ETIKA DALAM PENELITIAN

KEPERAWATAN

Muhamat Nofiyanto
Deby Zulkarnain
UNIVERSITAS JEN. A. YANI
YOGYAKARTA
 In any discipline that involves
research with human beings or
animals, researchers must address
ethical issues (Pollit&Beck)
 OBJECTIVES

• Alasan pentingnya etik dalam penelitian

• Penelitian yang tidak etis
• Peraturan pemerintah untuk melindungi
responden dalam penelitian
• Dilema etik dalam melakukan penelitian
• Prinsip etik untuk melindungi responden
penelitian
 Lanjutan.......

• Prosedur untuk melindungi responden pada

suatu penelitian
• Bio etik
 Historical Background
• The Nazi medical experiments (1930-40an)
disregard for ethical conduct

• involved the use of prisoners of war and racial

“enemies” in numerous experiments designed
to test the limits of human endurance and
human reaction to diseases and untested drugs.
 Lanjutan........
• U.S. Public Health Service (1932-72):
Tuskegee Syphilis Study investigated the
effects of syphilis among 400 men from a poor
African American community, tidak diobati
• Dr. Herbert Green of the National Women’s
Hospital in Auckland, New Zealand: studied
women with cervical cancer in the 1980s
tidak diobati natural progression of the
disease
 Lanjutan........

• Injection of live cancer cells into elderly

patients at the Jewish Chronic Disease
Hospital in Brooklyn in the 1960s without the
consent of those patients
• Dr. Saul Krugman was conducting research at
Willowbrook, an institution for the mentally
retarded, where children were deliberately
infected with the hepatitis virus
 Codes of Ethics
• Nuremberg Code, developed in 1949
• Declaration of Helsinki, which was adopted in
1964 by the World Medical Association and
most recently revised in 2000, with
clarifications published in 2004.
• Guidelines for psychologists were published
by the American Psychological Association
(2002) in Ethical Principles of Psychologist
and Code of Conduct
 Lanjutan........

• The American Medical Association regularly

updates its Code of Medical Ethics.
• American Nurses Association (ANA) issued
Ethical Guidelines in the Conduct,
Dissemination, and Implementation of Nursing
Research in 1995
 Lanjutan........

• ANA also published in 2001 a revised Code of

Ethics for Nurses with Interpretive Statements
• The Canadian Nurses Association most
recently published its Ethical Research
Guidelines for Registered Nurses in 2002
• the ICN Code of Ethics for Nurses, which was
most recently updated in 2006
 Hak & Kewajiban Peneliti-
Responden

• Hak responden: dihargai privasinya,

dirahasiakan informasinya, jaminan keamanan
dan keselamatan, imbalan/kompensasi
• Kewajiban responden: memberikan informasi
yang sebenarnya yang diperlukan peneliti
setelah ttd
 Identifikasi ketidaknyamanan ketika
dalam kondisi berikut:
• Privasi terganggu
• Terganggu kegiatan dan pekerjaan
• Berpikir keras untuk menjawab pertanyaan
• Munculnya trauma
• Tindakan invasif
 Manfaat potensial penelitian bagi
responden
• Akses akan intervensi
• Perasaan nyaman
• Meningkatkan pengetahuan
• Meningkatkan harga diri
• Lepas dari rutinitas
• Informasi yang diberikan dapat membantu
orang lain
• Dapat materi/ uang
 e rt a
t u k pe s
ia n u n
en e l i t
n a p
Da
Harus pertimbangkan dana kompensasi jika:
• Bahaya fisik
• Rasa tidak nyaman
• Distress psikologis
• Kehilangan privacy
• Kehilangan waktu
• Kompensasi transport
 Government Regulations for
Protecting Study Participants
• Peran pemerintah menetapkan kebijakan
• Health Canada specified the Tri-Council Policy
Statement: Ethical Conduct for Research
Involving Humans as the guidelines to protect
human subjects in all types of research.
• In Australia, the National Health and Medical
Research Council, issued the National
Statement on Ethical Conduct in Research
Involving Humans in 1999
 Lanjutan.........
• Di Indonesia: Kode Etik Penelitian
Kedokteran dan Pembentukan panitia Etik
kedokteran, Pedoman Etik Penelitian
Kedokteran Indonesia, Penetapan standar
profesi penelitian , komite bio etik nasional
dan Pedoman operasional Komisi Etik
Penelitian Kesehatan
 Ethical Dilemmas in
Conducting Research
• Pertanyaan penelitian: apakah perilaku empati
perawat sama ketika merawat pasien pria dan
wanita di ICU
• Dilema etik: etik mengharuskan responden
mengetahui tujuan penelitian. Ketika peneliti
memberitahukan bahwa perawat akan
diobservasi perilakunya, apakah masih akan
tetap berjalan alamiah?
 Ethical Dilemmas in
Conducting Research
• Pertanyaan penelitian: bagaimanakah koping
orang tua saat anaknya dalam fase terminal?
• Dilema etik: peneliti harus menggali dalam
respon psikologis klien yang bisa saja nanti
bersifat sangat menyakitkan dan traumatik
bagi responden?
 Ethical Dilemmas in
Conducting Research
• Pertanyaan penelitian: apakah obat baru dapat
meningkatkan harapan hidup pasien kanker?
• Dilema etik: cara paling efektif melihat respon
obat adalah ada kelompok pembanding.
Kelompok perlakuan beresiko efek samping
obat, kelompok yang dibiarkan mungkin tidak
akan mendapatkan keuntungan obat baru?
The research goal is to develop the highest-
quality evidence for practice, using the best
methods available but they must also
adhere to rules for protecting human rights
 ETHICAL PRINCIPLES FOR
PROTECTING
STUDY PARTICIPANTS
1. Beneficence
• The Right to Freedom from Harm and
Discomfort
• The Right to Protection from Exploitation
2. Respect for Human Dignity
• The Right to Self-Determination
• The Right to Full Disclosure
 Lanjutan......
3. Justice
• The Right to Fair Treatment
• The Right to Privacy
 Prinsip Utama Etika Penelitian (Milton, 1999;
Loiselle, Profetto-McGrath, Polit & Beck, 2004)
• Menghormati harkat dan martabat manusia
(respect for human dignity).
• Menghormati privasi dan kerahasiaan subyek
penelitian (respect for privacy and
confidentiality)
• Keadilan dan inklusivitas (respect for justice
and inclusiveness).
• Memperhitungkan manfaat dan kerugian yang
ditimbulkan (balancing harms and benefits)
 PROCEDURES FOR PROTECTING
STUDY PARTICIPANTS
• Risk–Benefit Assessments: costs, be they
financial, physical, emotional, or social
• Informed Consent
• Confidentiality Procedures: anonim,
Confidentiality in the Absence of Anonymity,
• Debriefings and Referrals
• Treatment of Vulnerable Groups: anak,
gangguan mental, sakit kritis,pasien terminal,
wanita hamil
 Lanjutan......
• External Reviews and the Protection of
Human Rights: menghindari bias komite
eik terkait
 BIOETIK

ETIK YANG DIAPLIKASIKAN

DALAM KEHIDUPAN
(PENGAMBILAN KEPUTUSAN
MENYANGKUT HIDUP DAN
MATI)
ETHICAL THEORIES

Bioetik
 SEJARAH
• Istilah bioethics pertamaVan Rensselaer
Potter

Bioetikailmu menggabungkan pengetahuan

ilmu-ilmu hayati dengan pengetahuan
tentang sistem-sistem nilai manusiawi dari
etika
 Lanjutan...........
Andre Hellegers

Bioetikakerjasama antara ilmu-ilmu

hayati, ilmu soisal dan etika dalam
memikirkan masalah-masalah
kemasyarakatan dan moral yang
timbul dalam perkembangan ilmu-
ilmu biomedis.
Ciri Bioetik
BIOETIK PENELITIAN
Bioethics is a discipline dealing with
the ethical implications of biological
research methods and results,
especially in medicine.
 SEJARAH
Pelanggaran etik penelitian : 1950-1970 (stdi
hepatitis), 1963 (injeksi sel kanker orang jompo),
1932-72 (studi sifilis)
1946 Nuremberg Code informed concern
1964 Declaration of Helsinki (amendment 2000,
Edinburgh)  utamakan aman dan sehat pasien
1966 Beecher Report- 100 artikel, 12
penelitian tidak etis
1982 International Guidelines, Council for
International organization of Medical Sciences
(CIOMS)
 Perkembangan Etik Penelitian di
Indonesia
1982- Kode Etik Penelitian Kedokteran dan Pembentukan
1985 panitia Etik kedokteran FKUI
1986- Pedoman Etik Penelitian Kedokteran Indonesia
1987
1987 Panitia Etik Penelitian Kesehatan Balitbangkes
1995 PP 39/ 1995: Penetapan standar profesi penelitian oleh
Litbangkes
2004 Pembentukan komite bioetik nasional
2005 Pedoman operasional Komisi Etik Penelitian Kesehatan
 ETIKA PENELITIAN
PADA MAKHLUK HIDUP
1. Pada Manusia

Ethical Clearance: PSP

 Lanjutan...........
2. Pada Hewan (WHO)
• BB lebih kecil dari 1 kg
• Mudah diambil darah
• Mudah dipegang dan dikendalikan
• Pemberian materi mdh dilakukan dgn
berbagai cara
 Lanjutan...........
• Mudah dikembang biakkan & mudah
dipelihara
• Lama hidup relatif singkat
• Fisiologi diperkirakan sesuai dengan
manusia atau hewan yang dituju
 Ethical Issues in Using
Animals in Research

• Penelitian biophysiologic phenomena pakai

hewan coba
• informed consent is not relevant for animal
subjects
 the Public Health Service United States
principles for the proper care and treatment
of animals used in research
• transport of research animals,
• alternatives to using animals,
• pain and distress in animal subjects,
• researcher qualifications,
• use of appropriate anesthesia,
• euthanizing animals under certain conditions
during or after the study
 Ethical Issues: Research
Misconduct
• ethics in research involves not only the
protection of the rights of human and animal
subjects, but also protection of the public trust
• Fabrication: make up data
• Falsification: manipulasi material, peralatan,
proses, merubah data
• plagiarism in proposing, conducting, or
reviewing research, or in reporting results.
PROPOSAL PENELITIAN YANG
ETIS
• Dapat dipertanggungjawabkan secara ilmiah:
konsisten, important, valid
• Etis dari sudut pandang isu etis: manfaat, adil,
menghormati harkat martabat
• Jelaskan langkah untuk memenuhi aspek etis:
bgmn data diperoleh, jaga rahasia, publikasi,
ijin, penjelasan, dll
• Penelitian dari CM: ajukan ke komite etik untuk
tidak pake inform concern,jelaskan kenapa tidak
butuh
 Daftar Pustaka
1. Dahlan, M.S. 2009. Langkah-langkah Membuat Proposal
Penelitian Bidang Kedokteran dan Kesehatan. Jakarta: CV.
Sagung Seto
2. Notoatmodjo, S. 2010. Metodologi Penelitian Kesehatan.
Jakarta: Rineka Cipta
3. RN.com. 2012. Ethics and the Healthcare Professional.
RN.com. AMN Health Care Education Services
4. Ismani, N. Etika Keperawatan. Jakarta: Widya Medika
5. Polit, Denise., Beck, CT. 2006. Nursing Research Principles
and Methods. -7th Ed. Philadelpia: Lippincott.
6. Sastroasmoro, 1995. Dasar- dasar Metodelogi Penelitian
Klinis. FKUI. Jakarta
7. Tjokronegoro, 1999. Metodelogi Penelitian Bidang
Kedokteran. FKUI. Jakarta
8. Yurisa, 2008. Etika Penelitian Kesehatan. Riau : FK UNRI