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.

2.

Kewajiban menghormati kesediaan dan

pengorbanan : partisipasi sebagai subjek
penelitian
Melindungi kehidupan, kesehatan dan
keleluasaan pribadi (privacy) dan martabat
(dignity) subjek 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 (Dorlands 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.
2.
3.

Menghormati harkat/martabat manusia

(respect for persons)
Berbuat baik (beneficence)
Keadilan (justice)

Laporan Belmont menetapkan bahwa setiap

lembaga yang melakukan penelitian kesehatan
yang mengikutsertakan relawan manusia
sebagai subjek 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

maleficence)
Prinsip etik berbuat baik menyangkut kewajiban membantu orang
lain dilakukan dengan mengupayakan manfaat maksimal dengan
kerugian minimal.
Prinsip etik berbuat baik, mempersyaratkan bahwa :
a.
b.
c.
d.

Risiko penelitian harus wajar (reasonable) dibanding manfaat yang

diharapkan.
Desain penelitian harus memenuhi persyaratan ilmiah (scientifically
sound)
Para peneliti mampu melaksanakan penelitian dan sekaligus mampu
menjaga kesejahteraan subjek penelitian, dan
Diikuti prinsip do no harm (non maleficence tidak merugikan) yang
menentang segala tindakan yang dengan sengaja merugikan subjek
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 subjek 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
respect an
individuals
autonomy

Risks associated
with research are
distributed across
groups

Do no harm

Maximize possible
benefit

Individuals with
diminished
Minimize harm
autonomy are
entitled to additional
protection

One group will not

solely bear the risks
of developing
therapeutic
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.
2.
3.

informed consent of the participants,

assessment and disclosure of risks and benefits, and
appropriate selection of research subjects.

In todays 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

(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.