Historia de la experimentacion humana y desarrollo de la bioética

Felipe Gustavo Gercovich

Ernesto Gil Deza

Instituto Henry Moore

Desarrollo de la clase

Objetivo Acuerdos de términos Historia de experimentacion humana Impactos en bioética Conclusiones

Objetivo de la clase

“… the goal of teaching ethics to health care practitioners is not only to convey information about available moral theories but also to cultivate moral sensitivity in practical situations …”

Suzanne M. Jaeger PhD

Teaching health care ethics: the importance of moral sensitivity for moral reasoning

Nursing PhilosophyVolume 2 Issue 2 Page 131 - July 2001

Desarrollo de la clase

Objetivo Acuerdos de términos Historia de experimentacion humana Impactos en bioética Conclusiones

Bioetica

Costumbre Religión Moral Ética Ley Norma Guía

Bioetica

Costumbre – Modo/moda - Hábito Religión: preformal – formal – institucional

- informal Moral Etica Ley Norma Guía

Bioetica

Costumbre Religión Moral (arte) y práctica de las buenas costumbres –

seculares o religiosas Etica (ciencia) y teoría de los fundamentos y

razones de las conductas deseables Ley: Norma Guía

Bioetica

Costumbre Religión Moral Etica Ley: mínimo de moral exigible Norma: conducta impuesta Guía: conducta sugerida

Filosofía moral vs. ética

El objeto de la filosofía moral son las actividades humanas orientadas a un fin, teniendo en cuenta que el hombre actúe en forma voluntaria y libre.

Hombre: Inteligencia (abstracta) y Voluntad (libre) libre– Coerciones– Coacciones

La ética: descriptiva, analítica y de la ciencia, procura emplear el método científico y los conocimientos científicos del individuo y la sociedad para definir una conducta deseable.

P (x,x’/RUCD)

Mario Bunge Etica, Ciencia y

Técnica

Filosofía moral vs. ética

Desarrollo de la clase

Objetivo Acuerdos de términos Historia de experimentacion humana Impactos en bioética Conclusiones

Del siglo VI antes de Cristo hasta 1931

Experimentacion humana

Primera evidencia de experimentacion humana – Capítulo 1 del Libro de Daniel (VI AC)

El rey ordenó a Aspenaz, jefe de sus eunucos, escoger

entre los israelitas de estirpe real o de la nobleza

algunos jóvenes sin defecto físico, bien parecidos,

expertos en sabiduría, cultos e inteligentes, aptos para

servir en la corte del rey, con el fin de enseñarles la

lengua y la literatura de los caldeos. El rey les asignó

una ración diaria de la comida del rey y del vino de su

mesa. Deberían ser educados durante tres años, al

cabo de los cuales entrarían al servicio del rey.

Entre ellos se encontraban los judíos Daniel,

Ananías, Misael y Azarías. El jefe de los eunucos

les puso nombres nuevos, llamando a Daniel

Baltasar, a Ananías Sidrac, a Misael Misac y

Azarías Abdénago. Daniel decidió no

contaminarse con la comida del rey y el vino de

su mesa y pidió al jefe de los eunucos

autorización para no contaminarse. Dios

concedió a Daniel el favor y la compasión

del jefe de los eunucos.

Y éste dijo a Daniel: «Temo al rey, mi señor,

quien os ha asignado vuestra comida y vuestra

bebida, y si encuentra vuestros semblantes

más desmejorados que los de vuestros

compañeros, expondréis mi cabeza ante él.»

Entonces Daniel dijo al guardián que el jefe de

los eunucos había asignado a Daniel, Ananías,

Misael y Azarías: «Por favor, pon a prueba

a tus siervos durante diez días: que nos

den legumbres para comer y agua para

beber; luego compara nuestro aspecto

con el de los jóvenes que comen los

alimentos del rey y actúa con nosotros

según los resultados.» Él aceptó la

propuesta y los puso a prueba durante diez

días.

Al cabo de los diez días tenían mejor

aspecto y estaban más fuertes que

todos los jóvenes que comían los

alimentos del rey. Desde entonces el

guardián retiró sus raciones de comida y

de vino y les dio legumbres.

Conclusiones del primer relato

Los conflictos deben enfrentarse La experimentacion es una nueva forma de

resolver conflictos liberándonos de prejuicios e independizando los resultados de la voluntad de cada parte.

La conducta posterior queda ligada a la obtención de un conocimiento.

Segundas conclusiones El tamaño de la muestra es pequeño. No fue randomizado No se consignan las calorías ingeridas No se establece porque un lapso de diez días es

suficiente. La evaluación es subjetiva No se define semblante No se consigna peso y fuerza pre y postest No hay análisis estadístico

Terceras conclusiones

Hoy no se hubiera publicado en ninguna revista de tercer categoría…

Terceras conclusiones (cont)

…Pero si usted es Dios puede publicarlo en el texto mas leído de todos los tiempos.

Hipocrates vs Alcmeon (V AC)

Mientras el primero sentaba las bases de su etica en:

“Primero no causes daño” El segundo, un gran anatomista (nervio

óptico y demostró que el esperma no provenía de la médula espinal) practicaba la vivisección en los condenados a muerte.

Cleopatra (I AC)

Duda del momento en el cual se formaba el feto masculino y el feto femenino.

– Disecaba a condenadas a muerte en distintos momentos de gestación para aclarar la duda.

Roger Bacon (XIII)

Sienta las bases de la realidad en la contrastación de las teorías o ideas con los hechos. Eso explica el “oscurantismo” del primer milenio de la era cristiana ya que predominaba el platonismo, donde la realidad es ideal y lo concreto es un palido y deformado reflejo o sombra de la misma.

William Harvey (XVII)

Demuestra que la teroría galénica de la circulación de la sangre es incorrecta.– Sienta las bases de la experimentación animal.

Produce la revolución científica de la reforma.

Edward Jenner (XVIII)

Inyecta pus extraída de pustulas de la vacuna (cowpox) a James Phillips, un niño sano de ocho años de edad. Tres meses después lo inocula con viruela (smallpox).

Es reconocido como el padre de la vacuna

Edward Jenner (XVIII)

Inyecta pus extraída de pustulas de la vacuna (cowpox) a James Phillips, un niño sano de ocho años de edad. Tres meses después lo inocula con viruela (smallpox).

Es reconocido como el padre de la vacuna Experimentó con un menor Sin evidencias preclínicas de utilidad sino

solo información folklórica

Serturner (1803)

Aisló la morfina del opio. La anécdota histórica cuenta que luego de

aislar unos cristales amarillentos invitó a cenar a cuatro amigos y los convidó con ellos a los postres. Al ver que les producia sueño le llamo morfeo en honor al dios del sueño.

Horace Wells (1845) William Morton (1846)

Ambos dentistas demostraron el valor de la anestesia– HW con oxido nitroso (gas hilarante)

autoexperimentación.

– WM utilidad del eter ( Paciente Abbott)

– Dr.Warren el cirujano terminó la operacion diciendo su famoso : “Señores esto no es un engaño”)

J Marion Sims (1845-1849)Padre de la obstetricia Múltiples operaciones en esclavas – sin

anestesia- la mayoría murieron por infecciones, una de ellas fue sometida a 34 cirugía.

Nueva evidencia de experimentacion en poblacion de riesgo

Claude Bernard (1865)

Escribe “Introducción al estudio de la experimentación humana”

“Nunca realizar un experimento que pueda ser dañino para el paciente aunque pueda ser enormemente ventajoso para la ciencia o la salud de otros”

Arthur Wentworth (1896)

En el Children’s Hospital, Boston, realiza 29 punciones lumbares innecesarias en niños para determinar si el procedimiento es peligroso.

Dr. John Roberts of Philadelphia, noting the non-therapeutic indication, labeled Wentworth’s procedures “human vivisection.”

Sanarelli (1895)

Inyecta cinco sujetos con bacilos para determinar el origen de la fiebre amarilla.

Walter Reed (1900)

Inyecta 22 trabajadores rurales cubanos con el agente de la fiebre amarilla. Les pagaba $100 si sobrevivían y $200 si contraían la enfermedad.

Código de ética de Berlin (1900) Royal Prussian Minister of Religion, Education,

and Medical Affairs guaranteed that: "all medical interventions for other than diagnostic, healing, and immunization purposes, regardless of other legal or moral authorization are excluded under all circumstances if (1) the human subject is a minor or not competent due to other reasons; (2) the human subject has not given his unambiguous consent; (3) the consent is not preceded by a proper explanation of the possible negative consequences of the intervention."

Richard Strong (1906)

Profesor de Medicina Tropical en Harvard experimenta con cólera en prisioneros filipinos mata a 13.

Cámara de Pennsilvania (1913)

Registra:– 146 children had been inoculated with syphilis,

"through the courtesy of the various hospitals" and that

– 15 children in St. Vincent's House in Philadelphia had had their eyes tested with tuberculin. Several of these children became permanently blind.

– The experimenters were not punished

Mas experimentos…

1915: A doctor in Mississippi, working for the U.S. Public Health Office produces Pellagra in twelve Mississippi inmates in an attempt to discover a cure for the disease

 1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.

 1931: Lubeck, Germany, 75 children die in from pediatrician's experiment with tuberculosis vaccine.

Esterilizaciones… 1927: Carrie Buck of Charlottesville is legally sterilized

against her will at the Virginia Colony Home for the Mentally Infirm. Carrie Buck was the mentally normal daughter of a mentally retarded mother, but under the Virginia law, she was declared potentially capable of having a "less than normal child." By the 1930s, seventeen states in the U.S. have laws permitting forced sterilization

The settlement of Poe v. Lynchburg Training School and Hospital (same institution, different name) in 1981 brought to an end the Virginia law. It is estimated that as many as 10,000 perfectly normal women were forcibly sterilized for "legal" reasons including alcoholism, prostitution, and criminal behavior in general.

Cornelius Rhoads (1931) a pathologist, conducted a cancer experiment in Puerto Rico

under the auspices of the Rockefeller Institute for Medical Investigations. Dr. Rhoads has been accused of purposely infecting his Puerto Rican subjects with cancer cells. Thirteen of the subjects died. A Puerto Rican physician uncovered the experiment an investigation covered-up the facts. Despite Rhoads' hand written statements that the Puerto Rican population should be eradicated, Rhoads went on to establish U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and was later named to the U.S. Atomic Energy Commission. Rhoads was also responsible for the radiation experiments on prisoners, hospital patients, and soldiers. The American Association for Cancer Research honored him by naming its exemplary scientist award the Cornelius Rhoads Award.

Codigo de etica en Alemania (1931) "Regulation on New Therapy and

Experimentation" requiring all human experiments to be preceded by animal experiments. This law remained in effect during the Nazi regime.

1931 a 2000

Investigaciones Nazis

Inyectar gasolina intravenosa Inyectar virus vivos Mantener cepas de tifus usando como

medios de cultivos prisioneros Inmersión en agua helada Prueba del paracaidista Ulceras cutáneas con fósforo

NUREMBERGEL JUICIO A LOS MEDICOS

Los Jueces

Los fiscales

NUREMBERGEL JUICIO A LOS MEDICOS

Los acusados

Los experimentos

Código de Nuremberg

1945

NUREMBERG CODE   The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

1.The voluntary consent of the human subject is absolutely essential.  This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

2 The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

  3 The experiment should be so designed and based on the

results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

  4 The experiment should be so conducted as to avoid all

unnecessary physical and mental suffering and injury.  5 No experiment should be conducted where there is an a

priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Tuskegee 1939 - 1975

Taliaferro, Clark

¿ Qué tienen en común todos ellos ?

Estudio Tuskegee

Alabama 400 varones de raza negra afectados por

sífilis y 200 controles. Engañados para el seguimiento sin

tratamiento – bad blood- 1932 – 1972 a pesar de evidencias desde

1942 de que el grupo con sífilis evolucionaba peor que el control y que desde 1940 estaba disponible la penicilina

UNIDAD 731JAPON

1938-1943

Ishii Shiro

Cirugía sin anestesia

Vivisección de una joven embarazada

Torre en memoria de los muertos en la unidad 731

Fisiología de Hierro y Calcio

MIT y Harvard University

1949

Estudio con iones radioactivosFe - Ca

Jewish Chronical Disease Hospital Study

Nueva York

1963

Jewish Chronic Disease Hospital Study

Rechazo de células cancerosas Pacientes “sanos” debilitados No se explicó el estudio para no generar

miedo. Se consideró que no había riesgo porque los

sanos rechazarían las células

Willowbrook Study

Nueva York

1963

Etica médica

Hipócrates Platón Tomás de Aquino Descartes Kant Freud Beauchamp

• Secular

• Utilitarista

• Virtuosa (Benef)

• Respetuosa (Aut.)

• Equitativa (Just)

• Abierta

• Transdisciplinaria

Historia de un esfuerzo por mejorar

Hipócrates y “primero no dañar” Celso y su oposición a la “vivisección” 1830 en Inglaterra ley del consentimiento 1865 Claude Bernard “Principios de moralidad para clínicos y

cirujanos” – No experimentar cuando puede esperarse daño aunque sea interesante.

1900 Prusia: no experimentar en minusválidos ni incompetentes. 1910 Paul Ehrlich: fármacoterapia igual responsabilidad que

cirugía. 1931 Alemania “Guias para terapias innovativas y

experimentación científica” 1945: Nuremberg 1960: Declaración de Helsinki

DESARROLLO DE LA ETICA MEDICA

• De la deontología a la bioética.• Empirismo• Utilitarismo• Kantianismo: deber ser• Etica de principios• Etica de valores

PRINCIPIOS BIOETICOS

No maleficencia Beneficencia Autonomía Justicia

The Belmont Report

Office of the Secretary

Ethical Principles and Guidelines for the Protection of Human

Subjects of Research

The National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research

April 18, 1979

Members of the CommissionKenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania. Dorothy I. Height, President, National Council of Negro Women, Inc. Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center. Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion. *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley. Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas. ***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of Pennsylvania. *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.

*** Deceased.

1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information.

2. Beneficence. -- Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

3. Justice. -- Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally.

There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are

(1) to each person an equal share,(2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

1. Informed Consent.

2. Assessment of Risks and Benefits

3. Selection of Subjects

Primer muerte por terapia génica

Declaración de Helsinki

1964 - 2000

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI .pdfThe Helsinki Declaration in Norwegian. Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General AssemblyHelsinki, Finland, June 1964and amended by the29th WMA General Assembly, Tokyo, Japan, October 197535th WMA General Assembly, Venice, Italy, October 198341st WMA General Assembly, Hong Kong, September 198948th WMA General Assembly, Somerset West, Republic of South Africa, October 1996and the52nd WMA General Assembly, Edinburgh, Scotland, October 2000

A. INTRODUCTION 1. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

2. It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfillment of this duty.

7. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens.

8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.

9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.

10. It is the duty of the physician in medical research to protect

•the life, •health, •privacy, and •dignity of the human subject.

12.Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

13.The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.

19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

20. The subjects must be volunteers and informed participants in the research project.

21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

23.When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship.

27. Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.

CODE OF FEDERAL REGULATIONSTITLE 45

PUBLIC WELFAREDEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTHOFFICE FOR PROTECTION FROM RESEARCH RISKS

PART 46PROTECTION OF HUMAN SUBJECTS

* * *Revised November 13, 2001Effective December 13, 2001

REQUISITOS ETICOS DE LAS INVESTIGACIONES CLINICAS

Pacto Internacional de Derechos Civiles y Políticos

Art 7: Nadie será sometido a torturas ni a penas o tratos crueles, inhumanos o degradantes.

REQUISITOS ETICOS DE LAS INVESTIGACIONES CLINICAS

Pacto Internacional de Derechos Civiles y Políticos

Constitución de la Nación Argentina - 1994

Art 7: Nadie será sometido a torturas ni a penas o tratos crueles, inhumanos o degradantes. En particular nadie será sometido sin su libre consentimiento a experimentos médicos o científicos.

REQUISITOS ETICOS DE LAS INVESTIGACIONES CLINICAS

5330/97

• IGNORANCIA DE RESULTADO

• PROTOCOLO ESCRITO

• OBJETIVOS CLAROS

• NUMERO SUFICIENTE DE PACIENTES

• CONSENTIMIENTO INFORMADO

• SELECCIÓN DE INVESTIGADORES

• REVISION POR COMITÉ DE ETICA

• INFORMACION DE EFECTOS ADVERSOS SEVEROS

• SEGURO DE INVESTIGACION

REQUISITOS ETICOS DE LAS INVESTIGACIONES CLINICAS

CONSENTIMIENTO INFORMADO

• COMPLETO

• CLARO

• PUNTOS INSOSLAYABLES:

• CARÁCTER INVESTIGACIONAL

• LIBRE ACEPTACION

• NO IMPACTO EN RELACION MEDICO-PACIENTE.

• FIRMADO EN PRESENCIA DE UN TESTIGO

FASES DE INVESTIGACION

• FASE 0 = PRECLINICA• FASE I = TOLERANCIA (DMT - TDL)• FASE II = RESPUESTA• FASE III = COMPARACION CON STANDARD• FASE IV = FARMACOVIGILANCIA

EL PROBLEMA DE LAS INVESTIGACIONES QUE NO SIGUEN ESTE DESARROLLO ES LA FALTA DE RESPETO POR LA PERSONA ENFERMA Y EL RETRASO DE LAS INVESTIGACIONES

Bioética y Sociedad

Evidencias de un comportamiento humano cuestionable– Derechos políticos (Rev. Francesa – Americana)– Derechos humanos (Post guerras mundiales S.XX)– Liberación femenina (“Pill revolution”)– Liberación existencial (Hippies)– Ecología (“Green Revolution)

1971 - Van Rensselaer Potter (oncólogo): Bioethics: bridge to the future– Puente entre la ciencia de la vida y la ética de la vida.

– “Los valores éticos no pueden separarse de los hechos biológicos”

– “La ciencia sin conciencia no conduce sino a la ruina del hombre”

– Hacer ética no es un quehacer sólo de filósofos sino que pasa a ser un deber y un derecho de todo hombre.

Jacques Testart (“padre” de Amande la primer niña probeta francesa en 1982)– 1987: “Yo, Jacques Testart, investigador en el campo

de la biogenética, he decidido acabar definitivamente con la carrera enloquecida hacia la novedad científica; no quiero ir más lejos. Abandono por razones éticas ciertos campos de la investigación. Es preciso un control sobre las técnicas humanas de la procreación”. (Gonzalo Higueras - ¿Prudencia o miedo? – Razón y Fe, Marzo de 1987, pag 315

SEMIOLOGIA DE UN DILEMA ETICO Definición del problema (Motivo de

consulta)

– Conflicto de valores (fines o medios)• Concepto de valor• Axiología

– Conflicto de comunicación (incomprensión)• Comunicación• Información

– Conflicto de intereses (beneficios)

Historia y significación (Enfermedad actual)– Cronología (secuencia temporal)

• Percepción

• Emociones

– Causalidad (secuencia interpretativa)– Condicionantes (Five W : Who-What-When-Where-Why)

– Requerimiento

– Participantes

SEMIOLOGIA DE UN DILEMA ETICO

Contrastación (Examen Físico)– Entrevista con el Requerido

• Cronología (secuencia temporal)– Percepción

– Emociones

• Causalidad (secuencia interpretativa)

• Condicionantes

– Evaluación de Historia Clínica y/o Documentos

– Evaluación de lugar

SEMIOLOGIA DE UN DILEMA ETICO

Terapéutica de un dilema ético

Resolución arbitral Mediación Comité multidisciplinario

– Hospitalario (institucional)– De investigaciones clínicas

Justicia

Prevención de conflictos éticos

Idoneidad Consistencia Coherencia Respeto Honestidad Humildad Veracidad Tolerancia

Prevención de mala praxis

Prevención de conflictos éticos Registro completo

Aspectos generales e investigaciones con seres humanos

Cuidado del paciente muriente

Etica de la prescripción médica

Clonación

Tests genéticos en oncología

Bioética

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