Etika Penelitian pada Manusia

Sylvia Rianissa Putri

27 Desember 2016
 Latar Belakang
• Pelanggaran etik dalam penelitian kesehatan:
– Penelitian hepatitis (Willowbrook 1950-1970)
– Penelitian pada pasien penyakit kronik (Jewish
Hospital 1963)
– Penelitian sifilis (Tuskegee 1932-1972)
 Tuskegee 1932-1972
• By the US Public Health Service
• To study the natural progression of untreated
syphylis in rural African American men
• 399 of those men had previously contracted
syphilis before the study began, and 201 did
not have the disease.
• They were never told they had syphilis, nor
were they ever treated for it.
 Jewish Hospital 1963
• In New York City's Jewish Chronic Disease Hospital
• To develop information on the nature of the human
transplant rejection process.
• These studies involved the injection of live cancer cells
into patients who were hospitalized with various
chronic debilitating diseases.
• Researchers said that consent had been given orally,
but was not documented.
• Further, patients were not told that they would receive
cancer cells.
• Amendment of Declaration of Helsinki in Tokyo 1975
• Beecher Report 1966
• Declaration of Helsinki 1964
• Declaration of Human Rights 1948
• Nuremberg Code 1946
• International Guidelines for Ethical Review of 1991
Epidemiological Studies, CIOMS
• Amendment of Declaration of Helsinki in Hong 1989
Kong
• Amendment of Declaration of Helsinki in Venice 1983
• International Guidelines, Council for International 1982
Organization of Medical Sciences (CIOMS)
• Belmont Report 1979
• Amendment of Declaration of Helsinki in Seoul 2008
• Amendment of Declaration of Helsinki in Tokyo 2004
• Amendment of Declaration of Helsinki in 2002
Washington
• Amendment of Declaration of Helsinki in 2000
Edinburgh
• Amendment of Declaration of Helsinki in 1996
Somerset West
 Deklarasi Helsinki
(amandemen tahun 2008 di Seoul)
• Prinsip dasar:
– Melindungi hidup, kesehatan, privasi, dan harkat
manusia.
– Menggunakan prinsip ilmiah yang diakui.
– Memperoleh kelaikan etik dari komisi etik.
– Harus dilakukan oleh peneliti yang memenuhi
kualifikasi ilmiah dan diawasi oleh personil medis
yang berpengalaman secara klinis.
 Deklarasi Helsinki
(amandemen tahun 2008 di Seoul)
– Clinical trials harus terdaftar di database yang
dapat diakses publik sebelum rekrutmen subyek.
– Subyek harus bersifat sukarela berdasarkan
prinsip informed consent, dan diperbolehkan
menarik kembali consent.
 Amandemen Deklarasi Helsinki 2013
(Fortaleza, Brazil)
• Tambahan poin penting:
– Penelitian dilakukan dengan meminimalkan
kerusakan lingkungan
– Peneliti harus memenuhi syarat pendidikan,
pelatihan serta kualifikasi etik dan ilmiah.
– Menjamin kompensasi dan tata laksana yang
sesuai bagi subyek yang mendapat tindakan invasif.
– Meminimalkan kemungkinan adanya subyek yang
dependen pada pihak yang meminta consent.
 Amandemen Deklarasi Helsinki 2013
(Fortaleza, Brazil)
– Membuka kemungkinan adanya post-trial
provisions
– Semua data harus dipublikasikan
 PP 39/1995
• Pasal 4 (1): Penelitian dan pengembangan
kesehatan dilaksanakan berdasarkan standar
profesi penelitian kesehatan.
 PP 39/1995
• Pasal 10: komponen informasi yang harus
diterima subyek/yang mewakili
– Tujuan penelitian dan penggunaan hasilnya
– Jaminan kerahasiaan identitas dan data pribadi
– Metode penelitian
– Risiko yang mungkin timbul
– Hal lain yang perlu diketahui
 PP 39/1995
• Pasal 12: dapat sewaktu-waktu mengakhiri
atau menghentikan keterlibatannya dalam
penelitian dan pengembangan kesehatan.
• Pasal 14: berhak mendapat ganti rugi bila
terjadi gangguan kesehatan, cacat atau
kematian akibat kesalahan atau kelalaian
peneliti.
 PP 39/1995
• Pasal 15 (1): penerapan pada manusia harus
didahului penelitian pada hewan coba
• Pasal 15 (2): penerapan hanya boleh
dilaksanakan bila dapat
dipertanggungjawabkan dari segi kesehatan
dan keselamatan jiwa manusia.
 PP 39/1995
• Pasal 19: pelanggaran dapat dipidana
berdasarkan Pasal 81 ayat (2) UU No. 23 Tahun
1992.
• Pasal 20: hukuman pidana denda maksimal Rp
10.000.000,00
 Komite Etik
• Total (2014): 52 KE
• Tertua: FKUI (1984)
• Sebaran:
– KE FK: 7
– KERS: 6
– KE lembaga penelitian: 6
– KE ad hoc: 1
• 4 KE telah diakui SIDCER-FERCAP (2014)
Ethical Aspects of Biological
Samples
 Principles
• Materials should be treated as donations and
research involving these samples should be
conducted with respect and transparency
• Research should only go ahead if the potential
benefits outweigh any potential risks to the donors
of the samples
• Maximise the research use of collections of samples
to benefit science and society – both by planning for
the futures uses of new collections, and fully using
existing collections
• Researchers must decide at the outset what their
strategy will be regarding feedback of health related
findings
• The human body and its parts shall not, as such, give
rise to direct financial gain
• Whenever seeking consent to collect and use
samples for research, the information provided to
potential donors should be understandable and
supportive of the participant in making the decision
to donate or not
• Patients should be informed when material left over
following diagnosis or treatment (described as
surplus to clinical requirements) might be used for
research
• Research involving human biological material should
undergo independent ethical review (with very
limited exceptions)
• Researchers should treat all personal and medical
information relating to research participants as
confidential
• Researchers should be aware of, and keep up
to date with, all ethical, legislative, regulatory
and governance requirements relating to their
area of research
 What are Biological Samples?
• Tissues • Protein
• Organs • Cells
• Blood • Hair
• Plasma • Nail clippings
• Serum • Urine
• Skin • Saliva
• DNA • Other bodily fluids
• RNA
 Labeling
• Identified human biological materials  direct
• Coded human biological materials  re-
identify
• Anonymized human biological materials
• Anonymous human biological materials
 Collection
• Collected expressly for a specific research purpose
• Collected incidentally to medical or diagnostic
procedures with no initial intent to be used in
research
• They may be collected for research or medical or
diagnostic purposes with some expectation that
they may, or will, also be used in future research,
although the precise research project(s) may not
be known at the time
 Consent
• Of the participant who will donate biological
materials
• Of an authorized third party on behalf of a
participant who lacks decision-making
capacity
• Of a deceased participant through a donation
decision made prior to death, or by an
authorized third party
 Information Provided
• Type and amount of biological materials to be
taken
• The manner in which biological materials will be
taken, and the safety and invasiveness of the
procedures for acquisition
• The intended uses of the biological materials,
including any commercial use
• The measures employed to protect the privacy of
and minimize risks to participants
• The length of time the biological materials will
be kept, how they will be preserved, location of
storage, and process for disposal, if applicable
• Any anticipated linkage of biological materials
with information about the participant
• The researchers’ plan for handling results and
findings, including clinically relevant
information and incidental findings
 Researchers who haven’t obtained for
secondary uses
• Essential to the research.
• Unlikely to adversely affect the welfare of individuals
from whom the materials were collected.
• Appropriate measures to protect the privacy of
individuals and to safeguard the identifiable human
biological materials
• Will comply with any known preferences previously
expressed by individuals about any use of their
biological materials
• Impossible or impracticable to seek consent
• The researchers have obtained any other
necessary permission for secondary use of
human biological materials for research
purposes
 Biobanks
• Shall ensure that they have or use appropriate
facilities, equipment, policies and procedures
to store human biological materials safely, and
in accordance with applicable standards
• Shall establish appropriate physical,
administrative and technical safeguards to
protect human biological materials and any
information about participants from
unauthorized handling