experimentation with human and animals

7/31/2019 Experimentation With Human and Animals

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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!

experimentation with human and animals

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