‫به نام خدا‬
‫اخالق در پژوهش‬
‫دانشگاه علوم پزشکی شهید صدوقی یزد‬
‫اردیبهشت ‪89‬‬
‫دکتر محمد حسین مصدق‬
‫مسایل اخالقی در استفاده از حيوانات آزمايشگاهي در تحقيقات‬
‫زيست پزشکي‬
 Mankind has been using animals already for
a long time for food, for transport and as
companion. The use of animals in
experimental research parallels the
development of medicine, which had its roots
in ancient Greece (Aristotle,Hippocrate).
 It had its roots in ancient Greece where
Aristotle and Hippocrate laid down their
knowledge on structure and function of the
human body in their respective Historia
Animalium and Corpus Hippocraticum, mainly
based on dissections in animals.
 Galen (130–201 AD), physician of the Roman
emperor Marcus Aurelius, performed
physiological experiments on pigs, monkeys
and dogs, which provided a basis for medical
practices also in the centuries thereafter.
 After Galen, experimental science stopped till
the beginning of the Renaissance when
Vesalius took up the empirical approach,
starting with anatomical studies. Later on,
physiological studies were also performed.
 With the Cartesian philosophy in the 17th
century, experiments on animals could be
performed without great moral problems.
 The French philosopher Rene ´ Descartes
(1596–1650) stated that living systems could
be understood on pure mechanical principles.
 The discovery of anaesthetics and Darwin’s
publication on the Origin of Species in 1859,
defending the biological similarities between
man and animal, contributed to the increase
of animal experimentation.
 Claude Bernard published his book
‘Introduction a ` l’e ´ tude de la me ´ decine
expe ´ rimentale’ in 1865, introducing
methodology as a tool for the design of
physiological experiments.
 The development of microbiology caused an
increase in the use of animals, due to Koch’s
‘Postulates’ where it is stated that
pathogenicity of a microorganism can be
proven after successfully infecting healthy,
susceptible animals.
 The development of biomedical disciplines as
pharmacology, toxicology and immunology
caused a sharp increase in the use of animals
in the 20th century.
 From the early 1980s, a decrease started
probably due to public awareness and strict
legislation on animal use, the development of
animal ethics committees and an improved
quality of the animals.
 However, in last decades,use of animals started to
increase again, mainly due to the development of
genetically modified animals, which has caused an
increase in numbers of mice used of more than 23% per
year, not only due to growth in the numbers of these
animals in research but also to the large number of mice
necessary to create each genetically modified line, such
as breeding males, donor females, vasectomized males
and pseudo- pregnant recipient females. Furthermore,
nontransgenic and wild-type littermates may be produced
that are not suitable for research or further breeding.
 Today, 75–100 million vertebrates per year
are used in research and testing for a wide
range of purposes.
 The major areas are drug research, testing of
vaccines and other biological and cancer
research, whereas about 30% of the animals
are used for other purposes such as
fundamental research, diagnostics, etc.
 Mice and rats are the most frequently used
animal species.
 In many European countries, it is mandatory by
national law to grade the level of discomfort for
animals in experiments in minor, moderate and
severe. On average, 50% of the laboratory
animals experience minor discomfort (eg single
blood sampling), 30% moderate (eg recovery
from anaesthesia) and 20% severe (eg toxicity
tests).
 The increasing demand for high standard
animal models together with a critical view
on the use of animals led to the
development of Laboratory Animal Science
in the 1950s, a field that can be defined as a
multidisciplinary branch of science,
contributing to the quality of animal
experiments and to the welfare of laboratory
animals.
Laboratory Animal Science includes the
biology of laboratory animals and their
environmental requirements, genetic and
microbiological standardization,
prevention and treatment of diseases,
improvement of experimental techniques,
anaesthesia, analgesia and euthanasia,
alternatives to animal experiments and
ethics.
• Guiding principles are the three R’s of
Replacement, Reduction and Refinement,
launched by Russell and Burch in 1959 in
their book ‘The Principles of Humane
Experimental Technique’.3 Replacement
means the substitution of living animals
by in vitro techniques (eg cells, tissues),
computerized models, etc.
 Reduction means decrease of the number
of animals used by standardization of the
animal in terms of genotype and
microbiological quality, of the
experimental procedures and of the
environment in terms of standardized food
and climate in the animal room.
 Furthermore, the number of animals per
experimental group can be more
accurately estimated by using statistics
prior to the experiment, for example,
power analysis.
 Refinement means decrease in discomfort by
translating the behavioural and physiological
needs of the animal into adequate housing and
husbandry, by providing adequate anaesthesia,
analgesia and care, by guaranteeing skills of the
researcher/animal staff, which can be achieved
by education and training, by improving
experimental procedures and by determining a
human end point, where the animal can be
euthanized to prevent unnecessary suffering.
 Furthermore, the necessity of certain
animal experiments might be argued, such
as in cosmetic testing, LD 50 tests, tests
for military defence purposes, teaching,
etc.
 Undoubtedly, activities of the general
public such as protection organizations
have contributed to legislative regulations
for the protection of animals used for
experimental purposes.
 The first law, the Cruelty to Animals Act,
was adopted by the UK parliament in 1876.
 Since then, other countries have included
provisions in their laws as to protect
experimental animals.
 On a European level, two important
documents controlling the use of animals
in experiments were issued,
 In 1985 the Convention for the Protection
of Vertebrate Animals used for
Experimental and other Scientific
Purposes (ETS 123) of the Council of
Europe.
 In 1986 the Directive (Instruction) for the
Protection of Vertebrate Animals used for
Experimental and other Scientific Purposes
(86/609/EEC) of the EU, based on ETS 123,
but more stringent.
 The Directive applies to vertebrate animals
used in experiments likely to cause pain,
suffering, distress or lasting harm, covering
also the development of genetically modified
animals with the risk of experiencing pain and
distress.
 The Directive contains provisions on
accommodation and care of experimental
animals, on competence of researchers and
animal staff, on alternatives to animal
experiments, anaesthesia, euthanasia,
statistics on animal experimentation and
supply of animals.
 Animal experiments are considered acceptable
only if the benefit of the proposed experiment
outweighs the suffering of the animals.
 Ethical review of animal experiments will likely
benefit the animal and improve the quality of
animal-based research.
 As animal well being is a prerequisite for
reliable experimental results, it is of highest
importance to seek for methods and
procedures that can reduce suffering of the
animals and improve their welfare.
•MRC Ethics guide, Medical research council, London
•APA’s Guidelines for Ethical Conduct in the Care and
Use of Animals
•Australian code of practice for the care and use of
animals for scientific purposes 7th Edition, 2004
• AND MANY OTHERS…
‫نمونه های مشابه در سایر کشورها‬
USA
The UDSA is responsible for enforcing the
Animal Welfare Act, amended in 1985.
The Act applies to all research facilities:
public or private, academic or industry
based, whether or not they receive federal
funds.
 All covered facilities must register with the USDA
and report to the USDA verifying compliance and
indicating the number and species of animals
used by types of procedures (i.e. painless, pain
relief given or not given because of scientific
necessity).
The USDA is required to inspect each facility at
least annually.
The inspections are unannounced.
More frequent unscheduled inspections are made
if significant deficiencies are identified.
 All registered facilities are also required to establish
a Animal Care and Use Committee (IACUC) that
reviews and approves procedures involving animals
before they take place, and inspect facilities
semiannually for compliance with the AWA.
At least one member of the committee must be a
veterinarian.
At least one member must be a "public" member, not
affiliated with the institution, who represents the
general community interest in the care and treatment
of the animals.
 The US Public Health Service has an animal
welfare policy that applies to all federally
funded institutions.
The Public Health Service maintains a Guide
for the Care and Use of Laboratory Animals.
This guide is consistent with and similar to the
AWA and applies to all vertebrate animals.
The Public Health Policy and Government Principles
Regarding the Care and Use of Animals states
 Whenever US Government Agencies develop
requirements for testing, research or training
procedures involving the use of vertebrate animals,
the following principles shall be considered; and
whenever these agencies actually perform or sponsor
such procedures, the responsible institution shall
insure that these principles are adhered to:
· The transportation care and use of animals shall be
in accordance with the Animal Welfare Act (7USC
2131 et seq.) and other applicable Federal laws,
guidelines and policies.
 procedures involving animals should be designed
and performed with due consideration of their
relevance to human or animal health, the
advancement of knowledge, or the good of the
society
· The animals selected for a procedure should be of
an appropriate species and quality and the minimum
number required to obtain valid results. Methods
such as mathematical models, computer simulations,
and in vitro biological systems should be considered.
 Proper use of animals, including the
avoidance or minimization of discomfort,
distress, and pain when consistent with
sound scientific practices, is imperative.
 Unless the contrary is established,
investigators should consider that procedures
that cause pain or distress in humans beings
may cause pain or distress in other animals.
 Canadian Council on Animal Care Guide, Vol.1, (2nd Edition
)1993. Avilable
online:http://www.ccac.ca/en/CCAC_Programs/Guidelines_
Policies/GDLINES/Guidelis.htm
 -Guidance on the Operation of the Animals (Scientific
Procedures) Act 1986, Avilable online:
http://www.archive.officialdocuments.co.uk/document/hoc/321/321-02.htm
 -Australian code of practice for the care and use of animals
for scientific purposes, Avilable online:
http://www.nhmrc.gov.au/publications/synopses/_files/ea16.
pdf
 CCAC Programs -> Education Training, Avilable
online:
http://www.ccac.ca/en/CCAC_Programs/ETCC/Intr
o-coretopics-Web11.htm
 -Animal Procedure Committee Education &
Training Sub-Committee: Review of modular
Training , Avilable online:
http://www.apc.gov.uk/reference/apc-educationmodular-training.pdf
 - The University of Newcastle, Australia, 2007
Training Program, Research Animal Training
Scheme, Avilable online:
http://www.newcastle.edu.au/research/animal/doc
s/RATS- program%20information.pdf
‫تهيه و حمل و نقل حيوانات‬
‫الف‪ -‬قوانين معرفي گونه جديد به منطقه‬
‫ب‪ -‬نحوه اسارت حيوانات‬
‫ج‪ -‬نحوه نگهداري در اسارت‬
‫د‪ -‬چگونگي حمل و نقل شامل وسايل حمل و نقل و قفسها‬
‫روشهاي نگهداري‬
‫الف‪ -‬مكان‪ :‬شامل فضاي نگهداري‪ ،‬شرايط قفسها‪ ،‬نگهداري در‬
‫فضاي باز‪ ،‬تهويه‪ ،‬فاضالب‪ ،‬نور پردازي‪ ،‬راههاي فرار در‬
‫موارد اضطراري‬
‫ب‪ -‬امكانات‪ :‬شامل غذا‪ ،‬امكانات درماني‪ ،‬شستشو‬
‫نيروهاي اجرايي (مراقبتكنندگان حيوان)‬
‫الف‪ -‬آموزشهاي الزم براي حفظ سالمت حيوان و انسان‬
‫ب‪ -‬لباس و امكانات حفاظتي‬
‫ج‪ -‬عالقه به كار و امكانات رفاهي الزم‬
‫د‪ -‬آگاهي نسبت به اهميت موضوع پژوهش‬
‫ه‪ -‬اطالع از عاليم بيماري و سالمت حيوان‬
‫وـ رعايت خصوصيات زندگي طبيعي حيوان در شرايط اسارت تا حد ممكن‬
‫مانند اجتماعي بودن يا انفرادي بودن حيوان‬
‫زـ آگاهي از وضعيت آبستني و شيردهي حيوان‬
‫كاربران پژوهش و محققين‬
‫الف‪ -‬آگاهي از نوع‪ ،‬جنس و ساير شرايط حيوان مناسب براي‬
‫آزمايش‬
‫ب‪ -‬اطالعات الزم در مورد تاثير شرايط محيطي بر نتايج آزمايش‬
‫ج‪ -‬عدم استفاده از حيوانات بيمار در آزمايش‬
‫پیشنهادها‬
Products in Europe not tested on animals carry this symbol.
‫وجود مرکزی در کليه ی دانشگاهها برای نطارت اخالقی بر محلهای نگهداری‬
‫و کار بر روی حيوانات‪ ،‬بطور دوره ای و سامانمند‪.‬‬
‫الزام اخذ و تمديد دوره ای مجوز از سوی مراکز نگهداری و کار بر روی‬
‫حيوانات‪.‬‬
‫الزام گذراندن دوره ی کار بر روی حيوانات برای تمامی کسانی که به نحوی با‬
‫حيوانات سروکار دارند‪ ،‬بويژه پژوهشگران‪.‬‬
‫بررسی اوليه ی پروپوزال و نظارت بر پژوهشهای شامل کار بر روی‬
‫حيوانات از سوی کميته ی اخالقی ويژه‪.‬‬
Monument for animals used in
testing at Keio University
The End
‫مولوی می فرماید‪:‬‬
‫زانباری پر از گندم اگر یک مشت بنمایی‬
‫بدانکه جمله گندم را توان دانست ای دانا‬
‫کليات‬
‫‪‬‬
‫‪‬‬
‫‪‬‬
‫‪‬‬
‫تاريخ تحقيقات زيست پزشکي ونتايج ارزشمند مطالعات دانشمندان‪ ،‬اهميت‬
‫کاربرد حيوانات را در اين پژوهشها نشان مي دهد‬
‫هنوز در راه شناخت وضعيت سالمتي و چگونگي رخداد بيماريها راهي‬
‫طوالني در پيش است‪.‬‬
‫علي رغم وجود روشهاي متنوع مطالعات آزمايشگاهي مانند علوم سلولي و‬
‫ملکولي‪ ،‬تنها راه براي يادگيري بيشتر مطالعه روي حيوانات زنده است‪.‬‬
‫امروزمسائلي همچون آسايش‪ ،‬حقوق‪ ،‬رفاه حيوانات و رعايت اصول‬
‫اخالقي کار با حيوانات ازمايشگاهي بسيار مورد توجه قرار گرفته است‪.‬‬
‫کليات‬
‫‪ ‬در کشورهاي مختلف دنيا انجمن هاي حمايت از حيوانات و کميته هايي‬
‫درمراکز دانشگاهي و تحقيقاتي براي نظارت بر استفاده و مراقبت آنها‬
‫فعاليت دارند‪.‬‬
‫‪ ‬احساس مسئوليت در برابر حيوانات تحت آزمايش و توجه به رفاه وحقوق‬
‫آنان از وظايف اخالقي هر پژوهشگر مي باشد‪.‬‬
‫‪ ‬اين امر در صورتي محقق خواهد شد که پژوهشگران زندگي و نيازهاي‬
‫طبيعي حيوانات مورد آزمايش و اصول اخالقي هر گونه پژوهش بر آنها‬
‫را بشناسند و در اين زمينه آموزشهاي الزم را ببينند‪.‬‬
‫کاربرد حيوانات‬
‫‪ ‬انسان از گذشته هاي دور از حيوانات براي تغذيه‪ ،‬حمل ونقل‬
‫و‪....‬بهره مي برده است‪.‬‬
‫‪ ‬استفاده از حيوانات در پژوهش به موازات پيشرفت علم طب‬
‫‪ ‬طب ايران باستان و طب يونان‬
‫‪ ‬ممنوعيت تشريح جسد در طب يونان باستان‬
‫‪ ‬مطالعات فيزيولوژيک جالينوس‪ ،‬بزرگترين متخصص طب‬
‫تجربي‪ ،‬بااستفاده از آزمايشات روي خوک ‪ ،‬ميمون و سگ‬
‫ظهور اسالم نقطه عطفي در علم طب‬
‫‪ ‬پس از ظهور اسالم‪ ،‬مطالعات پزشکان نامدار ايراني درکالبد‬
‫شناسي و فيزيولوژي با استفاده ازحيوانات‬
‫‪ ‬تشريح ساختمان دستگاه عصبي توسط رازي از بزرگترين‬
‫ومبتکر ترين پزشکان مسلمان ايراني با استفاده ازحيوانات‬
‫‪ ‬شناخت آثار بسياري داروها با آزمايش روي حيوانات توسط‬
‫رازي‬
‫کاربرد حيوانات در اروپا بعد ازرنسانس‬
‫‪ ‬مطالعات آناتوميک گسترده با استفاده از حيوانات توسط‬
‫وزاليوس ‪،‬پدر علم تشريح‬
‫‪ ‬در قرن هفدهم شکل گيري فلسفه کارتزين‬
‫‪ ‬اعتقادات رنه دکارت‬
‫کاربرد امروزي حيوانات در پژوهش‬
‫‪‬‬
‫‪‬‬
‫‪‬‬
‫‪‬‬
‫ارزش و اهميت خاص استفاده از حيوانات آزمايشگاهي در پژوهشهاي‬
‫زيست پزشکي‬
‫اطمينان ازاثربخشي و ايمني داروهاي جديد‪ ،‬واکسن ها وتکنيک هاي‬
‫جراحي‬
‫مدل حيواني دربرنامه هاي پژوهشي مانند فرآوري دارو‪ ،‬بررسي‬
‫فارماكوكينتيك آنها و تعداد زيادي از مطالعات فيزيولوژيكي‬
‫کشف علل بيماريهاي شديد و کشنده‪ ،‬راههاي در ماني و طرق جديد‬
‫پيشگيري از بيماريها‬
‫در قرن بيستم‬
‫‪ ‬در قرن بيستم بهترين و مؤثرترين درمانهاي پزشکي با کشف‬
‫وآزمايش آنتي بيوتيکها‪ ،‬واکسنها‪ ،‬جراحي قلب‪ ،‬پيوند کليه و‪...‬‬
‫از طريق استفاده ازحيوانات ميسر شده است‪.‬‬
‫حمایت ازحیوانات‬
‫‪ ‬از دهه ‪ 1950‬با تمايل به باالرفتن استانداردهاي مدلهاي‬
‫حيواني خود به عنوان شاخه اي از علم منجر به بهبود کيفيت‬
‫آزمايشات و رفاه حيوانات‬
‫‪ ‬در سال‪ 1959‬راسل وبروس سه قاعده اساسي درکار با‬
‫حيوانات آزمايشگاهي‬
‫‪ ‬گروه هاي حمايت از حيوانات در دنيا‬
‫‪ ‬اولين قانون تحت عنوان ‪ ANIMAL ACT‬در سال ‪1976‬‬
‫در انگلستان‬
‫قانون حمايت از حيوانات‬
‫‪ ‬بر اساس اين قوانين محقق تنهادر محدوده هاي خاص و در ارتباط با‬
‫امر تحقيق مي تواند روي حيوان آزمايش نمايدو آسايش حيوانات‬
‫اولين چيزي است که در چگونگي اداره آزمايشات بايد مورد توجه قرار‬
‫گيرد ‪.‬‬
‫نظارت بر کار با حیوانات آزمایشگاهي‬
‫‪ ‬صدورگواهينامه هاي مخصوص براي افرادي که در تحقيقات خود از‬
‫مدل حيواني استفاده مي کنند‬
‫‪ ‬کميته هاي ارزيابي اخالقي پژوهش و نظارت بر نگهداري وتحقيقات‬
‫برحيوانات آزمايشگاهي در دانشگاهها و مراکز تحقيقاتي دنيا‬
‫نظارت بر کار با حیوانات آزمایشگاهي در ایران‬
‫‪ ‬وسعت استفاده حيوانات آزمايشگاهي در کشور‬
‫‪ ‬وجود فرهنگ عطوفت به موجودات زنده و عدم آزار رساني به‬
‫حيوانات در دستورات ديني ما‬
‫‪ ‬مسئوليت انسان در قبال نعمتها و مواهب الهي و هر آنچه که‬
‫پروردگار مسخر او قرار داده طبق تعاليم اسالمي‬
‫‪ ‬حدودتصرف انسان در حيات موجودات ازمنظر اخالق در‬
‫پژوهش‬
‫نظارت بر کار با حیوانات آزمایشگاهي در ایران‬
‫‪ ‬تدوين راهنماي اخالقي کار با حيوانات آزمايشگاهي در کشور‬
‫‪ ‬تطابق نداشتن دانش و عملکرد پژوهشگران دانشگاهها و مراکز‬
‫تحقيقاتي در بعضي موارد با استانداردهاي الزم‬
‫‪ ‬آگاهي نداشتن ازدستورالعمل کشوري موجود کار با حيوانات‬
‫آزمايشگاهي‬
‫اقدامات ضروري در کشور‬
‫‪ ‬تدوين برنامه هاي آموزشي براي آموزش استاندارد به‬
‫پژوهشگران و مراقبين حيوانات طبق نياز و امکانات کشورمان‬
‫‪ ‬واحدهاي درسي ‪ ،‬کارگاهها ‪ ،‬سمينارها‪ ،‬جزوات و بروشورهاي‬
‫آموزشي‬
‫‪ ‬تشکيل کميته هاي اخالق کار با حيوانات آزمايشگاهي‬
‫‪ ‬انسان هنوز راهي طوالني در کشف‬
‫حقايق فيزيولوژيک و چگونگي رخداد‬
‫بسياري بيماريها در بدن خود‪ ،‬درپيش‬
‫داردو در بعض ي موارد تنها راه براي‬
‫کسب اطالعات مطالعه مدلهاي حيواني‬
‫است‪.‬‬