ETHICS

IN
RESEARCH
 DEFINITION

• ETHICS-Greek word: ethos=custom or convention, or the

spirit of community
• Moral principles that govern a person’s behaviour or the
conducting of an activity: Oxford dictionary (2014)
• The branch of philosophy that deals with morality. Ethics
is concerned with distinguishing between good and evil in
the world, between right and wrong human actions, and
between virtuous and non virtuous characteristics of
people-The American Dictionary of Cultural Literacy
(2005)
 ETHICAL THEORIES

• Deontology- duty is the basis of all action

• Teleology- actions can only judged on the basis

of consequences they produce

• Utilitarianism-central concern is ‘the general

welfare rather than individual’s interest’
 EPILEPTIC CASE
Alex, a 35 year old man, is an epileptic. Although he is
under medication, he still suffers seizures from time to
time. One day, he was alone at home at around 1 a.m.
when he was suddenly awakened when he heard Rina, a
neighbor, frantically screaming for help. He ran towards
the door to check what the problem was and even before
he opened the door, he heard Rina banging at the door.
When Alex finally opened the door, he was shocked when
he saw blood in Rina’s hands and dress. Hysterically, she
said that her husband, Tony, was stabbed while having a
drinking session with some friends.
• She begged Alex to drive them to the nearest hospital.
Without any hesitation, Alex took his brother’s car keys and
ran with Rina to where Rina’s husband was. Tony’s body
was sprawled on the ground and blood was oozing
profusely from his throat and stomach. They were
screaming for help, but unfortunately, nobody responded.
The other neighbors stayed inside their houses and did not
seem to be involved. So, Alex, with all his strength, carried
Tony to the car, and, sped away. But, while he was driving,
Alex suddenly had a seizure and the car moved
uncontrollably that it hit three (3) people who were hailing
a cab. The 3 victims suffered from severe head injury and
broken ribs that after almost 5 hours of struggle at the
I.C.U., eventually died.
• What is your moral evaluation of the case?
Should Alex be held liable for an act that is
indirectly willed? Justify your answer.
 HISTORICAL EVENTS AND
DEVELOPMENT OF CODE OF ETHICS
NAZI MEDICAL EXPERIMENTS
(1933-1945)
• Atrocious, unethical activities
implemented in Third Reich in Europe
from 1933-1945
• Programs included sterilisation,
euthanasia, and numerous medical
experiments in Nazi concentration camps
• Sterilised Jews whom Nazis considered as
racial enemies
• Medical experiments involved exposing to high
altitudes, freezing temperature, malaria, poisons,
typhus fever, untested drugs and surgery without
anaesthesia

• Selection of subjects was racially based

• Subjects had no opportunity to refuse the

participation
NUREMBERG CODE- 1949
Mistreatment of human subjects in Nazi
experiments led to the development of Nuremberg
Code (1949)
Nuremberg Code contains guidelines for
• Voluntary consent
• Withdrawal of subjects from study
• Protection of subjects from physical and mental
suffering, injury, disability, and death
• The balance of benefits and risks in the study
DECLARATION OF
HELSINKI (1964)
• Greater care can be exercised
to protect subjects from harm

• Strong, independent
justification for exposing a
healthy volunteer to
substantial risk of harm

• Investigators must protect life

and health of research
subjects
TUSKEGEE SYPHILIS
STUDY(1932)
• U S Public Health Service initiated the
study in town of Tuskegee, Alabama
• Research subjects were divided into two
groups
• One group of 399 men who had untreated
syphilis
• Control group of 201 men without syphilis
WILLOWBROOK STUDY (1950-1970)
• Research on hepatitis by Dr. Krugman at
Willowbrook among mentally retarded
children
• Early subjects were fed extracts of stool
from infected individuals
• Later subjects received injections of
purified virus
• Parents were forced to give permission for
the child to be a subject
JEWISH CHRONIC DISEASE
HOSPITAL STUDY (1960)
• Study conducted to determine patients’
rejection responses to live cancer cells
• Twenty two patients were injected with a
suspension containing live cancer cells
• Physician from Sloan-Kettering Institute for
cancer research directed the study
• Study conducted without the informed
consent
 ETHICAL PRINCIPLES
The Belmont report articulates three primary
ethical principles

 Beneficence

 Respect for human dignity

 Justice
BENEFICENCE
• Imposes duty on researchers to
minimise harm and to maximise
benefits
The right to protect from harm and
discomfort
Freedom from exploitation
Benefits from research
 RISK BENEFIT RATIO

MAJOR POTENTIAL MAJOR POTENTIAL

BENEFITS TO RISKS TO PARTICIPANTS
PARTICIPANTS
•Access to an intervention that •Physical harm
otherwise be unavailable to •Boredom ,fatigue,physical
them discomfort
•Comfort to discuss situation •Psychological or emotional
with a friendly person discomfort
•Increased knowledge of •Social risks
themselves •Loss of privacy
•Satisfaction in helping others •Loss of time
•Monetary or material gains •Monetary costs
 THE PRINCIPLE OF RESPECT FOR
HUMAN DIGNITY
• The right to self determination-Humans should be
treated as autonomous agents, capable of
controlling their own activities

• The right to full disclosure-Researcher should

fully describe the nature of study, subject’s right
to refuse participation, researcher’s responsibility
and risks and benefits
ISSUES RELATED TO PRINCIPLE OF
RESPECT

• Inability of individuals to make well

informed judgements
• Bias
• Concealment
• Deception
THE PRINCIPLE OF
JUSTICE

• The right to fair

treatment

• The right to privacy

INFORMED CONSENT
 INFORMED CONSENT
• Participants have adequate knowledge
regarding research, have the power of
choice, enabling to decline participation
voluntarily.

• Informed assent-the process where by

minors may agree to participate in clinical
trials.
VULNERABLE SUBJECTS
 IMPORTANCE OF ETHICS IN
RESEARCH
• Protects the vulnerable group and other study
participants
• Participants are safeguarded from exploitation
• Establishes risk-benefit ratio for study subjects
• Ensures fullest respect, dignity, privacy,
disclosure and fair treatment for subject
• Builds capability of subjects to accept or reject
participation in study
RESEARCH MISCONDUCT

FABRICATION

FALSIFICATION

PLAGIARISM
RESEARCH MISCONDUCT
PLAGIARISM CHECKER
GUIDELINES FOR
CRITIQUING ETHICAL
ASPECTS OF STUDY
• Was the study approved
and monitored by IRB?
• Were participants
subjected to any physical
harm or psychological
distress?
• Did the benefits outweigh
potential risks?
• Was any type of coercion
or undue influence used to
recruit participants?
• Were the participants
deceived in any way?
• Were appropriate
informed consent
procedures used?
• Were adequate steps
taken to safeguard
participant’s privacy?
• Were vulnerable groups
involved in research?

• Were groups omitted

from the inquiry without
a justifiable rationale?
 ETHICAL CONCERNS IN
QUALITATIVE RESEARCH
• Distress

• Misinterpretation

• Identification

• Inconvenience
• ETHICAL CONCERNS
IN QUANTITATIVE
RESEARCH
Related to the stage of
research
• Formulating the research
questions
• Designing the study
• Collecting data
• Analysis
• Reporting
ETHICAL CONCERNS IN
MIXED METHOD
RESEARCH
• Identify and describe issues
related to the protection of
human subjects
• Understand the ethical issues
associated with quantitative
and qualitative research
• Be prepared to educate IRB
reviewers about mixed
method research
You are the director of the Human Resource Department and you received a
phone call from your boss and godfather, who was also the president of the
board of trustees, asking you to determine whether or not you received his
daughter’s application for a current job opening. Without making your boss in
distress, you already filed and prioritized her paper.

Later that day, your senior manager requested to see you. He said, “I heard
that the boss’ daughter has applied for the opening. You are to consider her,
aren’t you? She worked here years ago and there were problems. She’s an
indecent woman. Your colleagues will be very disappointed when you let her
in.” He smilingly added, “You have a prudent mind, use it well.”

What is your evaluation of this case? If you are in the same situation, how are
you going to resolve this dilemma? What is your stand? Will you still hire her or
not?