ETHICAL ISSUE IN HEALTH

RESEARCH
LAYOUT
 Introduction
 History The Development Of Research Ethics
 Institutional Ethics Committee Responsibilities
 Protocol Review
INTRODUCTION
 Humans  Best Creature, Khalifah
 All Research involving humans should be conducted to
the highest possible ethical standards
 Ethical guidelines need to be updated  new challenges
(development of science and technology, especially the
development biomolecular technology)

The diagnosis and treatment in medicine

HISTORY THE DEVELOPMENT OF
RESEARCH ETHICS
Nuremberg Military Tribunal and
Nuremberg Code(1947)
 In the aftermath of world war II ( in Nuremberg ):
 23 Nazi Doctors and Administrators  “Brutal
Experiment” to 1.750 victims from Concentration
Camp Prisoners

 Hundreds death victims were used to be sceleton

collection for anthropological studies
 Various studies :
 High – altitude / Low pressure experiment
 Freezing experiment
 Malaria experiment
 Mustar gas experiment
 Sulfanilamide experiment
 Typhus experiment
 Poison experiment
 Incendiary bomb experiment
 Sterilization experiment; chemicals/ X-ray

After above studies, followed by other studies

“The Nuremberg Code”(1947)

Nuremberg Code
 Nuremberg Code Consisted 10 (ten) Research Ethical
Code :
1. Human research participant’s voluntary consent is an
absolute and essential.
2. The output of the study has benefits for the wellbeing
of the community, and can not be achieved by the
other study methods
3. The study should be developed based on the animal
before this study will be carried out.
4. The study will be carried out without any physical and
mental sufferings
5. The study will be carried out without any disablement
or death, or if the medical researcher(s) in this studies
also as the subjects.
 Nuremberg Code
6. The level of possible risks compare to the human beneficiants from
the research question(s) that should be answered.
7. Preparation of the study should be facilitated appropriately to protect
from the possible disablement, disability and death.
8. The study should be carried out by some one who fulfill the scientific
criteria, thoroughful, skillful, needed in each step of the study.
9. During the study, human subjects have their freedom to choose to
stop or to continue in each step of the study, if their physical or
mental condition is not possible to continue as the research subjects
10. During the study, the researcher in duty, he or she ready to stop in
each step of the study, if he or she is not be trusted , if a thorough
consideration is needed, if the study will be continued, disablement,
disabilities and death of the human subject will be happened
TUSKEGEE STUDY
 Syphilis study
 In 1932 Macon County, Alabama
 To study the natural development of Syphilis, on
American – African males, without any treatment, even
at that time anti syphilis has been on hand
 In 1972 The Secretary Of Department of Health,
Education, and Welfare stopped the study

“Tuskegee study Exemplified a pattern of

Institutionalized Racism in Health Care“
 Between 1950-1960  the number of
researches was very high
 Thalidomide,
 Willowbrook
 and Tuskegee
professional code in human participants with
minimum protection to the human subjects.
 “Experimentation on Man“

( Henry Beecher, 1959)

wrote a statement : “It is unethical and immoral
to carry out a potentially dangerous experiment
without the subject’s knowledge and consent“
 USA Presidential Commission on Bioethics,
invited Bioethicist, Philosophers, Lawyers,
Sociologist, Anthropologist, Psychologist, and
Physicians, etc. to develop “The Basic Principles
of ethics“

As a result

“The Basic Ethical Principles and the Applications

as Outline is the Belmont Report“,
Click icon to add picture
 THE DECLARATION OF HELSINKI
• Ethical Principle for Medical Research Involving
Human Subject
 Basic Principles for all Medical Research (2000)

 ETHICAL LESSON from Unit 731’s Human Experiment

 CIOMS (2016)
• Council for International Organizations of Medical
Sciences
 Guidelines CIOMS (2016)
1. Social Value
2. Research conducted in low- resources settings
3. Equitable distribution of benefits and burdens
4. Potential benefits and risk of research
5. Choice of control in clinical trials
6. Caring for participants health needs
7. Community engagement
8. Collaborative partnership and capacity building
9. Individual informed consent
10. Modification and waivers of informed consent
11. Use of stored biological materials and related
data
12. Use of health – related data in research
13. Reimbursement and compensation for research
participants
14. Treatment and compensation for research – related harms
15. Research involving vulnerable person
16. Research involving individual’s who are not capable of
giving informed consent
17. Research involving children and adolescents
18. Women as research participants
19. Pregnant and lactating women as research participants
20. Research in disaster situation
21. Implementation research
22. Use of online information or tools in health – related
research
23. Requirements for establishing research ethics
committeesand their review of protocol
24. Public accountability for health – related research
25. Conflict of interest
INSTITUTIONAL ETHICS COMMITTEE
RESPONSIBILITIES
GOOD CLINICAL PRACTICE
 Protocol,
 Investigators,
 Research facility ,
 Sponsor,
 Monitor,
 IRB/IEC,
 Regulators
Ethics Committee Responsibilities
 Melindungi martabat, hak, keamanan dan
kesejahteraan semua subyek dalam penelitian
yang melibatkan manusia (principles of ethics)

Perhatian Penelitian yang melibatkan

khusus vulnerable subjects

Vulnerable subjects

Bayi dan anak-anak, lanjut usia, penderita

gangguan jiwa, tahanan
BASIC PRINCIPLES OF ETHICS
1. Respect for person
 Memperlakukan manusia  autonomous
agents (memiliki hak untuk memerintah
sendiri)
 Melindungi mereka yang less autonomy
(vulnerable populations)  anak-anak,
narapidana, lansia, pasien yang menderita
gangguan jiwa

Informed consent, kerahasiaan, sukarela,

hak mengundurkan diri, melindungi privasi
BASIC PRINCIPLES OF ETHICS
2. Beneficence
 Do no harm
 Besar manfaat dibanding dengan resiko
penelitian
 Dilakukan bukan karena mengharap imbalan

Pertimbangan risiko-manfaat, memaksimal-

kan manfaat, meminimalkan risiko, menjaga
kesejahteraan(kompensasi, asuransi, bebas
dari pemeriksaan klinis dan lab dll)
BASIC PRINCIPLES OF ETHICS
3. Justice
 Hak dan kewajiban
 Manfaat dan resiko

Pemilihan subyek dan cara pendistribusian

antar kelompok sebisa mungkin menghindari
subyek yang rentan
Ethics Committee - OBLIGATIONS
 Melaksanakan review protokol penelitian
(proposal) yang melibatkan manusia sebelum
dimulainya penelitian
 Evaluasi etika penelitian yang sedang
berlangsung
Ethics Committee - OBLIGATIONS
 Review protokol penelitian (proposal) yang
melibatkan manusia
 Meminta informasi dari peneliti untuk
memperjelas protokol (tertulis atau presentasi)
 Minta pendapat dari ahli yang tidak ada di
IRB/ERC untuk memecahkan masalah dalam
pembuatan keputusan
 Memutuskan untuk merevisi protokol, atau
menolak atau memberikan ethical clearance
 Evaluasi etika penelitian yang sedang
berlangsung
PROTOCOL REVIEW
PROTOCOL REVIEW
 Research backgounds,
 Aims of the research,
 Research design,
 Subject criterias (inclusion, exclusion,
withdrawn),
 Sample size (scientific calculation),
 Research data collecting (detail of procedure),
 The length of study,
 Subject protection,
compensation, insurance, free for clinical -
laboratory examination and medicine.
PROTOCOL REVIEW
 Benefit – risk analysis,
 Informed consent taking process,
 Tract records of PI and all member of
researchers,
 Supporting staff qualification,
 Other aspects :
 budgeting statement,
 afiliated institutions,
 conflict of interest,
 acces for therapy after the completition of
the research
FULL BOARD REVIEW
 Clinical trials
• Phase-1 (first applying to human – patients),
• Phase-2 (open trial),
• Phase-3 (RCT, multi-centre),
• Phase-4 (trial on safety aspect of marketed
drugs),
 Research involving vulnerable subjects (baby,
children, pregnant woman, elderly, mental illness
patients, prisoners)
 Research on TBC, Leprosy, HIV –AIDs  negative
stigma
 Researh on genetics
SUMMARY
 Nuremberg Code, Belmont Report, Declaration
of Helsinki, and CIOMS as the foundation
ethics in medical research
 The ethical principles developed by time
 The ethical principles should be learned and
discussed seriously
 Kata kunci : human research participant, rights,
dignity and integrity; the professionalism of
researchers, ethical research Committee
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