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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.2002) . (Derenzo and Moss. typically focusing on individual cases. 2006) Clinical ethics is defined as the process of dealing with the day-to-day moral decision-making of those caring for patients. and seeking to determine what should be done here and now with a particular patient. (Eggertsson.

Medical Ethics is the rules or principles governing the professional conduct of physicians (Dorland’s Med. 1993) . (Garrett TM. Bailie HW. Dictionary 1974) Ethics is that branch of philosophy that seeks to determine how human actions may be judged right or wrong. Garrett RM.

2006) Because applied ethics focuses on what “ought” to be done in a particular set of circumstances.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. Siegler. (Jonsen.clinical research ethics focuses on what “ought” to be done in research involving human subjects . 2010) The goal of clinical research is to obtain scientifically valid data efficiently while protecting research participants. (Derenzo and Moss. Winslade.

3. KemKes. 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) .Prinsip Etik Dasar (PED) penelitian berdasarkan laporan Belmont (Ruoco J. 2011. 2. 2011) 1..

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. yang mempersyaratkan bahwa manusia yang mampu menalar pilihan pribadinya harus dihormati kemampuannya untuk mengambil keputusan mandiri (self-determination). Prinsip menghormati harkat martabat manusia (respect for persons). mempersyaratkan bahwa manusia yang berketergantungan (dependent) atau rentan (vulnerable) perlu diberikan perlindungan terhadap kerugian atau penyalahgunaan (harm and abuse) .Ketiga prinsip etik dasar tersebut adalah sebagai berikut : 1. dan b. menghormati otonomi. Melindungi manusia yang otonominya terganggu atau kurang. Secara mendasar prinsip ini bertujuan untuk : a.

.... Risiko penelitian harus wajar (reasonable) dibanding manfaat yang diharapkan. b.. 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. d.... .. lanjutan 2.. Desain penelitian harus memenuhi persyaratan ilmiah (scientifically sound) Para peneliti mampu melaksanakan penelitian dan sekaligus mampu menjaga kesejahteraan subjek penelitian........ c.. dan Diikuti prinsip do no harm (non maleficence – tidak merugikan) yang menentang segala tindakan yang dengan sengaja merugikan subjek penelitian. mempersyaratkan bahwa : a...

.............lanjutan ............. Prinsip etik keadilan terutama menyangkut keadilan distributif (distributive justice) yang mempersyaratkan pembagian seimbang (equitable)............ 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.. ............. 3... dalam hal beban dan manfaat yang diperoleh subjek dari keikutsertaan dalam penelitian........

J. 2011) Respect for Persons Beneficence Justice Acknowledge and respect an individual’s 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 .Ethical Principles that apply to research involving human participants as Establish in The Belmont Report (Ruoco.

and appropriate selection of research subjects. 3. 2. (Sieber. 2. 1993) . and 5. informed consent of the participants. a balance of risk and benefit for study participants.Contemporary Foundational Principles (cit. In today’s practice. patient privacy. application of these principles requires other components such as : 1. 4. optimal study design. 2005) Principles of biomedical ethics imply several contemporary requirements for the ethical conduct of research (Wells.Piantadosi. investigator competence. 3. These include : 1. impartial oversight of consent procedures. 1992). assessment and disclosure of risks and benefits.

The best synthesis of these ideas is given by Emanuel et al..continued.. (2000). who provided requirements for evaluating the ethics of clinical research studies. (cit. 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 .Piantadosi...

oversight. Members of the community participate in planning.Ethical Clinical Trials  Collaborative partnership. A collaborative patnership implies that the research involves the community in which it takes place. 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” . and use of research results. If the study has scientific value.  Scientific value. useful knowledge will be derived from the research.

 Scientific validity. 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 . Is a consequence of good study design..continued...

 Independent review.continued...  Favorable risk – benefit.. they must be chosen. Review of proposed and ongoing research studies is performed by institutions through the Institutional Review Board (IRB) . If a alternative ways of providing the anticipated benefits to the patient without involving research are known. Investigators must distinguish between the probability of harm and the severity of the effect. The assessment of risk and benefits implies that the research is properly designed and has had competent objective review..

..continued. Second is allowing participants to change their mind and withdraw from the trial without incurring penalties. perhaps during the course of the trial.. .  Respect for enrolled subjects. as well as the ongoing engagement of those who agree to participate in the study. The requirement for consent is grounded in moral and legal theory and clinical practice.  Informed consent. One feature of respect is privacy. Informed consent is a complex but important aspect of the practice and regulation of clinical trials.. the new information gathered from the study must be made available to participants. Respect for subjects pertains to the way that potential participants are approached and given options. Third.

2009) .Model of the research process (Portney & Watkins.

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. the ethics of clinical research is not identical to the ethics of clinical research/service. 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. is the ability to identify and analize an ethical question and to reach a reasonable conclusion and recommendations for action. Owing to these fundamental differences in purpose and process. . In clinical research. physician-investigators are not offering personalized medical therapy for individual patients. Core to the practical applications of ethical principles of clinical ethics in clinical service.

and any professional and/or surrogate involved in the performance of a research study with human subjects. oversight bodies. The balance between risks and benefits must always be tipped in favor of protecting the rights and welfare of individual study participants.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. .