MODULE 9
PRINCIPLE OF ETHICAL RESEARCH
LEARNING OBJECTIVES:
At the end of the lesson, the students will be able to:
a.Discuss the important of informed consent in doing human experimentation.
b. Identify the pros and cons of the informed consent.
c. Appreciate the importance of research in the medical field.
INTRODUCTION
An international tribunal planned and implemented by the United Nations
War Crimes Commission to detect, apprehend, try and punish people accused
of people at war crimes, establishing the Nuremberg code. The principle and
practice of informed consent was reinforced by the precedent set in the trials
in which Nazi physician were declared guilty of crimes against humanity in
performing experiments on human being who were not volunteer and did
not consent. The principles and the practice of informed consent in health
care grew from the Declaration of Helsinki, that crimes against humanity
are offenses subject to criminal persecution.
Time allotment/ duration:
3hrs per session
Core-Related values and Biblical Reflection:
Service
Psalm 98: 1-2 The Lord has revealed to the people his saving power.
LEARNING CONTENT
Topic Content:
Unit 1 Nuremburg
Unit 2 Declaration of Helsinki
Unit 3 Belmont Repot
CODE OF ETHICS
NUREMBURG CODE OF MEDICAL ETHICS
-the right of research subject
-adopted by the World Medical Association in 1948
- true informed consent, freely given prior to experimental procedures and allow
discontinuation of participation at any time.
-requires that the person performing the research task be qualified
- no experiment shall be undertaken where death or disabling injury will likely
to occur and the proper preparation and adequate facilities to protect subjects
and prevent further injury.
-upon observing the likely risk of injury, disability or death the research should
terminate the experiment.
THE NUREMBERG CODE
a.voluntary consent
b.fruitful result for the good of society
c.anticipated result will justify the performance of experiment
d.avoid all unnecessary physical or mental suffering
e.no research should be conducted where there is no reason to believe
that death or disabling injury will occur.
f.the degree of risk to be taken should never exceed that determined by
the humanitarian importance of the problem to be solved.
g.proper preparation should be made-protect the research subject against
injury, or death
h.research should be conducted only be scientifically qualified persons
i.during research the subjects should be at liberty to bring the research
at the end
j. reseach should be ready to terminate the research at any stage if there is
possibility to hurt research subjects
World Medical Association Declaration of Helsinki Ethical Principles
for Medical Research Involving Human Subjects
DECLARATION OF HELSINKI
1.the well-being of the human subject should take precedence over the
interests of science and society
2.consent should be in writing
3.use caution if participant is in dependent relationship with researcher
BELMONT REPORT
National Commission for the Protection of Human Subject of Biomedical
and Behavioral Research created ‘Belmont Repot’
*RESPACT FOR PERSONS- treating people as autonomous agents
and protecting those with diminish autonomy
*BENEFICENCE – minimizing potential harms and maximizing benefits
of participants
*JUSTICE- distributing benefits\ risks fair
