This document provides an overview of ethics in research. It defines ethics and discusses key historical events that shaped modern research ethics like the Nazi experiments and the Nuremberg Code. The three primary ethical principles of beneficence, respect for human dignity, and justice are examined. Informed consent, risks/benefits analysis, and the role of institutional review boards in ensuring ethical research are covered. Challenges in vulnerable populations and qualitative/mixed methods research are also summarized.

1. WELCOME

2. ETHICS
IN
RESEARCH
PRESENTED BY
JIYA G PANTHANALIL
IST YEAR MSC NURSING
NIMHANS, BANGALORE

3. INTRODUCTION
• Research contributes to nursing knowledge
• Research influence patient care standards
• Professional nurses are obliged to ensure
safe, robust and ethical research

4. 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)

5. • 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)

6. 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

7. 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

8. 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’

9. HISTORICAL EVENTS AND
DEVELOPMENT OF CODE OF ETHICS

10. NAZI MEDICAL EXPERIMENTS
(1933-1945)

11. • 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

12. • 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

13. NUREMBERG CODE- 1949

14. 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

15. 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

16. TUSKEGEE SYPHILIS
STUDY(1932)

17. • 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

18. WILLOWBROOK STUDY (1950-1970)

19. • 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

20. JEWISH CHRONIC DISEASE
HOSPITAL STUDY (1960)

21. • 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

22. 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

23. ETHICAL PRINCIPLES
The Belmont report articulates three primary
ethical principles
 Beneficence
 Respect for human dignity
 Justice

24. 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

25. RISK BENEFIT RATIO
MAJOR POTENTIAL
BENEFITS TO
PARTICIPANTS
MAJOR POTENTIAL RISKS
TO PARTICIPANTS
•Access to an intervention that
otherwise be unavailable to
them
•Comfort to discuss situation
with a friendly person
•Increased knowledge of
themselves
•Satisfaction in helping others
•Monetary or material gains
•Physical harm
•Boredom ,fatigue,physical
discomfort
•Psychological or emotional
discomfort
•Social risks
•Loss of privacy
•Loss of time
•Monetary costs

26. 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

27. ISSUES RELATED TO PRINCIPLE OF
RESPECT
• Inability of individuals to make well
informed judgements
• Bias
• Concealment
• Deception

28. THE PRINCIPLE OF
JUSTICE
• The right to fair
treatment
• The right to privacy

29. INFORMED CONSENT

30. 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.

31. VULNERABLE SUBJECTS

32. 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

33. 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

34. ETHICAL DILEMMAS

35. CODE OF ETHICS FOR
DIFFERENT DISCIPLINES

36. 1978
• Important Code of ethics adopted by National
Commission for the Protection of Human
Subjects of Biomedical and Behavioural
Research (U. S)
1992
• Guidelines for psychologists published by the
American Psychological Association in Ethical
principles of Psychologists and Code of Conduct
1995
• The American Nurses’ Association put forth a
document entitled Ethical guidelines in the
Conduct, Dissemination and Implementation of
Nursing Research

37. CODE OF ETHICS FOR
NURSES IN INDIA

38. 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

39. LEVELS OF REVIEW
BY IRB
• Exempt from interview
• Expedited interview
• Complete review

40. RESEARCH MISCONDUCT
FABRICATION
FALSIFICATION
PLAGIARISM

41. RESEARCH MISCONDUCT

42. PLAGIARISM CHECKER

43. 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

44. 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?

45. • 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?

46. • Were vulnerable groups
involved in research?
• Were groups omitted
from the inquiry without
a justifiable rationale?

47. ETHICAL CONCERNS IN
QUALITATIVE RESEARCH
• Distress
• Misinterpretation
• Identification
• Inconvenience

48. • ETHICAL CONCERNS
IN QUANTITATIVE
RESEARCH
Related to the stage of
research
• Formulating the research
questions
• Designing the study
• Collecting data
• Analysis
• Reporting

49. 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

50. 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

51. • 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

52. ETHICS IN NURSING RESEARCH –
INDIAN SCENARIO
• TYPES OF UNETHICAL PUBLICATIONS
Plagiarism
Authorship irregularities
Publication irregularities
Scientific fraud
• ETHICAL ISSUES IN USING ANIMALS
IN RESEARCH

53. 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

54. 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

55. CONCLUSION
• If research is based on
a robust design and in
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

56. DISCUSSION