Etika u medicinskim istraivanjima - PowerPoint PPT Presentation

Title: Etika u medicinskim istraivanjima


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Etika u medicinskim istraivanjima

• Bioetika

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Generalna skuptina UN 1948
GENERALNA SKUPTINA PROGLAAVA OVU OPTU
DEKLARACIJU O PRAVIMA COVEKA kao zajednicki domet
koji treba da postignu svi narodi i sve nacije da
bi svaki pojedinac i svaki organ drutva, imajuci
ovu Deklaraciju stalno na umu, teio da ucenjem i
vaspitavanjem doprinese potovanju ovih prava i
sloboda da bi se postupnim unutranjim i
medjunarodnim merama obezbedilo njihovo opte i
stvarno priznanje i potovanje kako medju
narodima samih drava clanica, tako i medju
narodima onih teritorija koje su pod njihovom
upravom. Clan 1. Sva ljudska bica radjaju
se slobodna i jednaka u dostojanstvu i pravima.
Ona su obdarena razumom i svecu i treba jedni
prema drugima da postupaju u duhu bratstva.
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Savet Evrope 1997
CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS
AND DIGNITY OF THE HUMAN BEING WITH REGARD TO
THE APPLICATION OF BIOLOGY AND MEDICINE CONVENTI
ON ON HUMAN RIGHTS AND BIOMEDICINE Oviedo,
4.IV.1997
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Savet Evrope 1997
Chapter I General provisions Article 1
Purpose and object Parties to this Convention
shall protect the dignity and identity of all
human beings and guarantee everyone, without
discrimination, respect for their integrity and
other rights and fundamental freedoms with regard
to the application of biology and medicine.
Chapter II Consent Article 5 General
rule An intervention in the health field may only
be carried out after the person concerned has
given free and informed consent to it. This
person shall beforehand be given appropriate
information as to the purpose and nature of the
intervention as well as on its consequences and
risks. The person concerned may freely withdraw
consent at any time.
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Savet Evrope 1997
Chapter IV Human genome Article 11
Non-discrimination Any form of discrimination
against a person on grounds of his or her genetic
heritage is prohibited. Article 12 Predictive
genetic tests Tests which are predictive of
genetic diseases or which serve either to
identify the subject as a carrier of a gene
responsible for a disease or to detect a genetic
predisposition or susceptibility to a disease may
be performed only for health purposes or for
scientific research linked to health purposes,
and subject to appropriate genetic
counselling. Article 13 Interventions on the
human genome An intervention seeking to modify
the human genome may only be undertaken for
preventive, diagnostic or therapeutic purposes
and only if its aim is not to introduce any
modification in the genome of any
descendants. Article 14 Non-selection of
sex The use of techniques of medically assisted
procreation shall not be allowed for the purpose
of choosing a future child's sex, except where
serious hereditary sex-related disease is to be
avoided.
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Savet Evrope 1997
Chapter V Scientific research Article 15
General rule Scientific research in the field of
biology and medicine shall be carried out freely,
subject to the provisions of this Convention and
the other legal provisions ensuring the
protection of the human being. Article 16
Protection of persons undergoing
research Research on a person may only be
undertaken if all the following conditions are
met i there is no alternative of comparable
effectiveness to research on humans ii the
risks which may be incurred by that person are
not disproportionate to the potential benefits of
the research iii the research project has been
approved by the competent body after independent
examination of its scientific merit, including
assessment of the importance of the aim of the
research, and multidisciplinary review of its
ethical acceptability, iv the persons undergoing
research have been informed of their rights and
the safeguards prescribed by law for their
protection v the necessary consent as provided
for under Article 5 has been given expressly,
specifically and is documented. Such consent may
be freely withdrawn at any time.
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Savet Evrope 1997
Article 18 Research on embryos in vitro 1
Where the law allows research on embryos in
vitro, it shall ensure adequate protection of the
embryo. 2 The creation of human embryos for
research purposes is prohibited. Chapter VI
Organ and tissue removal from living donors for
transplantation purposes Article 19 General
rule 1 Removal of organs or tissue from a living
person for transplantation purposes may be
carried out solely for the therapeutic benefit of
the recipient and where there is no suitable
organ or tissue available from a deceased person
and no other alternative therapeutic method of
comparable effectiveness.
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Helsinka deklaracija 1964-2004
http//www.wma.net/e/policy/b3.htm
WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKI 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 Note of Clarification on Paragraph 29 added
by the WMA General Assembly, Washington 2002 Note
of Clarification on Paragraph 30 added by the WMA
General Assembly, Tokyo 2004 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.
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Helsinka deklaracija 1964-2004
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. 3. The
Declaration of Geneva of the World Medical
Association binds the physician with the words,
"The health of my patient will be my first
consideration," and the International Code of
Medical Ethics declares that, "A physician shall
act only in the patient's interest when providing
medical care which might have the effect of
weakening the physical and mental condition of
the patient." 4. Medical progress is based on
research which ultimately must rest in part on
experimentation involving human subjects. 5. In
medical research on human subjects,
considerations related to the well-being of the
human subject should take precedence over the
interests of science and society.
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Helsinka deklaracija 1964-2004
B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 10.
It is the duty of the physician in medical
research to protect the life, health, privacy,
and dignity of the human subject. 11. Medical
research involving human subjects must conform to
generally accepted scientific principles, be
based on a thorough knowledge of the
scientific literature, other relevant sources of
information, and on adequate laboratory
and, where appropriate, animal experimentation. 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. 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.
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European Convention for the Protection of
Vertebrate Animals
European Convention for the Protection of
Vertebrate Animals used for Experimental and
Other Scientific Purposes (http//conventions.co
e.int/treaty/en/treaties/html/123.htm) Strasbourg,
18.III.1986 Text amended according to the
provisions of the Protocol (ETS No. 170) as of
its entry into force on 2 December 2005.
Recognising that man has a moral obligation to
respect all animals and to have due consideration
for their capacity for suffering and
memory Accepting nevertheless that man in his
quest for knowledge, health and safety has a need
to use animals where there is a reasonable
expectation that the result will be to extend
knowledge or be to the overall benefit of man or
animal, just as he uses them for food, clothing
and as beasts of burden Resolved to limit the
use of animals for experimental and other
scientific purposes, with the aim of replacing
such use wherever practical, in particular by
seeking alternative measures and encouraging the
use of these alternative measures Desirous to
adopt common provisions in order to protect
animals used in those procedures which may
possibly cause pain, suffering, distress or
lasting harm and to ensure that where unavoidable
they shall be kept to a minimum
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Helsinka deklaracija 1964-2004
A procedure may be performed for one or more of
the following purposes only and subject to the
restrictions laid down in this Convention a i
avoidance or prevention of disease, ill-health or
other abnormality, or their effects, in man,
vertebrate or invertebrate animals or plants,
including the production and the quality,
efficacy and safety testing of drugs, substances
or products ii diagnosis or treatment of
disease, ill-health or other abnormality, or
their effects, in man, vertebrate or invertebrate
animals or plants b detection, assessment,
regulation or modification of physiological
conditions in man, vertebrate and invertebrate
animals or plants c protection of the
environment d scientific research e education
and training f forensic inquiries.
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Web
http//www.mrc.ac.za/ethics/definitions.htm -
definicije
http//www.mrc.ac.za/ethics/human.htm - tkiva
http//www.mrc.ac.za/ethics/reproductive.htm -
reprodukcija
http//www.mrc.ac.za/ethics/authorship.htm -
publikovanje
http//www.isscr.org/public/ethics.htm -
istraivanje na maticnim celijama
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Maticne celije
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels,
3.4.2003 SEC(2003) 441 COMMISSION STAFF WORKING
PAPER REPORT ON HUMAN EMBRYONIC STEM CELL RESEARCH
Stem cell research is one of the promising areas
of biotechnology, which offers the prospect of
developing new methods to repair or replace
tissues or cells damaged by injuries or diseases
and to treat serious chronic diseases, such as
diabetes, Parkinsons, chronic heart failure as
well as stroke and spinal cord injuries. Stem
cell research is expected to be equally important
for basic science to understand cell
differentiation and growth as well as for other
specific medical applications such as for the
understanding of disease development and for the
development of safer and more effective drugs.
Scientists are intensively studying the
fundamental properties of stem cells. One of the
possible sources for stem cells is human
pre-implantation embryos. However, when this
research involves the use of human embryos it
raises the question of ethical values at stake
and of the limits and conditions for such
research.
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