HUMAN EXPERIMENTATION: AN ETHICO-LEGAL OVERVIEW

MAJDAH ZAWAWI AHMAD IBRAHIM KULLIYYAH OF LAWS IIUM

The basis of human research certain experiments yield results for the good of society that cannot be obtained through methods of animal experimentation. Advances in biomedical sciences and technology in medicine are provoking some anxiety among the public and confronting society with new ethical problems among them - stem cell research and human cloning.

 EXPERIMENTATION WITH HUMANS: NUREMBERG CODE DECLARATION OF HELSINKI INTERNATIONAL ETHICAL GUIDELINES FOR RESEARCH 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

WHY THE WORRY?

Society is expressing concern about what it fears would be abuses in scientific investigation and biomedical technology. CONSTRUCTION OF HYPOTHESES

STEP 1

STEP 2

HYPOTHESES TESTED IN LABS FIRST ON ANIMALS FINDINGS TO BE CLINICALLY USEFUL MUST EXPERIMENT ON HUMANS

STEP 3

THE PROBLEM
EXISTENCE OF RISK Even though carefully designed, such research entails some risk to the subjects. Example harmful side effects that may be worse than the disease sought to be treated. THE POSSIBILITY OF BENEFIT This risk is justified not by any personal benefit to the researcher or the research institution. It must benefit the human subjects involved, It has potential contribution to human knowledge, to the relief of suffering or to the prolongation of life.

NUREMBERG CODE
HISTORY
WORLD WAR II Nazi and Japanese physicians conducted unethical research on
Prisoners of war Physically and mentally disabled Children

Resulted in the Nuremberg Code.

ESTABLISHED MORAL FRAMEWORK

Voluntary informed consent

Danger stop!

No random or unnecessary experiments

Withdrawal at any time

Animal experiments first

Done by medically trained professional.

Avoid unnecessar y pain and suffering

DECLARATION OF HELSINKI
RESEARCH
MUST CONFORM TO ACCEPTABLE SCIENTIFIC PRINCIPLES APPROVED BY COMMITTEE PRECEDED BY EXPERIMENTION ON ANIMALS

QUALIFIED RESEARCHERS RISK-BENEFIT ASSESSMENT

SUPERVISED BY MEDICALLY QUALIFIED PERSON FULL RESPONSIBILITY OVER RESEARCH SUBJECT

THE RISK IS PREDICTABLE BENEFIT OUTWEIGH THR RISK

CONTINUE
SUBJECT INTEGRITY FULL DISCLOSURE
RESPECT PRIVACY ENSURE PHYSICAL AND MENTAL WELFARE AIMS OF RESEARCH METHODS AND POTENTIAL HAZARD

INFORMED CONSENT

VOLUNTARY AND COMPETENT FREE TO WITHDRAW AT ANYTIME

CONVENTION ON HUMAN RIGHTS & BIOMEDICINE

No alternative compared to human research

Informed consent

Purpose to protect human dignity and identity

Risk not disproporti onate with benefit

Research approved by competent body

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

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.

HAAJIYAAT
Needs in life; To allow the proper functioning of life beyond the requirements of basic survival. Example Laws protecting the body form being hurt.

TAHSINIYAAT
Refinements in life; Aims at attaining a higher level of human dignity; Mankind can do without, but if a person has it, the quality of life is enhanced; Example Laws protecting the acquiring of property.

5 ESSENTIALS DHARURIYAAT
HIFZ AL-DEEN HIFZ AL-NAFS HIFZ AL-NASL HIFZ AL-AQL HIFZ AL-MAL

STEM CELL RESEARCH

Importance of stem cells Nuffield Council
human stem cells can give rise to many different types of cells, such as muscle cells, nerve cells, heart cells, blood cells and others. They raise the possibility, therefore, of major advances in healthcare. For example, stem cells could be used to generate replacement cells and tissues to treat many diseases and conditions, including Parkinsons disease, Alzheimer's disease, leukaemia, stroke, heart disease, diabetes, multiple sclerosis, rheumatoid arthritis, spinal cord injury and skin conditions, including burns

Benefits of stem cell research

POTENTIAL APPLICATIONS
Basic research into
human development & disorders Discovery of novel proteins for tissue regeneration & repair Development of human cell model for drug discovery and toxicology Development of tissue for transplantation

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.

Status of embryo
A clump of cells or a human being?

Scientific theories
Requires maternal environment in the womb to develop into a whole human being Just a ball of cells an embryo is no different from a live cell or piece of human tissue. Develop the primitive streak stage at 14 days at which both the development of individual embryos and cell determination for the future foetus are established

Existing Legislations & Guidelines in Malaysia

Human Tissues Act, 1974 - Limited application - Deals with use of human bodies of deceased persons for therapeutic purposes Private Healthcare Facilities & Services Act 1998 -Deals with the control of private healthcare facilities and services Guidelines on ART and Stem Cell Research & Fatwa:

MOH - Malaysian Code of Practice and Guidelines for Assisted Reproductive -- Too broad unless amended to Techniques (ART) Centres, include facilities that can offer ART 2002 & stem cell therapy MMC Guidelines on ART

MOH Guidelines on Stem Cell Research 2007

Fatwa by National Fatwa Committee 2006

The Malaysian Code of Practice and Guidelines for Assisted Reproductive Techniques (ART) Centres, 2002
In pari materia with the Code of Practice issued by the United Kingdom Human Fertilisation and Embryology Authority, 2002 which is actually read with the Human Fertilisation and Embryology 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.

Part 6 of the Msian Code of 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 10 with approval from the Regulatory Authority

6.11 Consent to Use

For treatment of the couples For research

Part 8 of Msian Code of Practice

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 that embryos do not continue to develop after 14 days or after the appearance of the primitive streak.

Part 10 - Msian Code of Practice

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.

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

10.5 Msian Code of Practice

Embryos that have been appropriated for research must not be used for any other purposes

Malaysian Medical Council Guidelines 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 using any human oocyte Provisions are too vague to provide any guidance on how research on embryos are to be regulated.

1. The Ministry of Health will undertake to encourage and

promote stem cell research in Malaysia. Should the Government be encouraging and promoting stem cell research in Malaysia? 2. All stem cell research must pass through an institutional review board and an institutional ethics committee to prevent unethical research and unethical use of stem cells. Decentralization of review body. Creates difficulty in monitoring and enforcing any laws.

Guidelines for stem cell research in Malaysia KKM 2007

4.

CONTINUE
3. Research on stem cells derived from adult stem cells is allowed in accordance to existing guidelines. 4. Use of fetal tissues from legally performed termination of pregnancy is also allowed in accordance to existing guidelines. What existing guidelines?

..

CONTINUE

6. Use of non-human stem cell lines are also allowed (mice and primates). Is it wise to confine to only these two animals? 7. Use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed. Must also make provisions on the sources of these stem cell lines are they to be taken from inside the country from left over embryos or SCNT or are they to be imported?

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

Status of Embryos in Islam

In vivo embryos Upon fertilisation accorded with the right to live. Accorded with ahliyah al-wujub alnaqisah incomplete legal capacity
Has right to life Has right to inheritance but operates only once he/she is born

To destroy would mean to abort prohibited by all Majority of the Ulama except if life of the mother is in danger. Majma al-Fiqh al-Islami 17th Meeting, 1990
Forbade the creation of embryos that would be more than what is safe for implantation 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 implanted in 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 of storage period then allow to perish but no embryos may be intentionally discarded, destroyed or donated.

1.

Fatwa on Therapeutic Human Cloning and Stem Cell Research 2005

Therapeutic human cloning is permitted (diharuskan) if for medical treatment through the creation of certain cells or replacing damaged organs dengan mengambil kira langkah sempadan 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 therapeutic purposes is also permitted provided that The couples consented The embryo is not implanted into any womb.

Continue
6. Any type of research for commercial gain or that which has no relation to the health of the mother or the fetus is not permitted. 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 on sadd al-zarai (blocking the means of evil) This contradicts with ruling 1.

Construction of the Fatwa

Not a blanket approval diharuskan in Arabic is known as mubah which means something which is permitted does not mean something which is promoted or encouraged. Research must be for therapeutic purposes only which must be necessary and not for commercial purposes. Research must be legal and conducted in a responsible manner Need to iron out the contradictions.

 Recognises diverse opinions on the acceptability or non-acceptability of research on embryos. For countries that allow should have a regulatory framework which provides the limits of the permissible. In all aspects of research importance must be given to the respect to human dignity and the respect and principles in the UDHR (1948) and the UD on the Human Genome and Human Rights (1997)

UNESCOs Report by the International Bioethics Committee 2001

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 obtaining human stem cell lines from adult stem cells or from SCNT - to be used only for therapeutic research

Convention on Human Rights and Biomedicine (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.

SHUKRAN JAZILAN WA MAASALAMAH!