proposed model combines the strengths of the competence model and supported decision-making. (shrink)

In this article, I argue for a distinct and novel right-based account of risks and I call it the Sophisticated High-risk Thesis. I argue that there is a distinction between rights-infringing risk impositions and no-rights-infringing risk impositions. An action imposing a high risk of harm infringes rights, whereas an act imposing a low risk of harm does not. I also suggest three principles that govern the permissibility of highly risky actions. If a highly risky action meets the (...) conditions specified by any of these three principles, it can be justified. These principles are the consent principle*, the prevent disaster principle* and the reciprocity principle**. I show that the Sophisticated High-risk Thesis is, in general, better than the alternative Risk Thesis defended by McCarthy. (shrink)

One of the major objectives in a democratic state is ensuring health security of the citizens including combating epidemic diseases. The subject matter of this article is the presentation and analysis of legal regulations regarding preventive vaccination in Poland, in particular the aspect of imposing a legal obligation and restricting parents’ right to express consent for medical intervention. The reflections made herein are aimed at finding an answer to the question whether the adopted legal solutions are admissible in a democratic (...) state with regard to ensuring health security. The purpose of the analysis is also to assess whether the abovementioned legal regulations have been formulated in a clear way and do not raise interpretation doubts and, consequently, whether they are comprehensible to the parents obliged to comply with them. As it follows from analysis of the legal provisions, parents must not refuse to subject a child to obligatory preventive vaccination and their consent is not required by law, both as regards the medical qualifying examination to exclude contraindications to performing vaccination and the vaccination itself. It is a legal obligation, from which exemption is only possible on grounds of certain medical conditions that would render vaccination inadvisable. The legal provisions that concern obligatory preventive vaccination in Poland, including in particular those referring to its enforceability, have not been formulated in a way that is sufficiently comprehensible to parents who are under the obligation of complying with them, irrespective of the fact that the language of the provisions of law should be clear and raise no interpretative doubts. In a democratic state the protection of public health against epidemic hazards justifies the implementation of legal solutions that restrict an individual’s freedom of self-determination, thus limiting the right of patients or their statutory representatives to grant or refuse consent for a medical intervention in the form of preventive vaccination – the purpose of this legal solution being to prioritize the safeguarding of state health security. It is vitally important to engage in a social dialogue with the purpose of convincing the public of the need for vaccination, its significance and its implementation for the better good. (shrink)

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government (...) programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006–2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. (shrink)

BackgroundAlthough the Covid-19 epidemic challenged existing medical care norms and practices, it was no excuse for unlawful conduct. On the contrary, legal compliance proved essential in fighting the pandemic. Within the European legal framework for the pandemic, patients were still entitled to be treated equally, by a specialized physician, with the possibility of seeking a second medical opinion, in a confidential setting, following prior and informed consent. This study examines physicians’ practices regarding patients’ rights during the Covid-19 pandemic and (...) the effects of age, experience, and specialty on physicians’ behavior and preferences. Additionally, it explores the nexus of malpractice complaints, malpractice fear, and legal compliance.MethodsA cross-sectional study was conducted on a convenience sample of attending physicians and general practitioners to assess compliance with patients’ rights regulations. Respondents were physicians practicing in private and public settings in Southwestern Romania from July 2021 to May 2022.Results396 attending physicians and 109 general practitioners participated in the research. Attending physicians acknowledged patients’ rights in 55.7% of statements, while general practitioners showed a slightly higher level of compliance at 59.9%. Emergency and Anesthesia and Intensive Care physicians showed the lowest compliance. There were no significant behavioral differences based on physicians’ age, years in practice, work sector, or location. However, when faced with the question of prioritizing treatment for patients with similar medical conditions, 46.2% of attending physicians reported favoring the younger patients. This preference was common among physicians under 39. Additionally, over half of the attending physicians reported working outside their area of expertise due to staff shortages. Malpractice fear was high among physicians, although unrelated to patients’ claims, legal compliance, or working outside the scope of practice. It resulted in pressure and behavioral changes.ConclusionAdherence to patients’ rights was low during the Covid-19 pandemic. Physicians could benefit from educational and administrative support to ensure better legal compliance. Further research is needed to determine if this behavior persists beyond the pandemic context. (shrink)

In the past 50 years, ethical concerns concerning human experimentation have arisen with the advancement of new medical research and technology. While the benefits of human experimentation are well known in the fields of biology, psychology, sociology, and medicine, the conditions of human subject research have been persistently controversial. This book discusses ethical perspectives, emerging developments and global challenged of patient rights. Topics include effective medical informed consent; rights to health and dental care; the ethics of HIV screening (...) targeted to the seriously mentally ill; and problems in ethics for medical publication. (shrink)

Shared Decision Making (‘SDM’) is one of the most significant developments in Western health care practices in recent years. Whereas traditional models of care operate on the basis of the physician as the primary medical decision maker, SDM requires patients to be supported to consider options in order to achieve informed preferences by mutually sharing the best available evidence. According to its proponents, SDM is the right way to interpret the clinician-patient relationship because it fulfils the ethical imperative of respecting (...) patient autonomy. However, there is no consensus about how decisions in SDM contexts relate to the principle of respect for autonomy. In response, I demonstrate that in order to make decisions about what treatment they will or will not receive, patients will be required to meet different conditions depending on the approach proponents of SDM take to understanding personal autonomy. Due to the fact that different conceptions of autonomy yield different obligations, I argue that if physicians and patients satisfied all the conditions described in standard accounts of SDM, then SDM would undermine patient autonomy. (shrink)

This chapter surveys attempts to provide liberal justification for specific rights available to Indigenous citizens of democratic societies. The most important of these, by Will Kymlicka, relied on the equal right of all citizens to the good of cultural membership to argue for specific rights to protect minority cultures. After noting that Rawls’s political liberalism offers other resources to argue for specific constitutional or legal rights for colonised Indigenous citizens, the chapter turns to consider James Tully’s argument (...) for an inter-cultural constitutionalism based on the principles of recognition, consent and continuity. Finally, the chapter refers to the work of Robert A. Williams Jr in order to suggest that the conditions of a just and fair colonial constitution are similar to the conditions of a just and stable political society in which there are incommensurable comprehensive moral views. (shrink)

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not (...) imply that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there (...) should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

The volume consists of two parts, of which the former describes the two central elements of Locke’s account. First, Sreenivasan explains how he understands Locke’s attempt to show that common ownership of natural resources is consistent with the existence of a procedure whereby private ownership rights can be acquired without universal agreement. Solving this consent problem, Locke construes common ownership as involving merely a right to those conditions necessary for self-preservation. He then argues that where non-appropriators are left with (...) enough to achieve subsistence, unilateral appropriation does not violate such a right. Locke’s sufficiency condition ensures this by requiring that the able-bodied must have access to the relevant production or employment opportunities, while the disabled must be capable of subsisting through charity. (shrink)

This paper is an analysis of the events recounted in 'Informed consent to septoplasty: An anecdote from the field.' As a commentary, it assesses the behavior of many agents who are parties to the story - physicians, nurses, friends of the patient, the patient's wife and the patient himself. This story is interesting for being mundane. The medical condition involved and the failures of care are not momentous. The patient's role as a medical ethicist led him to see things in (...) particular perspective and motivated or influenced his conduct sometimes not in the smartest of ways. Several accounts of informed consent are reviewed and used as measures of what happened. The moral vision behind informed consent, the rights and duties it implies and the elements of its contents are identified. No account was fulfilled. Some of the reasons and causes for this are discussed. Many sources of information and forces acting on the situation are explored. Post-operative experiences include severe irritation and discomfort as well as severe frustration and a sense of alienation and abandonment. The case communicates a hint about what physicians do not know in order to have informed consent occur. Physicians' lack of awareness about, e.g., post-operative experience means that they will not provide what the informed aspect of informed consent requires. Patients can feel abandoned and perhaps are abandoned in a variety of ways, subtle and not so subtle. A few issues besides informed consent are discussed (the roles of wives in working at their physician-husband's front desk, the language of reassurance). (shrink)

In their paper Hortonet alargue that it is acceptable to contact an anonymous egg-donor to facilitate diagnostic genetic testing for the donor conceived child, despite the donor, ‘indicating on a historical consent form that she did not wish to take part in future research, and that she did not wish to be informed if she was found to be a carrier of a “harmful inherited condition”’. There are a number of claims embedded in Hortonet al’s position that it is acceptable (...) to contact the donor and request that she at least think about participating in genetic testing. In this response. I will go through their main claims and argue that the area of genomic medicine does not justify exceptions to general consent conditions as the authors suppose and conclude that the donor should not be contacted. I will then go on to suggest a policy change that would address Hortonet al’s concerns but would not involve over-riding any previously expressed wishes. (shrink)

Studies suggest that machine learning models may accurately predict depression and other mental health-related conditions based on social media data. I have recently argued that individuals should have sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. In a comment, Holm claims that there are scenarios in which individuals have a reason to prefer attempts of social control exercised on the basis of accurate AI predictions and that the suggested (...) right burdens individuals unfairly by allowing for those individuals to consent to AI profiling. In this reply, I address both of these alleged problems and their underlying assumptions and show why they fail to provide any reasons not to introduce the suggested right. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:It’s a Human Rights Issue!Daniela TrufferI was born in 1965 in Switzerland with a severe heart defect and ambiguous genitalia. The doctors couldn‘t tell if I was a girl or a boy. First they diagnosed me with CAH and an enlarged clitoris, and cut me between my legs looking for a vagina.Because of my heart condition, the doctors assumed I would die soon. After an emergency baptism, I (...) stayed in the hospital for three months. My mother would travel to the city as often as possible, though she was only allowed to see me through a glass window.When I was two months old, and still in the hospital, doctors opened my abdomen and found healthy testes, which they threw in the garbage bin. According to my medical records, my parents had not provided consent. Further tests showed I am chromosomally male.Later the “castration” was declared a “mistake”: one doctor said I was a boy with hypospadias. As they had already removed the testes, however, they would have “to continue this way and the small patient must be made a girl.”After three months, my parents were finally allowed to take me home.During my childhood, I spent a lot of time in doctor’s offices and hospitals, suffering countless examinations of my genitals and urethral opening. When I was two, our family doctor stuck his finger into my urethral opening; I was screaming very loud, my father says. My mother had to put me into warm water because every time I had to pee I screamed in pain. Later I was hurried to the hospital with a bad infection. Still today my urethra often hurts after going to the toilet.I knew early in my life that I was different.I learned fragments of the truth only after decades of ignorance and denial. I was lucky to obtain my medical records. The hospital initially told me they no longer existed. When I insisted, they eventually sent me some recent files pertaining only to care I received after I was an adult. I kept calling. Once I was put through directly to the archive, where I was told that indeed there were “lots of files on microfilm.” However, it was only when I threatened to return with a lawyer that the hospital sent me a large pile of printouts.Finally I had it in black and white: The doctors had systematically lied to my parents, instructing them to “raise me as a girl” and never talk to me or to anyone else about “the gender issue.” Asked if I could have children, the doctors told them it was “doubtful.” At seven, the doctors still claimed it had been necessary to “remove the ovaries,” and at fourteen told me that I didn‘t menstruate because my “uterus was very small.”Because of the castration, my bone growth was reduced. To this day, I have to deal with health problems like a ruined metabolism, recurring fatigue and vertigo, and osteopenia.I would eventually grow older than doctors had originally predicted. At seven, they decided to operate on my heart septum and valve. I went to the hospital for preparatory cardiac catheterization. However, because of an infection, doctors put off the procedure. Since I had already been admitted, they decided to “use the opportunity to conduct the genital correction already planned in 1965,” and shortened my micropenis to the size of a “very small clitoris,” allegedly with my consent.Fortunately they didn‘t amputate the glans, and I still have sexual feelings left. But I remember the pain and unease, and how I often ran home from [End Page 111] school crying. Today I have a lot of scar tissue, which often hurts and itches.After a few days I was brought back to the cardiologist for the catheterization, and a few months later heart surgery. The doctors saved my life and destroyed it in the same year.I spent my childhood in fear, isolation, and shame. When I had to see a doctor, I was always scared stiff, but I never cried, and endured everything without any protest. I felt sick days in advance, and in... (shrink)

The simple principle of individual liberty evidently does identify particular rights as rights which ought to be recognised and enforced by the laws and customs of every civil society, namely, the rights of self-regarding liberty and individuality. If sex between consenting adults is purely self-regarding conduct under some conditions, for instance, then adults should have a right to spontaneously engage in sex under those conditions if they wish.

Informed consent has become one of the central problems in medical ehtics. At first sight, it would seem that no argument can be made against a person's right to be fully aware of the extent, course, and implications of his medical condition. It seems equally obvious that it is the patient's right to participate in, influence, or fully and solely assume the decisions of medical actions that should be undertaken or withheld with regard to his disease. Nevertheless, there are circumstances (...) in which these commonly held assumptions about a patient's rights may not apply. It is the purpose of this report to describe a case where informed consent was deliverately not sought, and to discuss the ethical issues involved. (shrink)

The author examines two proposals to expand legal recognition of individual control over physical integrity. Protections for individual autonomy are discussed in relation to the right to die, euthanasia, medical treatment, and consensual and assaultive sexual behaviours. The author argues that at present, the legal doctrine of consent protects only those individual preferences which are seen to be congruent with dominant societal values; social preferences and convenience override all other individual choices. Under these conditions, more freedom to waive rights (...) of physical integrity can only place socially vulnerable persons at great risk of abuse. (shrink)

No reverberatory effect of the great war has caused American public opinion more solicitude than the failure of the “melting-pot.” The tendency... has been for the national clusters of immigrants, as they became more and more firmly established and more and more prosperous to cultivate more and more assiduously the literatures and cultural traditions of their homelands. Assimilation, in other words, instead of washing out the memories of Europe, made them more and more intensely real. Just as these clusters became (...) more and more objectively American, did they become more and more German or Scandinavian or Bohemian or Polish.... [This] is not, however, to admit the failure of Americanization. It is not to fear the failure of democracy. It is rather to urge us to an investigation of what Americanism may rightly mean. It is to ask ourselves whether our ideal has been broad or narrow—whether perhaps the time has not come to assert a higher ideal than the “melting pot.”... We act as if we wanted Americanization to take place only on our own terms, and not by the consent of the governed. All our elaborate machinery of settlement and school and union, of social and political naturalization, however, will move with friction just in so far as it neglects to take into account this strong and virile insistence that American shall be what the immigrant will have a hand in making it, and not what a ruling class, descendent of those British stocks which were the first permanent immigrants, decide that America shall be made. Randolph Bourne (1916/1977, 248ff). (shrink)

Addresses the issues at the heart of international medicine and social responsibility. A number of international declarations have proclaimed that health care is a fundamental human right. But if we accept this broad commitment, how should we concretely define the state’s responsibility for the health of its citizens? Although there is growing debate over this issue, there are few books for general readers that provide engaging accounts of critical incidents, practices, and ideas in the field of human rights, health (...) care, and medicine. Included in the book are case studies of such issues as AIDS among orphans in Romania, organ trafficking, prison conditions, health care rationing, medical research in the third world, and South Africa’s constitutionally guaranteed right of access to health care. It uses these topics to address themes of protection of vulnerable populations, equity and fairness in delivering competent medical care, informed consent and the free flow of information, and state responsibility for ensuring physical, mental, and social well-being. (shrink)

Though historically important, the notion of tacit consent plays little role in contemporary discussions of political legitimacy. The idea, in fact, is often dismissed as obviously implausible. The ambition of this paper is to challenge this assumption and show that tacit consent can become a key ingredient in a theory of legitimacy. Instead of defining tacit consent through residence (where, according to John Locke or Plato's Socrates, staying in the country amounts to tacitly consenting to its system of rule), the (...) paper explores a different strategy, delimiting tacit consent as an absence of active dissent. The basic idea starts from the fact that widespread anti-government protests and demonstrations always carry a potent delegitimating force. Political legitimacy is therefore never permanent and unchangeable, regardless of the nature of the regime, and can be undermined at all times by active dissent from the population. Having established the relationship between dissent and delegitimation of political power, even the inverted, stronger claim is defended: the absence of active dissent (i.e., tacit consent) can, under certain circumstances, serve to legitimize political power. The paper sets up and defends several conditions that need to be met for the right normative mandate to be created by the population tacitly accepting the existing power arrangements. If those are fulfilled (especially when full freedom of expression and information is granted), tacit consent can become a vital element of political legitimacy. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to them, and, based on that information, (...) make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests. (shrink)

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed (...) consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)

An episiotomy is ‘an intrapartum procedure that involves an incision to enlarge the vaginal orifice,’1 and is primarily justified as a way to prevent higher degrees of perineal trauma or to facilitate a faster birth in cases of suspected fetal distress. Yet the effectiveness of episiotomies is controversial, and many professional bodies recommend against the routine use of episiotomies. In any case, unconsented episiotomies are alarmingly common, and some care providers in obstetric settings often fail to see consent as necessary (...) in context. In their article, ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al reiterate that consent is necessary for episiotomies. They specify, further, that the antenatal period is crucial for exchanging information, establishing trust between the birthing subject and provider, and exploring the birthing subject’s—rather than the care provider’s—values and preferences regarding episiotomies. They recommend an individualised approach, which would enable birthing subjects to choose how and when they want to give consent. I applaud van der Pijl et al on their practicable recommendations regarding consent for episiotomies. This is certainly a step in the right direction where respect for birthing subjects’ bodily autonomy and integrity is concerned. Still, we must be reminded that consent alone is not coextensive with autonomy. The conditions for securing informed consent in healthcare does not guarantee that one’s decision is truly reflective of their values. After all, even valid consent does not rule out ‘normatively significant external influence’.2 Consent acquisition for obstetric procedures present no …. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent (...) is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

This article examines Francisco Suárez’s views on consent and the social contract, challenging the interpretation that portrays him as a precursor to modern theorists like Hobbes, Locke, and Rousseau. While Suárez’s political thought incorporates elements that may seem similar to contractarian principles, it fundamentally diverges from the modern social contract tradition. Rather than basing political legitimacy on individual consent, Suárez grounds it in the divine origin of power. He sees the community’s consent, expressed through a “virtual pact,” as a necessary (...) condition for transferring power to a sovereign, but not as the foundation of political obligation or authority. For him, the duty to obey laws rests on humanity’s nature and God’s will. The article argues that Suárez rejects key premises of modern social contract theory, notably the ideas that political communities are artificial constructs and that political obligation stems from a contract. (shrink)

A question of interpersonal sovereignty dating back to the early modern era has resurfaced in contemporary political philosophy: viz. Should one individual have, prior to any consent, property rights in another person? Libertarians answer that they should not – and that this commitment requires us to reject all positive duties. Liberal-egalitarians largely agree with the libertarian’s answer to the question, but deny the corollary they draw from it, arguing instead that egalitarian regimes do not require other-ownership. Drawing on recent (...) property theory I argue the libertarians are wrong that positive duties necessarily imply other-ownership, and the egalitarians are wrong that egalitarian entitlements largely avoid other-ownership. Instead, a prohibition on other-ownership guides us towards a middling political position, both allowing and constraining our positive duties and liabilities to others. I conclude by suggesting that a prohibition on other-ownership creates an attractive boundary condition for property in general. (shrink)

A chief objection to opt-out organ donor registration policies is that they do not secure people's actual consent to donation, and so fail to respect their autonomy rights to decide what happens to their organs after they die. However, scholars have recently offered two powerful responses to this objection. First, Michael B Gill argues that opt-out policies do not fail to respect people's autonomy simply because they do not secure people's actual consent to donation. Second, Ben Saunders argues that (...) opt-out policies do secure people's actual—if not explicit—consent, provided that certain conditions are satisfied. I argue that Gill and Saunders’ arguments are not successful. My conclusion does not imply that jurisdictions should not implement opt-out policies—their failure to secure people's actual consent may be outweighed by other considerations. But, my conclusion does imply that Gill and Saunders are mistaken to claim that opt-out policies are respectful of people's autonomy. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 165-168 [Access article in PDF] UPMC Presbyterian Policy and Procedure Manual Guidelines for Disclosure and Discussion of Conditions and Events with Patients, Families and Guardians* I. Introduction and Background In the course of hospital care, an extensive amount of clinical information is generated. It includes diagnostic findings, treatment options, responses to interventions, and professional opinions. The information can be positive or negative. (...) Clinical events may or may not be caused by clinicians and consequently may be iatrogenic (caused by medical treatment), nosocomial (occurring in the hospital) or natural events.In accordance with the informed consent policy (#4011), Patients' Bill of Rights (# 0154, Section II H), and the Guidelines on Forgoing Life Sustaining Treatment (#4007), patients have the right to information regarding their condition and care. Physicians and other caregivers are obligated to provide accurate information as expeditiously as possible. While it is usually easy to provide positive information, negative information is more difficult to disclose, especially when the cause is iatrogenic."Therapeutic privilege" has been invoked to explain why certain negative information might be withheld. By invoking therapeutic privilege, the physician refrains from full disclosure to protect the patient from the effects of receiving the information itself. The use of therapeutic privilege is increasingly being called into question because it decreases patient autonomy and reduces trust.The following recommendations are provided to clinicians to help guide delivery of sensitive information, positive and negative. Specific recommendations [End Page 165] are provided for situations where the information is about an unfavorable or adverse event, or where the information might best be characterized as "bad news." II. Definitions Unfavorable event or unfavorable condition. For the purposes of these guidelines, an unfavorable condition is an occurrence or diagnosis that results in or is likely to result in a significant negative outcome, and/or a significant alteration in the care plan.An unfavorable event in this context is not the same as a sentinel event, which in policy #4025 is defined as, "a serious, unexpected, adverse patient event which has resulted in, or if repeated would have a significant probability of resulting in, loss of life or serious physical or psychological injury, that is judged to be a warning of an underlying problem involving hospital facilities, policies, procedures, systems or personnel."Adverse Event. An unfavorable event for the purposes of these guidelines is also distinguished from the FDA definition of the term "adverse event", which is a reportable negative effect of a drug or device potentially resulting in death, hospitalization, or medical or surgical intervention. (See policy #4022 Safe Medical Device Act.)Examples of unfavorable events or conditions for the purpose of these guidelines include a new diagnosis of cancer, a perioperative myocardial infarction, or unintended delivery of an incorrect medication that results in clinical change.Examples of events not covered by these guidelines are intravenous saline infiltration and medication dosing errors that have no clinical impact on care.Iatrogenic. Event caused by the treatment of a healthcare provider. III. Guidelines and Principles It is appropriate that UPMC Presbyterian support basic principles for patient and family notification regarding all clinical events and conditions, including unfavorable ones. Physicians must be honest because that is a cornerstone of the patient-physician relationship, and because it fosters patient autonomy.UPMC Presbyterian supports the following AMA position regarding patient information: [End Page 166] It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgement. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. Ethical responsibility includes informing patients of changes in their diagnoses... (shrink)

We argue that while presidential candidates have the right to medical privacy, the public nature and importance of the presidency generates a moral requirement that candidates waive those rights in certain circumstances. Specifically, candidates are required to disclose information about medical conditions that are likely to seriously undermine their ability to fulfill what we call the "core functions" of the office of the presidency. This requirement exists because (1) people have the right to be governed only with their consent, (...) (2) people's consent is meaningful only when they have access to information necessary for making informed voting decisions, (3) such information is necessary for making informed voting decisions, and (4) there are no countervailing reasons sufficiently strong to override this right. We also investigate alternative mechanisms for legally encouraging or requiring disclosure. Protecting the public's right to this information is of particular importance because of the documented history of deception and secrecy regarding the health of presidents and presidential candidates. (shrink)

According to what we propose to call “the competence model,” competence is a necessary condition for valid informed consent. If a person is not competent to make a treatment decision, the decision must be made by a substitute decision-maker on her behalf. Recent reports of various United Nations human rights bodies claim that article 12 of the Convention on the Rights of Persons with Disabilities involves a wholesale rejection of this model, regardless of whether the model is based (...) on a status, outcome, or functional approach to competence. The alleged rationale of this rejection is that denying persons the right to make their own treatment decisions based on an assessment of competence necessarily discriminates against persons with mental disorders. Based on a philosophical account of the nature of discrimination, we argue that a version of the competence model that combines supported decision-making with a functional approach to competence does not discriminate against persons with mental disorders. Furthermore, we argue that status- and outcome-based versions of the competence model are discriminatory. (shrink)

However much one may wish for nonviolent solutions to the problems of unjust and unrestrained human violence that Glover explores in Humanity, some of those problems at present require violent responses. One cannot read his account of the Clinton administration’s campaign to sabotage efforts to stop the massacre in Rwanda in 1994 – a campaign motivated by fear that American involvement would cost American lives and therefore votes – without concluding that Glover himself believes that military intervention was morally required (...) in that case. Military intervention in another state that is intended to stop one group within that state from brutally persecuting or violating the human rights of members of another group is now known as “humanitarian intervention.” Those against whom the intervention is directed are almost always the government and its supporters, though this is not a necessary feature of humanitarian intervention. It is, however, a conceptual condition of humanitarian intervention that it does not occur at the request or with the consent of the government. The use of force within another state with the consent of the government counts as assistance rather than intervention. The principal reason that humanitarian intervention is contentious is that it seems to violate the target state’s sovereign right to control its own domestic affairs. Because humanitarian intervention is a response to human rights violations within the target state, it is regarded as altogether different from wars of defense against aggression. Indeed, since aggression is normally understood to be war against a state that.. (shrink)

This is a review and critical commentary on Michael Plaxton's 2015 book, Implied Consent and Sexual Assault, in which he proposes that the legal definition of sexual consent be amended to permit sexual partners to define the terms and conditions of sexual consent in accordance with private "normative commitments" between themselves. The proposed "reform" is intended to permit an individual to agree to be a party to sexual activity that would otherwise constitute sexual assault under Canadian law. For reasons explained (...) in the review, this reviewer concludes that Plaxton's proposal and the rationale he presents in support of its adoption are unpersuasive. (shrink)

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay (...) while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the Food and (...) Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

The articles of the Convention of Human Rights and Biomedicine connect any medical intervention with the »informed consent« of the patient out of respect to Human Dignity by physicians as weil as for treatments and research projects. Nevertheless it becomes apparent that the observation of this principle looses its significance for patients who are incapacitated because of temporal or permanent incompetance to represent their own interests or who are too young to do so. In these cases other attributes of (...) Human Dignity and their observation have to replace the »informed consent«. For inclusion of patients who can't give their consent in clinical studies the MRK formulated strict conditions which exceed the legal prerequisites in Germany. Here clearly the investigation has to benefit each patient directly. The MRK widens this condition to investigations which may not benefit the patient himself, but serve a group of patients with the same illness or solve problems related to the desease. The deciding bodies will have to inform themselves very carefully not only about the facts for urgent research with incapacitated patients, but also must define terms like »no direct benefit « before German Law will allow adaptation to and ratification of the MRK. (shrink)

Criminal offenders may be offered to participate in voluntary rehabilitation programs aiming at correcting undesirable behaviour, as a condition of early release. Behavioural treatment may include direct intervention into the central nervous system (CNS). This article discusses under which circumstances voluntary rehabilitation by CNS intervention is justified. It is argued that although the context of voluntary rehabilitation is a coercive circumstance, consent may still be effective, in the sense that it can meet formal criteria for informed consent. Further, for a (...) consent to be normatively valid (“take the wronging out of the act”) under a coercive circumstance, the subject to be treated must (1) have the sovereign authority to consent, and (2) the offer-giver must be in the right normative position to make the offer. While I argue that subjects do have the sovereign authority to consent to treatment, I also argue that inappropriate offers yield invalid consents. Considerations on inappropriate offers should therefore inform which kinds of CNS intervention-based rehabilitation schemes the state may propose as part of the criminal justice system. Yet as I conclude in this paper, while there are some intrinsic constraints on voluntary rehabilitation programs, the main constraints on voluntary rehabilitation are likely to be contingent overriders. However, CNS intervention is not ruled out as such in the context of voluntary rehabilitation. (shrink)

Following a Canadian Supreme Court ruling invalidating an absolute prohibition on physician assisted dying, two reports and several commentators have recommended that the Canadian criminal law allow medical assistance in dying (MAID) for persons with a diagnosis of mental disorder. A key element in this process is that the person requesting MAID be deemed to have the ‘mental capacity’ or ‘mental competence’ to consent to that option. In this context, mental capacity and mental competence refer to ‘decision-making capacity’, which is (...) a distinct area of clinical study and research in the theory of informed consent. The purpose of this discussion is to bring several controversial but insufficiently acknowledged problems associated with decision-making capacity to the forefront of the proposed extension of MAID to persons diagnosed with mental disorders. Open-ended access to MAID by persons who suffer from mental health conditions already exists in Belgium and the Netherlands, where the issues raised here are equally relevant. In this paper, we highlight the serious limitations of relying on capacity assessments to allow access to MAID/Euthanasia. (shrink)

The article analyses the role and moral force of consent in BDSM (Sado-masochistic and related practice). The view defended accepts consent as a key feature in sexual morality, and explains in detail the relation between consent and autonomy. In brief, it is argued that consent as a genuine extension of personal autonomy both justifies and draws limits to justifiable BDSM-practices: autonomy-undermining practices cannot be justified by appealing to autonomy. The paper discusses in detail the necessary conditions for consent with an (...) emphasis on relevant pitfalls in the context of BDSM and moves to an analysis of the prevalent “official” morality of the BDSM-community, expressed in the slogan “safe, sane, and consensual.” Finally, it draws attention to an un-discussed parallel between sexual morality and the concept of exit-rights as it is known from political philosophy. (shrink)

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give (...) informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only.. Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: the emergency research could not be conducted using other research participants capable of giving informed consent; and informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible. A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. (shrink)