More Related Content Similar to Chapter 009 (20) More from stanbridge (20) Chapter 0091. 1Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Chapter 9
Ethics in Research
2. 2Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Principal Issues Related To
Nursing Research
Protection of research subjects
Prevention of researcher misconduct
3. 3Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Protection of Research Subjects
Research may only be conducted if there is
an identified gap in the knowledge base and
the benefits of filling the gap outweigh the
costs for the subjects (physical, mental,
privacy, and so forth)
Consent is required for most research
Protection of raw data is imperative
Anonymity of subjects must be maintained
Institutional review for protection of subjects
is required for all research
4. 4Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Prevention of Researcher
Misconduct
Funding source must be revealed in all
research reports (written or other)
Findings must be represented honestly
Raw data must be retained and made
available if honesty is questioned
All substantive authors and contributors must
be revealed
All stated authors must take part in the
research process
5. 5Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Key Points
Ethical issues begin with justification of a reason for
the study to be performed
They continue throughout planning, conduct of the
study, preparation for publication, and the
after-publication phase
They extend through the memory lifespan of the
researcher, since he or she is responsible for
protecting anonymity and confidentiality,
indefinitely
6. 6Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Historical Events
Four egregious research programs:
Nazi medical experiments
Tuskegee Syphilis Study
Willowbrook Study
Jewish Chronic Disease Hospital study
Each example contains specific
transgressions against human subjects
7. 7Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Nazi Medical Experiments
Little useful scientific knowledge generated
An excuse to maltreat persons identified as
non-Aryan
Research ethics outgrowth of the Nazi trials—
the Nuremberg Code (1949)
8. 8Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Nuremberg Code: Principal
Points
Voluntary consent
Overt benefit to society
Animal research first, then human
Do no harm—avoid unnecessary suffering
and injury
No death or disabling injury foreseen
9. 9Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Nuremberg Code: Principal
Points (Cont’d)
Benefit outweighs risk
Protection of subjects
Researcher qualifications—highest degree of
skill and care
Subjects may withdraw from the experiment
Researcher must terminate experiment if
injury, disability, death foreseen
10. 10Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Declaration of Helsinki
Generated in 1964 by the World Medical
Association (WMA) General Assembly and
revised at intervals to reflect current problems
and viewpoints
Differentiates therapeutic from nontherapeutic
research
Therapeutic: ill patient may receive an
experimental treatment
Nontherapeutic: “basic” research; patients are
not ill
11. 11Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Principles of the Declaration of
Helsinki
Life, well-being, health, privacy, and dignity of
subject protected
Benefits must outweigh potential harm
Withholding the usual therapeutic intervention
not allowed unless justifiable argument for
experimental treatment
Clinical trials must focus on improving
treatment without subject exposure of
additional risk
12. 12Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Tuskegee Syphilis Study
Forty-year study (started in 1932) of the
natural course of syphilis in the adult black
male
Descriptive in nature
Two cohorts—one with syphilis, one without
Periodic examinations; no treatment given
13. 13Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Transgressions in the
Tuskegee Syphilis Study
Inadequate information given to subjects
Some individuals not aware that they were subjects
in the study
Many not informed of the study’s purpose and
procedures
Even after penicillin was developed and found to be
an effective treatment, subjects were not informed of
penicillin’s availability
Ethical violations: researchers did not protect
subjects from harm by treating their syphilis
14. 14Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Willowbrook Study
Hepatitis research
Mentally retarded children deliberately
infected with hepatitis virus
Coerced consent of parents
Rationalizations about the likelihood that the
children would acquire hepatitis upon
admission to institution
15. 15Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Jewish Chronic Disease Hospital
Study
Twenty-two patients injected with live cancer
cells
No patient consent or awareness that they
were research subjects
No institutional review of the research by
Jewish Chronic Disease Hospital or by Sloan-
Kettering (the institution of the principal
researcher)
16. 16Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
U.S. Department Of Health, Education,
And Welfare (DHEW) Regulations
First set of regulations published in 1973,
updated since
Protection provided for persons with limited
consent
All research involving human subjects
underwent institutional review
PROBLEM: the system became bogged
down because of too much work
17. 17Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research (1978)
Formed due to concerns with DHEW
regulations
Developed The Belmont Report: principles of
respect for persons, beneficence, justice
Federal regulations instituted in 1981 to
protect human research subjects; revised
since
18. 18Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
U.S. Department of Health and
Human Services (DHHS)
U.S. DHHS now oversees research, nation-wide
Provides direction for:
Protection of human subjects, with special attention to
vulnerable populations (pregnant women, human fetuses,
neonates, children, and prisoners)
Documentation of informed consent
Implementation of the institutional review board process
Applies to all funded research, and to all research in public
institutions and schools
19. 19Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
HIPAA
Health Insurance Portability and
Accountability Act (2003)
Protection of information
Affects all research conducted using
databases with protected health information
20. 20Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Human Rights
Claims and demands that have been justified
in the eyes of an individual or by the
consensus of a group of individual
Necessary for the self-respect, dignity, and
health of an individual
Protected by researchers and reviewers of
research because of ethical responsibility
21. 21Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Protection of Human Rights
Five human rights that require protection in
research:
Self-determination
Privacy
Anonymity/confidentiality
Fair treatment/justice
Protection from discomfort and harm
22. 22Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right to Self-determination
Based on the ethical principle of respect for
persons
Prospective subjects treated as autonomous
agents
Voluntary participation (may refuse, without
penalty)
Right to withdraw at any time
Persons with diminished autonomy have
additional protection
23. 23Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Preventing Violation of Research
Subjects’ Right to Self-determination
No coercion through either threat, harm, or
lure of excessive reward
No covert data collection: subjects must know
they are research participants
No deception: the purpose of the research
must be stated and clear
24. 24Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Protecting Persons With
Diminished Autonomy
Vulnerable groups of individuals, include
pregnant women, human fetuses, neonates,
children, mentally incompetent persons, and
prisoners, among others
Researchers must justify including subjects
with diminished autonomy in a study; need for
justification increases as the subjects' risk
and vulnerability increase.
25. 25Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Legally and Mentally Incompetent
Subjects
Persons not able to consent for themselves
Neonates and children
The mentally impaired
Unconscious patients
26. 26Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Legally and Mentally Incompetent
Subjects (Cont’d)
Difficult to obtain consent unless:
There is a potential benefit to participants
The research uses a mixture of vulnerable and
non-vulnerable subjects
Previous research provides data for assessing
potential risks to subjects
Risk is minimized
The consent process is strictly followed (consent
by next of kin, spokesperson, parent, conservator,
etc.)
27. 27Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Special Considerations with
Vulnerable Subjects
Neonates: under no conditions can research
be performed on a non-viable neonate, in
order to gain information that would help a
viable neonate
Children: assent must be obtained for
children 7 and older, even though their
parents’ consent; children should potentially
benefit by the research and should not suffer
permanent harm
28. 28Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Special Considerations With
Vulnerable Subjects (Cont’d)
Pregnant women: require additional protection in
research because of the fetus; research should be of
potential or direct benefit to mother or fetus; no
pregnancy termination inducements may occur
Fetuses in utero: fathers must also consent if there
may be a direct benefit only to the fetus
Adults with diminished capacity: legally authorized
representative consents; adults themselves assent, if
they can understand what this means
29. 29Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Standards for Participation of
Incompetent Individuals (Levine)
Best-interest standard: doing what is best for
the individual on the basis of balancing risks
and benefits
Substituted judgment standard: recommends
the course of action that incompetent
individuals would take if they were capable of
making a choice
30. 30Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Special Considerations with
Vulnerable Subjects
The Terminally Ill: Researcher must
determine:
Who will benefit
Whether having someone else benefit by research
on terminally ill subjects is acceptable
Whether or not subjects wish to participate
Whether the study is ethical
31. 31Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Special Considerations With
Vulnerable Subjects (Cont’d)
Hospitalized/other institutionalized patients:
May perceive that they should participate in
research and feel coerced
The researcher must be attuned to subtle coercion
Prisoners:
Fear of harm and expectation of special treatment
may pose coercion potential
Risks of research must be no greater for them
Must be given option to refuse to participate
Purposeful selection of research participants in
prisons is forbidden
32. 32Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right to Privacy
An individual’s right to determine the time,
extent, and general circumstances under
which personal information will be shared with
or withheld from others
Includes one’s attitudes, beliefs, behaviors,
opinions, and records
33. 33Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right to Privacy (Cont’d)
Privacy Act of 1974
Right to refuse
Right to be consented before research
participation
Right to access one’s own records
Extended by HIPAA Privacy Rule
Does not extend to a researcher who
receives permission to use “de-identified
data” from a limited database or data set (no
consent required for this)
34. 34Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
De-identifying Protected Health
Information Under The Privacy Rule
Involves removing the 18 elements that could
be used to identify an individual or persons
connected with the individual
After these elements are removed, the
individual is not identifiable
35. 35Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Limited Data Set and Data Use
Agreement
Covered entities (healthcare provider, health
plan, and healthcare clearinghouse) may use
and disclose a limited data set to a
researcher for a study without an individual
subject’s authorization or an IRB waiver
A limited data set is considered protected
health information, and the covered entity and
the researcher must have a data use
agreement
36. 36Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right To Autonomy And
Confidentiality
Anonymity: The subject’s identity cannot be linked
with his/her data, even by the researcher
Confidentiality: the researcher's management of
private information shared by a subject that must not
be shared with others without the authorization of the
subject
A breach occurs when
An unauthorized person gains access to raw data
The subject’s identity is accidentally revealed
37. 37Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
How Confidentiality is Maintained
All subject data is stripped of identifiers and given a
code number, either one created by the
researcher, or one generated by the subject
A master list of the subjects’ names and numbers is
kept in a locked place, separate from the data set
When the data analysis phase is complete, the
master list is destroyed
The same end can be achieved by giving each
subject a pseudonym, which is then used by the
researcher in publications resulting from the research
38. 38Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Special Issues for Qualitative
Research
Participants reveal personal details during interviews
that can lead to identification
Identifiers are intentionally changed, as are details of
narratives, when reporting data:
“A middle-aged Hispanic woman, Muriel,….” is, in actuality,
Henry: a 56-year-old African-American man
The general rule is, “When in doubt, don’t.....” when
using a quotation that might inform too much about a
participant
Real names are never mentioned on tapes
Videotapes should cloud faces and disguise voices
39. 39Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right to Fair Treatment
Based on the ethical principle of justice: each
person should be treated fairly and should
receive what he or she is due or owed
The selection of subjects and their treatment
during the course of a study should be fair
40. 40Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Fair Selection of Subjects
The privileged should not be over-included in
therapeutic research, when a definite benefit
is anticipated; benefit should be shared
across groups
The underprivileged should not be over-
included in research, if harm is a distinct
possibility; the risk should be borne equally by
all
41. 41Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Fair Treatment of Subjects
Promised benefits must be delivered
What the subjects are told will happen to
them must remain the case
The sample should be, more or less, a cross-
section of the available population
42. 42Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Right to Protection from
Discomfort and Harm
Beneficence: do good and, above all, no
harm
If harm is likely, subjects must be informed
and allowed to decline to participate
Researchers should try to bring about the
greatest possible balance of benefits in
comparison with harm
43. 43Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Five Levels of Discomfort and
Harm
No anticipated effects (example: review of existent
records; having one’s fingernails swabbed for
cultures)
Temporary discomfort (examples: three blood draws;
having to stand in one place for half an hour)
Unusual levels of temporary discomfort (examples:
detailed narrative reporting of one’s experiences as a
prisoner of war; bone marrow biopsies; prolonged
sensory deprivation)
44. 44Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Five Levels of Discomfort and
Harm (Cont’d)
Risk of permanent damage (examples: an
experimental cancer treatment with 25% risk
of severe hearing damage)
Certainty of permanent damage (examples:
destruction of brain tissue that results in
unilateral blindness, in order to cure an
advanced cancer)
45. 45Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Predicting the Benefit-risk Ratio
If the benefit-risk ratio does not show more
benefit than risk, the study will not be given
Institutional Review Board approval. The
benefit-to-risk ratio is part of the research
protocol submitted to the Board
46. 46Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Predicting the Benefit-risk Ratio
(Cont’d)
Individually: predict the outcome of the study,
maximize potential benefits, minimize
potential harm, and assess the individual’s
likelihood of risks and of benefits
Collectively: predict the outcome of the study,
maximize individual benefits and minimize
individual harm, and then assess the world’s
likelihood of benefit, in comparison with the
risk to which the research subjects are
collectively subjected
47. 47Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Benefit-risk Ratio
48. 48Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Informed Consent
Subject is told what the study will involve, what will be
done to/with the subject, how the data will be treated,
and what the possible benefits and risks of
participation are, including remuneration given for
participation
Must involve information as to what will happen if the
potential subject refuses to participate
Must disclose why the study is being conducted
(academic requirement, internal review, external
funding to test a product, etc.)
49. 49Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Obtaining Informed Consent
The subject must understand and must be
allowed to ask questions; burden for
confirming understanding is the researcher’s
The subject must be competent
The subject must voluntarily agree, must
understand that refusal to participate is
acceptable, and must be told that the subject
can withdraw from the study at any time
50. 50Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
The Consent Form
Should be typed
Should be in plain English
Should have short concise segments, with
titles (risks, benefits, freedom to refuse, etc.)
Should provide a place for signature at the
end
Should provide a place for initialing on each
page
51. 51Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Studies Without Written Consent
“Completing this questionnaire implies
consent”: often used for anonymous
participation—mailed questionnaires, online
surveys, cards filled out in shopping centers
Studies in which written consent implies guilt
for a crime (successful cat burglars and their
descriptions of gaining access to second-
story windows)
52. 52Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Institutional Review Board (IRB)
Committee of the researcher’s peers
At least five members, from various backgrounds
(may not include the researcher)
Collectively, they must understand the research and
the ethical concerns inherent for the study’s
location, population, procedures, etc.
Membership must include at least one non-scientist,
and at least one person not affiliated with the
institution
53. 53Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Institutional Review Board (IRB)
(Cont’d)
Sole responsibility: to examine a study in
order to assure ethical researcher behavior
Required for experimental research review in
1966
Required for all research since mid-1974
Realistically, limited to agencies with federal
grants or public funding
Since 1990 all IRBs must be registered with
the federal Department of Health and Human
Services
54. 54Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Levels Of Reviews Conducted By
Institutional Review Boards
IRB determines the minuteness of the review
required
Level of review (exempt, expedited, complete) is
initially indicated on application by the researcher,
BUT the IRB may change this designation, if they feel
that it is incorrect
Students typically complete one IRB review for the
institution at which they are studying AND one at the
institution at which they conduct research
55. 55Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
No Apparent Risk = Exempt
From Review
Examples: most educational research; use of
de- identified specimens already collected by
previous research; most public behavior
observations; research on how public service
programs are delivered
Caveat: the researcher needs to submit at
least one copy of the protocol to the IRB
Chairperson, so that one person can affirm
that the research is exempt
56. 56Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Minimal Risk = Expedited Review
“Everyday” risk
Examples: collection of body secretions
without pain, anonymous surveys,
noninvasive monitoring, some blood draws,
research on benign drugs (vitamin
supplements)
Several copies of the research protocol are
submitted to the IRB, and one or more of
them review the protocol
Consent required
57. 57Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Greater than Minimal Risk =
Complete IRB Review
More difficult to obtain but not impossible
Protocol must carefully address minimization
of risk; risk:benefit ratio; equitable subject
selection; the consenting process; how
subjects will be monitored for safety
Researcher should expect revisions to the
protocol, as these are made crystal-clear by
IRB
58. 58Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Research Misconduct
Data fabrication or falsification
Intentional fraud
Misinterpreting findings
Operating outside the approved protocol
Consent violations
Plagiarism
Financial interest in results
59. 59Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Publication Guidelines for
Researchers
Retain all raw data
More than one person must be involved in each step
of the research process
Individuals are listed as coauthors only if actively
involved in the conduct/publication of the research
Disclose sponsorship
Follow the protocol, and consent subjects properly
If paraphrasing another author, give credit; do not
use exact words
60. 60Copyright © 2013, 2009, 2005, 2001, 1997 by Saunders, an imprint of Elsevier Inc.
Animals as Research Subjects
According to codes of conduct, experimental
treatments that involve more than minimal
risk should be first tested on animals
If animals are used as subjects, they require
humane treatment
Federal guidelines and other guidelines