1 history and islamic perspectives of ethics presenter: dr. asya al-riyami,ph.d research and studies...

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History and Islamic Perspectives of Ethics

Presenter: Dr. Asya AL-Riyami,Ph.D Research and Studies Expert

Outline

History of research ethics.

Islamic perspectives of ethics

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History of Ethics

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History of Research EthicsBefore 20th century Small scale, involving few individuals

Beginning of 20th century Larger scale clinical trials collect systematic data groups of individuals vulnerable groups

• Prisoners• Orphans• Mentally ill

No Formal Codes of Research Ethics

World War II

Experiments

Hypothermia Experiments

The goal of this type of experiments was to determine how long German pilots would survive after parachuting into the cold north sea.

A prisoner is submerged in a tank filled with cold water.

High Altitude Experiments

• High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen.

• Many of those who did not die immediately were put under water until they died.

Nuremburg Doctors’ Trial (1947)

doctors and scientists

put on trial for the murder

of concentration camp

inmates who were used as

research subjects

15 of 23 guilty, 7 hanged, 5 life sentences

How Could This Happen?

German physicians had sworn to

“do no harm” by the Hippocratic Oath

Science corrupted by politics?

Relevance of Hippocratic Ethics to Human Experimentation

Medical Practice Ethics: guided by Hippocratic Oath Doctor’s primary obligation is patient’s welfare Doctor acts in the patients’ best

Research Lies outside of the context of the physician-patient

relationship Two Interests

Test a hypothesis

Subject welfare

Two different types of practices

Balancing Two GoalsWithout an Adequate Framework of Research

Ethics

Advancement of Science

Protection of Subject Welfare/Rights>>>

Hippocratic Oath

Expand on Hippocratic Ethics to Protect Research Subjects

In the context of researchCould not protect human welfare Could not respect human rights

+ Concept of Human Rights

Nuremberg Code

Do No Harm

Nuremberg Code (1947)First Codification of Research Guidelines

Human Rights + Welfare of SubjectsThe first and longest

principle

Article (9)Subjects have the right

towithdraw at any time

“The voluntary consent of the human subject is absolutely essential.”

Articles (2-8, 10)• Scientific value• Favorable risk/benefit ratio• Suffering by subjects

should be avoided

Nuremberg Code (1947)Impact??

Little impact did not have the strength of law unrelated to the world of biomedical research Nuremberg gives standards for criminal

prosecutionUS researchers code did not apply to them ethical conduct implicit in their work medical science left on its own

The Declaration of Helsinki

Developed by the World Medical Association in Finland in 1964.

Provide guidance for physicians and participants in medical research.

Many updates were introduced in 1975, 1983, 1989, 1996 and lastly 2000.

The Declaration of Helsinki- It indicates:

• The well-being of the subject should take precedence over the interests of science

and society.• Physician should obtain the subject’s

freely given informed consent in writing.

- Ethical review committee approval is a must.

Research Abuses

Henry Beecher: Published 22 examples of abusesWithholding antibiotics from patients with rheumatic feverPurposely infecting institutionalized children with hepatitis Injecting live cancer cells into nursing home patients

Abuses and exploitations of humans in research continued despite having ethics codes

Tuskegee Syphilis Study (1932 - 1972)

Tuskegee, Alabama High prevalence of syphilis Although treatment existed, blacks in the rural

southern town were not receiving treatment.

Tuskegee Syphilis Study (1932 - 1972)

Ethical Issues• Inadequate disclosure of

information.

• Subjects believed they were getting free treatment.

• Told that spinal taps was therapy.

• US Gov’t actively prevented men from receiving penicillin.

• 1972 press reports caused the U.S. Gov’t to stop the study.

Response to Ethical Lapses

CIOMS 2002Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects

International Clinical Trials

Islamic Organization for Medical Sciences (IOMS)

Islamic Code of Medical Research Ethics

IOMS Cairo Conference, Dec. 2004:

*International Ethical Guidelines– an Islamic

Perspective– CIOMS and IOMS

*Developing the Islamic Charter of Medical and Health

Ethics– Basis of Muslim Ethics

Potential for evolving understanding between

Contemporary Bioethics and Muslim Ethics

Who are research participants?

They are:

Living individuals about whom a researcher conducting research obtains:

- Data through intervention or interaction.

-Identifiable human materials.

-Identifiable private information.

Vulnerable population• Pregnant women / fetuses.• Children.• Prisoners.• Elderly.• Mentally disabled.• Sick persons• Unconscious persons• Poor persons.• Persons with little education.

Islamic Perspectives

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ISLAMIC RELIGIOUS ETHICS: BASIC CONCEPTS

Historically, Muslim moral and ethical thought rooted in Revelation and human reason (al-’aql wa ‘l-shari’)

Recognizes rights of individuals, but emphasizes human obligations to establish social justice

Those more privileged in life have greater responsibilities towards the less fortunate

Asks the question – “is the acting agent/physician a moral person?” (“hal al-Tabib shakhsun salihun, shakhs du akhlaq?”)

ETHICS vs. AKHLAQ/ADAB

Ethics for physicians is translated in Arabic (and Urdu) as Akhlaq al-Tabib

The historical and social construct of how Muslims comprehend akhlaq is much broader than the contemporary use of term “ethics”

An understanding of akhlaq incorporates both the virtuous agent and his/her ethical act

VIRTUES FOR PHYSICIANS:MUSLIM SOURCES

“The physician is an instrument of God’s mercy on earth.” Ibn Ali al-Ruhawi (d. late 9th century)

From ethical concepts in the names of Allah: al-Rahim (compassionate), al-Rahman (gracious), al-Ghafur (forgiving), al-Haq (truth, justice)

From the Qur’an and Hadith: Cultivate al-birr (piety, godliness), ahsana (the ideal), hilm (gentleness, patience, moral reasonableness), ‘adl wa qist (justice, equity), tawazan (balance). Avoid kibr (pride), bakhila (avarice), istaghna (unbound confidence in self), bagha (injustice, intoxication with worldly power)

VIRTUES FOR PHYSICIANS:MUSLIM SOURCES (CONT.)

From Muslim ulema and fuqaha: The usul al-akhlaq of Imam Abu Hamid al-Ghazali – hikma (wisdom), shuja’a (courage), ‘iffa (temperance), and ‘adl (justice)

From Muslim physicians: Kitab al-Tibb al-Ruhani of Abu Bakr al Razi – the exemplary physician “must cultivate good moral character, good health, and be cultured in manners.” Must “listen more, talk less.”

Adab al-Tabib by Al-Ruhawi – “train by employing good morals and actions with sympathy, mercy, gentleness, chastity, courage, generosity, justice. Do not aim for an excess of worldly riches.” The physician with “exemplary adab is one who truly fears God.”

During the islamic era

Shareea included all the basic ethical principles known in modern history which include:

من العديد كتابات فى التعاليم هذه وجدتالرومى الدين جالل مثل المسلمين العلماء

م) 1253 – 1207(

1.Respect for persons2.Non-maleficence3.Beneficence4. Justice

FINAL WORDS

“The believers whose faith is most perfect

are those who have the best character.”

(Akmalu al-momineen imanan ahsanuhum

khuluqan)

Hadith of the Prophet (SAW)

(from Imam Ibn Hanbal)

How to Start

“Give them a fishing Rod instead of

A fish”

Conclusion

These requirements are universal, but they must be adapted to:

The health

The economic

The cultural

The legal conditions in

which clinical research is conducted

Conclusion (cont)

Ethics aims to protect participants from harm and to promote their welfare: - acts to restrain science

Ethics

Trust can take years to build and a moment to

break

Remember

http://www.wma.net

http://www.cioms.ch

http://ohsr.od.nih.gov/

http://www.cancer.gov/clinicaltrials/learning/page3

Links to more information

From Fundamental Ethical Principles to Local Guidelines

Respect for Persons, Beneficence, Justice

Respect for Persons, Beneficence, Justice

Institution operational guidelines

Institution operational guidelines

National regulations

National regulations

International recommendations

International recommendations

Local Regulations and Guidelines

• Developed countries have their own guidelines.

• Some developing countries have national

guidelines as Brazil, India, South Africa,

Thailand & Uganda.

What are the most urgent problems in our region

Ethics education and training

Establishing Ethics Review Committees

National guidelines

Auditing and Monitoring

شكرا