6.

An Ethical Framework for CAM

Research, Practice, and Policy

Rina Nurbani
1806264201
Akupunktur Medik
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 Value commitments that inform this
chapter
1. A social commitment to public welfare
2. A commitment to protect patients and the
public generally from hazardous medical
practices and to inform practitioners, policy
makers, and the public of select therapeutic
modalities that are potentially injurious or
deleterious to health.
3. A respect for patient autonomy
4. Recognition of medical pluralism
5. public accountability

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 Value Judgments In Defining CAM

• Defining modalities as “CAM therapies” are not only

scientific but also political, social, and conceptual
• The origin of the practice (e.g., acupuncture) is outside
of the dominant system
• The amount of data is considered insufficient or
otherwise inadequate (e.g., herbalism and
megavitamin therapy)
• The use of the practice is not widely available within
conventional hospitals (e.g., chiropractic)
• The amount of research funding, infrastructure, and
capacity for investigating the practice is low (e.g.,
massage)

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 Ethical Issues In CAM Research (1)

• Social or Scientific Value

– The value of a research project is the extent to
which it holds the promise of improving health or
increasing knowledge important to health, when it
is judged on either social or scientific grounds
– CAM therapies do not constitute a consistent or
unified set of practices but constitute a wide-
ranging set of highly variable practices, valued in
different ways by the constituencies that deliver
and receive them

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 Ethical Issues In CAM Research (2)

• Scientific Validity
– Validity results when scientific principles and
methods are used to produce reliable outcomes
– For CAM research, it is important to ask about the
range of scientific validity that is appropriate and
what should count as a validated therapy

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 Ethical Issues In CAM Research (3)

• Fair Subject Selection

– selecting subjects so that there is an equitable
distribution of benefits and burdens

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 Ethical Issues In CAM Research (4)

• Favorable Risk-Benefit Ratios

– obligation to minimize risks to subjects during the trial
(nonmaleficence), to enhance potential benefits
(beneficence), and to ensure that the benefits to
subjects or society, or both, are worth the risks
incurred (proportionality and nonexploitation)
– many CAM practices the absence of standardization
among practitioners, combined with imprecise
measures of outcomes, could make the riskbenefit
ratio more difficult to assess

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 Ethical Issues In CAM Research (5)

• Informed Consent
– researchers must inform potential subjects of the
purpose of research, its risks and benefits, along
with the alternatives, in a manner that ensures
that the participants understand these elements
of research and can act freely to enroll or decline.
– the issue is their expectations, with the subjects
often attributing more therapeutic potential to a
research project than the evidence or the trial
design warrants “therapeutic misconception,”

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 Ethical Issues In CAM Research (6)

• Independent Review
– a review of the research design, subject
population, risk-benefit ratio by persons with
expertise in these facets of research
– to minimize conflicts of interests, ensure
objectivity, and enhance public accountability

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Ethical Issues In CAM Research (7)
• Respect for Potential and Enrolled Subjects
– permitting subject withdrawal from the research
– protecting subject privacy through confidentiality
– informing subjects of changes in risks and benefits
during the trial
– making the research results available to the
subjects of that research
– maintaining the welfare of the subjects
throughout the trial

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 Ethical Issues In The Integration Of CAM
Therapies Into Convensional Medical Practice (1)

• The Code of Ethics of the American

Chiropractic Association includes
– duties of confidentiality, privacy, and loyalty;
obligations not to neglect or abandon the patient;
duties of honesty and competency; and the use of
modalities that are in the patient’s best interest
and not in conflict with applicable statutory or
administrative rules

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 Ethical Issues In The Integration Of CAM
Therapies Into Convensional Medical Practice (2)

• the Model Code of Ethics of the Acupuncture

– practitioners be competent,
– maintain patient confidences and records,
– not abandon patients,
– provide a clear treatment plan,
– charge fees that are not excessive,
– inform the patient regarding contraindications,
maintain appropriate therapeutic boundaries, and
refrain from false or misleading advertising
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 Ethical Issues In The Integration Of CAM
Therapies Into Convensional Medical Practice (3)

• when and how practicioners can collaborate or

integrate forms of care while respecting the pluralism
necessary to sustain what is valuable and distinctive
within each system of care.
• integrate CAM therapies into conventional medicine
practice can present
– Physician-patient relationships
– “health” and “care”
– new responsibilities and some potential hazards
– conventional medicine practitioners ask about a patient’s
use of CAM when the patient’s history is taken

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 Ethical Issues In The Integration Of CAM
Therapies Into Convensional Medical Practice (4)

• the physician’s obligation to be well informed about

the CAM modalities most frequently used by patients
• an obligation of candor about the physician’s level of
knowledge of the CAM modalities in question
• an obligation to make patients aware of whatever
safety and efficacy information is available
• Ernst and Cohen (2001): the duty “to tell patients
about the degree of uncertainty associated with the
efficacy and safety of the treatment, as well as the
availability and risk-benefit ratio of other treatment
options.”

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Related Legal And Regulatory Issues (1)
• Ethical concerns in clinical care frequently overlap
with legal considerations
– the clinician is ethically and legally provide adequate
informed consent (the risk and benefit of the
procedure and the alternative option) and discuss it
with patient  decision based on patient autonomy
• National Institutes of Health Consensus Paneld
etermine that acupuncture is effective for the
relief of nausea following chemotherapy, failure
to recommend such a therapy potentially could
be considered malpractice if it results in patient
injury
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Related Legal And Regulatory Issues (2)
 CAM providers have a legal and ethical duty to refer
a patient for conventional medical care when the
patient’s condition requires such referral
 CAM therapies in clinical settings should be guided
by considerations of nonmaleficence, beneficence,
autonomy, pluralism, and accountability
 Medicine is constantly shaping and being shaped by
the larger social, cultural, and political forces of its
era

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