We propose to analyze the specificity of ethical problems in public health issues and to elucidate the applicability of principlism as a problem-solving strategy in this realm. Although well-established in clinical ethics, principlism is not an adequate model to be used in public health, since it is basically intended to serve as a moral guide in the physician-patient encounter. We discuss the possible adequacy of principles like "solidarity", "ontic responsibility" (as proposed by Jonas), and "caring or diaconal responsibility" as presented by Lévinas. Solidarity appears to be insufficiently specified, whereas the other two perspectives may be adapted to public health issues by bringing together Jonas' ontological and Lévinas' transcendental concerns to form a principle of protection that might better serve the purposes of such an ethics. This principle would help to identify more clearly the goals and agents involved in the implementation of public policies that are expected to be both morally correct and pragmatically effective.

Human beings are essentially vulnerable in the view that their existence qua humans is not given but constructed. This vulnerability received 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.

The so-called European principles of bioethics are a welcome enrichment of principlist bioethics. Nevertheless, vulnerability, dignity and integrity can perhaps be more accurately understood as anthropological descriptions of the human condition. They may inspire a normative language, but they do not contain it primarily lest a naturalistic fallacy be committed. These anthropological features strongly suggest the need to develop deontic arguments in support of the protection such essential attributes of humanity require. Protection is to be universalized, since all human beings share vulnerability, integrity and dignity, thus fundamenting a mandate requiring justice and respect for fundamental human rights. Being a feature of all humanity, vulnerability is improperly extended to designate destitute individuals and populations. Rather, they are in a state of fallen vulnerability, for they already are harmed in some way, and have become deprived of their range of capabilities. These individuals are destitute and are no longer in command of their fundamental human rights. They have lost the status of unharmed vulnerability; identifying them as susceptible--vulnerated and no longer only vulnerable--stresses the point that bioethics demands specific social action to palliate or remove their distress. When harm does occur--in the form of disease, for example-, individuals are no longer vulnerable--for they have ceased to be intact -, they become susceptible to additional deprivations and sickness; integrity is demeaned and dignity is offended, leading to states of dysfunction that require specific remedial social practices, aimed at treating and removing injuries. The main point this paper addresses is that vulnerability--as well as dignity and integrity--are descriptive characteristics of human beings qua humans, which are not normative in themselves, but fundamental enough to inspire bioethical requirements of protection and respect for human rights in the wake of social justice. A clear distinction must be made in regard to human beings who are injured by poverty, sickness, discriminating deprivations or suffer other destitutions, having ceased to be only vulnerable for they are no longer intact. These individuals and populations require more than protection, their needs must be met by specific care and remedial measures to be identified and instigated by bioethics qua applied ethics.

Autonomy has been hailed as the foremost principle of bioethics, and yet patients' decisions and research subjects' voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others. Clinical research settings are even more prone to erode subjects' autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings. Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy.

Este artigo contextualiza o surgimento do campo da ética em pesquisa em eventos históricos, sociais e políticos dos últimos 60 anos. Faz uma distinção entre ética profissional e bioética, focalizando os antecedentes históricos e filosóficos do campo da bioética. Situa ainda o surgimento da ética em pesquisa como resultado da divulgação de condutas impróprias na prática científica, discutindo as primeiras normas sobre ética em pesquisa, as diretrizes contidas no Relatório Belmont e sua influência sobre a elaboração da teoria bioética principialista. Analisa também o funcionamento dos comitês de ética em pesquisa e as possíveis limitações à atividade científica. Por fim, pontua alguns temas que continuam pendentes, como o pagamento aos participantes dos estudos, a realização de pesquisas com pessoas inconscientes, a utilização de crianças em experimentos para testes de novos medicamentos ou novas indicações terapêuticas, a definição de risco mínimo e a forma como se tem dado a bioética em países em desenvolvimento. Palavras-chavehistória da ética; bioética, ética em pesquisa; ética profissional; teoria principialista