THE FOUR PRINCIPLES OF ETHICS

Soenarto Sastrowijoto
Center for Bioethics and Medical Humanities
Yogyakarta, September 2015
1. The Nuremberg War Crime Trials after WW II
• 23 Nazi biomedical researchers, studied 1,750 prisoners,
on:
1) High attitude (law-presusure) exp.
2) Freezing experiment (9 – 14 hours)
3) Malaria exp – su posedly malaria antidrugs
4) Mustard gas exp – on wound
5) Sulfanilamide exp – control group without treatment
6) Typhus exp – antityphus vaccine
7) Poison exp – various poisons were bed to prisoners
8) Incendiary bomb exp – burned with phophozous
materials
9) Sterilization exp – sugfical and chemical †
2. USA studies
1) Tuskegee syphilis study (1932)
African American Males – 400 men with syphilis.
Syphilis has been studied/ published (1940s). All were not
informed about the issues, bahwa banyak yang †
2) Willowbrooke study ( Beecher K, 1966)
» Children and adolecents with disabilities hepatitis + (New
York)
» Recruited were coercive (kekerasan)
» 22 studies violated the basic standards in ethical
research on human.
The national commision for the protection of human subjects of
Biomedical and Behavioral Research (1974)
3. Ethical lesson from unit 731’s Human Experiment
• The medical atrocities (kekejaman) enduring legacy in
Japanese research ethics
• Cruel human exp, human experimentation become taboo;
treated human being like guinea pigi barbarism performed by
medical doctors.
• Protection of human subject; declaration of Helsinki, both
should be seriously considered. (Tsuchiy T, 2006). Th 8th
World Congress of Bioethics, a just and healthy society.
• The basic ethics of the Nuremberg Code Continue to serve
as cornestone for modern regulation on the user of human
participant in experimentation
• Its principles emphasize a profound respect for the voluntary
nature of research participation, the idea of true informed
consent , and the personal ethical responsibilities of the
investigator to ensure human welfare
4. In 1979, The Belmont Report
Ethical principles and guidelines for the protection of human
subjects of research, was published in the USA.
The ethical principles (Belmont Report):
a. Respect for Persons
In research, respect for persons demands that participants
enter into a research program voluntarily and with good
information about the research goals.
b. Beneficence
Investigators and their institution have to plan to maximize
benefit and minimize risks.
c. Justice
The benefits and burdens of research should be justly
distributed
5. Informed Consent
• A critical component of respecting human reseach
participants is the informed consent process.
• Participant signature – agreement the entire process
involved:
1) Giving a participant adequate information about the
study;
2) Providing adequate apportunity for participant to
consider all options, responding to participant’s
question;
3) Ensuring that participant has comprehended this
information;
4) Obtaining the participant’s voluntary agreement to
participate, and
5) Continuing provide information as the participant or
situation requires
Conclusion/ Summary of informed consent:

• The informed consent process must allow human

participants, as much as they are able, to be given
opportunity to choose what will or will not happen to them.
The consent process must include information to the
participant about the research; the participant must
understand the information and volunteer rather then be
coerced into participation.
• The risk to participants has been outweighed by the sum of
both the anticipated benefit to participants, and the
anticipated benefit to society in the form of new knowledge
to be gained by the research.
6. The Four Basic Principles
The most prevalence of ethics problems is the medical
practice, research, and education. Beauchamp and childres,
developed the Four Principles of ethical to:
1. Respect for autonomy
2. Non maleficence
3. Beneficence
4. Justice
Autonomy changed from person, because the point here is
not the person itself, but his or her autonomy as a person.
Non maleficence or do no harm should be included in the
basic principles of ethics to be Biomedical Ethics
Fig. 1 Basic ethical principles and applications as outlined in the Belmont Report
Ethical Principals for Research
Respect for Persons
· Individuals should be treated as
autonomous agents
· Persons with diminished autonomy are
entitled to protection.
Beneficence
· Human participants should not be harmed
· Research should maximize possible
benefits and minimize possible risks
Justice
· The benefits and risks of research must be
distributed fairly
Applications of Ethical Principles for Research
Informed Consent
· Volunteer research participants, to the degree
that they are capable, must be given the
opportunity to choose what shall or shall not
happen to them
· The consent process must include three
elements:
o Information,
o Comprehension, and
o Voluntary participation
Assessment of risks and benefits
· The nature and scope of risks and benefits must
be assessed in a systematic way
Selection of participants
· There must be fair procedures and outcomes in
the selection of research participants