Diego Gracia

Ethical case deliberation and decision making.

During the last thirty years different methods have been proposed in order to manage and resolve ethical quandaries, specially in the clinical setting. Some of these methodologies are based on the principles of Decision-making theory. Others looked to other philosophical traditions, like Principlism, Hermeneutics, Narrativism, Casuistry, Pragmatism, etc. This paper defends the view that deliberation is the cornerstone of any adequate methodology. This is due to the fact that moral decisions must take into account not only principles and ideas, but also emotions, values and beliefs. Deliberation is the process in which everyone concerned by the decision is considered a valid moral agent, obliged to give reasons for their own points of view, and to listen to the reasons of others. The goal of this process is not the reaching of a consensus but the enrichment of ones own point of view with that of the others, increasing in this way the maturity of ones own decision, in order to make it more wise or prudent. In many cases the members of a group of deliberation will differ in the final solution of the case, but the confrontation of their reasons will modify the perception of the problem of everyone. This is the profit of the process. Our moral decisions cannot be completely rational, due to the fact that they are influenced by feelings, values, beliefs, etc., but they must be reasonable, that is, wise and prudent. Deliberation is the main procedure to reach this goal. It obliges us to take others into account, respecting their different beliefs and values and prompting them to give reasons for their own points of view. This method has been traditional in Western clinical medicine all over its history, and it should be also the main procedure for clinical ethics.

The many faces of autonomy

What does autonomy mean from a moral point of view? Throughout Western history, autonomy has had no less than four different meanings. The first is political: the capacity of old cities and modern states to give themselves their own laws. The second is metaphysical, and was introduced by Kant in the second half of the 18th century. In this meaning, autonomy is understood as an intrinsic characteristic of all rational beings. Opposed to this is the legal meaning, in which actions are called autonomous when performed with due information and competency and without coercion. This last meaning, the most frequently used in bioethics, is primarily legal instead of moral. Is there a proper moral meaning of the word autonomy? If so, this would be a fourth meaning. Acts can only be called moral when they are postconventional (using the terminology coined by Lawrence Kohlberg), inner-directed (as expressed by David Riesman), and responsible (according to Hannah Arendt). Such acts are autonomous in this new, fourth, and to my mind, the only one proper, moral meaning. The goal of ethics cannot be other than forming human beings capable of making autonomous and responsible decisions, and doing so because they think this is their duty and not because of any other nonmoral motivation, like comfort, convenience, or satisfaction. The goal of ethics is to promote postconventional and mature human beings. This was what Socrates tried to do with the young people of Athens. And it is also the objective of every course of ethics and of any process of training.

Ética profesional y ética institucional: ¿Convergencia o conflicto?

During the last decades, an important debate about professions in general, and particularly about the medical profession, has taken place. The classic idea that professionals do have a «special morality», different from the common morality, which among other things give them legal impunity, came to a head. This cause a great deal of confusion among the professionals, incapable of reacting and redefining precisely their own identity. Some new concepts, like that of «internal morality» of professional activities, made the debate more difficult and confusing. On the other hand, the everyday more powerful influence of free market forces in the health care economy, has made that some decisions taken by health care managers would be considered by physicians as opposed to their professional duties and incompatible with them. This has been the origin of a debate about what is called in North America «New Professionalism». This debate deals with basic questions about the health care professionals identity at the beginning of this new Century.

When Should Re‐consent of Subjects Participating in a Clinical Trial Be Requested? A Case‐Oriented Algorithm to Assist in the Decision‐Making Process

Investigators, sponsors, and institutional review boards have to decide when re‐consent of clinical trials’ participants must be obtained when new information becomes available. We present an algorithm to help in the decision‐making process, which takes into consideration the kind of new information, the risk of exposure (patients could be on the treatment or in the follow‐up phases), and the possibility of managing the case. Re‐consent should be obtained in three of the eight possible situations.

Diferencias entre las versiones en español y en inglés de la última actualización de la Declaración de Helsinki

La ultima version de la Declaracion de Helsinki fue publicada tras la 52.a Asamblea General de la Asociacion Medica Mundial (AMM), celebrada en Edimburgo. La gestacion de esta version, que se ha prolongado durante 3 anos, incluye importantes cambios sobre la precedente (octubre de 1996), que han dado lugar a una viva polemica1-6, que se esta prolongando incluso tras su publicacion7. El 9 de octubre de 2000, la AMM puso a disposicion de la opinion publica, a traves de su pagina web, las versiones en ingles, frances y espanol de la Declaracion. La rapidez en su disponibilidad para todos los investigadores es, sin duda, una ventaja que, sin embargo, en este caso, se ha visto empanada por las deficiencias encontradas en las traducciones hechas a partir de la version original en ingles. Asi, la lectura atenta de la version original8 y de su traduccion al espanol9 revelan multitud de errores de traduccion. No es solo cuestion de que, segun nuestro criterio, no sean aceptables algunos terminos en castellano –que, en ciertos casos, bien pudieran serlo en paises de Latinoamerica–, sino que se han omitido o anadido palabras y, peor aun, en ocasiones se ha modificado el sentido de la version original inglesa. En la tabla 1 se recogen los errores que se han identificado y la traduccion sugerida. En la tabla 2 se expone la Declaracion de Helsinki con las modificaciones incorporadas. Como se observara, se ha respetado, siempre que ha sido posible, la traduccion en espanol de la AMM, aunque en varios casos se podrian haber introducido mas modificaciones. Por otra parte, al estar sujetos a la version original en ingles, nos hemos visto obligados a seguir un texto cuya redaccion, entendemos, es manifiestamente mejorable. En todo caso, y admitiendo que distamos mucho de ser linguistas, ha primado la interpretacion mas habitual en nuestro medio de los terminos que se han corregido. Esto nos ha conducido a modificar, en ciertas ocasiones, palabras que, en la version en espanol de la AMM, son aceptables por la Real Academia Espanola, pero que pueden conducir a interpretaciones erroneas entre los investigadores espanoles.

Ownership of the Human Body: Some Historical Remarks

Am I the owner of my body? In what sense? Is it mine or is it me? What is the difference between proper and property, own and ownership? Am I my proper body, or have I the property of my body? Are there property rights in relation with the body? Can I donate or gift my own organs? Can I sell them? Should the state be permitted to expropriate some organs of my body in view of the common good? These are some of the questions raised by the new biomedical technology, specially organ transplants and genetic engineering. Bioethicists must consider these questions, and propose serious, clear and practical solutions. What is in danger is so important that we must be extremely cautious. And one of the first things we should do in such a situation is to look back and see if we can learn from the lessons of history.

Planificación anticipada de los cuidados: un problema presente, un reto futuro

El artículo de revisión del Dr. Juan Herrera Tejedor titulado Preferencias de las personas muy mayores sobre la atención anitaria», publicado en este mismo número de la revista, consata la satisfacción de las personas muy mayores por la atención édica recibida, pero a la vez concluye que «las preferencias de as personas muy mayores no son consideradas en la planificación anitaria», por lo que recomienda «potenciar la planificación anticiada de los cuidados». Con esto plantea un problema de fondo en la sistencia sanitaria en general, y en la geriátrica en particular, que on el paso del tiempo no hace sino adquirir caracteres cada vez ás acuciantes. El respeto de la autonomía de las personas, tanto sanas como nfermas, ha llevado en el último medio siglo a la introducción n la práctica clínica de un cierto número de documentos. Los más mportantes son los consentimientos informados (CI) y las llamadas n la Ley básica 41/2002 instrucciones previas (IP) o «voluntades nticipadas», en alguna legislación autonómica. En ambos casos se usca cumplir con unos requisitos mínimos exigidos por la legislaión y dejar constancia documentada de ello. A día de hoy, el CI se a convertido ya en una práctica rutinaria en la medicina española, i bien las IP continúan siendo una rareza en nuestro medio. Según os datos del Registro Nacional de Instrucciones Previas, la tasa de P cumplimentadas por 1.000 habitantes en España es de tan solo ,52. Por tanto, de cada 1.000 personas, no llegan a 5 las que han ormalizado ese tipo de documento. Parece necesario preguntarse por las razones de tan baja coberura. Y por más que puedan aducirse muchas y muy diversas azones, hay una que resulta obvia a poco que se analice el tema. Se rata de que las personas, sobre todo las jóvenes y sanas, son muy eticentes a rellenar y firmar este tipo de documentos. No es un azar ue el número de IP cumplimentadas aumente con la edad, y que l mayor número de las que figuran en el Registro Nacional corresondan a personas mayores de 65 años (el 47,66%). Pero aun así,

Cuando la información para los participantes de un ensayo de efectividad comparativa acaba en los tribunales: ¿se abre la caja de Pandora?

Investigación Clínica, Programa BUC (Biociencias UAN+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, España Servicio de Neonatología, Departamento de Pediatría, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, España Departamento de Medicina Preventiva, Salud Pública e Historia de la Ciencia, Universidad Complutense, Madrid, España

Ethical problems arising from the use of placebo in clinical trials with drugs for migraine. Their analysis by the moral deliberation method.

Abstract Introduction Migraine is characterised as episodes of headache plus a variety of accompanying symptoms. Its pharmacological control remains unsatisfactory for some patients. The use of placebo in drug clinical trials on migraine commonly leads to numerous ethical uncertainties. Methods The purpose of this paper is to illustrate how the deliberation method helps in analysing the issues and finding solutions to selected ethical problems. Ethical decisions that try to solve conflicts arising from placebo use in clinical trials may be adopted using the moral deliberation method. Thus, the conflict is systematically assessed by identifying the following: Relevant facts; Values in conflict; Duties, or in other words, possible courses of action. Moral duty is following the optimal course of action. To identify this, it is recommended to state extreme courses of action, then intermediate courses of action, and then to proceed to the optimal course(s) of action. Results and conclusions In this paper, the application of this method is shown in several conflicting situations arising in two placebo-controlled clinical trials with drugs under development for the prophylaxis and acute treatment of migraine

THE ETHICS OF DIAGNOSIS IN EARLY CHRISTIANITY AND THE MIDDLE AGES

The approach to illness for the ancient people of Israel, as for all archaic Semitic peoples, is of an ethico-religious nature since these peoples view illness, as the consequence of sin. Hence the search for the cause of illness, the “etiological diagnosis”, is carried out by means of a systematic inquiry into the moral precept that has been transgressed. This is the procedure followed in the medicine of Mesopotamia as well as that of the people of Israel.