dr.Christina Olly Lada,M.

Gizi
Fakultas Kedokteran
Universitas Nusa Cendana
 Perkembangan Ilmu & Pengetahuan
bidang kedokteran & kesehatan
demikian pesat
 Perlembangan ini dipicu penelitian
yang makin dalam & luas
 Manusia merupakan salah satu
subyek penting dalam penelitian
 Dalam hubungannya dengan
pelayanan kesehatan ada norma yang
mengatur
 Walaupun tidak tertulis norma
tersebut menggaris bawahi
tentang sikap orang yang
mengobati terhadap yang diobati
 Norma tertua yang tertulis adalah;
sumpah dokter Hindu 1500 SM 
jangan merugikan pasien yang
sedang diobati
 Sumpah Hippocrates  seorang
dokter harus mengutamakan
kepentingan pasien
 Kemajuan pesat mulai abad ke-18: Penemuan
Pasteur & Koch
 Penemuan etiologi penyakit, Roentgen,
diagnostik, bidang klinik oleh Addison,
Charcot, Billroth dll
 Perang dunia ke 2 banyak penelitian yang
dilakukan pada tawanan perang
 Keberhasilan pencangkokan tubuh,
manipulasi genetik, dll
 Dana penelitian yang tersedia  jenis
penelitian dan jumlahnya semakin meningkat
 Mudah terjadi penyimpangan dan
pelanggaran hak asasi manusia
 Nuremberg Code, forum internasional
pertama yang menyepakati tentang etika
penelitian
 Nuremberg Code  reaksi terhadap
kekejaman dokter Nazi
 Experiments on twins
 Bone, muscle, and nerve
transplantation experiments
 Head injury experiments
 Freezing experiments
 Malaria experiments
 Mustard gas experiments
 Sulfonamide experiments
 Sea water experiments
 Sterilization experiments
 Experiments with poison
 Incendiary bomb
experiments
 High altitude experiments
 Menyepakati harus
adanya informed
consent (persetujuan
setelah penjelasan) dari
manusia yang digunakan
sebagai percobaan
 Tahun 1964, World
Medical Association
mengeluarkan rangkaian
aturan unutk penelitian
pada manusia 
Deklarasi Helsinski I
1. The voluntary consent of the human subject is absolutely essential
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by
other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a
knowledge of the natural history of the disease or other problem under study that the anticipated
results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering
and injury.
5. No experiment should be conducted where there is a prior reason to believe that death or disabling
injury will occur; except, perhaps, in those experiments where the experimental physicians also serve
as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance
of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental
subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of
skill and care should be required through all stages of the experiment of those who conduct or
engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment
to an end if he has reached the physical or mental state where continuation of the experiment seems
to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the
experiment at any stage, if he has probable cause to believe, in the exercise of the good faith,
superior skill and careful judgment required of him that a continuation of the experiment is likely to
result in injury, disability, or death to the experimental subject.
 Declaration of Helsinki
 Information for a prospective research
subject
 Incentives for research subjects
 Vulnerable subjects
 Woman in childbearing age
 Ethics in animal experimentation
 Ethics in publication

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Antara lain:
 Pedoman untuk penelitian klinis
 Editor jurnal kedokteran dan kesehatan
diimbau unutk tidak memuat artikel
penelitian yang menggunakan manusia
sebagai subyek tanpa informed consent
 Penelitian berdampak positif bagi pasien dan
masyarakat
 Declaration of Helsinki by the World
Medical Assembly:
◦ 1964: Original version. 18th Meeting, Helsinki
◦ 1975: First revision. 29th Meeting, Tokyo
◦ 1983: Second revision. 35th Meeting, Venice
◦ 1989: Third revision. 41st Meeting, Hong
Kong
◦ 1996: Fourth revision. 48th Meeting,
Somerset West (SA)
◦ 2000: Fifth revision. 52nd Meeting, Edinburgh
◦ 2002: First clarification, Washington
◦ 2004: Second clarification, Tokyo
◦ 2008: Sixth revision, 59th Meeting, Seoul

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Retrolental Fibroplasia and Oxygen Therapy
(JAMA 1954; 155: 233-56)
Objective: to find relationship between
oxygen therapy and development of RLF in
premature newborns.
Design:
parallel, controlled study

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Group 1 (n=64): highly concentrated oxygen
Group 2 (n=36): 50% oxygen
Results:
 Group 1:
survived 36: 8 severe RLF, irreversible,
bilateral. 6 lost sight of both eyes.
 Group 2:
survived 28: No RLF (p<0.05)

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A. Introduction
1. Decl. of Helsinki (DH): guidance in medical
research involving human subjects,
including identifiable human material or
human identifiable data
2. Duty of physicians: promote and safeguard
the health of the people
3. Declaration of Geneve:
◦ the wealth of patients is the first consideration

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 International Code of Medical Ethics:
◦ Providing medical care which weakens a patient’s
condition can only be done in the patient’s
interest
4. Medical progress: ultimately must rest on
experimentation in man
5. In research involving human subjects:
the wellbeing of human subjects is more
important than the interest of science and
society

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6. Primary purpose of a clinical trial:
improve prophylactic, diagnostic,
therapeutic procedures. All these should be
continuously challenged
7. In medical research, most procedures
involve risks and burdens
8. Vulnerable subjects need special
protection
9. Investigators should be aware of the
ethical, legal, and regulatory aspect in their
own countries + international requirements

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B. Basic principles for all medical research
10. The physician in medical research should
protect the life, health, privacy, and
dignity of the human subjects
11. Should conform to the scientific
principles and be based on scientific
literature
12. Be careful to research affecting
environment. Animal’s welfare should be
respected.

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13. Research protocol should be formulated
and reviewed by an ethical review
committee. Any serious adverse events
should be immediately reported. Sponsors,
funds, conflict of interests, and subject’s
incentives should also be informed for
review.
14. The protocol should state that it complies
with principles in this declaration.

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15. Should be conducted only by scientifically
qualified persons and supervised by a
clinically competent person.
Responsibility should rest with the
medically qualified person, not the subject.
16. Predictable risks and burdens should be
first assessed against foreseeable benefit

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17. Physicians are not allowed to participate
in a clinical trial if they are not sure that the
risks have been assessed and can be
managed.
They should stop a study if the risk are
found to outweigh the potential benefit or if
there is a conclusive proof that positive
results have been established.

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18. A study can only be conducted if the
importance of the objective outweighs the
risks and burdens to the subject, especially
in healthy volunteers.
19. A study in a population is only justified if
there is a reasonable likelihood the
population will get benefit from the result
of the study
20. Subjects must be volunteers and
informed participants

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21. Subject’s right to safeguard their
integrity, privacy, and confidentiality should
be respected.
Impact of the study to subjects integrity and
personality should be minimized.
22. A consent should be obtained after
adequate information has been provided to
a subject.
23. Vulnerable subjects should be managed
cautiously.

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24. Legally incompetent subjects should be
represented by their legally authorized
representatives. They can only be included
if the objective of the study cannot be
conducted on legally competent subjects.
25. In addition to the parent’s consent,
informed consent should also be obtained
from a minor child if the investigator thinks
the child is able to give assent to decision.

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26. Clinical studies on patients from whom a
consent is impossible to obtain, including
proxy or advance consent, can only be done
if the physical/mental condition that
prevents obtaining informed consent is a
needed characteristic in the study. The
consent should, however, be sought as
soon as possible.

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27. Both authors and publishers have ethical
obligations. Negative results should also be
published. Sources of conflict of interests,
funding, and institutional affiliation should
be disclosed in the publication.
Reports of experimentation not in
accordance with the principles laid down in
this declaration should not be accepted for
publication.

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Additional principles for medical research
combined with medical care
28. Combination of research and medical care
is allowed only to the extent that the
research provides potential prophylactic,
diagnostic, or therapeutic value.
29. The benefits, risks, burden of a new
method should be compared to the best
current method. Placebo may be used if no
known standard treatment exists.

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30. At the conclusion of the study, every
patient should be given the best proven
drug/method identified in the trial.
31. The subjects should be informed which
aspects of the care are related to the
research. Patient’s refusal to participate
must not interfere patient-physician
relationship

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32. Physician must be free to use new
therapeutic measures if in his judgment it
offers a better hope for the patient’s
interests.

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