Challenges: Monitoring of Research: The Options

1
RESEARCH ETHICS ISLAMIC PERSPECTIVE
Muhammad Maher Hammami, MD, PhD, FACP,
FACE Senior Clinical Scientist/Consultant
Endocrinologist Director, Office of Research
Affairs King Faisal Specialist Hospital
Research Center
2
(No Transcript)
3
Ethical Guidelines on Biomedical Research
The Nuremberg Code 1947Declaration of
Helsinki 1964, 2000Council of International
Organizations of Medical Sciences
(CIOMS)International Ethical Guidelines for
Biomedical ResearchInvolving Human Subjects
1982,93,? International Guidelines for
Ethical Review of Epidemiological Studies 1991
4
Ethical Guidelines on Biomedical Research
International Conference on Harmonization (ICH)
Guidance on Good Clinical Practice
1996Operational Guidelines for Ethical
Committees That Review Biomedical Research
2000
5
Ethical Guidelines on Biomedical Research
UK Nuffield Council on Bioethics
1991Council of Europe. Convention on Human
Rights and Biomedicine 1997The Canadian
Tri-Council Policy Statement. Ethical Conduct
for Research Involving Humans 1998
6
Ethical Guidelines on Biomedical Research
The Belmont report 197945 CFR 46
1981,1991OPRR (OHRP) IRB Guide Book
1982,1993National Bioethics Advisory
Commission 1995
7
Are these consistent with Islamic ethics?
8
Research Aims
Research Methods
Consent
Ethics Committee Membership
9
Respect for persons Beneficence Non-maleficence
Justice
10
Source Characteristics of Islamic
Ethics/Morality
General Aims Guiding principles of Islamic
Ethics
Islam and Contemporary Ethical Approaches
11

• Morality concerns
• What behavior we ought to do.
• What kind of persons we ought to be.
• Ethics is the disciplined study of morality.

12
Islam means submission, obedience, and surrender
to God (Allah). It is both a religion and a
comprehensive way of life that concerns all
behaviors and character traits in all aspects of
human existence.
13
Are Moral and Ethical Systems Required?
14
Are Moral and Ethical Systems Required?
In order to organize life and build up a healthy
and harmonious society, Islam has legislated a
universal moral law.
15
Are Moral and Ethical Systems Required?
Just in the same way, whenever We sent a Warner
before thee to any people, the wealthy ones among
them said We found our fathers following a
certain religion, and we will certainly follow in
their footsteps. He said What! even if I
brought you a better guidance than that which ye
found your fathers following? They said For
us, we deny that ye (prophets) are sent (on a
mission at all). (Az-Zukhruf 43,23-24)
16
Are Moral and Ethical Systems Required?
O David! We did indeed make thee a vicegerent
on earth so judge thou between men in Truth (and
justice) nor follow thou the lusts (of thy
heart), for they will mislead thee from the Path
of Allah. (Sad 38, 26)
17
Are Moral and Ethical Systems Required?
And We sent down the Book to thee for the
express purpose, that thou shouldst make clear to
them those things in which they differ, and that
it should be a guide and a mercy to those who
believe. (An-Nahl 16, 64)
Allah doth wish to make clear to you and to show
you the ordinances of those before you
(An-Nisaa 4, 26)
18
Are Moral and Ethical Systems Required?
Those who follow the Messenger, the unlettered
Prophet, whom they fined mentioned in their own
(Scriptures)-in the Law and the Gospel- for he
commands them what is just and forbids them what
is evil he allows them as lawful what is good
(and pure) and prohibits them from what is bad
(and impure) he releases them from their heavy
burdens and from the yokes that are upon them. So
it is those who believe in him, honour him, help
him, and follow the Light which is sent down with
him, it is they who will prosper. (Al-Aaraf 7,
157)
19
Source of Ethics/Morality in the West
-the law -individual, family, and groups
experiences -religious beliefs -traditions
-professional education, training, and consensus
-authorities and experts opinions
-institutional policies and practices
20
Source of Ethics/Morality in Islam
The Divine Islamic Moral Law or The Shariah
21
Source of Ethics/Morality in Islam
If not Him, ye worship nothing but names that ye
have named - ye and your fathers - for which
Allah hath sent down no authority the Command is
for none but Allah He hath commanded that ye
worship none but Him that is the right religion,
but most men understand not. (Yusuf 12, 40)
22
Source of Ethics/Morality in Islam
The Shariah

• Al-Nas
• - Al-Quran (the direct words of Allah)
• As-Sunna (prophet Muhammads words and
• acts - the indirect words of Allah)
• Ijtihad
• - consensus of independent Islamic scholars
• - opinion of individual Islamic scholar

23
Source of Ethics/Morality in Islam
The Shariah
O ye who believe! Obey Allah, and obey the
Messenger, and those charged with authority among
you. If ye differ in anything among yourselves,
refer to Allah and His Messenger, if you believe
in Allah and the last day that is best, and most
suitable for final determination (An-Nissa 4,59)
24
Characteristics of Islamic Ethics/Morality
- Combines who is to say what is right or
wrong with what is to say an action is right or
wrong.
Divine Command Conscience Duty and Virtue
Common Good, Justice, Rights/Respects and
Utilitarianism
- Provides one source for Law and morals.
25
Ethical/Moral Classification of Behaviors and
Character Traits in Islam
Forbidden Discouraged Neutral
(permitted) Recommended (desirable) Obligatory
(required)
26
Ethical/Moral Classification of Behaviors and
Character Traits in Islam

O
R
Neutral
Desirability 0
D
F
-
27
General Aims Guiding principles of Islamic
Ethics
The purpose of the Shariah is to promote and
protect the interests of people by bringing
benefits and preventing harms in relation to
their necessities, needs, and wants
Necessities take precedence over needs, and needs
take precedence over wants
28
General Aims Guiding principles of Islamic
Ethics
THE FIVE NECESSITIES
The Shariah (culture and group
survival) Individual life Sound
mind Integrity/Dignity Property
29
General Aims Guiding principles of Islamic
Ethics
Harm should be removed
Harm should not be removed by harm
A smaller harm is tolerated in order to prevent a
bigger harm
Individual harm is tolerated in order to prevent
public harm
Preventing harm takes precedence over bringing
benefit
Necessities render that what is forbidden
allowable
Necessities should be carefully assessed
30
General Aims Guiding principles of Islamic
Ethics
Difficulty brings ease (Such as the difficulties
arising from travel, illness, being forced,
forgetness, unawareness, impracticality, and
legal incompetence)
Difficulty should be removed
Needs are considered necessities in regard to
rendering what is forbidden allowable
31
General Aims Guiding principles of Islamic
Ethics
But if one is forced by necessity, without
willful disobedience, nor transgressing due
limits, then he is guiltless. For Allah is
Oft-Forgiving, Most Merciful. (Al-Baqara 2,173)
and (Allah) has imposed no difficulties on you
in religion. (Al-Hajj 22,78) Allah intends
every facility for you He does not want to put
you to difficulties. (Al-Baqara 2,185) Allah
doth wish to lighten your (difficulties) for man
was created weak (in flesh). (An-Nisaa 4,28)
32
General Aims Guiding principles of Islamic
Ethics
Interests are divided into individual (or mostly
individual) interests, the disposition of which
is controlled by the individual, or societal (or
mostly societal) interests that are controlled by
the society.
33
General Aims Guiding principles of Islamic
Ethics
All things are permitted until proven otherwise
People are innocent until proven otherwise
Tradition (orf) is taken into account unless it
contradicts Shariah
Obligations and engagements should be fulfilled
34
General Aims Guiding principles of Islamic
Ethics
O ye who believe! Fulfill (all)
obligations. (Al-Maidah 5,1)
and fulfill (every) engagement, for every
engagement, will be enquired into (on the day of
Reckoning). (Al-Israa 17,34)
35
Islam and Contemporary Ethical Approaches
Who/what counts ?
Ethical relativism
The utilitarian approach
The rights /respect approach
The justice approach
The virtue approach
The common good approach
Privacy and confidentiality
36
Islam and Contemporary Ethical Approaches
Who/what counts ?
An individual has a moral standing if we believe
that it makes a difference, morally, how that
individual is treated, apart from the effects the
treatment has on others
Capacity to reason Capacity to experience
pleasure or pain Anything with interests Entire
natural systems
37
Islam and Contemporary Ethical Approaches
Who/what counts ?
O mankind! We created you from a single (pair)
of a male and a female, and made you into nations
and tribes, that ye may know each other (not that
ye may despise each other). Verily the most
honoured of you in the sight of Allah is (he who
is) the most righteous of you. And Allah has full
Knowledge and is well-acquainted (with all
things). (Al-Hujurat 49,13)
38
Islam and Contemporary Ethical Approaches
Who/what counts ?
There is not an animal (that lives) on the
earth, nor a being that flies on its wings, but
(forms part of) communities like you. Nothing
have We omitted from the Book, and they (all)
shall be gathered to their Lord in the end.
(Al-Anaam 6, 38)
39
Islam and Contemporary Ethical Approaches
Who/what counts ?
a woman was put in hell because of a cat that
she tied up, neither did she feed it nor did she
give it the freedom to eat on its own. (Al
Bukhari, Bada Alkhalk 3071)
Allah gave forgiveness to a prostitute because
when she passed by a dog near a well, nearly
dying of thirst, she took off her shoe tied it
with her scarf, and filled it with water for the
dog to drink. (Al Bukhari, Bada Alkhalk 3074)
40
Islam and Contemporary Ethical Approaches
Who/what counts ?
The seven heavens and the earth, and all beings
therein, declare His glory there is not a thing
but celebrates His praise and yet ye understand
not how they declare His glory! (Al-Israa 17,44)
41
Islam and Contemporary Ethical Approaches
Who/what counts ?
And He has subjected to you, as from Him, all
that is in the heavens and on earth behold, in
that are Signs indeed for those who
reflect. (Al-Jathia 45, 13)
42
Islam and Contemporary Ethical Approaches
Ethical relativism
Morality is relative and culture- and
circumstances-dependent

• CIOMS Guidelines PreambleDifferent conclusions
  may
• result from different ethical reviews of the
  same issue or
• proposal, and each conclusion may be ethically
  reached, given
• varying circumstances of place and time
• - Item 13 of Helsinki 2000
• - Guideline 22 of the CIOMS draft guidelines

43
Islam and Contemporary Ethical Approaches
Ethical relativism
Values Beliefs Judgment Feelings Behavior
44
Islam and Contemporary Ethical Approaches
Ethical relativism
Ethical Values VS Commercial Values
45
Values Hierarchy Which one of the two people
below is more likely to lie to help a friend?
Relationships xxx yyy zzz Honesty
Honesty xxx yyy zzz Relationships
46
Islam and Contemporary Ethical Approaches
Ethical relativism
Values help us determine whats right or wrong,
good or bad, and whats worthwhile for us or
not. Beliefs are our perceptions of how the
world is right now.
47
Islam and Contemporary Ethical Approaches
Ethical relativism
Relativism VS Double standards
48
Islam and Contemporary Ethical Approaches
Ethical relativism
On no soul doth Allah place a burden greater
than it can bear.(Al-Baqarah 2, 286)
Allah puts no burden on any person beyond what
He has given him. (At-Talaq 65, 7)
So fear Allah as much as you can (At-Tagabun
64, 16)
49
Islam and Contemporary Ethical Approaches
Ethical relativism
Ethical relativism is consistent with Islamic
ethics as long as
1) It is based on differing circumstances/realitie
s rather than differing values/beliefs.
2) Relativism is not confused with subjectivism
and double standards.
50
(No Transcript)
51
(No Transcript)
52
Islam and Contemporary Ethical Approaches
The utilitarian approach
Of any two actions, the most ethical one will
produce the greatest balance of benefits over
harms for all persons directly or indirectly
affected by the action
-Item 6 in the Nuremberg Code -Items 16 18 of
Helsinki 2000 -Guideline 4 of draft revision of
CIOMS guidelines -Beneficence principle of the
CIOMS guidelines for epidemiological studies
and the Belmont report
53
Islam and Contemporary Ethical Approaches
The utilitarian approach
They ask thee concerning wine and gambling. Say
In them is great sin, and some profit, for men
but the sin is greater than the profit..Thus
doth Allah make clear to you His Signs in order
that ye may consider. (Their bearings) on this
life and the Hereafter.. (Al-Baqarah 2, 219-20)
54
Islam and Contemporary Ethical Approaches
The utilitarian approach
As for the boat, it belonged to certain men in
dire want they plied on the water I but wished
to render it unserviceable, for there was after
them a certain king who seized on every boat by
force. As for the youth, his parents were people
of Faith, and We feared that he would grieve them
by obstinate rebellion and ingratitude (to Allah
and man). So we desired that their Lord would
give them in exchange (a son) better in purity
(of conduct) and closer in affection. .. I did it
not of my own accord. (Al-Kahf 18,79-81)
55
Islam and Contemporary Ethical Approaches
The utilitarian approach
It appears that this approach is consistent with
Islamic ethics as long as
1) Benefits and harms are defined and assigned
values according to the Islamic ethics scale.
2) Proper consideration is given to account for
all of the consequences of the action.
3) Two questions are considered what effect
will my doing this act in this situation
have?and what effect would everyones doing
this kind of action have?
56
The utilitarian approach
V
C
D
B
A
b
b
c
c
b
c
b
c
57
Islam and Contemporary Ethical Approaches
The rights /respect approach
An action is morally right only if those persons
affected are not used merely as instruments for
advancing some goal, but are fully informed, and
treated only as they have freely and knowingly
consented to be treated
-Item 1 of the Nuremberg code -Items 20-26 of
Helsinki 2000 -Guidelines 8-10 of draft revision
of CIOMS guidelines -Principle of respect for
person of the CIOMS guidelines for
epidemiological studies and the Belmont report
58
Islam and Contemporary Ethical Approaches
The rights /respect approach
Let there be no compulsion in religion (Al-Baqar
a 2, 256)
O ye who believe! Fulfill (all)
obligations (Al-Maidah5, 1)
59
Islam and Contemporary Ethical Approaches
The rights /respect approach
And it is He Who has restrained their hands from
you and your hands from them in the midst of
Mecca, after that He gave you the victory over
them. And Allah sees well all that ye do. . Had
there not been believing men and believing women
whom ye did not know that ye were trampling down
and on whose account a crime would have accrued
to you without (your) knowledge, (Allah would
have allowed you to force your way, but He held
back your hands).. (Al-Fat-h 48,24-25)
60
Islam and Contemporary Ethical Approaches
The rights/respect approach
O ye who believe! Let not some men among you
laugh at others it may be that the (latter) are
better than the (former) nor let some women
laugh at others it may be that the (latter) are
better than the (former) nor defame nor be
sarcastic to each other, nor call each other by
(offensive) nicknames ill-seeming is a name
connoting wickedness, (to be used of one) after
he has believed and those who do not desist are
(indeed) doing wrong. O ye who believe! avoid
suspicion as much (as possible) for suspicion
in some cases is a sin and spy not on each
other nor speak ill of each other behind their
backs. Would any of you like to eat the flesh of
his dead brother? Nay, ye would abhor it. But
fear Allah, for Allah is Oft-Returning,
Most-Merciful. (Al-Hujurat 49,11-12)
61
Islam and Contemporary Ethical Approaches
The rights/respect approach
It appears that this approach is consistent with
Islamic ethics as long as
1) Statements about what rights people have are
regarded as conclusions of moral arguments,
rather than as starting points. Rights are
protectors of morally legitimate interests.
2) The interests to be protected by rights should
be interests recognized by Islamic ethics.
3) The interests to be protected by rights should
be weighted according to the Islamic ethics scale
(interests related to necessities vs. needs vs.
wants, to individual vs. society, to bringing
benefit vs. preventing harm, to Shariah vs.
individual life vs. sound mind vs.
integrity/degnity vs. property, etc.).
62
Islam and Contemporary Ethical Approaches
The justice approach
Treat people the same unless there are morally
relevant differences between them
- Guideline 12 of draft revision of CIOMS
guidelines - Justice principle of the CIOMS
guidelines for epidemiological studies and
the Belmont report
63
Islam and Contemporary Ethical Approaches
The justice approach
Allah doth command you to render back your
Trusts to those to whom they are due and when ye
judge between man and man, that ye judge with
justice ( Al-Nisaa 4,58)
O ye who believe! stand out firmly for justice,
as witness to Allah, even as against yourselves,
or your parents, or your kin, and whether it be
(against) rich or poor for Allah can best
protect both. Follow not the lusts (of your
hearts), lest ye swerve, and if ye distort
(justice) or decline to do justice, verily Allah
is well acquainted with all that ye
do. (An-Nisaa 4,135)
64
Islam and Contemporary Ethical Approaches
The justice approach
O ye who believe! stand firmly for Allah, as
witness to fair dealing, and let not the hatred
of others to you make you swerve to wrong and
depart from justice. Be just that is next to
Piety and fear Allah. For Allah is
well-acquainted with all that ye do.
(Al-Maidah 5,8)
Allah commands justice, (An-Nahl 16,90)
65
Islam and Contemporary Ethical Approaches
The justice approach

• This approach is essential to Islamic ethics as
  long as
• Statements about justice are regarded as
  conclusions of moral arguments, rather than as
  starting points. Justice is based on morally
  legitimate similarities/differences.
• 2) Morally relevant differences are defined
  according to the Shariah.

66
Islam and Contemporary Ethical Approaches
The virtue approach
What is ethical is what develops moral values in
ourselves and our communities
what should I do? vs. what kind of person
should I be?
Fiduciary role
- Items 2- 3 and 29-30 of Helsinki 2000 -
Guidelines 6 23 of draft revision of CIOMS
guidelines
67
Islam and Contemporary Ethical Approaches
The virtue approach
Allah commands justice, the doing of good, and
liberality to kith and kin, and He forbids all
shameful deeds, and injustice and rebellionHe
instructs you, that you may receive
admonition (An-Nahl 16,90)
68
Islam and Contemporary Ethical Approaches
The virtue approach
It is not their meat nor their blood, that
reaches Allah it is your piety that reaches
Him. (An-Hajj 22,37)
69
Islam and Contemporary Ethical Approaches
The virtue approach
O ye people! Adore your Guardian Lord, who
created you and those who came before you, that
ye may have the chance to learn
righteousness. (Al-Baqara 2, 21)
70
Islam and Contemporary Ethical Approaches
The virtue approach
This approach is essential to Islamic ethics, as
one of the most important aims of ethical
behavior is to cultivate virtues. However, it
appears that although Islamic ethics highly
encourages people to take a fiduciary role, it
does not make such a role mandatory but leaves it
to them to consider according to their
circumstances.
71
The justice approach
72
Islam and Contemporary Ethical Approaches
The common good approach
What is ethical is what advances the common
(community) good
-Item 2 of the Nuremberg code -Item 18 of
Helsinki 2000 -Beneficence principle in the CIOMS
guidelines for epidemiological studies and the
Belmont report
73
Islam and Contemporary Ethical Approaches
The common good approach
In medical research on human subjects,
considerations related to the well-being of the
human subject should take precedence over the
interests of science and society
Helsinki 2000, 5
74
Islam and Contemporary Ethical Approaches
The common good approach
Consumption
Excludability
75
Islam and Contemporary Ethical Approaches
The common good approach
Group/individual paternalism Free
riders Sacrifice of self-interest injustice in
sharing burdens
76
Islam and Contemporary Ethical Approaches
The common good approach
Allah hath purchased of the Believers their
persons and their goods for theirs (in return)
is the Garden (of Paradise) they fight in His
Cause.. (At-Tauba 9, 116)
77
Islam and Contemporary Ethical Approaches
The common good approach
Let there arise out of you a band of people
inviting to all that is good, enjoining what is
right, and forbidding what is wrong they are the
ones to attain felicity. (Al-i-Imran 3, 104)
78
Islam and Contemporary Ethical Approaches
The common good approach
And He has subjected to you, as from Him, all
that is in the heavens and on earth behold, in
that are Signs indeed for those who
reflect. (Al-Jathiya 45, 13)
79
Islam and Contemporary Ethical Approaches
The common good approach
This approach is consistent with Islamic ethics
as long as
1) Community is defined according to Islamic
ethics.
2) Goods are defined and scored according to
Islamic ethics.
80
Islam and Contemporary Ethical Approaches
Privacy and confidentiality
-Items 10 of Helsinki 2000 -Guideline 19 of draft
revision of CIOMS guidelines
81
Islam and Contemporary Ethical Approaches
Privacy and confidentiality
O ye who believe! enter not houses other than
your own, until ye have asked permission and
saluted those in them that is best for you, in
order that ye may heed (what is seemly). If ye
find none in the house, enter not until
permission is given to you if ye are asked to go
back, go back that makes for greater purity for
yourselves and Allah knows well all that ye
do. (An-Nour 24, 27-28)
82
Islam and Contemporary Ethical Approaches
Privacy and confidentiality
if you hear from someone something that he does
not wish to be mentioned of him then it is a
trust, even if he does not request that it is not
mentioned. (Musnad Ahmad, Musnad Al-Kabael
26237)
83
FURTHER READING ??? ???? ????? ??????? ??????
?? ???????? ???
?????? ???? ??? ?????
??? ????? ??????? ?? ?????? ???? ???
???? ???? ????? ??????? ??? ????
????? ??? ?????? ????
??? ????? A primer on
bioethics. L B McCullough, PhD, Baylor College
of Medicine The evolution of ethics
www.evolutionaryethics.com Markkula center for
applied ethics, Santa Clara University
www.scu.edu/SCU/Centers/Ethics/
Referrences
84
(No Transcript)