WELCOME

ETHICS
IN
RESEARCH
PRESENTED BY
JIYA G PANTHANALIL
IST YEAR MSC NURSING
NIMHANS, BANGALORE
 INTRODUCTION
• Research contributes to nursing knowledge

• Research influence patient care standards

• Professional nurses are obliged to ensure

safe, robust and ethical 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)
• Nursing ethics is defined as the principles of
proper professional conduct concerning the rights
and duties of nurses themselves, their patients,
and their fellow practitioners, as well as their
actions in the care of patients and in relations with
their families- U S National Library of Medicine
(2014)
 WHAT ETHICS IS AND WHAT IT
IS NOT
WHAT ETHICS IS
• About commitment to
positive values
• A communal activity, applying
rational principles and
universal standards to social
life
• About real power relations
and responsible power
sharing
WHAT ETHICS IS NOT
• About negative code of
conduct, moral prohibitions,
disciplinary rules
• A private matter, nor about
subjective feelings, personal
attitudes and choices
• Introspective self
examination, or judging one’s
or other’s moral state
 WHAT ETHICS IS
• About active participation
in a moral community
• Problem solving activity
• An educational process
WHAT ETHICS IS NOT
• Personal reliance on
experts, lawyers,
philosophers or religious
authorities
• Interminable disputes, or
insoluble dilemma
• Occult processes
 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’
 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 400 men who had untreated
syphilis
• Control group of 200 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
 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
 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 RISKS

BENEFITS TO 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
 THERAPEUTIC
MISCONCEPTION

• Research subject misinterpret and enrol in

the study thinking it to be routine medical
care

• Misinterpret the information and believes

that research directly benefits him
 POST TRIAL ACCESS
• Holds special importance for clinical
research
• Pharmaceutical companies from developed
countries collect data from developing
countries
• Most of these drugs would never be used by
the communities from where the
experimental data is collected
ETHICAL DILEMMAS
 CODE OF ETHICS FOR
DIFFERENT DISCIPLINES
 • Important Code of ethics adopted by National
Commission for the Protection of Human
Subjects of Biomedical and Behavioural
1978 Research (U. S)

• Guidelines for psychologists published by the

American Psychological Association in Ethical
principles of Psychologists and Code of Conduct
1992

• The American Nurses’ Association put forth a

document entitled Ethical guidelines in the
Conduct, Dissemination and Implementation of
1995 Nursing Research
CODE OF ETHICS FOR
NURSES IN INDIA
 INSTITUTIONAL
REVIEW/INSTITUTIONAL ETHICAL
COMMITTEE
• Committee that reviews research to ensure
that the investigator is conducting research
ethically
• Consists of at least five members from
different background
• IRB in hospitals composed of physicians,
lawyers, clergy, community and lay persons
and more recently nurses
LEVELS OF REVIEW
BY IRB

• Exempt from interview

• Expedited interview

• Complete review
RESEARCH MISCONDUCT

FABRICATION

FALSIFICATION

PLAGIARISM
RESEARCH MISCONDUCT
PLAGIARISM CHECKER
ROLE OF PEER REVIEWERS, JOURNAL
EDITORS, AND RESEARCHERS
• Fraudulent- If there is documentation or
testimony from co-authors that publication
didnot reflect what had actually been done
• Questionable- If no co-author could produce
the original data or had personally observed
or performed or participated in research
publication
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
 ETHICS IN RESEARCH-INDIAN
SCENARIO
Twelve general principles are-
• Principle of essentiality
• Principles of voluntariness, informed consent,
and community agreement
• Principle of non-exploitation
• Principle of privacy and confidentiality
• Principle of precaution and risk minimisation
• Principle of professional competence
• Principle of accountability and
transparency
• Principle of the maximisation of public
interest and of distributive justice
• Principle of institutional arrangements
• Principle of public domain
• Principle of totality of responsibility
• Principle of compliance
 ETHICS IN NURSING RESEARCH –
INDIAN SCENARIO

• TYPES OF UNETHICAL PUBLICATIONS

Plagiarism
Authorship irregularities
Publication irregularities
Scientific fraud
• ETHICAL ISSUES IN USING ANIMALS
IN RESEARCH
STUDENTS’ ROLE IN ETHICS
IN RESEARCH
• Ethical clearance should be
get done
• Need to get approval from
guides and co-guides
• Unethical to publish
including guide as co-
author
INTERNET ETHICS

• Development of internet over

years led to use of internet
based research.
• Numerous approaches
include web page content
analysis, online focus groups,
online interviews, analysis of
e-conversations
 • If research is based on
a robust design and in
CONCLUSION a safe and ethical
manner, it can be of
benefit to all
• Professional codes,
laws, regulations, and
ethics committees can
provide guidance but
ultimate determinant
rests with researcher’s
value system and moral
code
DISCUSSION