Professional Documents
Culture Documents
KESEHATAN
(isnaeni DTN)
1
TUJUAN PERKULIAHAN;
MEMAHAMI
KONSEP ETIK PENELITIAN
PRINSIP ETIK DALAM
PENELITIAN KES
MEMAHAMI PRINSIP- ETIK
DALAM PENELITIAN
MAMPU MENYIAPKAN
PEROLEHAN INFORMED
CONSENT
PRINSIP ETIK PADA
HEWAN COBA
PENULISAN KARANGAN
ILMIAH
PENDAHULUAN
Pergeseran IPTEK & sarana penunjang
(Dana/Alat )
Perlu Persetujuan
(Ethical clearance/Ethical Approval)
dari Komisi Etik (ETHICS COMMITTEE)
Medis/Keperawatan setempat
(Syarat publikasi)
Expertise
Diligent
Honesty
Integrity
(Burn Grove,
1997)
HISTORY OF UNETHICAL RESEARCH STUDIES
IN USA (Wood, Haber, 2006)
1 “DOCTOR TRIAL” (nazi medical experiment 1933-1945):
The Nazi regime included sterilization, euthanasia
numerous medical experiments to produce a
population of racially (No protection human subject:
dignity & safety or respect for person)
2. Hyman vs. Jewish Chronic Disease Hospital Case (1965)
Doctor Injected Cancer-ridden aged & senile patients with
their own cancer cells to study the rejection response:
INFORMED CONSENT was not obtines & no indication
that the study had been riviewed & approved by
ethics committee) ethic at principle violated: .
3. Wllobrook hospital (1972) Focus study: Mentally
Incompetent : n= 350)
In study examining the natural history of infectious
hepatitis & effect of gamma globulin (Principle of
voluntary consent was violated : parent coerced to
consent to their clidren’s participation as research
subject)
4. Tuskegee Syphilis Study1932 – US Public
Health Service
initiated a study of syphilis in black men in
the small rural town of Tuskegee,
Alabama .Cont’d for 40 years (to1962)
To determine the course of syphilis in the
adult black male
2 groups: n = 400 untreated syphilis
(treatment group) n = 200 without syphilis
(control group)
Consent – participants not informed about
the purpose and procedures
Deliberate steps to keep subjects from
receiving treatment
No effort to stop the study
MENGAPA PENELITIAN PERLU
ETIK?
NUREMBERG CODE (1974)
Menjaga integritas penelitian, kondisi melaks
penelitian yg etis, menekankan persetujuan
(voluntary consent)
These include:
Physical harm to participants.
Psychological distress and discomfort.
Social disadvantage.
Harm to participants? financial status.
An invasion of participants? privacy
and anonymity.
Principle of Balancing Harms and
Benefits
Based on the principle of beneficence
One should do good and above all do
no harm
Freedom from harm, freedom from
exploitation, risk-benefit ratio
Risk-benefit ratio:
consider how comfortable you would
feel having family members participate
in the study
Would be comfortable
Benefit to society and the nursing
profession
PENELITIAN EKSPERIMEN
& ETIKA
Penelitian eksperimen, kelp. eksperimen
memperoleh manfaat/keuntungan dari
eksperimen yang dilakukan oleh peneliti.
Sedangkan kelompok kontrol tidak
memperoleh keuntungan yang sama.
Oleh sebab itu, setelah pengumpulan data
pasca intervensi (post test), perlakukan
yang sama diberikan spt pada kelompok
kontrol.
Bila tidak, maka terhadap kelompok
kontrol perlu diberikan manfaat yg lain.
PENGHARGAAN or KOMPENSASI
(Inducement)
---------------------------------- ---------------------------
Benefits
Risks outweigh
outweigh
risks
benefits
Potentially Ethical
unethical study
PERLU DI INGAT
JIKA ILMUWAN MENGAMBIL JALAN
PINTAS YG SALAH DGN ALASAN APAPUN