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3
Muhammad Maher Hammami, MD, PhD, FACP,
FACE Principal Clinical Scientist Senior Clinical
Endocrinologist King Faisal Specialist Hospital
Research Center
-MD 1979 Damascus University, Syria -American
Board of Internal Medicine 1986 -American Board
of Endocrinology Metabolism 1989 -PhD
(Physiology) 1990, University California San
Francisco -Award of Academic Achievement in
Medical Management 2002, ACPE -Head,
Endocrinology 93/97, KFSHRC -Director, Office of
Research Affairs 98/03, KFSHRC -Director, Center
for Clinical Research 02/present, KFSHRC
4
?????
Introduction
"?? ??? ?????? ??????? ????????? ??? ??? ???????
? -???????? ????? ???????? ".
The extent to which ethical principles are
considered universal or as culturally relative
-the universalist versus the pluralist view
???????? ?????????? (Ethical Relativism) ??
??? ??????? ???? ????????
?????? ????? ?? ?????? ?? ??????? (actuality)
?? ???????? ??? ??????? ????? ??????? (reality)
?? ??? ?????? ???? ????? ?? ????????/????? ?????
(values hierarchy)
5
?????
Introduction
"?? ??? ?????? ??????? ????????? ??? ??? ???????
? -???????? ????? ???????? ".
The extent to which ethical principles are
considered universal or as culturally relative
-the universalist versus the pluralist view
Relative Relativism
?? ???? ???? ??????? ??? ??????? ?????? ????
?? ?????????? ?? ???? ???? ????? ??? ??
????? ??? ???? ??? ??? ??? ???? ??? ??? ????
6
?????
Introduction
"?? ??? ?????? ??????? ????????? ??? ??? ???????
? -???????? ????? ???????? ".
The extent to which ethical principles are
considered universal or as culturally relative
-the universalist versus the pluralist view
???????? ????????? (Ethical Pluralism)
- ??? ??????? ??? ??????? ?????????
???????? ???????? ??????? ?????? (Common Good,
Utilitarianism) ???????? ??????? ?????? (Ethical
Egoism) ???????? ?????? (Rights) ???????? ?????
(Justice) ???????? ??????? ??????? (Virtue)
???????? ?????? (Ethics of Care) ??????.
- ??? ??? ?????? ?????? ??? ?????? ??????
???????? (satisficing) ?????? ??????? ???????
?????? ???????? (optimizing) ??????? ????????.
7
??????? ?????????? ????????
International Instruments and Guidelines
?? ???? ?? ???? ??? ??? ??? ??????? ?? ?????
?????? ???? ???????. ??? ??? ?????? ??? ????
????? ????????? ???????? ????????.
8
??????? ?????????? ????????
International Instruments and Guidelines
??????????? ??????? "?? ????? ?? ?????" "????
???? ??? ????. ??? ????? ??????
???????? "?? ?????? ?????? ??? ?????? ???
???????? ??????? ??? ????? ?????????
?? ??????? " ??? ???? ?? ?????? ???? ???????
???? ???? ??? ?? ??? ?? ?????? ?????.. ????? ????
?????? ????? ??????...."
9
??????? ?????????? ????????
International Instruments and Guidelines
?? ?????? " ????? ?? ??? ????? " " ???? ???
????? ??????? " " ????? ?? ??? " "???? ??? ????
????? ????????
????? ??????? " ???? ????? ??? ??? " " ??? ????
????"
10
??????? ????????? ??????
General Ethical Principles
?? ???? ?? ???? ??? ????????? ?? ??? ?? ????
???? ??? ?? ????? ???? ?????? ?? ?????? ?? ??????
?? ??? ?? ???? ??? ????? ????? ?? ?????? ????? ??
??? ???????? ?? ???? ?? ?? ????? ??????? ????
???? ?? ????? ?? ?? ?????. ?? ???? ??? ???
????? ????? ?? ?????? ????????? ?? ???? ?? ????
??? ?? ???? ????? ??????. ?? ???? ??? ???????
??? ??????? ???????? ???? ????? ??? ????? ??
?????? ??????.
11
??????? ????????? ??????
General Ethical Principles
?????? ??????? ??????? (???? ???????) ?????
12
??????? ????????? ??????
General Ethical Principles
?? ???? ????? ??????? ???? ???? ????? ?????
????????
?? ?????? ??????? ???????? ???? ??????? ?? ?????
??????? ????
?? ?? ??????? ???????? ?? ???? ????? ??????????
?? ????? ?????? ??? ?? ???? ????? ???????
???????? ?? ????? ?? ???? ????? ????????? ??????
????? ???????
13
??????? ????????? ??????
General Ethical Principles
?????? ??????????? (Autonomy) " ?? ????? ??
????? " ??? ??? ?????? ??? ??? ??????"
????? ??????? ?????? (Vulnerable Subjects) "??
???? ???? ?????? ?????????"
14
??????? ????????? ??????
General Ethical Principles
???? ???????/ ??????? ????????? (Utilitarianism)
" ?? ????? ??? ???? ?????? ????? ??????? ????
?? ?????? "
15
??????? ????????? ??????
General Ethical Principles
????? " ??? ?????? ????? ?? ?????? " ???
??????? ???? ??? ??? ??? ?????? ?????? " ??
???? ???? ?????? " " ???? ????? ??? ????? ??
?????? ??????
" ??? ?????? ????? ??????? " " ??? ?? ?????? ???
???????? ???? ??????"
16
??????? ????????? ??????
General Ethical Principles
????? ???? ??????? ?? ?????? " ??? ??? ?????
?????? ??? ????? ?? ?? ????? ??????? ?????
??????? " ??? ????? ??????? ??????? "
17
?????
Preamble
" ?????? ????? ???? " " ??????? / ??????? " "
??? ?????? ???? ?????? " " ?????? ??????? ???
??? "
18
??????? ?????
?????? ???????? ????? ????? ??????? ??? ???????
???? ?? ????????? ????? ?????? ? ????? ? ?????
?? ???? ????? ????? ???????
" ??? ??? ?? ??? ?? ?? ???"
" ?????? ?? ???? ???????
19
??????? ??????
???? ????? ???????? ?????
Ethical Review Committees
??? ????? ???? ?? ??? ??? ???? "
??????? ??????? ?????? " ?? ??? ?? ?????? ????
???? ?" "?????? ?? ?????? ???? ???? ?"
??????? ???????? ????????? ???????? ??????
????????
20
??????? ??????
?????? ???????? ?? ??????
Externally Sponsored Research
??? ??? ???????? ????????? ??????? ( ?? ?????
????? ?? ??? ???? ???????? ????? ?? ??? ???????
???????? ?????) ?? ??? ???? ???? ?? ??? ?????
????? ?? ?????
and the ethical standards applied should be no
less stringent than they would be for research
carried out in that country
?? ??? ?????? ?? ???? ???????? ????????
????????? ?? ????? ???? ?????? ?? ??????
?? ??? ?????? ?? ???? ???????? ????????
????????? ????? ?????? ?? ????? ???? ?????? ??
????? ???????
?? ??? ?????? ?? ????- ???????? ????????
????????? ?? ????? ???? ?????? ?? ????? ??????
(?? ?? ????? ?? ???? ???? ?? ??? ????? ??????)?
21
??????? ??????
???????? ???????? ???????
Individual Informed Consent
??? ??????? ?? ????? ?????? ???????? " ??????
??????????? ????? ????????" ???? ?? ????? ?????
???????? ???????? ??? ?????? ?????????.
???? ????? ???????? ???? ?????? ???? ????? ??
??????? ?????????? ?? ???? ??????? ?? ????? ???
?????? ????????? ? ?? ?????? ????? ?? ????? ?
?? ?? ????? ???????? ????????? ?? ????? ??? ?
????? ?????? ??? ?? ??? ??? ??? ( ?? ?? ????).
22
??????? ??????
???????? ???????? ???????
Individual Informed Consent
"?? ???? ??? ?? ??? "??????? ?????? ?? ????
(????? ??????)
"??? ??????" ? "?? ?????? ?????? ??? ?????? ???
???????? (????????)
"??? ???? ???????? ?????? ???? " ??? ????
???? "???? ????? ??? ??? (????????)
23
??????? ??????
???????? ???????? ???????
Individual Informed Consent
???? ??????? " ??????
?? ??????? ?? ??? ????? ??? ??? ?????? ??? ?????.
?? ??????? ?? ?? ?????? ?? ??? ?????? ?? ??????.
?? ??????? ?? ??? ?????? ?? ??? ?????? ?? ???
????.
?? ???????? ????? ???????? ?? ?? ??? ??? ?????
???? ????? ?????? ?? ??? ?? ????? ???????
?? ??????? ?? " ????? ???????? " (6) ??" ???
???? ????? ????? ?" ?? ???? ?? ???????? ???
????? ?
24
??????? ??????
???????? ???????? ???????
Individual Informed Consent
????? ?????? (minimal risk)
????? ????? ??????? ????????? (routine medical
and psychological examination)
????? ??????? ??????? ????? ??????? ??????????
????? ???????? ???????? ?? ???? ???????
??????? "???? ????? ???? ?????"
25
??????? ??????
???????? ???????? ???????
Individual Informed Consent
??? ?????? ?? ?????? ?????? ?? ????? ?"
?? ??????? ?? " ????? ???????? " (4) ??? ??? ???
????? ?????? (????? ??????) ??? ???? ????????
??????? ????? ???? ???????? ??????? ?
"?? ?????? ???? ?? ?????? ?? ??? ???? ???????
?????? ??????? ??????? ( ?? ????) ???? ?? ??????
?? ?????"
26
??????? ??????
????????? ???????? ???????? ????????
Essential Information for Informed Consent
?? ???? ??? ???? (26) ???? ????? ?????????? ????
??? ?? ????? ?? ???????? ????????
?? ????? ??? ??????? ??????? ??????? ?? ????????.
???? ?????? ???????? ?? ???????? ?? ???.
????? ??????? ???? ????? ?? ????? ?????? ???
????? ???? ???? ????????? ?? ???????? ?? ?????.
27
??????? ??????
???????? ???????? ?????? ??????
Informed Consent Investigators Obligation
????? ??? ??????? ???? ????? ???? ?????????
?????? ?? ??????? ???? ????? ?? ?????? ??????
?????.
-?? ???? ??? ??? ????? ???????? -?? ??? ??????
??? ?? ??? ???? ??? ????? ??????? ????
?????? -?? ??? ?? ??? ????? ????? ?????
(act-utilitarianism) (?????? ?? ?????
???????rule-utilitarianism ) ? -?? ???? ?? ????
??? ?? ??? ???????? ???? ????????? ????? ????????
????? ???????? ?? ????? ??????????
28
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???? ??? ???????? ?? ?????
?? ???? ??????? ???? ????? ????? ??????? ?? ?????
???? ?? ???? ?? ????? ??????.

• ???? ?? ???????? ???????
• ???? ??? ?????? ??????
• ???? ????? ???? ????? ?????

????? ?? ???? ??? ? ) ????? ?? ????
???????? 2) ????? ??????? ???? ????? ??? ?????
???? ????? ????? ??? ??? 3) ??????? ???????
???????? ???? ?? ???????? ???????? ?? ????? ?????
?????? ?? ?? ?????? ????????.
?? ??? ???? -??? ??????? ?? ???? ?? ????????? ??
?????? ???????? ???????? ??? ???????? ??????.
-??? ??? ?????? ????? ????? ?????? ????? ??
????? ??? ???? ??? ??????? ???? ??????
29
??????? ??????
???? ??? ???????? ?? ?????
??? ?? ??? ?? ??? ?? ????? ????? ?? ????? ??
???????? ???? ??? ?? ??? ??? ?? ??? ??????? ???
???????? ?? ?????? ??? ???? ?????? ????????
 ?? ??? ??? ??????? ???? ????? ??? ???? ??
??????? ?? ????? ??? ??? ????? ( ????? ????
?????? ????? ????? ???????? ?????????)
?? ??? ???? ??? ??? ????????? ????????
?? ?? ??? ??????? ??? ??????? ???? ????? ????????
30
??????? ??????
????? ????? ????? ??????
????? ???? ??????? ???????/ ??????? ??? ???????
???????? ??? ??? ??????
" ???? ?? ??? ??? ????"
"?? ????? ??????? ???????? ?????? ??????? ??? ???
?????
??? ???? ?? ???? ??????? ???? ????? ????????
????? ???????? ??? ??? ????? ???? ????? ??????
??????? ??? ????? ????? ????? ???? ????? ??????
31
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?????? ??? ???? ??? ????? ??? ???? ?????? ???
???????? ????????
????? ??? ??? ???? ??????? ??? ??? ??? ???????
?? ???? ????? ??? ??? ??????
?? ??? ???? ??????? ????? ????
32
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????? ?? ????????? ??? ??????? ??????
" ?? ?? ????? ????? ?? ?????? ?? ??????? ??
??????? ????? ???? ????? ?????? ??? ??????? ?
???????? ?????????? "
???? ??????
(Ethics of Care)
" ?? ???? ???? ?????? ???????? ?????? ??
?????? "?????????? ??????? ???? ?????? ????????
????????? ?????? ?? ?????? ?????? ????? ???????
?????? "
?? ??? ????? ?? ????? ??? ??? ??????? ???? ?????
????? ?? ????? ???? (????? ????? ???????
??????????? ???????? ??????) ??? ????? ???? ?????
????????
33
??????? ??????
????? ?? ????????? ??? ??????? ??????
" ?? ?? ????? ????? ?? ?????? ?? ??????? ??
??????? ????? ???? ????? ?????? ??? ??????? ?
???????? ?????????? "
?? ??? ?????? ????? ?? ?????? ?
?? ???? ??? ??? ??? ????? ?????? ???? ??? ?? ????
????
34
??????? ?????? ???
?????? ?????? ?? ???????? ????????
????????? ?????????? ????? (control) ?????? ???
??????? ??????? ??????? (established effective
intervention) ??????? ??????? (placebo) ?????
????? ?? ???? ??????? ??????? ??????? ??????? ??
????? ??????
?? ??? ????? ??????? (maximizing utilitarianism)
? ?? ???? ???? ????? ?????? ????? ?????
(satisficing utilitarianism) ?
?? ???? ???? ??? ???? ????? ????? ???? ?????
??????
??????? ????????
35
??????? ?????? ???
????? ?? ?????? ???????? ??????? ??????? ????????
?? ?????
- ??? ???? ???????? ???????? - ?? ????? ????? ??
??????? ??? ???????? ??????? ??? ?? ????? ???
??????? ? - ?? ?? ??? ????? ??????????
"??? ??????? ???? ??? ??? ??? ??????"
36
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????? ?? ?????? ???????? ??????? ??????? ????????
?? ?????
????? ?? ?? ?? ???. ?????? ?????????? ????
?????? ???? ?????????? ???? ??? ?????.
-?? ?? ????????/ ?????? ??????? ?? ??? ???????
??? ?? ?????? ???????? ??? ??? ??? ????????
?????? ??????? ?????? ??????? -??? ??? ?????? ??
??? ??? ????? ????? ?? ??? ??? ?? ???? -?? ???
??????? ??? ????? ??????? ?????? ???????? -??
????? ????? ??? ??? ??? ??? ????? ????????? ????
??? ??? ??? ????
37
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?? ?????
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???? ?????? ?? ?? ???????? ??? ??? ???? ???? (??
???? ????? ?????? ?????? ???????? ?? ?????).
??? ?? ??? ?? ????? ????? ?????? ????????? ???
???? ??? ????? ?????? ?? ???????? ?? ????? ?????
??? ??? ???? (?? ???? ?????? ??? ????? ??????? ??
????? ?? ??? ??????? ?? ??? ?????? ????? ??????
????????? ????...)
38
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???? ??????? ?????? ???????? ?? ????? ?? ????
??????
????? ?? ??? ??? ??????? ???? ???????? "?" ? "?"
???? ?? ???? ??????
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????? ????? ?????? ?????.
?? ??? ????? ????? ?
40
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? 2?? "?" ?? "??" ???? 2? 3 ?? "?" ?? "??".
????? ??????? ??? ??????.
????? ????? ?????? ??????? ??? ??????.
41
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"????? ?? ??? ?????" "????? ?? ??? "???? ???
???? ????? ????????"
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"??? ????? ?????? ?? ???? ????? ??????"
42
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?????? ( ????? ?????) ?? ???? ??? ????? ???
?????? ( ?? ??? ??? ??????)
????? ???? ????? ??? ????? ??????
43
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?????.
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???? ?????? ??? ?? ??????.
44
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?? ??? ??????? ?? ???? ??? ?????? ?? ??? ???????
???? ????? ??????? ???????? ?? ?????
???? ?? "????? ????????" ?? ??????? ???? ??????
??? ???????? ???????? ???? ????? ?? ????????? ??
????? ??????? ???? ?????. - ?? ?? ??? ??????? ???
?????? ???????? ???? ?????? - ?? ???? ??????
?????????? ?? ??????? ???? ????? ????? ????????
?? ??????
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??? ????? ??? ???? ??????? . ?????? ????? ?? ??
??????? ??? ????? ?? ????? ????????.
"??? ???? ???? ????? ???? ?????? ?? ????? ????
?????? ???????? ?????????....."
??? ??? ???? ??????? ????? ????? ?? ????
????????? ??? ??????? ?????? ?? ???? ???????
46
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??????? ?? ??? ???????? ????? ????????.
?????? ???? ????? ????? ?? ??? ?????????.
47
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