International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight‐jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, (...) is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all.In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research. (shrink)

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight‐jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, (...) is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all. In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent(s) the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of (...) Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to “enticing offers” that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability (...) to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report’s list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research. (shrink)

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared wit.

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on (...) similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too ‘aspirational’ and not sufficiently ‘pragmatic’. (shrink)

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (shrink)

ABSTRACT This module is designed to sensitise you to the special needs of participants who belong to populations that are more vulner.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

“Dissecting Bioethics,” edited by Tuija Takala and Matti Häyry, welcomes contributions on the conceptual and theoretical dimensions of bioethics.The section is dedicated to the idea that words defined by bioethicists and others should not be allowed to imprison people's actual concerns, emotions, and thoughts. Papers that expose the many meanings of a concept, describe the different readings of a moral doctrine, or provide an alternative angle to seemingly self-evident issues are therefore particularly appreciated.The themes covered in the section so far (...) include dignity, naturalness, public interest, community, disability, autonomy, parity of reasoning, symbolic appeals, and toleration. (shrink)

The so-called European principles of bioethicsare a welcome enrichment of principlistbioethics. Nevertheless, vulnerability, dignityand integrity can perhaps be moreaccurately understood as anthropologicaldescriptions of the human condition. Theymay inspire a normative language, but they donot contain it primarily lest a naturalisticfallacy be committed. These anthropologicalfeatures strongly suggest the need todevelop deontic arguments in support of theprotection such essential attributes ofhumanity require. Protection is to beuniversalized, since all human beings sharevulnerability, integrity and dignity, thusfundamenting a mandate requiring justice andrespect for fundamental human (...) rights.Being a feature of all humanity, vulnerabilityis improperly extended to designatedestitute individuals and populations. Rather,they are in a state of fallen vulnerability,for they already are harmed in some way, andhave become deprived of their range ofcapabilities. These individuals are destituteand are no longer in command of theirfundamental human rights. They have lost thestatus of unharmed vulnerability;identifying them as susceptible – vulnerated andno longer only vulnerable – stresses thepoint that bioethics demands specific socialaction to palliate or remove their distress.When harm does occur – in the form of disease,for example –, individuals are no longervulnerable – for they have ceased to be intact–, they become susceptible to additionaldeprivations and sickness; integrity isdemeaned and dignity is offended, leading tostates of dysfunction that require specificremedial social practices, aimed at treatingand removing injuries.The main point this paper addresses is thatvulnerability – as well as dignity and integrity – are descriptive characteristics ofhuman beings qua humans, which are not normative in themselves, but fundamental enoughto inspire bioethical requirements of protection and respect for human rights in thewake of social justice. A clear distinction must be made in regard to human beings who areinjured by poverty, sickness, discriminating deprivations or suffer otherdestitutions, having ceased to be only vulnerable for they are no longer intact. Theseindividuals and populations require more than protection, their needs must be met byspecific care and remedial measures to be identified and instigated by bioethics quaapplied ethics. (shrink)

Human beings are essentially vulnerable in the view that their existence qua humans is not given but construed. This vulnerability receives basic protection from the State, expressed in the form of the universal rights all citizens are meant to enjoy. In addition, many individuals fall prey to destitution and deprivation, requiring social action aimed at recognising the specific harms they suffer and providing remedial assistance to palliate or remove their plights.Citizens receive protection against their biologic vulnerability by means of an (...) in rem right to health [care], which is more an attitude of protection than a specific programme. When individuals become susceptible, that is, biologically weak or diseased, they also increase their predisposition to additional harm, and require social actions to treat their demeaned condition. Such assistance takes the form of positive healthcare rights.Research on human beings has been slow to observe that the subjects recruited are susceptible, especially so if research is done in less developed countries. By mislabelling them as vulnerable – a characteristic they share with all humans – sponsors avoid registering the deprivation these people suffer, and the ethical obligation to offer them remedial help.The distinction between vulnerability and susceptibility also marks the difference between being intact but fragile – vulnerable – and being injured and predisposed to compound additional harm – susceptible. Awareness of this difference should give additional force to the rejection of double standards in research ethics. (shrink)

To later generations, much of the moral philosophy of the twentieth century will look like a struggle to escape from utilitarianism. We seem to succeed in disproving one utilitarian doctrine, only to find ourselves caught in the grip of another. I believe that this is because a basic feature of the consequentialist outlook still pervades and distorts our thinking: the view that the business of morality is to bring something about . Too often, the rest of us have pitched our (...) protests as if we were merely objecting to the utilitarian account of what the moral agent ought to bring about or how he ought to do it. Deontological considerations have been characterized as “side constraints,” as if they were essentially restrictions on ways to realize ends. More importantly, moral philosophers have persistently assumed that the primal scene of morality is a scene in which someone does something to or for someone else. This is the same mistake that children make about another primal scene. The primal scene of morality, I will argue, is not one in which I do something to you or you do something to me, but one in which we do something together. The subject matter of morality is not what we should bring about, but how we should relate to one another. If only Rawls has succeeded in escaping utilitarianism, it is because only Rawls has fully grasped this point. His primal scene, the original position, is one in which a group of people must make a decision together. Their task is to find the reasons they can share. (shrink)

This article summarizes some of the results of the BIOMED II project “Basic Ethical Principles in European Bioethics and Biolaw” connected to a research project of the Danish Research Councils “Bioethics and Law”. The BIOMED project was based on cooperation between 22 partners in most EU countries. The aim of the project was to identify the ethical principles of respect for autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics and biolaw. The research concluded (...) that the basic ethical principles cannot be understood as universal everlasting ideas or transcendental truths but they rather function reflective guidelines and important values in European culture. The method of the research was conceptual, philosophical analysis of the cultural background of the four values or normative ideas that people use and find important in their existence. Moreover, this was combined with analysis of empirical legal material and policy documents. Also, a number of qualitative interviews with relevant experts were carried out. Another important result of the BIOMED project was the partner's Policy Proposals to the European Commission, the Barcelona Declaration, unique as a philosophical and political agreement between experts in bioethics and biolaw from many different countries. The Policy Proposals are reprinted here at the end of the article. (shrink)

Health care costs have been rising steadily in most industrialized countries. These increases are driven primarily by technological advances and, to a lesser degree, by aging of the population. Many factors make it unlikely that market forces alone will limit increases in the costs of health care. These unremitting increases make health care rationing appear both necessary and inevitable.One of the least controversial mechanisms for rationing could be to allow patients to make their own choices as to which kinds of (...) care they would be willing to forgo. This is appealing because it preserves individual freedom of choice regarding health care in a way that other rationing mechanisms often do not. Rationing by patient choice, however, can only happen if patients recognize that resources are limited and need to be conserved, and are willing to forgo marginal benefits. (shrink)

First, to what level of quality can medical ethics a spire, if it ignores callous discrimination in medrcal practice against large populations of the innocent poor? Second, how effective can such theories be in addressing the critical issues of medical and clinical ethics if they are unable to contribute to the closing of the gap of sociomedical disparity?Marcio Fabri dos Anjos, Medical Ethics in the Developing World: A Liberation Theology Perspective.

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)