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Title:

Ethics in Research

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Title: Informed Consent Author: Kim Stubbs Last modified by: Samreza Created Date: 2/12/1997 10:53:48 AM Document presentation format: Letter Paper (8.5x11 in) – PowerPoint PPT presentation

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Title: 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
  • ? ?? ????? ????? ? ????? ? ????? ? ?????? ?
    ?????
  • ????? ????? ????? ????? ? ????? ????? ? ??? ?????
    ????????? ?? ???? ?? ?? ?????? ??? ??????? ????
    ???
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    ?
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    ????? ?
  • ?? ?????? ?????? ????? ?? ??????? ?? ???? ?????
    ?? ???? ?? ?? ?????? ?? ????? ??????? ???? ? ??
    ?????? ?????? ???? ??????? ???? ????

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

63
  • ??? ??????? ?? ????? ?? ????? ?? ???.
  • ?????? ?? ?????? ?????? ???? ??? ????? ???? ???
    ?? ????.
  • ??? ???? ? ??? ?????? ?? ?? ??? ???? ??????
    ?????? ?? ???.
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    ????.
  • ?????? ?? ???? ??? ?? ????? ?? ???? ?????
    ??????.
  • ??????? ???? ??????? ? ???? ?? ??? ??? ?? ?????
    ?? ???.

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
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