Literature Reading

RESEARCH ETHICS

Pudyastuti Rachyanti

Supervisor : Dr.dr. Ratna Anggraeni A., M.Kes., Sp.T.H.T.K.L.(K).

Department of Otorhinolaryngology,Head and Neck Surgery

Hasan Sadikin General Hospital – Padjajaran University
Bandung
2020
Medical Ethics Research

Research
Large amount of Deviation of supervisor with
research Ethical Codes human as
objects

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
History
Nurenberg Code
• As reactions to cruel experiments by Nazi  The Doctor’s trial
• Protect the integrity of research subjects,
• Establish requirements to ethically carry out health research by involving
humans as research subjects
• Voluntary consent from human subjects
Universal Declaration of Human Rights (1948)
• Stipulated by the general assembly of united nations

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
History
The International covenant on Civil & political Rights (1966)
• No one shall be subjected or to cruel, inhuman, degrading treatment or punishment. In
particular, no one shall be subjected without his free consent to medical or scientific
experimentation
Declarations of Helsinki I
• World Medical Association (1964)
• Ethical principles for medical research involving human subjects
• A guide for doctors who conduct clinical research

Violation of Ethics  Tuskesgee Study (1930-1972)

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
 Declaration of Helsinki I

Medical journal editors are advised not to load articles research

that uses human as subjects without informed consent. Except: Results
Resultswill
will
1. Subject can’t give consent have a positive
have a positive
2. Medical record
3. Sample has been preserved and can not trace to its source impact
impact

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
Principles of Ethics
The Belmont Reports (1976)
• Self determination
• Dependable or vulnerable human beings (vulnerable)
Respect For Persons need to be protected against loss or abuse (harm and
abuse).
• Reasonable Scientifically
Beneficence & Non- sound
Maleficence • Take care of well being Do no harm
• Distributive justice and equitable
Justice • Vulnerability
The Development of Research Ethics
• Operational guidelines for ethics committees that review biomedical research
• Key guidelines for forming a health research ethics commission and determining
WHO working procedure
2000
• The international ethical guidelines for biomedical research involving human
subjects
CIOMS
2002

• The international guidelines for ethical review of epidemiological studies

CIOMS
2008
Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar
Metodologi Penelitian Klinis. Edisi ke 4. Jakarta: Sagung Seto. 2011
The Implementation of Medical Research
Ethics
World Health Assembly (Tokyo-1975)  Declaration of
Helsinki II

Regulations that requiring human research protocols are first

reviewed by a committee for consideration, guidance, and
comment

It must be stated in the protocol that ethical considerations have

been made and the results of the study should not be published if
there is no ethical clearance  Research ethics committee
 Research Ethics Committee
◦ In line with the committees at the international level, then at the national level in various
countries committees were formed and made ethical rules for medical research
The united states public health service (1966)  a set of
rules regarding research that uses humans as subjects.

Revision in 1971 & 1974  ethical review in human as

subject

National commission for the protection of human

subjects of biomedical and behavioral research (1974)

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
Research Ethics Committee
◦ Canada : The medical research council of Canada (1966)  Local review committee
◦ In its development now it is also required to study the research design and methodology;
which is called scientific review
◦ The medical research council of Canada (1976)  The working group of human
experimentation : in charge of reviewing the old rules and making recommendations
◦ The Working Group formulates recommendations so that in each institution a central
committee formed for scientists and non-scientists who can judge norms in society.
◦ Germany  scientific board and government

Oemijati, Samsudin, Assin, Tamaela, Nasar. Penerapan etika dalam penelitian. Dalam: Sastroasmoro, Ismael, editor. Dasar-Dasar Metodologi Penelitian Klinis.
Edisi ke 4. Jakarta: Sagung Seto. 2011
Health Research Ethics Commission
WHO : an independent commission in a country, consisting of health
WHO : an independent commission in a country, consisting of health
professionals and non-medical members, is responsible for protecting
professionals and non-medical members, is responsible for protecting
the rights, security and welfare of the human subjects involved in the
the rights, security and welfare of the human subjects involved in the
trial and for providing guarantees of public protection which, by,
trial and for providing guarantees of public protection which, by,
among other things, express their opinions at the protocol decision
among other things, express their opinions at the protocol decision
session, the suitability of the researchers and the adequacy of the
session, the suitability of the researchers and the adequacy of the
facilities, and on the methods and documents that will be used to
facilities, and on the methods and documents that will be used to
inform the subject of the experiment and obtain approval
inform the subject of the experiment and obtain approval

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
The Role of Health Research Ethics
Commission
◦ Protect and support human autonomy as both candidates and research subjects;
◦ Protect the welfare of candidates and research subjects and;
◦ Balancing a number of relevant moral considerations when considering
research proposals / protocols, including respecting autonomy, protection and
enhancing their welfare.

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Health Research Ethics Commission
Institution Standards
1. Responsibility for establishing a health research ethics review system
2. Composition of Members of the Health Research Ethics Commission
3. Health Research Ethics Commission resource
4. Health Research Ethics Commission independence
5. Training for Health Research Ethics Commission member
6. Transparancy, accountability, and quality of Health Research Ethics Commission
7. Ethical criteria for decision making in Health Research Ethics Commission

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Research Ethics Standard for
Researcher
Before Research
Competent in the field of research topics

Human subject  scientific qualification, medical

officer

Understand health research ethical standard

Risk and burden assesment

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Research Ethics Standard for
Researcher
Before Research
Minimize risk

Protecting the subjects

According to the agreed protocol

Only legally justified animals can be used for research.

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Research Ethics Standard for
Researcher
During Research
Application of ethical research studies protocol

Conduct research according to the agreed protocol

Not making changes to the protocol without approval

Report if there are changes in the research location

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Research Ethics Standard for
Researcher
During Research

Report on research safety

Report on research progress and follow

up

Information to the subjects during the

study
Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Research Ethics Standard for
Researcher
After Research

Report if research is complete

Publish result of the research

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Cathegory of Ethical Offense
Abstract w/
Fabrication Authorships no data

Conflict of
Falsification Redundant interest

Cause Effect/
Plagiarism Correlation

Kementerian Kesehatan Republik Indonesia. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan. 2017.
Conclusion
◦ In connection with international declarations then in various ways the country also has
regulations or codes of ethics medical research and management committees research in terms
of ethics
◦ Ethical issues are not static; he always develops according to the progress of the times. That is
why there are scientific journals that specialize in the ethical problems of medical research.
Committee or commission The application of ethics in medical ethics research itself, as one
element of scientific development must be open to accept criticism from anywhere for
improvement in the future.
THANK YOU

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