ETHICS INFORMED CONSENT

1. Armed Forces
Medical College
21st century:
Ethics and Informed Consent
Major(Dr) Shashikant Sharma
Department of Hospital Administration

2. Armed Forces
Medical College
Informed Consent
Essential Legal and Ethical Principles for Nurses
Juliet Battard Menendez, RN, MSHL, CPHRM
JONA’S Healthcare Law, Ethics, and Regulation / Volume 15,
Number 4 / Copyright B December 2013 Wolters Kluwer
Health | Lippincott Williams & Wilkins

3. Armed Forces
Medical College
Sequence of Thought
• Informed Consent
– Why do we need ?
– Who is responsible ?
– When is it required ?
– Evidence
– Consequences
– Content
– Barriers
– Remedies
– Conclusion
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• Main Article
• Related Article
• Discussion
• Theory & principles of
Health Care Ethics

4. Armed Forces
Medical College
Introduction
• Shared decision making
• Mutual participation & respect for autonomy
• Patient legal right
• Actual application
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5. Armed Forces
Medical College
Rationale for Nurses Engagement
• Ultimately, physician responsible
• However, nurses as enlightened patient advocates
• Special circumstances
– Surgery refusal
– Limited mental capacity
– Surrogate decision making
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6. Armed Forces
Medical College
Principles of Informed Consent
• Willingly accept
• Move beyond physician disclosure of info
• Shared medical decision making
• Content vs comprehension
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7. Armed Forces
Medical College
Delivery Methods
• Vary among different surgeons
• Vary among different patients
• Traditionally: oral followed by signing
• Videos & computer software
• Any delivery method may be used
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8. Armed Forces
Medical College
Ethical Consideration
• Opportunity the process presents
• Challenging dilemma for surgeons
• Autonomy/Beneficience/Paternalism
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9. Armed Forces
Medical College
Nurses’ Role in Informed Consent
• Appropriate participation in the process
• Misconception : consent = signature
• Nurses : charged with facilitation of legal
documentation
• Advocacy role of nurses
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10. Armed Forces
Medical College
Nurses Role: Patient Education
• Educational tools: springboards/videos/AV aids
• Waiver of liability
• Nurses involved in process: evidence
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11. Armed Forces
Medical College
Nurses Role: Patient Comprehension
• Comprehension of info: precondition
• Factors
– Disease process/Anxiety/Pain/Therapeutic
Intervention
• Surgeon responsible
• Nurses : Repeat back process
• Nurses more familiar & skilled in repeat back
process
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12. Armed Forces
Medical College
Nurses Role: Patient Anxiety
• Surgeons circumvent the process
– Attempt to avoid anxiety
• Nurse patient Relationship
– Identify & address anxiety
– Patient customized learning aids
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13. Armed Forces
Medical College
Distinction : Form vs process
• Only offering legal protection
• Overshadow ethical goal
• Informed Consent : Continuous process
• Patient may consult families/relatives before
even seeing the form
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14. Armed Forces
Medical College
Surrogate Decision Making
• Decisional Capacity
• Process information & meaningful response
• Clinical situation & should be a part of
informed consent process
• Florida Advanced Health care directive
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15. Armed Forces
Medical College
Refusal of Consent
• Patient competent ?
• Freely given & withdrawn
• Refusal does not mean doctor did not provide
adequate information
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16. Armed Forces
Medical College
Discussion
• Process of informed consent : Multifaceted
• Right to consent : basic patient right
• Nurses integral to process
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17. Armed Forces
Medical College
Nurses may serve to
• Ensure patient comprehension
• Facilitate documentation of consent
• Address patient anxiety
• Identify the appropriate surrogate decision
maker when needed
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18. Armed Forces
Medical College
Nurses may serve to….
• Ensuring that the informed consent process is
completed in accordance with law &
regulation
• Compliance accreditation standards : patients
participate fully in decisions about their care,
treatment and services
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19. Armed Forces
Medical College
Implications
• Surgeons erroneously conceptualize informed
consent as a formal legal document
• Paradoxically: detracts from the actual
exchange of information
• Appropriate knowledgeable nurses:
collaborate with surgeons in the informed
consent process
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20. Armed Forces
Medical College
Implications…
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‘‘Did the patient agree to the surgery?”
‘‘Did the physician provide the patient with an adequate
amount of information for the patient to consent?’’

21. Armed Forces
Medical College
Critical appraisal
• Article lacks objectivity
• Theoretical approach
• Practice
• What should a nurse do ?
• How the process is carried out
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22. Armed Forces
Medical College
Strategies for Enhancing the Nurse’s
Role in Assessing and Promoting
a Patient’s Decisional Capacity
Marcia Sue DeWolf Bosek, DNSc, RN
JONA’S Healthcare Law, Ethics, and Regulation / Volume 7,
Number 3 / B 2005, Lippincott Williams & Wilkins, Inc.

23. Armed Forces
Medical College
Introduction
• Patient care partnership: Understanding
expectations, rights and responsibilities
• Nurses & nurse managers : assume leadership
promoting patient autonomy in every clinical
setting
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24. Armed Forces
Medical College
The American Nurses Association
Code of Ethics for Nurses
• Each nurse has an obligation to be
knowledgeable about the moral and legal rights
of all patients to self-determination
• The nurse preserves, protects and supports
those interests by assessing the patient’s
comprehension of both the information
presented and the implications of the decisions
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25. Armed Forces
Medical College
Case Study
Ms. G 80-year-old mother of 4 sons
3 days post ORIF of a hip # Pre surgical
workup, found to have hematuria
Urologist : renal cancer need periodic
blood transfusions
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26. Armed Forces
Medical College
Background
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BUN and Creatinine have decreased
still not fully oriented
G’s son Howard power of attorney for
healthcare , Mark (other son) no morals
Nurse initiated an ethics consultation

27. Armed Forces
Medical College
Patient conference
Ethicist
PhysicianNurse
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Assisted
identify
preferred
surrogate
Agreement

28. Armed Forces
Medical College
Assessing Decisional Capacity
Competence
Problem
Available
options
Benefits &
burdens
Rationale
support
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29. Armed Forces
Medical College
Understanding of her
present condition & prognosis
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Tell me about why you
were admitted to the
hospital?

30. Armed Forces
Medical College
Understanding of her
present condition & prognosis
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What have the doctors told
you about your kidney
function and why you have
blood in your urine?

31. Armed Forces
Medical College
Understanding of her
present condition & prognosis
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How do healthcare
decisions get made if you
are not able to decide what
to do?

32. Armed Forces
Medical College
Understanding of her
present condition & prognosis
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Do you know what a
Durable Power of
Attorney is? If so, what
does it do?

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Medical College
Aware of the available options
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Is there one person who you believe best knows
your values and beliefs about healthcare?
How do you believe decisions about your
healthcare should be made if you are unable to
tell us your wishes?

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Medical College
If she recognizes both benefits & burdens
associated with each available option
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What are some of the benefits associated with naming
your son Kevin as your surrogate?
What would be some of the undesired consequences or
negatives that might occur if Kevin were your surrogate?
What would be some of the good outcomes if your
children as a group were to make decisions for you?

35. Armed Forces
Medical College
Advocacy Vs Badgering
• Advocacy : Ethicist notified Ms. G’s decisional
capacity should be re-evaluated when her
cognitive function (MME) had improved
• Badgering/ persecute persistently: when
numerous individuals repeatedly ask the same
questions
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36. Armed Forces
Medical College
Nurse Administrator’s Role
• May not be directly involved assessing a patient’s
decisional capacity
• Create an environment : Pt ethical friendly
• Journal club discussions, or brown-bag lunches
should be organized
• Staff are aware of the institution’s ethical
resources
• Promote the use of ethical resources.
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37. Armed Forces
Medical College
Discussion

38. Armed Forces
Medical College
References
1. Text book : Health care ethical critical issues 21st
century by Eileen E Morrison
2. From “What Did the Doctor Say?: Improving Health
Literacy to Protect Patient Safety” The Joint
Commission, 2007
3. American Medical Association Guidelines
4. Review Article : Role of nurses in informed consent :
Jennifer M. Sims ( Dimensions of Critical Care Nursing)
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39. Armed Forces
Medical College
Theory of Health Care Ethics
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• right thing based on authorityAuthority
• order of natureNatural law
• consequences of actionTeleological
• determining our dutiesDeontological
• seeking proper end for humansVirtue
• maximize person’s self interestEgoistic

40. Armed Forces
Medical College
Principles of Health Care Ethics
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Non
Maleficiance
Autonomy
Justice
Beneficence

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Medical College
1. Non maleficiance
• First do no harm
• Consequentialist: prevents the good
• Natural law : oppose to rational natures
• Deontologist : prevents to carry duty
• Virtue : away from eudemonia
• Egoist : oppose to self interest
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Medical College
What is harm in clinical setting
• No simple matter
• Justify harm for greater good
• Consider harm to mean physical harm
• Ways are infinite
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43. Armed Forces
Medical College
Harm as Violation of Autonomy
• Imposing a treatment
• Substituted judgment
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Harm as Negligence
• Failure to engage in protocols
• Malpractice

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Medical College
2. Beneficence
• More than just avoiding harm
• Act of kindness & courtesy
• Fundamental principle of health care ethics
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45. Armed Forces
Medical College
Non maleficiance & Beneficence
Insufficient Principles
• Physician defined ‘harm’& ‘good’
• Paternalism
• Assertion/ Coercion
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Medical College
3. Autonomy
• Often unclear
• Are patient competent
• Free of coercion
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Medical College
4. Justice
• Procedural
– Due process
• Distributive
– Equal share of burden & benefits
– Resource allocation
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48. Armed Forces
Medical College
Equilibrium at work
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Common
morality
Ethical
Theories
Considered
Judgments
Ethical
Principles
Care issues
at hand

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Medical College
In Pro Cycling...
“It’s Not About
the Bike”
With Informed
Consent...
... It’s Not About
the Form

50. Armed Forces
Medical College
What is Informed Consent?
……It’s more than a signature on a piece of paper!
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The process of communication between a patient and
physician that results in the patient’s authorization or
agreement to undergo a specific medical intervention
American Medical Association 1998

51. Armed Forces
Medical College
Why Do We Need Informed Consent?
The Short Answer
Safety
quality
Law
Access
Diversity
Ethical
thing

52. Armed Forces
Medical College
Why Do We Need Informed
Consent?
• The Slightly Longer Answer:
– Greater patient safety & satisfaction
– Attainment of higher ethical standards &
organizational morale
– Adherence to legal requirements and reduced risk
of litigation
– Increased levels of institutional quality (e.g.,
compliance with accreditation standards)
– Potential time and money savings related to
reduced litigation

53. Armed Forces
Medical College
Who is Responsible for
Informed Consent?
• The clinician has core responsibility... but...
... a team approach is required with
contributions from:
Entire clinical staff
Administrative &
Clinical Leadership
Legal counsel

54. Armed Forces
Medical College
When is Informed Consent
Required?
• In most institutions, for:
– surgery
– anesthesia
– other invasive or complex medical or radiologic
procedures
• Laws vary about exactly when and how formal
informed consent must be provided.

55. Armed Forces
Medical College
Why Do We Need to Improve
Informed Consent?
• Patient Factors:
– Low health literacy
– Limited English proficiency
– Cognitive impairments
– Confusion about the purpose of consent process
– Feeling of intimidation & stress or time pressure
Even after signing: still do not understand the risks &
benefits

56. Armed Forces
Medical College
Why Do We Need to Improve
Informed Consent?
• Provider Factors:
– Lack of time for up-front patient education
– Overly complex or overly broad written materials
– Lack of support with interpreters
– Wrong assumptions about patient comprehension
• Even after signing: still do not understand the
risks & benefits

57. Armed Forces
Medical College
Low Health Literacy — A Common Theme
in Poor Clinician-Patient Communication
“Many leave the doctor’s office with questions
unspoken and unanswered...”
From “What Did the Doctor Say?: Improving Health Literacy to Protect Patient Safety”
The Joint Commission, 2007 www.jointcommission.org
“The communications gap between the abilities
of ordinary citizens and especially those with low
health literacy and low English proficiency and
the skills required to comprehend everyday
health care information must be narrowed.”

58. Armed Forces
Medical College
What’s the Evidence that the Informed
Consent Process is Not Working Well?
– Only 9% of decisions were completely informed
– Only 20% to 38% of the encounters met
less stringent criteria for completeness
• Braddock et al
1999
• Audiotape
recordings
• 1057
physician-
patient
encounters

59. Armed Forces
Medical College
What’s the Evidence that Informed
Consent Forms are Poorly Written?
Only 26% included all four elements
(nature of procedure, risks, benefits, alternatives)
Less than half of the forms provided specific information about
risks
Alternatives were noted only in 57% of forms
• Bottrell et al
2000
• 540 informed
consent
forms
• 157
hospitals

60. Armed Forces
Medical College
What’s the Evidence that Informed
Consent Forms are Poorly Written?
Average were written at grade level of 12.6 Just over
half could be understood by patient with high school
education
Only about 5% could be understood by patient
with 8th grade reading level
• Hopper et
al. 1998
• 616 forms
assessed
• computer
for
readability

61. Armed Forces
Medical College
What are the Potential Consequences
of Lack of True Informed Consent
– Increased chance of a patient safety incident or
medical error
– Increased chance for malpractice cases
– Violation of professional and ethical obligation to
clinicians to communicate clearly

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Medical College
Source: AMA 1998
What’s Needed for
Informed Consent?
The physician (not a delegated representative)
Diagnosis Alternatives
Risks and benefits of not
receiving treatments
Risks & benefits of
alternatives
Nature
Purpose
Risks
Benefits

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Medical College
How Much Needs to be
Disclosed?
– Requires local interpretation, common sense
– Many states rely on a standard of what a “reasonable
physician” would provide or what a “reasonable
patient” would need
– Most laws describe the need to cover all “material”
(i.e., significant) risks
– Information also needs to be tailored for each
individual

64. Armed Forces
Medical College
What are the Main Barriers to
Effective Informed Consent?
Lack of clinician time
Confusion among clinicians: when
Caution: too much information
Legal release: for hospital to proceed
They can refuse
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65. Armed Forces
Medical College
What are the Main Barriers to
Effective Informed Consent?
Patient language and cultural issues
Poor quality of consent form
Patient inability to comprehend
Clinician inability to detect patient’s lack
of comprehension
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66. Armed Forces
Medical College
What Can we Do to Improve
Our Informed Consent?
1. Redesign: process /include forms written in simple
sentences & in the language of the patient
2. Use ‘teach back” during the informed consent
discussion.
3. Engage the patient in a dialogue about the nature
and scope of the procedure
From “What Did the Doctor Say?: Improving Health Literacy to Protect Patient Safety”
The Joint Commission, 2007 www.jointcommission.org

67. Armed Forces
Medical College
What Can we Do to Improve
Our Informed Consent?
1. Improve our written consent forms and
related written educational materials
– Readability (5th grade level)
– Layout/design
– Language
From “What Did the Doctor Say?: Improving Health Literacy to Protect Patient Safety”
The Joint Commission, 2007 www.jointcommission.org

68. Armed Forces
Medical College
What Can we Do to Improve
Our Informed Consent?
2. Improve our informed consent process
– Create the time for it
– Simplify our language
– Allow time for questions
– Make sure the patient understands
– Plan for language assistance in advance of
appointment
From “What Did the Doctor Say?: Improving Health Literacy to Protect Patient Safety”
The Joint Commission, 2007 www.jointcommission.org

69. Armed Forces
Medical College
What Can We Do to Improve
Our Informed Consent?
3. Improve understanding of informed consent
and the responsibilities and liabilities to
health care organizations
– Train support staff, nursing, administrators,
interpreters, etc.
From “What Did the Doctor Say?: Improving Health Literacy to Protect Patient Safety”
The Joint Commission, 2007 www.jointcommission.org

70. Armed Forces
Medical College
What Can We Do to Improve
Our Informed Consent?
4. Keep track of incidents related to informed
consent process
– Use CQI processes to monitor incidents related
to informed consent
– Develop targeted remediation to identified
problems

71. Armed Forces
Medical College
Lang’s model
STRUCTURE CRITERIA
PROCESS CRITERIA
OUTCOME CRITERIA
VALUES
MEASURE
ANALYSE
PLAN ACTION
TAKE ACTION
RE-EVALUATE
Quality in Informed Consent

72. Armed Forces
Medical College
Regulations in India
• India Medical Council Act 1956 & Regulations 2002
• Indian Nursing/Dental/Pharmacy/Act
• The Clinical Est Act 2010
• The Consumer Protection Act 1986
• The MTP Act 1971 & regulations thereon
• The PNDT Act 1994
• The Right to Education Act 2008
• The Right to Information Act
• ………………….may more
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73. Armed Forces
Medical College
Latest : Today Times of India
• From Jan1 : Pharma co can no longer gift
freebies to doctors
• At present pharma: Self Regulation Code
• Code viewed for 06 months
• If not followed will be made mandatory
• Governed by IMC ( Professional Conduct &
Etiquette and Ethics) Regulations 2002
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74. Armed Forces
Medical College
Conclusion
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