11/20/20

Etik Penelitian pada

Relawan Manusia
Wienta Diarsvitri, dr, M.Sc, Ph.D, FISPH, FISCM
Bagian Ilmu Kesehatan Masyarakat FK UHT
[email protected]
081316834913

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Course objective

´To understand how the ethical principles of research

involving human subjects have been developed and
evolved
´To know the basic ethical principles of research
involving human subjects
´To know the process to conduct ethical review

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3 Why is history important?

ETHICS

HISTORY

Those who fail to learn the mistakes from their

predecessor are destined to repeat it (Churchill)
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HISTORY

Example:

1932–1972 The Tuskegee syphilis study

1939–1945 The Nazi experiments
1950-1961 Thalidomide disaster

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5 The Tuskegee Syphilis study

´ Researcher :
US Public Health Service & Tuskegee Institute
´ Periode : 1932-1972 (40 th)
´ Objective : to document natural history of
syphilis in African-American men
´ Subjects : 600 men with and without syphilis
´ Men were denied antibiotics (1940-1943: Penicillin)
´ Problems :
No informed consent, deception, withholding available
treatment, disease transmission & death

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The Tuskegee Syphilis study

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Syphilis
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Nazi medical experiments

´Researcher : Nazi
´Periode : 1933-
´Subjects : > 6 millions sub-humans in Nazi
concentration camps (extermination or experiment)
´Experiments : Freezing victims for hypothermia
experiments, famine experiments, tuberculosis
experiments, typhoid experiments, malaria experiments, etc
´Problems : No informed consent, illegal procedures, lead
to death

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Nazi medical experiments

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Famine experiments Hypothermia experiments

Tuberculosis experiments
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Typhoid experiments

10 Thalidomide
´ Released in 1950 as anti-emetic to treat morning
sickness
´ Samples of thalidomide had been freely
distributed to physician’s office, prior to testing
´ Thalidomide had been studied in mice, but mice
were less sensitive to it.
´ 1961 thalidomide caused the largest man-made
medical disaster in history
´ >10,000 severe birth defects in children
´ Increase miscarriage rates
´ Thalidomide disaster lead to drug testing reforms
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The development of research ethics

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´1946 Nuremberg Code

´1949 Declaration of Human Rights
´1964 Declaration of Helsinki
´1966 Beecher Report
´1979 Belmont Report
´1982 International Guidelines on Research
Ethics (Council for International
Organization of Medical Sciences CIOMS)
´1991 International Guidelines for Ethical
Review of Epidemiological Studies (CIOMS)
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Nuremberg Code

´1946
´When is research criminal ?
´Only addresses research on normal subjects
´The beginning of codification of research regulation
´Need for scientific merit, informed consent, right to
withdraw, risk/benefit judgement

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17 The Belmont Report

´1979
´Writer : National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research
´Ethical principles and guidelines fro the protection of
human subjects of research
´3 basic ethical principles:
´Respect for persons
´Beneficence
´Justice
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Decision matrix
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Definition
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´Research :
a systematic investigation designed to develop or
contribute to generalizable knowledge

´Human subject : a living individual about whom an

investigator conducting research obtains:
´Data through intervention or interaction with the individual,
or
´Identifiable private information

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Definition

´Ethics :
- The study of standards and conducts and
moral judgment
- The system or code of morals of a particular
person, religion, group, or profession

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21 What is research ethics about?

´Integrity of researchers, which involves:

Commitment to
´Contributing to knowledge
´Pursuit & protection of truth
´Reliance on appropriate research methods
´Honesty

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22 What research needs approval?

´All research projects involving human participants as

subjects are to be reviewed by institutional ethics
committees.
´Methods: interviews and focus groups, surveys and
questionnaires, archived data which identifies
individuals, medical records, observation, photography,
audio/video taping, experimental procedures

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Why do you need a research ethic

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approval?

´To protect the rights and welfare of human

participants;
´To ensure that any risk of discomfort or harm to
participants is minimal, and justified by the potential
benefits of the research;
´To minimise the potential for claims of negligence
made against researchers and the University

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24 What aspects of research should be

considered?
´Is there a risk of physical, psychological, spiritual or
emotional harm?
´Is there potential for infringement of privacy,
confidentiality, or ownership?
´Does the person s involvement impose burdens with
little benefit?

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25 Vulnerable population

´Indigenous people
´Patients
´Children
´Pregnant women
´Disabled people

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Research Ethics
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´Treat individuals as autonomous human beings

´Let them choose for themselves
´Provide extra protection for those with limited
autonomy
´Limited mental capacity
´Lack of freedom or influence of others
´Informed Consent / Respect of Privacy

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Informed consent

´ The goal of the informed consent

process is to provide people with sufficient
information so they can make informed
choices about whether to begin or continue
participation in clinical research.

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Informed consent
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Elements of the informed consent requiring that:

´The aims and research procedures should be explain
´Information necessary to make a decision must be
presented that is, the risks and benefits, if any, of
participation.
´The information must be presented at a level that can
be understood by the patient or study subject.
´ Participation must be voluntary and can withdraw
anytime.
´Confidentiality should be maintain
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Beneficence

´Minimize harms and maximize benefits

´Best possible research design to maximize
benefits / minimize harms
´Need favorable risk-benefit ratio
´Capable researchers to perform procedures

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Justice
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´Treat people fairly and design studies so

the burdens and benefits are shared
equitably
´Subject selection
´Avoid exploitation of vulnerable populations

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31 Case
´A researcher wants to determine prevalence of illicit
drug use in a elementary school
´Subjects will be aged 10-12 years from one urban school
´Will screen existing urine samples from previous protein
study
´Samples will be stripped of identifiers

Research involving the collection or study of existing data, documents,

records, pathological specimens, or diagnostic specimens, if these sources
are publicly available or if the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects

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HUMAN STEM CELL

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´Stem cell:
Undifferentiated cells on which other cells originate.
Stem cells have the ability either to divide undefinetely
or to differentiate into other cell types
´Embryonic stem cells are obtained from embryos
remaining after fertility treatment.
´Adult type stem cells are obtained from fully
developed individuals.

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Objectives
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´Cure:
´Heart disease: might replace damage cardiac
muscle cells and arteries
´Alzheimer s disease: might replace damaged nerve cells
´Burn victims: might provide healthy skin tissue
´Type-1 diabetes: might add healthy pancreatic cells that
produce insulin
´Spinal cord injury: might replace damaged nerve cells
´Parkinson s disease: might add nerve cells that secrete
dopamine

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References
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´ Keputusan Menteri Kesehatan. KMK No. 562/Menkes/SK/V/2007 tentang Komisi

Nasional Etik Penelitian Kesehatan (KNEPK)
´ KNEPK. 2007. Pedoman Nasional Etik Penelitian Kesehatan (PNEPK).
´ Finnish National Ethics Committees: National Advisory Board on Research Ethics.
2005. Human stem cell, cloning and research.
´ Power, C., and Rasko, JEJ. 2011. Promises and challenges of stem cell research for
regenerative medicine. Annals of Internal Medicine 155(10): 706-13.
´ Vargessen, N. 2015. Review thalidomide-induced teratogenesis: history and
mechanism. Birth Defect Research (Part C) 105: 140-156.
´ WHO. 2011. Standards and operational guidance for ethics review of health-related
research with human participants.
http://www.who.int/ethics/publications/research_standards_9789241502948/en/ind
ex.html

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