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 Philosophy
Volume 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
Filosofía moral vs. ética
 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
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
NUREMBERG
EL JUICIO A LOS MEDICOS
Los Jueces
Los fiscales
NUREMBERG
EL 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 731
JAPON
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 radioactivos
Fe - 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 Commission
Kenneth 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 wellbeing. 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
.pdf
The Helsinki Declaration in Norwegian.
Ethical Principles for Medical Research Involving Human
Subjects
Adopted by the 18th WMA General Assembly
Helsinki, Finland, June 1964
and amended by the
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South
Africa, October 1996
and the
52nd 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 REGULATIONS
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46
PROTECTION OF HUMAN SUBJECTS
***
Revised November 13, 2001
Effective 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)
SEMIOLOGIA DE UN DILEMA
ETICO
 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
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
Bioética
Aspectos generales e investigaciones
con seres humanos
Cuidado del paciente muriente
Etica de la prescripción médica
Clonación
Tests genéticos en oncología
Muchas gracias