Introduction to Research Ethics

Dr. Amalia Muhaimin, MSc.

Department of Bioethics; Health Research Ethics Committee (KEPK)
Faculty of Medicine, Universitas Jenderal Soedirman
 Branches of Bioethics

Public
health
ethics
Medical Clinical
ethics ethics

Bioethics

Bioethics Research
education ethics
Environ-
mental
ethics

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 Learning objectives

At the end of this course, students are expected to be able to:

1. Explain the historical background and development of research ethics
2. Explain current ethical guidelines in research involving human
subjects and animals
3. Explain various forms of research misconducts
4. Explain the basic principles in research ethics
5. Explain the importance of ethical review in research
6. Understand the role and function of research ethics committees
7. Construct an informed consent form for their own research involving
human subjects

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 What do you know about research ethics?

Do you know of any

issues on research ethics
in Indonesia?

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 The Case of H5N1 NAMRU 2 Indonesia
(2005 2009)

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 1. Historical Background and Development

Ibnu Sina (Avicenna)

(980-1037)
Introduced
experimentation into
medicine and the idea of
a set of rules for testing
the effectiveness of
treatments

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 Avicennas Cannon
1. The drug must be free from any extraneous accidental quality
2. It must be used on a simple, not a composite, disease
3. The drug must be tested with two contrary types of disease,
because sometimes a drug cures one disease by its essential
qualities and cures another by its accidental ones
4. The quality of the drug must correspond to the strength of the
disease
5. The time of action must be observed, so that essence and
accident are not confused
6. The effect of the drug must be seen to occur constantly or in
many cases, for if did this not happen, it was an accidental effect
7. The experimentation must be done with the human body, for
testing a drug on a lion or a horse might not prove anything about
its effect on men

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 NAZI Human Experimentations
1. Experiments on twins
2. Bone, muscle, and nerve transplantation experiments
3. Head injury experiments
4. Freezing experiments
5. Malaria experiments
6. Mustard gas experiments
7. Sulfonamide experiments
8. Sea water experiments
9. Sterilization experiments
10. Experiments with poison
11. Incendiary bomb experiments
12. High altitude experiments

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 The Nuremburg Trials (1946-1947)
To prosecute the accused Nazi
doctors

A list of ethical guidelines for

the conduct of research The
Nuremberg Code

The Nuremberg Code consisted

of ten basic ethical principles
that the accused violated.

Birth of modern research ethics

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 The Nuremburg Code
1. Participants must voluntarily consent to research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death
are potential outcomes
6. The degree of risk taken with research participants cannot exceed
anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at
any time
10. Scientists must be prepared to terminate the experiment if there is
cause to believe that continuation will be harmful or result in injury or
death

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 The Tuskegee Syphilis Study

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 The Tuskegee Syphilis Study
(Black Men in US; 1932 - 1972)
1932 Study starts. Black men with syphilis are enrolled
told to be treated, but not treated in actuality Not treating
is hypothesized as giving some medical benefits.
Penicillin not yet found
1945 Penicillin accepted as treatment of choice for syphilis.
1947 USPHS establishes "Rapid Treatment Centers" to treat
syphilis; men in study are not treated, but syphilis declines.
1969 CDC reaffirms need for study and gains local medical
societies' support
1972 Study ends.
1973 Congress holds hearings and a class-action lawsuit is
filed on behalf of the study participants.

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 The Helsinki Declaration
Developed by the World Medical Association (WMA)

Revised and updated periodically since 1964 last update in

October 2013 during the 64th WMA General Assembly,
Fortaleza, Brazil

Basic ethical principles for conducting biomedical research

Contains all the basic ethical elements specified in the

Nuremberg Code but then

Advances further guidelines specifically designed to address

the unique vulnerabilities of human subjects

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 The unique principles developed within the Helsinki
Declaration:

The necessity of using an independent investigator to review

potential research projects
Employing a medically qualified person to supervise the
research
The importance of preserving the accuracy of research
results
Suggestions on how to obtain informed consent from research
participants
Rules concerning research with children and mentally
incompetent persons
Evaluating and using experimental treatments on patients
The importance of determining which medical situations and
conditions are appropriate and safe for research

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 Research with animals
Why use animals?
Testing new pharmaceuticals,
Teaching tools for medical students,
Experimental subjects for new surgical procedures, etc.

The Animal Welfare Act in 1966 (last revised in 2006):

1. Insure that animals for use in research are provided humane
care and treatment
2. Assure the humane treatment of animals during transportation
in commerce;
3. Protect the owners of animals from the theft of their animals
by preventing the sale/use of animals which have been stolen

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 Research Misconduct
Defined as fabrication, falsification, or plagiarism in:
- proposing,
- performing,
- reviewing research,
- reporting research results
(US Office of Science and Technology Policy, 2000)

Research misconduct does not include honest error or

differences of opinion.

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 Fabrication is making up data or results and recording or
reporting them.

Falsification is manipulating research materials, equipment,

or processes, or changing or omitting data or results such that
the research is not accurately represented in the research
record.

Plagiarism is the appropriation of another persons ideas,

processes, results, or words without giving appropriate credit.

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 Basic principles in research ethics

1. Beneficence
Benefits must outweigh risks
2. Respect for Autonomy
To respect each participant capability of making an informed decision
Full disclosure of the study: risks, benefits & alternatives
Other principles related: privacy, confidentiality, vulnerability
Finds expression in the informed consent document
3. Justice
Ensure equal and fair opportunities for participants to receive maximum
benefits and minimum risks

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 Ethical review (telaah etik)
Institutional Review Board (IRB) = Research Ethics Committee (REC)
Komisi Etik Penelitian (Kesehatan) KEPK
What are the role and functions of an IRB/REC?
(fk.unsoed.ac.id KEPK)
Ethical approval = persetujuan etik
Ethical clearance = kelayakan etik
surat atau dokumen yang menyatakan bahwa sebuah rancangan penelitian
(berupa proposal atau protokol penelitian) telah memenuhi kaidah-kaidah
etik penelitian

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 Ethical review

Scientific review methodology

Ethical review methodology AND ethical aspects:
1. Risk and Benefit
2. Respect for Autonomy
3. Fairness/Justice
4. Confidentiality
5. Conflict of Interest

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 Informed Consent

Persetujuan Tindakan Medik (PTM)

Persetujuan Setelah Penjelasan (PSP)
Lembar Informasi + Lembar Persetujuan/Kesediaan
Lembar Informasi dan Kesediaan

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 Informed consent form
1. Purpose of the study
2. Voluntary participation
Your participation in this study is voluntary. You are free to not participate
at all or to withdraw from the study at any time despite consenting to
take part earlier.
3. Duration, procedures of the study and participants responsibilities
4. Potential benefits
5. Risks, hazards and discomforts
6. Reimbursements
7. Confidentiality
8. Clarification list of persons with contact details
9. Proof of consent signature from participant and informer

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 Assignment Block 5.2
Praktikum I : Menyusun informed consent form dan mendiskusikannya
dengan kelompok
Tugas mahasiswa:
Menyusun dokumen informed consent dari penelitian masing-masing atau
mencari informed consent form dari skripsi kakak tingkat (angkatan 2001-
2005) di Perpusatakaan FK Unsoed, bila penelitian tidak melibatkan subjek
manusia
Mencetak dan memperbanyak dokumen informed consent milik masing-
masing untuk dibagikan kepada teman kelompok dan tutor.
Mendiskusikan hasil review dengan tutor dan teman kelompoknya
Praktikum II : Menyampaikan informed consent kepada orang awam
Tugas mahasiswa:
Berpraktik menyampaikan informed consent kepada orang awam
Menerima masukan dari teman kelompok dan tutor tentang performanya

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