1. Ethics in Medical Research
Tri setyawati
Biokimia
PSPD FKIK UNTAD

2. Current Medical Research
Xeno-transplant
Bio-molecular basis
Cloning technology
Therapeutic cloning
Embryonic
Adult stem cell
Reproductive cloning
Bio-robotic
etc

3. The development of research ethics code

4. Nuremberg and Helsinki
Nuremberg Code (1947)
Voluntary consent of the human subjects is absolutely essential
The experiment should yield “fruitful” results
Experiment based on results of animal experimentation or natural history to justify the experiment
Experiment should avoid all unnecessary physical/mental suffering/injury
No experiment where reason to believe that death/injury will occur

5. The degree of risk should never exceed the importance of the problem to be solved
Proper preparations/facilities to protect the subject
Experiment conducted only by science/qualified
Subject should be at liberty to end experiment
The scientist must terminate an experiment where there is probable cause to believe that injury, disability, or death will result

6. Declaration of Helsinki 1965
Declaration of Helsinki 1965 (World Medical Association)
Voluntary consent of the research participant
Independent review of the project
Assessment of the risk
Involvement of competent researchers of integrity and
Research merit

7. The Universal Declaration of Human Rights
1948 Sidang Umum PBB
The Universal Declaration of Human Rights
1966 The International Covenant on Civil and Political Rights Artikel 7
No one be subjected to torture or cruel, inhuman or degrading treatment or punishment. In particular no one shall be subjected without his free consent to medical or scientific experimentation

8. Tokyo
1975 Tokyo
Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication

9. 1982 Council of International Organizations of Medical Sciences (CIOMS )
The International Ethical Guidelines for Biomedical Research Involving Human Subjects I (1982) II (1993) III (2002)

10. 1995 World Health Organization (WHO)
Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products International Conference on Harmonization of Technical Requirement for Registration of Pharmaceutical for Human Use
menjadi
Good Clinical Practice (ICH-GCP)

11. 2000 World Health Organisation (WHO)
Operational Guideline for Ethics Committee that Review Biomedical Research

12. 2001 Badan Pengawas Obat dan Makanan (BPOM)
Cara Uji Klinik yang Baik (CUKB) Telah ditetapkan untuk dilaksanakan di Indonesia dengan Keputusan Kepala BPOM RI Nomor 02002/SK/KBPOM

13. 1995 PP RI No 39 tahun 1995 tentang Penelitian dan Pengembangan Kesehatan
Pasal 8
Penelitian dan pengembangan kesehatan terhadap manusia hanya dapat dilakukan atas dasar persetujuan tertulis dari manusia yang bersangkutan

14. Pasal 20
Barang siapa dengan sengaja menyelenggarakan penelitian dan pengembangan kesehatan tanpa persetujuan tertulis sebagaimana dimaksud dalam Pasal 8, dipidana dengan paling banyak Rp ,- (sepuluh juta rupiah)

15. 2002 Keputusan Menteri Kesehatan R. I
2002 Keputusan Menteri Kesehatan R.I. Nomor 1333/Menkes/SK/X/2002 tentang Persetujuan Penelitian Kesehatan terhadap Manusia
Disamping denda tersebut dapat dikenakan sanksi administratif

16. 2002 Komisi Nasional Etik Penelitian Kesehatan (KNEPK)
Dibentuk dengan Kepmenkes No. 1334/Menkes/SK/X/2002
2005 Pedoman Nasional Etik Penelitian Kesehatan
Telah ditetapkan berlakunya dengan Kepmenkes RI No.1031/ Menkes/SK/ VII/2005

17. Belmont Report Differentiate research and practice
"practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success

18. The Process in Biomedical Research
The presence of an treated problem generate a research need
Epidemiological
studies-Whos
is affected?
Health
problem in a
patient
Information obtained from basic research generate ideas for drugs, devices or techniques to treat the problem
Basic research-
What are the
mechanism?
A safe, effectice drugs, devices & treatments are used for treatment of problem
Drug/Medical
Device discovery
& development
Clinical trial-
Testing on
volunteer
Drug/Medical
Device testing-efficacy
& toxicity
Drugs, devices & treatments are tested for safety & efficacy-first in laboratory, then in animal finally in human volunteers
The entire process of initiation of project to development of a treatment may take many years and cost hundreds of millions of dollars
laboratory
animal
volunteer

19. The ethical researcher
"Many people say that it is the intellect which
makes a great scientist. They are wrong: it is
character." -- Albert Einstein

20. What is ethics? “The subject of ethics is best thought of as the
critical scrutiny of moral thought and morality as
it affects our ideas of right conduct”
Source: Campbell A, Gillett G, Jones G. Practical medical ethics. Auckland, Oxford University Press, 1992.

21. What is ethical human research?
Integrity
Respect for persons
Beneficence
Harm
Scientific adequacy
Justice
Informed Consent
Privacy and Confidentiality

22. Integrity of researchers
Commitment to advancement of knowledge
Commitment to pursuit and protection of truth
Commitment to rigorous scientific method
Honesty
Accountability to:
the institution and academic community
general community
individuals and groups who have a defined interest in the research
Komitmen terhadap kemajuan ilmu pengetahuan
Komitmen terhadap cita-cita dan menjaga kepercayaan
Komitmen dengan ketat terhadap metodologi ilmiah
Kejujuran
Bertanggung jawab terhadap ………………..

23. Enhancing ethical research
Awareness of, and adherence to, national standards and codes
Sound institutional policies and procedures
Transparent processes for approval and monitoring
Accessible mechanisms for handling complaints and investigations
Meningkatkat etik research

24. recognition of autonomy of individuals and groups
Respect for persons
recognition of autonomy of individuals and groups
regard for welfare, rights, beliefs, and customs
protection for people with diminished autonomy
1. MENGHORMATI SESEORANG (RESPECT FOR PERSONS) (a) MENGHORMATI OTONOMI
(b) MEMPERHATIKAN KESEJAHTERAAN, HAK, KEYAKINAN DAN KEBIASAAN (c) MELINDUNGI YANG OTONOMINYA TERGANGGU ATAU KURANG

25. avoiding harm and promoting well-being
Beneficence
avoiding harm and promoting well-being
maximise possible benefits and minimise possible harms to participants
2. KEMANFAATAN (BENEFICENCE) (a) MANFAAT MAKSIMAL, RISIKO MINIMAL (b) MEMENUHI PERSYARATAN ILMIAH (c) PENELITI MAMPU MENELITI & MENJAGA KESEJAHTERAAN SUBJEK PENELITIAN (d) NONMALEFICENCE, DO NO HARM

26. Harm Physical, psychological, social, cultural, financial
pain, discomfort, injury, adverse effects of drugs
anxiety, stress, guilt, embarrassment, loss of self-esteem
labelling, stigmatisation, discrimination
costs of participation, income or revenue loss
To individuals (participants or researchers) or to groups

27. Scientific adequacy
Research must be justifiable in terms of its potential contribution to knowledge.
Research design must account for/avoid biases in:
participant selection
data collection
data analysis
data interpretation
Researchers must have adequate expertise to conduct the project and analyse the data

28. Justice
within a population, the benefits of the research should be balanced against the burdens of the research
for each participant, a balance of burdens and benefits should be sought
3. KEADILAN (JUSTICE) (a) MEMPERLAKUKAN SETIAP ORANG DENGAN MORAL YANG BENAR DAN PANTAS SERTA MEMBERI SETIAP ORANG HAKNYA (b) DISTRIBUSI SEIMBANG DAN ADIL ANTARA BEBAN & MANFAAT KEIKUTSERTAAN

29. Informed consent
Provision of clear and coherent information to participants about purpose, methods, demands, risks, inconvenience, discomforts and possible outcomes (including publication)
Exercise voluntary choice to participate and to withdraw consent
Participant is competent to make that choice
Restricted circumstances for research without consent

30. Privacy and confidentiality
Individuals have a sphere of life from which they should be able to exclude any intrusion
Legal/ethical obligations to be observed when researcher receives information about another person
Safe storage of, and access to, data

31. Academic misconduct

32. Academic Misconduct • Cheating • Plagiarism
• Claiming the ideas of others as your own
• Falsifying data
• Interfering with the work of others

33. Cheating
• Getting help on a test, exam or assignment without explicit authorization from the instructor
• Giving help without explicit authorization
• Submitting the same work for two different classes without prior authorization from the instructor
Submitting the same work for more than one class may be permitted with prior authorization by both professors
Typically, a more substantial piece of work will be required in such cases

34. Plagiarism
• Using the words or ideas of others without explicit citation
• If you use the words of others, use quotation marks and reference the source
• If you use the ideas of others, make clear you are doing so and reference the source
It doesn’t matter if the work cited is published or unpublished, if it is the work of a friend, colleague, fellow student, professor, or anyone else
It doesn’t matter if your assignment is written or oral, you must still cite your sources

35. Claiming the Ideas of Others
• It is academic misconduct to claim to have originated ideas for research, interpretation, or other significant original thought
• It doesn’t matter if the other person is a friend, fellow-student, colleague, professor, or anyone else
• Use of others’ ideas in developing your own is allowable, as long as explicit credit is given for their contribution

36. Falsifying Data
• Falsifying or manipulating data to reach a desired conclusion is grave misconduct
• Falsifying data includes
– Selectively dropping cases or variables
– Making up data
– Selectively reporting or suppressing
results
Menyontek
Plagiat
Mengklaim ide orang lain
Memalsukan data
Interfensi kerja orang lain

37. Interfering With Others’ Work
• Altering, sabotaging, or otherwise interfering with the work of others

38. TERIMAKASIH
CONT…ETHICAL CLEARANCE