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Ethics

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Title: Ethics


1
(No Transcript)
2
Ethics in Medical Research
3
Ethics in Medical Research
  • History
  • Informed Consent
  • Medical Procedures in Researches
  • Research on Excess Blood samples and Tissues
  • Clinical Trial
  • Research on Vulnerable Groups
  • Confidentiality

4
History
From NIH Human Participant Protections
Education for Research Teams
5
History
From NIH Human Participant Protections
Education for Research Teams
6
The Nuremberg Trials
  • Their crimes included experiments involving
  • High altitude/low pressure
  • Freezing
  • Malaria
  • Sea water
  • Mustard gas
  • Twin tests
  • Sterilization
  • The Nazi regime exploited human beings by forcing
    them to participate in research without consent.
  • The mortality rate of these war time research
    studies was typically 25 - 30.
  • The Nuremberg Trials were heard from 12/46 to
    8/47

7
History
8
The Nuremberg code 1948
  • Should include voluntary participation
  • Subjects should give consent
  • Benefits must outweigh risks

9
Declaration of Helsinki 1964
  • Research with humans should be based on
    laboratory and animal experimentation
  • Research protocols should be reviewed by an
    independent committee
  • Informed consent is necessary
  • Research should be conducted by
    medically/scientifically qualified individuals
  • Risks should not exceed benefits

10
  • In New Zealand, women were denied standard
    treatment for cervical cancer. They were never
    asked to give their properly informed voluntary
    consent to participate in the experiment. Many of
    these women died when timely treatment almost
    certainly could have saved their lives.

11
  • Prisoners in the USA, in a series of studies,
    were subjected to malaria, typhoid, and cholera,
    and it has been asked why anyone would volunteer
    to accept such a risk.

12
The Thalidomide Study
  • Thalidomide was approved as a sedative in Europe
    in the late 1950s.
  • The FDA never approved the drug, but samples were
    sent to US doctors.
  • By 1961 thalidomide was shown to be very harmful
    to the fetus, interfering with the normal
    development of arms and legs.

13
The Thalidomide Study
  • These events lead to the passage of the Drug
    Amendments of 1962 to the Food, Drug and Cosmetic
    Act.
  • This was the first US statues that required
    subjects be informed of a drugs experimental
    nature and to consent before starting the
    research study.

14
Henry K. Beechers Article(1966)
  • Beecher was a very prominent member of the
    medical establishment and he was professor of
    anesthesiology at Harvard Medical School.
  • Beechers 22 examples included withholding
    antibiotics from men with rheumatic fever,
    purposely infecting institutionalized children
    with hepatitis (Willowbrook), injecting live
    cancer cells into nursing home patients (Jewish
    Chronic Disease Hospital).
  • The Beecher article was significant in that it
    showed that abuses and exploitations of humans in
    research continued despite codes of ethics.

15
  • The Henry K. Beecher Prize in Medical Ethics
    Since 1998, the Beecher Prize has been awarded by
    the Division of Medical Ethics to the HMS student
    who submits the most original and compelling
    essay on a topic in medical ethics. The 1,000
    prize was created in the name of one of the most
    important figures in the history of medical
    ethics as a way of fostering the development of
    students with strong interests in medical ethics.
  • The Harvard Medical School Student Journal of
    Ethics Begun in 1996, the student-written and
    edited Journal annually publishes the work of HMS
    students on issues in contemporary bioethics.
    Recent issues have focused on such topics as The
    Present and Future State of Ethical Issues in
    Reproductive Medicine and Genetics in Medicine
    Today and Tomorrow. The Division of Medical
    Ethics provides oversight and financial support.

16
Tuskegee Study of Syphilis(1932-1972)
  • Federally-funded study of natural history of
    syphilis (TSS)
  • In 1932, no effective treatment
  • 412 infected, indigent blacks enrolled
    (vulnerable population)
  • 1951-penicillin standard treatment TSS subjects
    excluded from penicillin
  • 1972/74-public disclosure hearings financial
    settlement
  • Told they were being treated for bad blood
  • Medical research staff lied to patients

17
Tuskegee Syphilis Study
18
Tuskegee Study of Syphilis
19
Research Ethics Guidelines
  • The Nuremberg Code(1947)
  • The Declaration Of Helsinki 7 declarations (1964
    2004)
  • CIOMS/WHO International Ethical Guidelines For
    Biomedical Research Involving Human
    Subjects(1993-2004)
  • ICH/GCP-International Conference on
    Harmonization- Good Clinical Practice(1996)

20
????? ????? ???? ????? ?? ????? ?? ?????
  • ???? ?? ?? ???? ???? ??????? ?? ????? ?? ?? ?????
    ????? ????????? ???? ????????. (8/11)
  • ???? ?? ?? ????? ?? ?????? ???? ?? ????? ?????
    ??? ???. (??? ??????????? ????? ????) (2 ????)
  • ????????? ????? ?? 80 ???? ????? ???? ?????
    ????? ??? ???.

??????? ???,???????? ???? ????? ????? ?????
???????? ????? ????? ?? ?????????? ??? ????????
????????? ??????? ???? ???? ???? ?????? 1378
21
????? ????? ???? ????? ?? ????? ?? ?????
  • ?? 13 ???? (32) ??????? ???? ??? ??? ?? ?????
    ????? ???? ??????? 5 ???? ???. ?? 3 ???? ????
    ????? ????? ????????, 5 ???? ?? ?????? ?????
    ????? ? ????? ????? ????? ???? ? 5 ???? ??? ??
    ????? ????? ???? ???.
  • ???? ?? ?? ???? ????? ???? ??????? ???????
    ??????? ???????? ??? ??? ?? ????? ?? ???? ????
    ????????? ?? ???? ???? ????.
  • ???? ?? ???? (9/3) ????? ?????? ?? ????? ?????
    ????? ??? ?? ???? ???? ?? ????? ????? ???.
  • ?? 8 ???? (7/15 ????) ?????? ???? ????? ??? ??
    ????? ????? ??? ??? ? ?? 27 ???? (9/52) ????? ??
    ?? ??????? ??? ?? ????? ???? ??? .

??????? ???,???????? ???? ????? ????? ?????
???????? ????? ????? ?? ?????????? ??? ????????
????????? ??????? ???? ???? ???? ?????? 1378
22
????? ???? ?? ????? ?? ????? ?? ????
  • ???? ???? ?? ????? ????? ?? ????? ?? ??? 1373
  • ????? ????? ??? ??????? ?? ????? (1377)
  • ????? ????????? ???????? ????? ?? ??????? ??
    ?????????? ???? ????? ? ????? ???????? (1378)
  • ????? ?????26???? ????? ???????? ???? (1379

23
(No Transcript)
24
Bioethics Principles
  • ???? ??? ????? ???? ???????? ?? ?????????????
    ??????
  • ?????? ?? ??? ? ???????? autonomy
  • ??????? beneficience
  • ??? ???????? non-maleficience
  • ????? justice

25
Autonomy
  • Individuals should be treated as autonomous
    agents (capable of self-determination)
  • Persons with diminished autonomy deserve
    protection
  • Application Informed consent and
    confidentiality

26
Beneficence / non-maleficience
  • Two general complementary rules
  • Do not harm
  • Maximize possible benefits and minimize possible
    harms
  • Application Risk/Benefit assessment

27
Justice
  • Fairness in the distribution of the benefits and
    burdens of research (distributive justice)
  • Application
  • Fair procedures and outcomes in the selection of
    subjects
  • Protection of vulnerable subjects

28
Beneficence / non-maleficience
  • ??? ????? ??????
  • ???????
  • ?????
  • ????? ??? ???? ???? ?? ?????
  • ??? ??????
  • ????? ??????
  • ?????? ?????
  • ??????
  • ?? ?? ??? ?????? ?????
  • ???????? ???? ? ????
  • ????? ?????? ? ???????? ??? ????
  • ????????
  • ????? ???????
  • ????? ????? ??? ???????

29
Informed consent
  • ????? ????? ????
  • ????? ??????? ????
  • ?????? ???????

30
Informed Consent
  • ????? ??????? ???? ? ?????
  • ???? ???? ???
  • ???? ?????? ???????
  • ??? ???? ? ????? ????
  • ???? ????? ????

31
????? ???? ???????
  • ??? ?? ?????? ???????? ???.
  • ????? ???? ??? ?????
  • ????????? ?? ?? ??? ????????? ???? ???? ? ?????
    ????? ?? ??? ?????? ?? ?? ?? ?? ??????? ??????
    ???? ??? ???? ??????.
  • ???? ??????????? ?? ?? ?? ?????? ????? ?????
  • ????? ????? ???? ??? ???? ?????? ???? ????
    ???????
  • ????? ??????? ?????? ???? ???? ???????. ???
    ?????? ????? ??????? ???? ???? ??????? ?????,
    ???? ?? ??? ????? ???? ?????.

32
????? ???? ???????
  • 7. ???? ???????? ????? ? ????? ? ????? ?? ?? ??
    ????.
  • 8. ????? ? ????? ?????? ?? ?? ????? ?????????
    ?? ??? ???? ?????.
  • 9. ????????? ?????? ?? ???? ????? ???? ???? ??
    ?????? ?? ??? ??? ?? ??????
  • 10. ?? ??????? ???? ?? ???? ???? ?? ?? ??????
    ??????? ????? ????? ? ???? ?? ??? ???
  • 11. ???? ?? ?????? ????????? ??? ? ???????? ??
    ???? ?????? ???? ? ?? ?? ???? ???? ??? ?? ??????
    ???? ??? ???? ???? ????? ?????? ????? ???? ? ??
    ?? ????? ?????? ????? ???.

33
????? ???? ???????
  • 12. ??????? ??????? ??????? ??? ???? ????? ?
    ????? ?? ?????? ????? ???? ????? ???? ?????
    ??????? ????? ????
  • 13. ??? ???? ????? ?? ??? ?????? ?? ????????
    ?? ???? ??? ?? ????? ?? ?? ?????? ?? ?????? ?????
    ?????? ???? ?????? ??.
  • 14. ??? ?? ?????? ?? ???? ?????? ???? ????
    ???????, ??????? ????? ? ?? ?? ???? ???? ??
    ?????? ??????? ?? ?? ???? ?????.

34
????? ???? ???????
  • 15. ????? ?? ?????? ?? ??? ?? ?????? ????
    ??????? ?? ?????? ???? ??? ???
  • ??? ?????? ???? ?????? ???? ????? ?? ??????.

35
????? ???????
  • ????? ?? ?????
  • ??? ?? ????
  • ??? ?? ?????? ????? ??????
  • ?????? ????
  • ??????? ??? ???? ???????

36
????????
  • ????? ?? ????? ?????? ???? ????? ?????? ?? ????
    ????? ??? ?????
  • ???????? ???? ????? ????? ?? ???? ?? ??? ???????
  • ????? ??? ???? ???? ???? ???? ????
  • ????????? ?????? ?? ???? ????
  • ????? ????? ?????

37
????? ?????
  • ??? ??? ??? ??????? ?? ????? ??? ???? ???
  • ?????? ?? ????? ????? ??? ???? ????

38
CRITERIA FOR CONDUCTING STUDIES WITH EXCEPTION
FROM INFORMED CONSENT
  • Subjects are in life-threatening situation
  • Available treatments are unproven and/or
    unsatisfactory
  • Participation in study holds prospect of direct
    benefit to patients
  • Study could not feasibly be conducted without
    exception from informed consent requirement

39
(No Transcript)
40
Confidentiality
  • A researcher may be entrusted with private
    information so
  • Field notes, tapes, questionnaires etc. must be
    stored in a safe place
  • Data should only be used for the purpose agreed
    with the participant and not shared with others
    unless that has been agreed
  • You should be ready to destroy material if the
    participant decides to withdraw participation or
    retract what they have told you.

41
Anonymity
  • The researcher has the responsibility of keeping
    the identity of participants private so that they
    will not be personally identifiable in any
    outputs UNLESS there is a specific reason why
    they should be identified or they specifically
    request their identity to be given.
  • The researcher should explain when anonymity may
    not be maintained (when someone can be identified
    by the position they hold, for example).

42
??????? ?? ?????? ??? ????? ?? ?????
  • ??? ?????? ? ??? ??? ??????? ???? ?? ????? ?????
    ????? ???
  • ??? ? ??? ?????? ?? ?? ??????? ?????? ????? ????
    ???? ? ??? ????? ??? ??????? ?? ???? ???? ?????
  • ???? ?????? ?? ?????? ?? ????? ? ???? ????
  • ?????? ??????? ?? ?????? ?? ???? ?????? ????? ??
    ????? ??? ????

43
???? ?? ???? ?? ?????
  • ?? ???? ???? ??????? ????? ????.

44
???? ???? ??????? ?? ??????? ???? ????? ??????
  • ??? ??? ? ????? ? ????? ???? ?...
  • ?? ?????
  • ????? ???? ? ????? Decoding
  • ?? ????? ????????? ??? ? ????? ????? ?? ??? ???
    ??????? ?? ????? ????? ????? ????? ?????? ???
    ????? ??????? ???? ???.

45
(No Transcript)
46
Ethics in clinical Trial
47
?????? ????????? ??????
Phase Participants Participants Research questions
Phase Number Characteristics Research questions
I 20-80 Usually young, healthy, male volunteers Tolerability Pharmacokinetics Pharmacodynamics
II 100-300 Patients rather than volunteers Effectiveness Dosage, Safety
III 1,000-3,000 Approximate real-life patient population Compare to placebo, current treatments Effects of compound on targets, side-effects
48
?????? ????????? ?????? (?????)
Phase Research questions
IIIb Marketing cost/value Compares with market leader Further data on safety and efficacy
IV New formulations Identify best patients Safety assessment
49
Good Clinical Practice (GCP)
  • A standard for clinical studies which encompasses
    the design, conduct, monitoring, termination,
    audit, analyses, reporting and documentation of
    the studies and which ensures that the studies
    are scientifically and ethically sound and that
    the clinical properties of the treatment under
    investigation are properly documented.

50
Protocol
  • A document that describes the objective(s),
    design, methodology, statistical considerations,
    and organization of a trial. The protocol usually
    also gives the background and rationale for the
    study, but these could be provided in other
    protocol referenced documents.

51
Protocol
  • Backgrounds
  • Objective
  • Population and sampling
  • Data collection
  • Statistical analysis
  • Legal and ethical considerations
  • Quality
  • Resources and requirements
  • Early termination

52
Protocol
  • Enroll appropriate subjects
  • Try to meet recruitment goals
  • Follow randomization and blinding procedures
  • Treatment administration per protocol
  • Measurement of study outcomes
  • Maintain audit trail (paper/electronic)
  • Complete/process/file all study reports
  • Appropriate post-study follow-up for participants
  • Participate in dissemination of results

53
???????
  • ??? ??????? ?? ??????? ?????? ????
  • ??? ????? ?? ???? ???? ?? ??????? ???? ????
  • ?? ?????? ?? ???? ?? ??????? ??????? ????
  • ???????? ??????.

54
??????? (?????)
  • Declaration of Helsinki (prior to 2000)
  • In any medical study, every patient--including
    those of the control group, if any--should be
    assured of the best proven diagnostic and
    therapeutic method. This does not exclude the
    use of inert placebo in studies where no proven
    diagnostic or therapeutic method exists (emphasis
    added).

55
??????? (?????)
  • Declaration of Helsinki (2000)
  • The benefits, risks, burdens and effectiveness of
    a new method should be tested against those of
    the best current prophylactic, diagnostic, and
    therapeutic methods. This does not exclude the
    use of placebo, or no treatment, in studies where
    no proven prophylactic, diagnostic, and
    therapeutic method exists (emphasis added).

56
??????? (?????)
  • Declaration of Helsinki (October 2002 statement)
  • ... a placebo-controlled trial may be ethically
    acceptable, even if proven therapy is available,
    under the following circumstances- Where for
    compelling and scientifically sound
    methodological reasons its use is necessary to
    determine the efficacy or safety of a
    prophylactic, diagnostic or therapeutic method,
    or - Where a prophylactic, diagnostic or
    therapeutic method is being investigated for a
    minor condition and the patients who receive
    placebo will not be subject to any additional
    risk of serious or irreversible harm.

57
??????? (?????)
  • When Placebo Controls May be Used
  • There is no standard treatment
  • Standard treatment has been shown to be no better
    than placebo
  • Evidence causes doubt about therapeutic advantage
    of standard therapy

58
??????? (?????)
  • When Placebo Controls May be Used
  • In a population of patients who are refractory to
    standard treatment and for whom there is no
    standard second-line treatment
  • Testing add-on treatment to standard therapy when
    all subjects in the trial receive all treatments
    that would normally be prescribed

59
??????? (?????)
  • When Placebo Controls May be Used (Controversial
    Conditions)
  • Many argue that persons with conditions with a
    low risk of harm (understand as low probability
    or low magnitude of harm) may be entered into a
    placebo arm
  • Many argue that placebo controls are ethical when
    resources are limited and standard treatment is
    not available

60
???????? ??????
  • ???????? ???? ???????
  • ??? ?????
  • Fetal tissue neuroimplants for Parkinsons
  • Arthroscopic knee surgery for arthritis
  • Spine-fusion surgery for osteoporosis

61
????? ?????? ?????? ?? ??? ???????? ????
  • ????????? ???????
  • ?????? ?? ????? ?????? ???? ?????????
  • ???? ??????? ?? ???? ???? ??????
  • ????? ???
  • ???? ???? ???? ???
  • ?????? ?? ???????? ???? ????
  • ????? ????? ??? ? ??? ?????? ????
  • ????????
  • ????????? ? ???????
  • ????? ????? ??? ??????? (?????? ???? ??)
  • ???? ? ????? ?????

62
Vulnerable Populations
63
Cognitively Impaired
64
????????? ?????? ?? ????? ?? ???? ? ????? ?????
  • ???? ?????
  • ?? ???????? ???????
  • ?? ?????? ??? ?????
  • ???? ???
  • ???? ?????? ?? ??? ????? ????? ?? ?????? ??? ??
    ??? ????? ??????? ????? ?? ?? ????? ???? ??????
    ??????.
  • ????? ????? ??? ?? ??????? ???? ??? ????.
  • ????? ???? ?? ???.
  • ????? ?? ??????? ??? ?????.

65
Informed Consent Cognitively Impaired
  • Persons with diagnosed cognitive impairment such
    as mental retardation, dementia, and coma, can
    participate in research.
  • This type of research must specifically address
    how an individuals capacity to give informed
    consent will be determined.
  • The signature of a legally authorized
    representative will be required
  • Research with Cognitively Impaired subjects
    cannot be considered exempt by the IRB

66
Informed Consent Cognitively Impaired
  • For persons whose cognitive status is suspect,
    but there is no definitive diagnosis
  • Use the Cognitive Impairment Algorithm in the
    Investigators Handbook to determine ability to
    give free informed consent
  • Document the use of the algorithm

67
Cognitively Impaired
  • Document carefully the enrollment of persons
    whose cognitive status is not outwardly obvious
    e.g. stroke patients, psychiatric patients or
    persons with speech or language disorders
  • If a person is enrolled in a study during a
    period of cognitive impairment and regains his
    ability to give consent he must be re-consented

68
????????? ?????? ?? ????? ?? ??????
?????(????????)
  • ???? ?????? ?? ??? ????? ????? ?? ?????? ??? ??
    ??? ????? ??????? ????? ?? ?? ????? ???? ??????
    ??????
  • ??? ?? ????? ?????
  • ???? ????? ?? ?? ?????? ?? ????? ?? ???? ???????
    ??????
  • ???? ???? ?????? ?? ????? ???? ?? ?????? (?????
    ??? ??? ?????)
  • ?? ??? ???? ????? ??? ??? ???? ?? ????? ???? ??
    ??????? ?? ???.

69
????????? ?????? ?? ??????? ????? ?????
  • ????? ?? ???? ??? ??? ???
  • ???????? ?? ????? ??? ???? ??? ?????
  • ???????? ?? ????? ????? ??? ??????
  • ??? ????????? ??????? ???? ????
  • ????? ???? ?? ???? ????????? ????
  • ?????? ???? ???? ????? ???
  • ???? ???? ??????? ???? ??????? ???? ????? ????
    ?????
  • ???? ??????? ??? ?????? ???? ????? ???? ????? ??
    ?????
  • ????? ???? ?? ???
  • ??????? ??? ?????? ???? ?? ??? ????? ?????? ?????
  • ????? ????? ?? ????? ?? ????? ????? ?????? ?
    ????? ???????? ???? ???? ???

70
????????? ?????? ?? ??????? ????? ?????
  • ?????? ?????? ??? ????? ?? ?? ????? ???? ????
    ???? ???? ???? ???? ? ????? ???? ???? ???
    ????????? ?? ?????? ????? ?? ??? ??? ????? ???
    ????.
  • ????? ?? ????? ????? ????? ????? ????.
  • ????? ?????? ?? ???? ?????? ???????.

71
????????? ?????? ?? ??????
  • ????? ???? ?? ???? ?????? ?? ?????? ?????
  • ????? ??? ???? ? ??? ????? ?? ?????
  • ????? ?? ?????? ??? ???? ? ????? ???? ???? ????
    ??? ????.
  • ????? ?????? ?????? ????
  • ???? ???? ?? ???? ????? ?????? ?? ??????
  • ???? ?? ??? ??????? ?? ??????? ????? ?? ??????

72
Consent for Children
  • Parental consent ( proxy)
  • Child assent
  • Complete consent/assent form for older children
    (age 13 to 17)
  • Briefer statement for younger children (8-12)
  • Very brief for young children ( 5-7)
  • No assent for the very young (lt5)

73
?????? ????? ?? ????????? ??????
  • ?? ??? ????? ?????? ????? ????
  • ??????? ???????? ?? ????????????? ?? ???? ??
    ?????.
  • ??????? ? ????? ??????.
  • ?? ????? ???? ????? ?????? ????
  • ???????? ?? ????? ?? ?? ?? ?? ?? ?? ???????
    ?????? ?? ?????? ?? ????????? ?????? ???? ??? ?
    ??? ?????? ????? ?????? ?? ??? ?? ????? ???? ??
    ??????.
  • ???? ???? ????? ???? ??? ?? ???? ?????? ??
    ??????? ??? ?????? ???? ???.
  • ??? ??? ?? ????? ?? ???? ????? ???? ????? ????
    ??? ??? ?? ?? ?? ????????? ??? ??? ???.

74
?????? ????? ?? ????????? ?????? (?????)
  • ?????????? ?????? ?????
  • ??? ?? ?????????? ????? ?? ?????? ???? ? ????
    ?????
  • ?? ??? ???? ?????? ??????
  • ???? ??? ?????? ?? ??? ?????? ???????
  • ???? ?? ???? ??? ?????? ????? ????? ?? ???? ????
  • ????????? ?????? ??? ?? ?? ??? ???????? ????.
  • ?? ????? ??? ???? ?????? ???? ????? ?????? ?????
    ????
  • ????? ????? ????.
  • ???? ?????? ???? ?????? ????.
  • ???? ?? ????? ????? ????? ??? ???? ?? ??????
    ?????? ?? ????? ????? ???.
  • ???? ?? ??? ?????? ?? ?? ????? ???????? ????
    ???????? ???.

75
?????? ????? ?? ????????? ?????? (?????)
  • ???? ?? ?? ? ???? (No fault)
  • ???? ????
  • ?? ?? ??? ??? ?????? ???? ?? ???
  • ??? ???? ?? ?????

76
???? ????? (Conflict of interest)
  • ?????? ?????? ?? ?? ?? ????? ???? ?? ?? ???? ??
    ??? ????? ???? ???? ??? ????? ?? ????? ??????
    ???? ????.
  • ????? ??????
  • ????
  • ?????? ????
  • ????
  • ?????? ????????
  • ????
  • ????? ???
  • ?????? per case

77
????? ??????? ???? ?????
  • ???? ???? ???? ???? ????? ?????
  • ???? ?? ????? ???? ???? ?? ??????
  • ???? ?? ????? ???? ??? ???? ?? ??????
  • ???? ??????? ???? ????? ???????? ???? ? ????
  • ????? ?? ??? ????? ????
  • ????? ?? ???? ???????
  • ???? ???? ?? ????? ??? ????? ?????? ??????
  • ??????? ???? ??

78
Protections for Financial Conflicts of Interest
  • Disclosure
  • To institution/IRB/COI committee
  • To patients
  • In journals
  • Management
  • Independent consent monitors
  • Prohibitions
  • Against types/amounts of financial interests

79
(No Transcript)
80
  • Acceptable Procedures in Medical Research

81
??????? ??? ??????
  • ?????????
  • ???? ?????
  • ?????????
  • ?????????????????
  • ?????? ???? ???? ???
  • ?????????????? ????

82
???? ???????
  • ???? ?? ??????? ??? ??? ????? ???? ??????? ?? ???
    ???? ??? ??? ??????? ???? ?????? ????.
  • ?????? ????? ?????
  • ??? ?? 50 ??? ??
  • ????? ??????? ? ???????
  • ????? ????? ???? ? ????? ???
  • ??? ????? ?????? ????? ??? ??mSv 50 ????.

83
??????? ?????? ???????? ???? ????
  • ????? ???? ??? ?????
  • ????? ?? ??? 3 ??? ??? ?? cc 500 ????.
  • ???? ????- ????
  • ????????? ? ?????? ?????
  • ?????? ???? ? ????

84
???????? ?? ??? ???? ?? ????? ????? ????? ???
???? ???? ????
  • ????? ???? ????
  • ???????????? ????
  • ?????? ???, ???
  • ?????? ??? ???????

85
????? ????? ???? ?? ???????
  • 3 ??? ????
  • ????????? ??? ??????
  • ??????? ??????
  • ?????? ????? ???? ???? ???
  • ?? ???????? ?? ???? ??? ?? ????? ?????? ?????? ??
    ????? 3 ??? ??? ???? ???

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

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  • ??????? ?? ????? ??? ?????

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    ??????????? ????? ????
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    ??? ??? (??????? ??? ????, ??? ????, ?????? ????
    ?????? ?? ???? ?? ?????? ?? ??????? ?...)

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

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Authorship (Central Principle)
  • Authorship should include person(s) who can take
    public intellectual responsibility for the
    content.
  • Responsibility
  • Can defend the intellectual content, including
    data and conclusions.
  • Must be willing to concede publicly any errors.
  • In the case of fraud be willing to state
    publicly the nature and extent, and account for
    its occurrence.

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Criteria for Authorship
  • 1. Generate at least part of the intellectual
    content.
  • A) Conception or design of the work
  • B) Data analysis and interpretation
  • 2. Drafting, reviewing or revising critically
    for important intellectual content.
  • 3. Final approval of the version to be published.
  • All three criteria must be met.

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Order of Authorship
  • Alphabetical
  • Significance to the Study (variable)
  • First - Primary responsibility for collecting
    analyzing data, writing draft of manuscript.
  • Last - Established investigator
  • Middle - Order of importance to the study.

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Acknowledgements
  • contributions that need acknowledging but do not
    justify authorship (advice, critical review of
    study proposal, data collection, participation in
    clinical trial)
  • acknowledgements of technical help
  • acknowledgements of financial and material
    support
  • financial relationships that may constitute a
    conflict of interest.

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IRB (Institutional Review Board)Ethics Committee
  • An IRB protects the rights, safety, and welfare
    of human research participants by
  • Reviewing the full protocols for planned research
    studies to ensure that, in its judgment, the
    research meets the appropriate criteria.
  • Confirming that the research plans do not expose
    participants to unreasonable risks.
  • Conducting continuing review of approved research
    at intervals commensurate with the degree of risk
    of the trial, but not less than once a year, to
    ensure that human participant protections remain
    in force.
  • Considering adverse events, interim findings, and
    any recent literature that may be relevant to the
    research.
  • Assessing suspected or alleged protocol
    violations, complaints expressed by research
    participants, or violations of institutional
    policies.

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IRB (Institutional Review Board)Ethics Committee
  • The IRB has the authority to
  • Approve, disapprove, or terminate all research
    activities that fall within its local
    jurisdiction.
  • Require modifications in protocols, including
    previously approved research.
  • Require that information be given to participants
    when the IRB determines that this information
    would add to the protection of their rights and
    welfare.
  • Require documentation of informed consent or
    allow waiver of documentation.

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Links for more Information
  • http//www.wma.net
  • http//www.cioms.ch
  • http//www.ich.org

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