ethical consideration in research

1. Ms. Chanda Jabeen
Lecturer
RN, RM, BSN
M.Phil. Epidemiology & Public Health
PhD (Scholar) Epidemiology & Public Health
UNIT 2:
ETHICAL CONSIDERATION IN
RESEARCH
1

2. OBJECTIVES
At the end of this session, the students will be able to:
 Define the terms related to ethics in research
 Discuss historical events of ethical mischiefs and
evolution of ethics as protecting human rights
 Discuss the ethical principles, declaration of Helsinki
and research code of ethics
 Discuss the research code of ethics
 Describe different types of informed consent, i.e
verbal, written, individual and institutional consent.
 Produce a meaningful informed consent form
 Identify role and importance of ethical considerations
in research. 2

3. ETHICAL RESEARCHER
 "Many people say that it is the intellect which
makes a great scientist. They are wrong: it is
character." -- Albert Einstein
3

4. INTEGRITY
 A character trait inwardly focused on the self of
being faithful to moral values and standing up
in their defense (Oxford Dictionary)
4

5. Integrity is doing right when no one is
watching.
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6. A branch of philosophy
A set of principles of right
conduct.
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7. “ A system of moral values that is concerned
with the degree to which research
procedures adhere to professional, legal,
and social obligations to the study
participants.” (Polit, beck, Hungler)
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What is Ethical Research
7

8. 8

9. The Nazi medical experiments of the 1930s and
1940s are the most famous example of recent
disregard for ethical conduct.
23 German Nazi physicians tortured and
murdered thousands of victims in the name of
research
Experiments done on prisoners of wars with out
their permission
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Nazi Trial (1935-1945)
9

10. CONT…
 Exposing substances to high altitudes, freezing
temperatures, malaria, poisons, typhus, &
untested drugs and operations without any form
of anesthesia
 Violated numerous rights of human research
subjects.
10

11. Tuskegee Syphilis a Study sponsored by
the U.S. Public Health Service, investigated
the effects of syphilis among 400 men
from a poor African-American community.
Medical treatment was deliberately
withheld to study the course of the
untreated disease.
11
Tuskegee Syphilis study 1932 - 1972
11

12. CONT…
 Over one hundred of the infected men died and
others suffered from serious syphilis related
conditions.
 Participants did not know sign consent
 Treatment was deliberately withheld
12

13. Institution for “mentally defective persons.”
New York
Designed to :
– Gain an understanding of the natural history
of infectious hepatitis.
– Test the effects of gamma globulin to prevent
the disease.
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Willow brook Study (1963-1966)
13

14. CONT…
 Mentally retarded children were deliberately
infected with hepatitis virus
 During the study the school closed door to all
sections except the “hepatitis section
14

15. PROBLEMS WITH THE WILLOWBROOK
STUDY
 Lacked child assent
 Lacked parental consent for the most part
 Perception that little choice is given to
participate in research
 Research conducted with no regard of the
protection of the subjects
15

16. JEWISH CHRONIC DISEASE HOSPITAL
STUDY (1960)
Another well-known case of unethical
research involved the injection of live
cancer cells into elderly patients at the
Jewish Chronic Disease Hospital in
Brooklyn, without the consent of those
patients.
16

17. CONT…
The purpose was to assess participants’
rejection responses to Cancer cells
injected into them.
The elderly were infected with live cancer
cells.
17

18. HISTORICAL CONTEXT
 1947: Nuremberg trials
 1948: United Nations Declaration of Human
Rights
 1964: Declaration of Helsinki
 1966: United Nations Covenant on Economic,
Social and Cultural Rights, Civil and Political
Rights
18

19. CODES OF ETHICS
 One of the first internationally recognized
efforts to establish ethical standards is referred
to as the Nuremberg Code, developed after the
Nazi trials.
19

20. CONT…
 Several other international standards have
subsequently been developed, the most
notable of which is the Declaration of Helsinki,
which was adopted in 1964 by the World
Medical Association and then later revised,
most recently in 2008.
20

21. 1. Research participants must voluntarily
consent to research participation
2. Research aims should contribute to the
good of society
3. Research must be based on sound theory
and prior animal testing
4. Research must avoid unnecessary physical
and mental suffering
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22. 5. No research projects can go forward where
serious injury and/or death are potential
outcomes
6. The degree of risk taken with research
participants cannot exceed anticipated benefits
of results
7. Proper environment and protection for
participants is necessary
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23. 8. Experiments can be conducted only by
scientifically qualified persons
9. Human subjects must be allowed to discontinue
their participation at any time
10. Scientists must be prepared to terminate the
experiment if there is cause to believe that
continuation will be harmful or result in injury or
death
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24. DECLARATION OF HELSINKI (1964)
Highlights
 Well being of the subject takes precedence over
science and society.
 Respect for persons & protection of subjects health &
rights.
 Vulnerable populations require special protection.
 Procedures must be detailed in a protocol &
submitted to an ethical review committee, including
the monitoring of information
24

25. CONT…
 Assessment of risks and benefits to the
subjects or others before conducting the
research.
– INFORMED consent is a must.
– INFORMED consent must be DOCUMENTED.
25

26. BELMONT REPORT 1979
Respect for Persons:
 – Concerns the ability of a person to direct
his/her actions.
Beneficence :
 Balance the risks and benefits.
 –Do no harm
26

27. CONT…
Justice :
 fair and equitable distribution of benefits and
burdens.
27

28. ETHICAL PRINCIPLES IN NURSING
RESEARCH:
 The American Nurses’ Association (ANA) put
forth a document in 1995 entitled Ethical
Guidelines in the Conduct, Dissemination, and
Implementation of Nursing Research (Silva,
1995).
28

29. CONT…
 Following are the nine ethical principles outlined in
that document.
 Respects autonomous research participants’ capacity to
consent to participate in research and to determine the
degree and duration of that participation without
negative consequences.
 Prevents harm, minimizes harm, and/or promotes good
to all research participants, including vulnerable groups
and others affected by the research.
 Respects the personhood of research participants, their
families, and significant others, valuing their diversity.
29

30. CONT…
 Ensures that the benefits and burdens of
research are equitably distributed in the
selection of research participants.
 Protects the privacy of research participants to
the maximum degree possible.
 Ensures the ethical integrity of the research
process by use of appropriate checks and
balances throughout the conduct,
dissemination, and implementation of the
research.
30

31. CONT…
 Reports suspected, alleged, or known incidents of scientific
misconduct in research to appropriate institutional officials
for investigation.
 Maintains competency in the subject matter and
methodologies of his or her research, as well as in other
professional and societal issues that affect nursing research
and the public good.
 Involved in animal research maximizes the benefits of the
research with the least possible harm or suffering to the
animals.
31

32. 32
Coercion
Coercion is the practice of forcing another party to
behave in an involuntary manner by use of threats,
rewards, or some other form of pressure or force.
Covert data collection
Subjects are unaware that research data are being
collected
Deception
Misinforming the subjects for the research purposes
32

33. Fabrication
• Making up data or results and reporting
them especially untruthful
Falsification
• Manipulating research materials or
processes such that the research is not
accurately presented
Plagiarism
• Owning others’ ideas
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34. PRINCIPLES OF ETHICS IN RESEARCH
1. THE PRINCIPLE OF BENEFICENCE
 One of the most fundamental ethical principles
in research is that of beneficence, which
encompasses the maxim: Above all, do no
harm.
 Ethical Principle 2 of the ANA guidelines
addresses beneficence.
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35. DIFFERENT DIMENSIONS OF BENEFICENCE
PRINCIPLE:
 A. Freedom From Harm:
 Researchers should strive to minimize all types of
harm and discomfort and to achieve insofar as
possible a balance between the potential benefits
and risks of being a participant.
35

36. CONT…
 B. Freedom From Exploitation:
 Participants need to be assured that their
participation, or information they might provide, will
not be used against them in any way.
36

37. CONT…
 C. Benefits From Research:
 Researchers should strive insofar as possible to
maximize benefits and to communicate potential
benefits to participants.
37

38. CONT…
 D. The Risk/Benefit Ratio:
 In designing a study, researchers must carefully
assess the risks and benefits that would be
incurred.
 The general guideline is that the degree of risk to
be taken by those participating in the research
should never exceed the potential humanitarian
benefits of the knowledge to be gained.
38

39. 2. THE PRINCIPLE OF RESPECT FOR
HUMAN DIGNITY:
 Respect for human dignity is the second ethical
principle articulated in the Belmont Report.
 This principle, which includes the right to self-
determination and the right to full disclosure,
Informed consent is covered in the ANA
guidelines under principles 1 and 3.
39

40. Human should be treated as Autonomous
agents
A person’s right to self-determination includes
freedom from coercion of any type.
They are allowed to participate or not
participate
They have the right to withdraw from the
study at any time with out penalty
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A. The Right to Self-
Determination:
40

41. B. THE RIGHT TO FULL DISCLOSURE:
 The principle of respect for human dignity
encompasses people’s right to make informed,
voluntary decisions about study participation,
which requires full disclosure.
41

42. CONT…
 Full disclosure means that the researcher has
fully described the nature of the study, the
person’s right to refuse participation, the
researcher’s responsibilities, and likely risks
and benefits.
Participants need to have full information
about the study
42

43. C. INFORMED CONSENT
 This means the study participants have
adequate information regarding research,
capability to comprehend the information and
have power of free will enabling them to
consent or decline participation.
43

44. 3. THE PRINCIPLE OF JUSTICE
 The third broad principle articulated in the
Belmont Report concerns justice.
 Justice, which includes participants’ right to
fair treatment and their right to privacy, is
covered in the ANA guidelines under principles
4 and 5
44

45. A. RIGHT TO FAIR TREATMENT
Study participants have the right to fair and
equitable treatment before, during, and after
their participation in the study. Fair treatment
includes the following features:.
 It includes fair selection of participants such
that any risks and benefits will be equitably
shared
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46. 4/14/2020 46
Participants should be selected based on
research requirements, not on the
vulnerability position
Respect for cultural and other forms of
human diversity should be maintained
 Participants’ Should have access to
research personnel at any point in the study
to clarify information
Cont…
46

47. 47
It is the freedom an individual has
to determine the time, extent, and
general circumstances under which
private information may be shared
with or withheld from others
B. Right to Privacy
47

48. C. RIGHT TO ANONYMITY AND
CONFIDENTIALITY
 Anonymity: It occurs when even the researcher
cannot link participants to their data.
 A promise of confidentiality is a pledge that any
information participants provide will not be
publicly reported in a manner that identifies
them and will not be made accessible to
others.
48 48

49. CONT…
 Confidentiality: It is defined such that any
information participants provide will not be
publicly reported in a manner that identifies
them and will not be made accessible to
others.
49

50. STEPS TO MAINTAIN CONFIDENTIALITY
 Obtain identifying information (e.g., name,
address) from participants only when essential.
 Assign an identification (ID) number to each
participant and attach it to the actual data.
 Maintain identifying information in a locked file.
50

51. STEPS CONT…
 Restrict access to identifying information to a
small number of people on a need-to-know
basis
 Destroy identifying information as quickly as
practical.
 Make research personnel sign confidentiality
pledges if they have access to data or
identifying information.
51

52. 5252

53. INFORMED CONSENT:
 Informed consent means that participants have
adequate information regarding the research,
are capable of comprehending the information,
and have the power of free choice, enabling
them to consent to or decline participation
voluntarily.
53

54. INFORMED CONSENT CONT…
 The right to self-determination and the right to
full disclosure are the two major elements on
which informed consent is based.
 Participants must know that they are getting
involved before they commit
 Must consent to participate is study as a
participant
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55. 55
Essential Information for Consent
Comprehension of Consent Information
Competency to give consent
Voluntary consent
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56. 4/14/2020 56
Introduction of research activities.
Purpose of the research
Why they were selected as potential subjects
Procedure is explained
Risks or discomforts explained
Benefits described
Any alternatives. E.g. history that may be
available
Essential Information
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57. 57
Assure anonymity (confidentiality)
Offer to answer question
Non coercion with discussion their
participation is voluntary
Option withdraw
If information being deliberately withheld
need to inform that certain information
withheld until with the study.
Cont…
57

58. 5858

59. VULNERABLE SUBJECTS
 Vulnerable subjects are those who may be
incapable to give fully informed consent e.g.
Mentally Retarded People
Or
 People who are at high risk of unintended side
effects because of their circumstances e.g.
pregnant women).
59

60. VULNERABLE GROUPS
 Children.
 Mentally or emotionally disabled people.
 Severely ill or physically disabled people.
 The terminally ill.
 Institutionalized people.
 Pregnant women.
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61. CHILDREN’S ASSENT
 Assent refers to the child’s affirmative
agreement to participate.
 If the child is at least 7 years of age, obtaining
Child’s Assent is also important.
61

62. CONT…
 If the child is developmentally mature enough
to understand the basic information involved in
informed consent (e.g., a 13-year old), it is
advisable to obtain written consent from the
child as well, as evidence of respect for the
child’s right to self-determination.
62

63.  An independent body constituted of medical
,scientific , and non scientific members whose
responsibility it is to ensure the protection of
the rights, safety and well being of human
subjects by; reviewing, approving, and providing
continuing review of protocols, amendments of
the methods ,material to be used in obtaining
and documenting informed consent of the
human subject.
63

64.  Every institution where an individual might
conduct research must have an IRB
 The Primary goal is to protect the rights of
research participants
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65. COMMON ROLE OF THE IRB
 Review of research.
 Informed consent.
 Assurance of compliance of the institution
 Should the study be done at all?
 Do the benefits outweigh the risks?
 What constitutes an adequate informed
consent?
65

66. REFERENCES
Polit, D. F., & Beck, C. T. (2017). Nursing research:
Generating and Assessing Evidence for Nursing
Practice (10th ed.). Philadelphia: Lippincott
Williams & Wilkins.
Polit, D. F., & Beck, C. T. (2006). Essential of nursing
research: Methods, appraisal, & utilization.
(6thed.). Philadelphia: Lippincott
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