ETIKA PENELITIAN KESEHATAN

P. Sudiharto
Bagian Ilmu Bedah/SMF Bedah Saraf
FK UGM/RSUP Dr. Sardjito
Yogyakarta
Inti Etik Penelitian Kesehatan adalah :
Kem Kes RI, 2011)
1. Kewajiban menghormati kesediaan dan
pengorbanan : partisipasi sebagai subyek
penelitian
2. Melindungi kehidupan, kesehatan dan
keleluasaan pribadi (privacy) dan martabat
(dignity) subyek penelitian
Clinical Ethics and Clinical Research Ethics

Clinical research ethics is the practise of addressing the

ethical aspects of research involving human subjects.
(Derenzo and Moss, 2006)

Clinical ethics is defined as the process of dealing with the

day-to-day moral decision-making of those caring for
patients, typically focusing on individual cases, and seeking
to determine what should be done here and now with a
particular patient. (Eggertsson,2002)
Medical Ethics is the rules or principles
governing the professional conduct of
physicians (Dorland’s Med. Dictionary 1974)

Ethics is that branch of philosophy that

seeks to determine how human actions
may be judged right or wrong. (Garrett TM,
Bailie HW, Garrett RM, 1993)
The core of clinical ethics is the ability to identify and analyze an
ethical question and to reach a reasonable conclusion and
recommendation for action. (Jonsen, Siegler, Winslade, 2010)

The goal of clinical research is to obtain scientifically valid data

efficiently while protecting research participants. (Derenzo and Moss,
2006)

Because applied ethics focuses on what “ought” to be done in a

particular set of circumstances,clinical research ethics focuses on
what “ought” to be done in research involving human subjects
Prinsip Etik Dasar (PED) penelitian
berdasarkan laporan Belmont (Ruoco J., 2011;
KemKes, 2011)
1. Menghormati harkat/martabat manusia
(respect for persons)
2. Berbuat baik (beneficence)
3. Keadilan (justice)
Laporan Belmont menetapkan bahwa setiap
lembaga yang melakukan penelitian kesehatan
yang mengikutsertakan relawan manusia
sebagai subyek penelitian wajib memiliki
Komisi Etik Penelitian Kesehatan (KEPK)
 Ketiga prinsip etik dasar tersebut adalah sebagai berikut :
1. Prinsip menghormati harkat martabat manusia (respect for persons).
Prinsip ini merupakan bentuk penghormatan terhadap harkat martabat
manusia sebagai pribadi (personal) yang memiliki kebebasan
berkehendak atau memilih dan sekaligus bertanggungjawab secara
pribadi terhadap keputusannya sendiri.

Secara mendasar prinsip ini bertujuan untuk :

a. menghormati otonomi, yang mempersyaratkan bahwa manusia yang
mampu menalar pilihan pribadinya harus dihormati kemampuannya
untuk mengambil keputusan mandiri (self-determination), dan
b. Melindungi manusia yang otonominya terganggu atau kurang,
mempersyaratkan bahwa manusia yang berketergantungan (dependent)
atau rentan (vulnerable) perlu diberikan perlindungan terhadap kerugian
atau penyalahgunaan (harm and abuse)
 lanjutan ......................
2. Prinsip berbuat baik (beneficence) dan tidak merugikan (non
malefincence)
Prinsip etik berbuat baik menyangkut kewajiban membantu orang
lain dilakukan dengan mengupayakan manfaat maksimal dengan
kerugian minimal.

Prinsip etik berbuat baik, mempersyarakatkan bahwa :

a. Resiko penelitian harus wajar (reasonable) dibanding manfaat yang
diharapkan.
b. Desain penelitian harus memenuhi persyaratan ilmiah (scientifically
sound)
c. Para peneliti mampu melaksanakan penelitian dan sekaligus mampu
menjaga kesejahteraan subyek penelitian, dan
d. Diikuti prinsip do no harm (non maleficence – tidak merugikan) yang
menentang segala tindakan yang dengan sengaja merugikan subyek
penelitian.
 lanjutan ...........................................................

3. Prinsip keadilan (justice)

Prinsip etik keadilan mengacu pada kewajiban
etik untuk memperlakukan setiap orang (sebagai
pribadi otonom) sama dengan moral yang benar
dan layak dalam memperoleh haknya.
Prinsip etik keadilan terutama menyangkut
keadilan distributif (distributive justice) yang
mempersyaratkan pembagian seimbang
(equitable), dalam hal beban dan manfaat yang
diperoleh subyek dari keikutsertaan dalam
penelitian.
Ethical Principles that apply to research involving human participants
as Establish in The Belmont Report (Ruoco, J, 2011)

Respect for Persons Beneficence Justice

Acknowledge and Do no harm Risks associated

respect an with research are
individual’s distributed across
autonomy groups
Maximize possible
benefit
Individuals with One group will not
diminished solely bear the risks
autonomy are Minimize harm of developing
entitled to additional therapeutic
protection interventions that
will ultimately benefit
a different group
 Contemporary Foundational Principles
(cit.Piantadosi, 2005)

Principles of biomedical ethics imply several

contemporary requirements for the ethical conduct of
research (Wells, 1992). These include :
1. informed consent of the participants,
2. assessment and disclosure of risks and benefits, and
3. appropriate selection of research subjects.
In today’s practice, application of these principles
requires other components such as :
1. optimal study design,
2. investigator competence,
3. a balance of risk and benefit for study participants,
4. patient privacy, and
5. impartial oversight of consent procedures. (Sieber, 1993)
 continued.....

The best synthesis of these ideas is given by Emanuel et al.

(2000), who provided requirements for evaluating the ethics of
clinical research studies. (cit.Piantadosi, 2005)
Ethical Clinical Trials
 Collaborative partnership
 Scientific value
 Scientific validity
 Fairness of subject selection
 Favorable risk – benefit
 Independent review
 Informed consent
 Respect for enrolled subjects
 Ethical Clinical Trials

 Collaborative partnership. A collaborative patnership implies that

the research involves the community in which it takes place.
Members of the community participate in planning, oversight, and
use of research results.

 Scientific value. If the study has scientific value, useful knowledge

will be derived from the research. This means not only that the
question of importance but also that the results will be made
available to society at large whether “positive” or “negative”
 continued.....

 Scientific validity. Is a consequence of good study design, and

means that patients on a trial are contributing to answering a
question that is important and that has a high chance of being
answered by the experiment being undertaken.

 Fairness of subject selection. In recent times participation in

research has been viewed increasingly as a benefit or a right
 continued.....

 Favorable risk – benefit. The assessment of risk and benefits

implies that the research is properly designed and has had
competent objective review. If a alternative ways of providing the
anticipated benefits to the patient without involving research are
known, they must be chosen. Investigators must distinguish between
the probability of harm and the severity of the effect.

 Independent review. Review of proposed and ongoing research

studies is performed by institutions through the Institutional Review
Board (IRB)
 continued.....

 Informed consent. Informed consent is a complex but important

aspect of the practice and regulation of clinical trials. The
requirement for consent is grounded in moral and legal theory and
clinical practice.

 Respect for enrolled subjects. Respect for subjects pertains to the

way that potential participants are approached and given options, as
well as the ongoing engagement of those who agree to participate in
the study. One feature of respect is privacy. Second is allowing
participants to change their mind and withdraw from the trial without
incurring penalties. Third, the new information gathered from the
study must be made available to participants, perhaps during the
course of the trial.
 Model of the research process
STEP 1
Identify the
STEP 5 Research Question
Communications
Identify the
Research problem
Report findings
Suggestion for
Further study
Review of literature
Theoretical
framework

Identify variable

STEP 4
Data Analysis
State hypotheses
Interpret findings Specify purpose
STEP 2
Design the study

Design the protocol

Choose a sample
Analyze data

STEP 3
Methods

Collect data :
Reduce data (Portney & Watkins, 2009)
 Differences which Distinguish Ethical Principles
Application in Research from Service

Physicians in clinical practice/service have a duty to promote the

medical best interest of patients by offering optimal medical care. In
clinical research, physician-investigators are not offering personalized
medical therapy for individual patients. They seek to answer clinically
relevant scientific questions by conducting experiments that test the
safety and efficacy of treatments in groups of patients. Treatment in
clinical practice is based on an individualized assessment of what is
best for a particular patient.
Owing to these fundamental differences in purpose and process,
the ethics of clinical research is not identical to the ethics of clinical
research/service.
Core to the practical applications of ethical principles of clinical
ethics in clinical service, is the ability to identify and analize an ethical
question and to reach a reasonable conclusion and recommendations
for action.
 Core to the practical applications of ethical principles
in research setings is the responsibility in balancing
risks and benefits. (Derenzo and Moss, 2006)
This responsibility is shared among investigators, oversight
bodies, and any professional and/or surrogate involved in
the performance of a research study with human subjects.
The balance between risks and benefits must always be
tipped in favor of protecting the rights and welfare of
individual study participants.