experimentation with human and animals
TRANSCRIPT
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HUMAN EXPERIMENTATION:AN ETHICO-LEGAL
OVERVIEWMAJDAH ZAWAWI
AHMAD IBRAHIM KULLIYYAH OF
LAWS
IIUM
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The basis of human research certain experimentsyield results for the good of society that cannot be
obtained through methods of animalexperimentation.
Advances in biomedical sciences and technology inmedicine are provoking some anxiety among thepublic and confronting society with new ethical
problems among them - stem cell research andhuman cloning.
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EXPERIMENTATION WITH HUMANS: NUREMBERG CODE DECLARATION OF HELSINKI
INTERNATIONAL ETHICAL GUIDELINES FORRESEARCH INVOLVING HUMAN SUBJECTS CONVENTION ON HUMAN RIGHTS &
BIOMEDICINE
ETHICAL AND LEGAL ISSUES IN ADVANCES IN
BIOMEDICAL SCIENCE AND TECHNOLOGY ORGAN TRANSPLANTATION, MAPPING THE HUMAN GENOME, STEM CELL RESEARCH & CLONING, GENE THERAPY
THE MUSLIM SCIENTIST
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WHY THE WORRY?
Society is expressing concern about what it fears would beabuses in scientific investigation and biomedical technology.
STEP 1 CONSTRUCTION OF HYPOTHESES
STEP 2
HYPOTHESES TESTED IN LABS
FIRST ON ANIMALS
STEP 3
FINDINGS TO BE CLINICALLY USEFUL
MUST EXPERIMENT ON HUMANS
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THE PROBLEM
EXISTENCE OF RISK
Even though carefully
designed, such research
entails some risk to thesubjects.
Example harmful side
effects that may be worse
than the disease sought tobe treated.
THE POSSIBILITY OF BENEFIT
This risk is justified not by
any personal benefit to the
researcher or the researchinstitution.
It must benefit the human
subjects involved,
It has potential contributionto human knowledge, to the
relief of suffering or to the
prolongation of life.
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NUREMBERG CODE
HISTORY
WORLD WAR II Nazi and
Japanese physicians
conducted unethicalresearch on
Prisoners of war
Physically and mentally
disabled
Children
Resulted in the Nuremberg
Code.
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ESTABLISHED MORALFRAMEWORK
Voluntaryinformedconsent
No randomor
unnecessary
experiments
Animalexperiments
first
Avoidunnecessary pain andsuffering
Done bymedicallytrained
professional.
Withdrawalat any time
Danger
stop!
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DECLARATION OF HELSINKI
MUST CONFORM TO ACCEPTABLE SCIENTIFICPRINCIPLES APPROVED BY COMMITTEE
PRECEDED BY EXPERIMENTION ON ANIMALSRESEARCH
SUPERVISED BY MEDICALLY QUALIFIED PERSON
FULL RESPONSIBILITY OVER RESEARCH SUBJECT
QUALIFIEDRESEARCHERS
THE RISK IS PREDICTABLE
BENEFIT OUTWEIGH THR RISK
RISK-BENEFITASSESSMENT
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CONTINUE
RESPECT PRIVACY
ENSURE PHYSICAL AND MENTALWELFARE
SUBJECTINTEGRITY
AIMS OF RESEARCH
METHODS AND POTENTIAL HAZARD
FULLDISCLOSURE
VOLUNTARY AND COMPETENT
FREE TO WITHDRAW AT ANYTIME
INFORMEDCONSENT
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CONVENTION ON HUMANRIGHTS & BIOMEDICINE
Purpose toprotect human
dignity andidentity
Noalternativecomparedto humanresearch
Risk notdisproportionate with
benefit
Researchapproved bycompetent
body
Informedconsent
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THE MUSLIM SCIENTIST
When considering the need to experiment on
humans must look at:
The Purposes of the Shariah:
To ensure the fulfillment of:-
Dharuriyyaat
Haajiyaat
Tahsiniyaat
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DHARURAT
Necessities in life;
Normal human life cannot exist and continue
without a dharurat;
Basic survival needs .
The Shariah first and foremost seeks to ensure
the fulfillment of this necessity. Example Law protecting life.
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5 ESSENTIALS -DHARURIYAAT
HIFZ AL-DEEN
HIFZ AL-NAFS
HIFZ AL-NASL HIFZ AL-AQL
HIFZ AL-MAL
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STEM CELL RESEARCH
Importance of stem cells NuffieldCouncil
human stem cells can give rise to many different types of
cells, such as muscle cells, nerve cells, heart cells, bloodcells and others. They raise the possibility, therefore, ofmajor advances in healthcare. For example, stem cellscould be used to generate replacement cells and tissues
to treat many diseases and conditions, includingParkinsons disease, Alzheimer's disease, leukaemia,stroke, heart disease, diabetes, multiple sclerosis,rheumatoid arthritis, spinal cord injury and skinconditions, including burns
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Benefits of stem cellresearch
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POTENTIAL APPLICATIONS
Basic research intohuman development &disorders
Discovery of novelproteins for tissueregeneration & repair
Development of humancell model for drug
discovery andtoxicology
Development of tissuefor transplantation
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SOURCE OF STEM CELLS
Adult stem cells
Embryonic stem cells (ESC)
Surplus embryos from IVF procedures
Embryos from SCNT
Special feature of Embryonic stem cells it is pluripotent in nature.
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Status of embryo
A clump of cells or a human being?
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Scientific theories
Requires maternal environment in the womb todevelop into a whole human being
Just a ball of cells
an embryo is no different from a live cell orpiece of human tissue.
Develop the primitive streak stage at 14 days at
which both the development of individualembryos and cell determination for the futurefoetus are established
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Existing Legislations &Guidelines in Malaysia
Human Tissues
Act, 1974
- Limited
application
- Deals with use
of human bodies
of deceased
persons fortherapeutic
purposes
Guidelines on ART and Stem
Cell Research & Fatwa:
MOH - Malaysian Code of
Practice and Guidelines for
Assisted Reproductive
Techniques (ART) Centres,
2002
MMC Guidelines on ART
MOH Guidelines on Stem
Cell Research 2007
Fatwa by National Fatwa
Committee 2006
Private Healthcare Facilities &
Services Act 1998
-Deals with the control of private
healthcare facilities and services
-- Too broad unless amended to
include facilities that can offer ART
& stem cell therapy
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The Malaysian Code of Practice andGuidelines for Assisted Reproductive
Techniques (ART) Centres, 2002
Inpari materia with the Code of Practice issued by the UnitedKingdom Human Fertilisation and Embryology Authority, 2002which is actually read with the Human Fertilisation andEmbryology Act, 1990.
Problems: Malaysia DOES NOT have a similar Act;
Malaysia DOES NOT have a body similar to HFE Authority.
Effect: The Government has no powers to monitor any persons or organisations which
conduct research on human embryos; The Government cannot enforce the Code of Practice;
Embryo Research in Malaysia cannot be legally controlled.
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Part 6 of the Msian Codeof Practice
Part 6 Consent
6.8 Consent to Storage
Couples must specify storage period
What is to be done with the embryos in the event of death or divorce of the
parties
6.9 Statutory Storage Period
Maximum 5 years
Minimum 10with approval from the Regulatory Authority
6.11 Consent to Use
For treatment of the couples
For research
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Part 8 of Msian Code ofPractice
8.10 The special status of the human
embryo Centres are to decide carefully
whether or not to dispose, how to dispose and
whether to use it for research purposes.
8.12 Centre should decide the culture period,
the method that is to be used to terminate
development and the procedure to ensure thatembryos do not continue to develop after 14
days or after the appearance of the primitive
streak.
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Part 10 - Msian Code ofPractice
10.1 All research must have
licence from the Ministry of Health
Licences will only be granted for
the following types of research
projects:
To promote advances in
treatment of infertility;
To increase knowledge
about causes of
miscarriage
Increase knowledge on
causes of congenital
disease
Develop better
contraceptives;
Develop methods for
detecting presence of gene
or chromosome
abnormalities before
implantation;
Increase knowledge about
serious diseases;
Allow such knowledge to be
applied in developing
treatments for serious
disease.
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Para 10.4 - Prohibitions
Keeping or using an embryo after the 14 day
period or after the appearance of the primitive
streak;
Placing an embryo in a non-human animal;
Replacing a nucleus of a cell of an embryo with
a nucleus taken from the cell of another person,
another embryo or a subsequent development
of an embryo altering the genetic structure of
any cell while it forms part of an embryo
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10.5 Msian Code ofPractice
Embryos that have been appropriated for
research must not be used for any other
purposes
M l i M di l C il
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Malaysian Medical CouncilGuidelines on Assisted
Reproduction Does not specifically deal with embryo research or stem cell
research
Para 9 Storage and Disposal of Gametes and Embryos
A couple undergoing ART should be asked for instruction
concerning the storage and disposal of embryos. Specific instruction must be asked of the couple and informed
consent duly obtained.
Para 14 Prohibited/Unacceptable Practices
No research or experimentation shall be performed on or usingany human oocyte
Provisions are too vague to provide any guidance on howresearch on embryos are to be regulated.
Guidelines for stem cell
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Guidelines for stem cellresearch in Malaysia KKM
20071. The Ministry of Health will undertake to encourage andpromote stem cell research in Malaysia.
Should the Government beencouraging and
promoting stem cell research in Malaysia?2. All stem cell research must pass through an
institutional review board and an institutional ethicscommittee to prevent unethical research and
unethical use of stem cells. Decentralization of review body. Creates difficulty in
monitoring and enforcing any laws.
4.
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CONTINUE
3. Research on stem cells derived from adult stemcells is allowed in accordance to existingguidelines.
4. Use of fetal tissues from legally performedtermination of pregnancy is also allowed inaccordance to existing guidelines.
What existing guidelines?
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CONTINUE
6. Use of non-human stem cell lines are alsoallowed (mice and primates).
Is it wise to confine to only these two animals?
7. Use of embryonic stem cell lines (from 64 celllines) for therapeutic purposes should be
allowed.
Must also make provisions on the sources ofthese stem cell lines are they to be taken from
inside the country from left over embryos or
SCNT or are they to be imported?
..
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CONTINUE
8.The creation of embryos either from ART or
SCNT specifically for the purpose of scientific
research is presently prohibited.
Must determine want to use from both, or only
left over embryos or only SCNT needs to be
considered further in view of the 2005 fatwa
allowing both
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Status of Embryos inIslam
In vivo embryos Upon fertilisation accorded with the
right to live.
Accorded with ahliyah al-wujub al-naqisah incomplete legal capacity Has right to life
Has right to inheritance but operates onlyonce he/she is born
To destroy would mean to abortprohibited by all Majority of the Ulamaexcept if life of the mother is in danger.
Majma al-Fiqh al-Islami 17th Meeting,1990
Forbade the creation of embryos thatwould be more than what is safe forimplantation into the womb of a woman
In vitro embryos Surah al-`Alaq: 1
He created man from a clinging clot.
No right to inheritance until implantedin womb.
Committee of Islamic Medical Sciences
to the Islamic Fiqh Academy of Jordan(in its 5th Meeting 5 Nov. 17 Dec, 1992 Creation of extra embryos only in special
circumstances
Divorce/death must be kept until end ofstorage period then allow to perish but noembryos may be intentionally discarded,
destroyed or donated.
Fatwa on Therapeutic Human
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Fatwa on Therapeutic HumanCloning and Stem Cell
Research 20051. Therapeutic human cloning is permitted (diharuskan) if for
medical treatment through the creation of certain cells orreplacing damaged organs dengan mengambil kira langkahsempadan yang dibenarkan oleh syarak.
2. Use of embryos left-over from IVF is permitted (harus) if The couples had consented
Before the embryo reaches the stage of alaqah.
3. Research on embryo for purposes other than for therapeuticpurposes is also permitted provided that
The couples consented
The embryo is not implanted into any womb.
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Continue
6. Any type of research for commercial gain or that which has norelation to the health of the mother or the fetus is notpermitted.
7. Research done must be Legal with a clear research proposal
For scientific purposes Carried out by qualified research personnel who are trustworthy and
responsible.
8. Sources of stem cell permitted
(i) excess embryos (consent obtained from parents)
(ii) Stem cell created from SCNT not permitted based onsadd al-zarai (blocking the means of evil)This contradictswith ruling 1.
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Construction of theFatwa
Not a blanket approvaldiharuskan in Arabicis known as mubah which means somethingwhich is permitted does not mean
something which is promoted or encouraged. Research must be for therapeutic purposes only
which must be necessary and not forcommercial purposes.
Research must be legal and conducted in aresponsible manner
Need to iron out the contradictions.
UNESCOs Report by the
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UNESCO s Report by theInternational Bioethics
Committee 2001 Recognises diverse opinions on the
acceptability or non-acceptability of research onembryos.
For countries that allow should have aregulatory framework which provides the limitsof the permissible.
In all aspects of research importance must begiven to the respect to human dignity and therespect and principles in the UDHR (1948) andthe UD on the Human Genome and Human
Rights (1997)
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Recommendations
If research involving embryos allowed to be
carried out within a regulatory framework with
appropriate guidelines and controls
Donation of embryos only after implication of
research are fully disclosed and subject to free
informed consent.
New and alternative technologies for obtaininghuman stem cell lines from adult stem cells or
from SCNT - to be used only for therapeutic
research
Convention on Human Rights and
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Convention on Human Rights andBiomedicine (Bioethics
Convention)1997
Art 18: specific prohibitions on the creation of
human embryos for research purposes
Article 18(1) : where the law allows research on
embryos in vitro, it shall ensure adequate
protection of the embryo.
Art 21: human body and its parts shall not, as
such, give rise to financial benefit.
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SHUKRAN JAZILAN WA MAASALAMAH!