Ethics in Research

1
Ethics in Research
2
What is meant by ethics?

• Ethics is the science of criteria, norms and
  values for human action and conduct. It is
  engaged in reflection and analysis of morals
  concerning whether an act is good or bad and how
  it influences our basic quest for meaning, our
  search for humanity and our attempt to create a
  humane society. Its intention is to safeguard
  human dignity and to promote justice, equality,
  truth and trust. In a nutshell, ethics is
  critical reflection on morality.

3
Medical ethics

• It can be described as the reflection on moral
  actions within the framework of health care. Its
  objective is to promote health, to care, to heal,
  to alleviate pain and to prevent suffering.

4
What is meant by research ethics?

• Ethics for health research is the enterprise that
  determines norms and values to guide the
  systematic reflection and scientific evaluation
  or assessment of clinical knowledge and any form
  of experimentation or survey, with the prime
  objective of promoting health care. Its sole
  intent is to benefit patients, to alleviate pain
  and to prevent suffering

5
????? ??????

• ????? ?????????? ?????-????? ????? ( 45-1943)
• ????? ??? ????? ?? ????? ????? ??
• ??????? ?? ?????????? ?? ??????? ?????? (1962)
• ????? ??????? ?????? ?? ??????? ??? (1963)
• ?????? ?????? (Tuskegee) (1972)

6
Tuskegee syphilis experiment

• Also known as the Tuskegee syphilis study or
  Public Health Service syphilis study was an
  infamous clinical study conducted between 1932
  and 1972 in Tuskegee, Alabama by the U.S. Public
  Health Service to study the natural progression
  of untreated syphilis in poor, rural black men
  who thought they were receiving free health care
  from the U.S. government.

7
Basic assumption and point of view

• The basic ethical assumption in health research
  is the autonomy of the individual within the
  broader context of human relations. The social
  and cultural environment should be taken into
  consideration in all circumstances. People should
  be treated as human beings in the context of
  their social, political, economic and religious
  environments.

8

• Assessment of both patients and healthy
  volunteers in research programmes should be made
  within the context of the family and cultural
  system. Research programmes should treat people
  as part of a community while simultaneously
  respecting their individual autonomy.

9
Basic ethics codes of behaviour

• The following should apply to any research
  programme
• 1. The participant as a person
• Respect for the autonomy of the
  participant, whether patient or volunteer,
  demands that the participant must be treated as a
  unique human person within the context of his or
  her community system. Freedom of choice must be
  safeguarded.

10

• Human rights
• Respect for the basic rights of the
  individual as a human being as well as the rights
  of groups and communities
• 3. The ethic of justice, fairness and
  objectivity
• Research should always respect the dignity
  of people involved and should never expose them
  to intentions and motives not directly attached
  to the research project, its methodology and
  objectives

11

• 4. Competence
• Researchers must be professionally and
  personally qualified. In all circumstances they
  must be accountable and act in a responsible
  manner. Professional standards should be upheld
  in accordance with academic training

12

• 5. Integrity
• Integrity should be promoted by being
  honest and fair. Researchers must be honest about
  their own limitations, competence, belief
  systems, values and needs.

13

• SensitivitySensitivity in research implies
  balancing scientific interest (the research) with
  general values and norms affecting the human
  dignity of the people involved
• 7. ConfidentialityConfidentiality must be
  respected under all circumstances. Documentation
  should be safeguarded and viewed as strictly
  private in terms of the limits set by the
  research project

14

• Demarcation of roles
• There should be mutual understanding of the
  roles and interests of investigators and
  participants in research
• Communication
• Clear and understandable verbal
  communication is required, with factual data.
  Emotional and cultural values should be
  considered

15
????? ??????? (Nuremberg Code-1947)

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

16
Possible dangers to be taken into consideration

• The danger of objectification and fragmentation
• Special care must be taken not to treat a
  participant as a mere object. Research objectives
  are subordinate to the following principle to
  treat human beings with respect.

17

• The danger of direct or indirect coercion
• Direct or indirect coercion of people in the
  name of research must be avoided under all
  circumstances. Coercion may include the
  exploitation of vulnerable people taking undue
  advantage of a participant, volunteer or any
  other person or the misuse of the authority and
  influence of the research

18
(No Transcript)
19
(No Transcript)
20
Basic Ethical Principles

• Respect for Persons
• Individuals should be treated as autonomous
  agents
• Persons with diminished autonomy are entitled to
  protection
• An autonomous person is an individual capable of
  deliberation about personal goals and of acting
  under the direction of such deliberation. To
  respect autonomy is to give weight to autonomous
  persons considered opinions and choices while
  refraining from obstructing their actions unless
  they are clearly detrimental to others.
• Respect for the immature and the incapacitated
  may require protecting them as they mature or
  while they are incapacitated.
• The procedural implementation for the principle
  of respect for persons is embodied in the process
  of informed consent.

21
Basic Ethical Principles

• Beneficence
• Persons are treated in an ethical manner not
  only by respecting their decisions and protecting
  them from harm, but also by efforts to secure
  their well-being. Such treatment falls under the
  principle of beneficence. Two general rules have
  been formulated as complementary
• Do not harm
• Maximize possible benefits and minimize possible
  harms
• By approving research proposals that incorporate
  these rules, IRB implement the principle of
  beneficence.

22
Basic Ethical Principles

• Justice
• An Injustice occurs when some benefit to which a
  person is entitled is denied without good reason
  or when some burden is imposed unduly. The formal
  principle of justice requires that individuals
  who are equal in relevant respect be treated
  equally. The implementation of this principle of
  fairness requires reasonable efforts to exercise
  equity in the selection of research subjects and
  is the application of knowledge gained through
  their participation.

23
???? ????? ????? ?????

• ?????? ?? ??????? ?? ???? ?? ?????? (Autonomy)
• ???????(Beneficence)
• ??? ??? ?????? ?? ??????(Non-Mal efficiency)
  (Hippocratic Oath!)
• ?????(Justice)

24
(No Transcript)
25
????? ?? ??????? ??...

• ???- ??????? ?????? ????? ????? ? ???? ?????
• -      ????? ????? ????? ???? ????? ???? ?????? ?
• -         ????? ????? ??????? ????? ? ??????
  ????? ?
• -         ??? ??????? ?? ???? ???? ? ????? ?
• -         ????? ???? ???? ??? ?????? ?

26

• ?- ??????? ??????? ????? ?????
• ????? ????? ? ????? ???? ?
• ????? ?? ???? ? ????? ?? ???????? ??? ????
  ?????? ? ??? ???????? ?? ???? ??? ?????" ?? ???
  ??????? ????? ?????? ?
• ??? ??? ???? ?????????? ?? ?? ???? ????? ????????
  ????? ???? ??? ?
• ??? ??????? ?? ????? ????? ? ???? ?????? ????
  

27

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

28

• ?- ?? ????? ????? ?????? ? ??????
• ???? ?? ???? ????? ???? ???????? ? ?????? ??
  ????? ??????? ???? ???? ?
• ?????? ?? ????? ??????? ?? ??? ??????? ???????
  ????? ???? ???????? ?? ????? ?????? ???? ????? ?
• ??? ?? ??? ??????? ?? ????? ? ?????

29

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

30
????? ?????? ?? ???????? ?? ??? ??????? ????? ??
????

• ????? ??? ??????? ????? ?? ????? ????? ??????
  ????? ?????? ????? ????? ? ??????? ???? ??????
  ???? ???? ???? ?????? ? ???????? ???? ? ???? ????
  ? ?????? ??? ????? . ???? ?????? ?? ???? ?? ????
  ????? ????? ?? ??? ????? ???? ???? ????? ??? ???
  

31

• 1- ????? ????? ???? ( ????? ???????? ????? ?
  ?????? ? ??????? ???? ? ????? ????? ? ???? ) ?
• 2- ?? ?????? ???? ( ????" ??????? ???? ??????
  ???? ?? ?? ????? ?????? ????? ???? ??? ?????? ??
  ?????? ?? ?????? ???? ???. ?? ????? ???? ???? ???
  ?????? ????? ????? ??? ) ?
• 3-????? ??? ????? ( ????? ????????? ???? ? ?????
  ?. )?
• 4- ?? ????? ?????? ?? ??????? ??????? ?? ?????
  ????? ( ????? ????????? ????? ????? ? ) ?

32

• 5- ?? ????? ???? ? ?????? ??? ??? ??? ????? ?????
  ?? ?????? ?? ???? ??? ?? ????? ????? ????? ?????
  ???? ????
• 6- ????? ???? ????? ?????? ?? ??????? ?? ?? ???
  ????? ???? ?????? ( ????" ?????? ???? ???? ????
  ?????? ??????? ?? ??????? ??? ?? ????? ????? ????
  ???? ?? ??????? ?? ????? ????? ????? ??? ?? ??
  ?????? ?? ??? ???? ????? ?? ??? ???? ????? ?? ???
  ? ??????? ????).

33
???? ????? ?????? ???????

• 1)   ????? ????? ????????? ??? ????? ?????? ??
  ?????? ??????? ??? ???? ????? ????? ???? ??? ????
  ????? ??? ?????????? ? ?????? ???? ? ????? ????
  ?? ??????? ???? ????? ????? ???.
• 2)  ????? ? ????? ?? ??? ?????????? ??? ?????
  ???? ?? ?? ??????? ???????? ?? ????? ????? ???
  ????? ?? ????? ????? ????? ? ????? ??? .

34

• 3- ??????? ????????? ??? ????? ???? ??????" ????
  ?????? ?? ?? ??? ???? ?????? ????? ???? ??? ?????
  ?? ?? ??? ?????? ???? ????? ????? ????? ????.
  ??????? ????? ???? ?????? ????? ?? ???? ??? ?
  ???? ??????? ??? ??? ????? ?? ??? ???? ?????? ???
  ??? ???? ??? ??? ?? ??? ??? ????? ???? ????.
• 4- ????? ????????? ??? ????? ???? ??????? ????
  ??? ?? ????? ??? ????? ?? ????? ????? ?? ?????
  ????? ???? .

35

• 5- ??????? ????????? ??? ????? ???? ????" ?? ???
  ??????? ??? ????? ?? ???? ?? ?? ????? ???? ???
  ???? ?? ????? ??????? ?? ???? ????? ???? ??????
  ?? ?????? ?????? ? ?????? ??? . ????? ????? ???
  ????? ???? ????? ?? ????? ????? ?? ??? ???? ????
  .
• 6-????? ??? ???? ?????? ???? ????? ???? ??? ???
  ????? ?? ? ?????? ??????? ???? ?? ?? ?????? ??
  ????? ? ??? ?????? ?? ???? ????? ???? ??? .
• 7-???? ???? ????? ????? ??? ????? ?? ???? ??? ??
  ???? ????? ???? ?? ????? ??????? ???? ??? ????
  ??? . ???? ? ?? ???? ????? ??? ?? ????? ????? ??
  ????? ?????? ????? ???? ???? ????? ?? ????? ??? .

36

• 8- ?? ?????? ????? ? ???? ???? ??? ??????? ??
  ????? ??? . ????? ???????? ?? ??? ????? ???
  ?????? ?????? ???? ?????? ??????? ???? .
• 9- ?? ?? ????? ??? ????? ? ????? ?????? ?? ?????
  ???? ?? ????? ? ?????? ????? ??????? ? ?????
  ?????? ????? ???????????? ?? ???? ??? ?? ?? ?????
  ????? ???? ????? ? ?? ???? ????? ??? ?? ?? ????
  ???? ????? ?? ?????? ????? ?? ??? ????. ???? ????
  ????? ??????? ? ??????? ???? ?? ??????" ?? ????
  ???? ?????? ???

37

• 10 ????? ??? ?????? ???? ? ???? ?????? ??? ???
  ?? ????? ?? ????? ???? ?????? ????? .??? ???????
  ???? ?? ????? ???? ?????? ??? ????? ????? ????
  ??? ?????? ????? ???? ???? ????? ?? ???? ???????
  ?? ???? ?????? ????? ??? .
• 11- ?? ???? ???????? ?????? ??????? ???? ? ???
  ?????? ????? ? ?? ??? ???? ??? ??? . ??? ?????
  ???? ????? ??? ??? ?????? ?? ?? ?? ???? ???? ??
  ??? ? ?? ?? ???? ????? ???? ?????? ???? ?? ??????
  ???? ????? ??? .
• 12- ?? ?? ??? ???????? ???? ????? ???? ??????
  ???? ??? ? ???? ??? ?? ?????? ??? ??? ?????
  ?????? ????? ???? ??? ????? ??? ??? .

38
??????? ????? ???? ?? ????? ( ????? ??????)

• ?? ????? ????? ? ???? ???? ?????? ??????? ???
  ?????? ?? ?????? ????? ?? ?? ??? ????? ?????
  ?????? ?? ??? ?? ??? ??? ???? ?? ??? ??? ? ????
  ???? ? ? ?????? ????? ?? ???? ????? ???? .
• ?????? ????? ? ?????????? ?????? ??? ???? ??
  ???? ???? ?? ?????? ?????? ??? ?????? ? ??????
  ????? ??????? ??? .
• ?? ?? ?????? ????? ? ?? ????? ?? ???? ?????
  ???? ???? ?????? ?? ?????? ?????? ?????? ?
  ?????? ????? ???? ??? ????

39

• ?????? ????? ?? ???? ?? ???? ?????? ????? ? ???
  ??? ??????? ?? ????? ??? ????? ?? ???? ?????
  ??????.
• ??? ??? ?? ????? ???? ? ??? ?????? ??????? ?????
  ????? ???? ???? ?? ???? ?? ??? ???? ?? ???
  ???????? ??? ??? ? ?? ??? ????? ????? ????.
• ?????? ? ???? ??????? ???? ????? ?? ????? ?? ??
  ????? ???? ?????? ?? ??? ??? ?? ??? ?????? ?
  ?????? ?? ??? ????? ????.

40
??????? ????????? ??? ?????? ?? ????? ( ?????
????????? ??? ?????? )

• ?? ????? ?? ????? ????? ?? ????" ???? ???? ?????
  ???? ? ???? ???? ???? ??? ? ??????? ?????? ????
  ?? ???? ?????? ???? ?? ?????.
• ????? ???? ?????? ???? ????? ?? ?? ??? ??????
  ????? ????? ???? ????? ???? ?? ?????? ????? ??
  ??? ??????? ??????? ?? ?????? ???? ?????? ???? .
• ???? ?? ?????? ?? ??? ???? ????? ???? ????? ??
  ????? ????? ???? ???? ???? ????? ?? ??? ???? ??
  ?? ????? ??????.
• ??????? ??? ????? ??? ??? ????? ????? ?????? ??
  ??? ?? ????? ????? ? ???? ?? ???? ???. ????? ????
  ????? ????? ????? ?? ????????? ?? ??? ????? ?????
  ?? ????

41

• ?????? ???? ?? ????? ?? ?????? ???????? ?? ?? ???
  ????? ????? ?? ???? ????? ?? ???? ???? ???????
  ???? ?????? ?? ??????? ???? ? ???? ?????? ???????
  ?? ??? ??????? ????? ??? ??? . ???? ?????? ??
  ????? ?? ???? ?? ????? ????? ??? ?? ?? ???? ??
  ???? ??? ????? ???.

42

• ????? ?????? ???? ???? ????? ???? ??????.
• ??? ???? ?? ??? ? ????? ?? ?? ??? ????
  ?????? ?????? ???? .
• ????? ? ?????? ?? ???????? ?????? ? ????? ???
  ?????? ? ???????? ???? ? ??????? .
• ???? ????? ????? ?? ????? ???? ??? ??? ?????
  ???? ?? ???? ??? ?????? ?? ???.
• ??? ??????? ?? ??????? ?? ??? ???? ???? ?? ????
  ?? ????.
• ???? ?? ???????? ? ??????? ????? ? ???? ????? .

43

• ??? ????? ?? ???? ????? ????? ?????.
• ????? ?? ??? ???? ??????? ?? ??? ?????? ????
  ????????? ????? ???? ??? ?? ???? .
• ??????? ????????? ??????? ?? ??? ???? .
• ??? ??? ??????? ?? ????? ???? ???????? ?? ???
  ???? ?????.
• ???? ?????? ????? ??? ????? ?? ???? ?? ?? ???? ??
  ????? ???? ??????? ?? ??? ???? ????.
• ????? ??????? ?? ???? ??? ?? ????? ???? ?????
  ???? ??? .
• ?????? ????????? ?????? ????? ?????? ? ??????
  ???? ?? ???? ?? ????

44
?????? ???????(Helsinki Declaration-1964)

• ????? ??????? ????? ?? ?????? ???? ? ?? ????
  ??????? ?????????? ? ?????? ????
• ??????? ????? ?? ???? ??? ????? ?????? ?? ???
  ?????
• ????? ??? ????? lt ????? ????? ??
• ????? ????? ????? lt ????? ????? ?? ???
• ???? ??? ????? ??? ???? ??????
• ????? ??????? ???? ??? ????
• ???? ??????? ? ????????? ?? ?????
• ?? ???? ?? ?????? ???? ??? ???? ????? ???? ??????
  ?? ???? ??????
• ????? ? ????? ?? ?????? ????? ???? ????
• ???? ????? ? ????? ??? ?? ?? ????? ?????

45
(No Transcript)
46
Informed Consent

• Informed consent is founded on the legal and
  ethical principles of autonomy, the right to
  self-determination, and non-maleficence, or do
  no harm.
• It is the outcome of a process in which
  information is shared between the patient/subject
  and practitioner. The patient/subject is the
  ultimate decision-maker in accepting or rejecting
  proposed medical treatment or research.

47
Informed Consent

• Informed consent is the exercise of making
  informed choices and giving permission for others
  to act on those choices.
• Informed consent in medicine/research requires
  respect for the informed and voluntary treatment
  choices of the patient/subject with respect to
  medical treatment being offered.

48
Elements of Informed Consent

• For an individual to give informed consent to
  participate in research, five elements are
  required
• Disclosure of information by investigator
• Capacity to have a preference and make a decision
• Voluntariness to choose without undue coercion
• Comprehension of information and its consequences
• Permission by subject to accept or refuse
  participation

49
Disclosure of Information

• The standard for disclosure of information that
  researchers and health care providers should
  employ in communicating with patients/subjects
  requires that the information disclosed be
  consistent with what a reasonable person would
  want to know in a similar situation.

50
Capacity

• Every adult is presumed to have the capacity to
  make health care decisions unless determined
  otherwise.
• The capacity to make health care decisions is
  typically defined as the ability to understand
  and appreciate the nature and consequence of
  health care decisions, including the benefits and
  risks of and alternatives to any proposed health
  care, and to reach an informed decision.

51
Voluntariness

• Informed consent requires that the
  patients/subjects participation in the
  decision-making process and in the decision
  arrived at be voluntary.
• Investigators, providers, families, and
  significant others must be careful to avoid undue
  coercion.

52
Factors Affecting the Informed Consent Process
Patients/Subjects

• values and priorities
• religious beliefs
• personality and coping style
• gender, age, race
• culture
• education

• desire for information and control
• roles of the spouse, parents, child, guardian
• degree of dependence upon and trust in the
  patient-professional relationship

53
Factors Affecting the Informed Consent Process
Health Care Providers/Investigators

• education
• experience
• values and priorities
• knowledge
• communication style
• gender, age, race
• culture
• religious beliefs

54
Elements of informed consent

• a statement that the study involves research, an
  explanation of the purposes of the research and
  the expected duration of the subject's
  participation, a description of the procedures to
  be followed, and identification of any procedures
  which are experimental

55

• 2. a description of any reasonably foreseeable
  risks or discomforts to the subject
• 3. a description of any benefits to the subject
  or to others which may reasonably be expected
  from the research

56

• 4. a disclosure of appropriate alternative
  procedures or courses of treatment, if any, that
  might be advantageous to the subject
• 5. a statement describing the extent, if any, to
  which confidentiality of records identifying the
  subject will be maintained

57

• 6. for research involving more than minimal risk,
  an explanation as to whether any compensation and
  an explanation as to whether any medical
  treatments are available if injury occurs and, if
  so, what they consist of, or where further
  information may be obtained
• 7. an explanation of whom to contact for answers
  to pertinent questions about the research and
  research subjects' rights, and whom to contact in
  the event of a research-related injury to the
  subject and

58

• 8. a statement that participation is voluntary,
  refusal to participate will involve no penalty or
  loss of benefits to which the subject is
  otherwise entitled, and the subject may
  discontinue participation at any time without
  penalty or loss of benefits to which the subject
  is otherwise entitled.

59

• When appropriate, one or more of the following
  elements of information shall also be provided to
  each subject
• 1. a statement that the particular treatment or
  procedure may involve risks to the subject (or to
  the embryo or fetus, if the subject is or may
  become pregnant) which are currently
  unforeseeable

60

• 2. anticipated circumstances under which
  the subject's participation may be terminated by
  the investigator without regard to the subject's
  consent
• 3. any additional costs to the subject that
  may result from participation in the research
• 4. the consequences of a subject's decision
  to withdraw from the research and procedures for
  orderly termination of participation by the
  subject

61

• 5. a statement that significant new findings
  developed during the course of the research which
  may relate to the subject's willingness to
  continue participation will be provided to the
  subject and
• 6. the approximate number of subjects
  involved in the study

62
??? ????? ????? ???? ???? ?? ?????

• ???? ????? ????? ??? ???? ?????? .
• ???? ????? ????? ???? ?? ?? ????? ??????? ????
  ??? ?????? ???.
• ????? ??? ???????? .
• ??? ???? ? ??????? ??

63

• ??? ??????? ?? ????? ?? ????? ?? ???.
• ?????? ?? ?????? ?????? ???? ??? ????? ???? ???
  ?? ????.
• ??? ???? ? ??? ?????? ?? ?? ??? ???? ??????
  ?????? ?? ???.
• ??? ???? ????? ??????? ??? ?????? ?? ?????? ????
  ????.
• ?????? ?? ???? ??? ?? ????? ?? ???? ?????
  ??????.
• ??????? ???? ??????? ? ???? ?? ??? ??? ?? ?????
  ?? ???.

64

• ????? ?????? ??? ??? ???? ???? ???? ???? ??
  ????? ????? ??????? ? ?????? ??? ????? ???? ???.
• ????? ?? ?? ?? ??? ??? ???? ?? ??????? ???????
  ???? ? ???????? ??????? ?????? ????? ????
  ???????? ? ?????? ?????????? ?????? ?? ?? ???? ??
  ?????.
• ??? ?? ???? ???? ? ?? ??????? ?? ?? ??? ?????? (
  ?????) ???? ?? ??? .
• ????? ??? ???? ?????? ??? ???? ???? ????.
• ????? .

65
????? ???? ???????(Informed Consent)

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

66

• ?? ??? ????? ? ????? ?? ?????? ?? ??????? ?? ????
  ? ???? ????? ???? ? ?????? ???? ????? ????? ????
  ??? ?? ????? ??? ? ?? ????? ?????? ?? ???? ??
  ????? ?????? ???? ???? ???????? ??? ??????? ???
  ?????.
• ????? ?? ?? ??? ????? ??????? ??

67

• ??????? ???????????? ?? ????? ????? ?? ????? ??
  ?????.
• ??????? ?????? ?? ???? ???? ???? ?? ??????
  ??????? .
• ????????? ?? ?? ???? ?????? ???? ????? ????? ??
  ???? ???? ?????? ?? ?????? ????" ??? ??? ????
  ??????? ?? ??? .

68

• ?? ???? ????? ??? ???? ??? ? ???? ??? ?? ?????
  ???? ?????? ???? ??????? ?????? ??? ????? ?????
  ??? ???? ??????.
• ???? ?? ????? ???? ?? ?????? ???????? ?? ???
  ????? ????? ?? ???? ?? ????? ?? ???? ?? ?????
  ???????? ? ??????? ?? ???? ????? ??? ????? ??????
  ?? ?????? ?? ???? ??????? ???? ?? ??? ???? ??????
  ? ?????? ?????? ???? ?????? ????

69

• ?? ??? ???? ? ?? ????? ????? ?????? ?????? ?????
  ?? ?????? ???? ????.
• ????? ??? ???? ?????? ??? ?? ?????? ??? ?????
  ????.
• ??? ??? ????? ???? ????? ?? ????? ????? ?????
  ?????.

70
????? ?? ?????? ???

• ??????

71

• ?? ??? ?????? ????? ?????? ???? ????? ??????? ??
  ???? ????? ????? ?????? ??????? ? ?????? ????
  ?????. ?? ????? ????? ?? ?????? ???? ????? ?
  ?????? ?????? ???? ??? ??? ?????? ?? ??????
  ???? ?????? ?????? ?????? ???? ?? ????? ???? .
  ?? ???????? ?? 12 ??? ?? ????? ??? ?????? ??????
  ??? ???? ????? ????? ????? ???

72
???????? ?? ?????? ???? ?????

• ?????? ???? ???? ?? ???? ?????? ??? ?? ?????? ???
  ??????? ???? ????? ????. ??? ???? ??? ?? ?????
  ??? ?????? ???? ?????? ? ?? ??????? ????? ???? ??
  ????? ???? ?????.

73
????

• ????????? ?? ??? ?????? ????? ????? ?? ???? ????
  ?????? ???? ?? ??? ????? ????? ???? .??????? ??
  ?????? ? ??????? ???? ?? ??? ????? ?? ?????? ????
  ????. ????? ?? ????? ???? ???? ???? ??? ??? ????
  ????? ???? ???? ?? ????? ??? ???? ?? ?? ????? ??
  ????? ?????? ?? ??? ? ?????? ????? ???? ?? ????
  ?????? ????? ?? ???? ????? ???? ???? .

74
???? ?????

• ?? ???? ????? ??? ?????? ?????? ?? ???? ????? ???
  . ??? ???? ?????? ?? ???? ?????? ?????? ???? ???
  ???????? ?? ???? ?? ??? ???? ??? ?? ????? ????
  ????. ??????? ??? ?? ???? ????? ??? ? ????? ????
  ?????????? ( In vitro fertilization ) ?????? ??
  ?????? ?? ?? ????? ??? ????? ?? ????????? ?????
  ???? ?? ???.

75
??????? ????? ???????

• ??????? ????? ?????? ?? ?? ????? ???? ?? ????
  ???? ?? ???? ??????? ???? ????? ? ??? ?? ?????
  ??? ???? ?????? ?? ??? ?? ????????. ????? ?????
  ???? ??? ???? ????? ?? ?
• ????? ???? ?????? ???? ???? ????????? ? ???????
  ???? ?? ?? ?????? ?????? ?????? ?????? ?????
  ?????? ????? ??????? ???? ????? ?????.
• ??? ????? ??? ?? ?????? ?? ?????? ????????
  ?????? ?????? ?????? ????? ?? ??????? ????? ????
  ?????? ?????? ????? ?????

76

• ??????? ????? ???? ?????? ?? ??? ?????? ?????
  ??? .
• ??? ? ???? ??? ?? ????? ????? ??? ??? ??????
  ????? ????? ????? ?? ????? ???? ???? ?? ??????
  ?? ????? ????
• ?? ???????? ?????? ?? ???? ????? ??????? ? ?????
  ??? ????? ????? ???????? ????? ???? ????? ??? ??
  ?????? ?? ???? ???? ????? ??????? ? ????? ???
  ???? ??? ??? ????? ???? ???? ???? ??? ?????? ??
  ????? ???? ??? ?????? ???? ????? ??? . ?? ?????
  ??? ?? ??? ????? ???? ?? ????? ??? ???? ??????
  ?????? ???? ?? ????? ?????? ???? ????? ?????
  ????? ?? ????.

77
Ethics in children research

• The interests and the needs of the child should
  prevail over all other interests in the design,
  enrolment, and execution of clinical trials
  involving children.

78

• Ethical Dimensions
• Respect for the dignity and freedom of the child
  (even where autonomy is limited)
• Expression of the health interests, concerns, and
  needs of the child
• Articulation of the autonomy of the child
• The primacy of the childs assent or consent

79