Transcript No Slide Title

An Introduction to Ethical
Reasoning
EATG Ethics Training
December 8-9, 2005
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Origin of
Biomedical Ethics
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What is Biomedical Ethics?
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Ethics is a branch of philosophy that attempts to
assist us in deciding what is right and wrong in
human conduct
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Ethical reasoning takes place whenever there is a
need to provide moral reflection on a specific action
or behavior, such as a research project or a
procedure
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The term “bio-medical ethics” was coined in the early
1970s to refer to the application of moral reasoning to
vexing questions at the frontiers of biology and
medicine
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The Evolution of Research Ethics
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Ethical review and bio-medical ethics evolved in
response to a history of medical abuses
– Medical abuses by Nazi doctors (Nuremburg
Trial and code of 1947)
– Public revelation of the Tuskegee syphilis
study in 1974
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These abuses prompted the creation of a series
of norms, guidelines, and regulations to help
guide the conduct of research
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The Evolution of Research Guidelines
Nuremberg Code
1964
India
1947
Uganda
Brazil
Declaration of Helsinki
1993
WHO/CIOMS
European Commission
Directive
2003
2000
UNAIDS Vaccine
Guidance
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Limitations of Existing Guidance

Most have only persuasive force and are enforceable
only via sanctions imposed by the professional
association that created them

Some have been enshrined in national laws (e.g. US
Policy for the Protection of Human Subjects, Ethics
Law in Denmark, Brazil and Uganda)
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Several take conflicting positions
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Few take into account the special circumstances that
characterize externally sponsored research in
developing countries (p. 54 Nuffield Council).
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Ethics Committees: Review of
Research
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“Ethical review” is now a standard part of
approval for most publicly funded scientific
research involving human beings
Primary role is to protect people participating
in research
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Scientific design and conduct of study
Care and protection of research participants
Community participation
Appropriate of informed consent
Confidentiality issues
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The Art of
“Doing Ethics”
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Principles of Research Ethics
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Research ethics rests on a set of fundamental ethical
principles
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These principles are the most fundamental unit of
ethical analysis – all norms and guidelines derive
from them
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Nonetheless, like constitutions, ethical principles and
guidelines need interpretation and debate
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Different ethical principles can at times be in conflict
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Ethics is not a formula, but a process of reflection
and weighing of choices
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Ethics is a process
Not a rule
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How decisions are arrived at is ethically relevant
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Different conclusions may result from different ethical
reviews of the same issue or proposal and each
conclusion may be ethically reached
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A conclusion is ethical not merely because of what
has been decided but also because of the process of
conscientious reflection and assessment by which it
is reached
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Whose voice is represented in the debate is also
important
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Core Ethical Principles
Belmont Report (1978)
– Respect for Persons
• Autonomy
• Protection of vulnerable or persons with
diminished capacity
– Beneficence
• Maximizing benefits
• Minimizing harms
– Justice
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Respect for Persons
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Autonomy, self-determination
– Those capable of deliberation should be
treated with respect for their capacity for self
determination
– Underlies requirement for “informed
consent”
Special measures for the vulnerable
– Those whose decision-making capacity is
impaired or diminished due to intrinsic
factors or circumstance
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Beneficence
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Maximize possible benefits
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Minimize possible harms or wrongs
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This principle gives rise to norms requiring:
– On balance, the research should generate
more good than harm
– Risks of research to be reasonable in light
of the expected benefits
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From Protectionism to Access

Traditionally, much of the debate over “beneficence”
has focused on protecting research participants from
harm
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But a second major reason for ethical review is to
ensure equitable distribution of the potential benefits
of research
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During the 1980s, emphasis in global ethics
discourse shifted from concern with the potential
harms of research to a demand for greater access to
its benefits.
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Justice
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People should receive what is due to them
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Benefits and risks of research should be
fairly distributed
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Research participants and sites should be
fairly selected
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An alternative Articulation of
Core Ethical Principles
Nuffield Council on Bioethics (2002)
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The duty to alleviate suffering
The duty to show respect for persons
The duty to be sensitive to cultural difference
The duty not to exploit the vulnerable or less
powerful
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Duty to Alleviate Suffering
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The duty to alleviate suffering enjoins us to do
what we can to reduce the amount of suffering in
the world.
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The more suffering we help to eliminate, the
better our action
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Acknowledging the duty, however, does not mean
that it overrides all other claims
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In situations were resources are limited, the
challenge is to strike an acceptable balance
between competing demands
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“Ought” implies “Can”
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A person’s duty to benefit another is related to
his or her capacity to do so, whether financial or
practical.
– If a benefit cannot be provided for reasons of
practical constraint, the duty to do so is weakened.
– Conversely, if a country’s wealth allows it to confer a
benefit on the inhabitants of another country, the
wealthier country has a stronger duty to provide that
benefit.
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“Can” implies “should”
“ If it is in our power to prevent something
bad from happening without thereby
sacrificing anything of comparable moral
importance, we ought morally to do it.”
Peter Singer,
Philosophy and Public Affairs 1972:1:229-43
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Informed Consent is a process
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Informed consent is a process of collaborative
communication and decision making, not the signing
of a form
Informed consent requires that prospective
participants:
– Be appropriately informed about the nature of the
research
– Adequately understand this information and its
implications
– Voluntarily decide to participate, without coercion
– Explicitly consent to participate, orally or in writing
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Legal and moral agenda can
sometimes conflict
Indemnify the research institution
VS.
Facilitate collaborative decision making
Length of forms
Degree of technical information imparted
Written versus oral consent
Emphasis on right to withdraw
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Therapeutic Misconception
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“Therapeutic misconception” refers to the tendency of
some research participants to wrongly assume that
whatever drug or intervention they are offered must
work or be beneficial (or why would it be offered?)
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It occurs when the goals of research and those of
therapy or “health care” become confused in the
participants mind.
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The therapeutic misconception is a major threat to
“informed consent.”
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Putting it all together:
What makes research
ethical?
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What Makes Research Ethical?
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Social or scientific value
Scientific validity
Fair subject selection
Favorable risk-benefit ratio
Independent review
Informed consent
Respect for potential and enrolled subjects
Collaborative partnership
Emanual et al., JAMA, 283, 2000
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Seven Steps for Ethical Research
1.
Priorities: Did the study address a priority issue? Whose?
2.
Planning: Was the study well designed to optimize the
chances of generating useful knowledge and protecting
subjects?
3.
Permission: Was the project reviewed and cleared by the
relevant institutions? Did the investigators obtain informed
consent?
4.
Performance: Was the study conducted in a way that
respected the rights of the subjects and minimized the risks to
them?
5.
Processing: Were the results correctly analyzed and
interpreted?
6.
Publication: Were the results published and disseminated?
Programming: Have the findings been translated to policy
and action?
7.
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