Transcript Ethical and bioethical issues 1

Ethical and bioethical issues
1
Bioethics - what is it
• Bioethics is a specific discipline that probes the
reasoning behind our moral life within the context
of the life sciences; how we decide what is
morally right or wrong bioscience
• Ethics is different from morals. Ethics tries to
probe the reasoning behind our moral life, by
examining and analyzing the thinking used to
justify our moral choices and actions in particular
situations
2
Bioethics – what is it
• Bioethics is normative ethics applied to the practice of
science and medicine. It falls under the general group of
applied and professional ethics
• It is predicated on an assumption that some solutions to the
ethical problems that arise in science and medicine are
more moral than others and that these solutions can be
arrived at by moral reasoning and reflections
3
Bioethics – what is it
• It is a branch of knowledge like mathematics, and thinking
in this field is not wholly different from thinking in those
other fields, however it cannot be reduced to them.
• Bioethical conclusions cannot be unambiguously proved
like mathematical theorems
• Research ethics or more specifically health research ethics
is the branch of bioethics that deals with issues relating to
the ethical conduct of research
4
History of bioethics
• There was little broad interest in research ethics before the
Second World War
• Smidovich’s The Confessions of a Physician (1901)
• Public concern about Walter Reed’s yellow fever research in the
United States
• The Nuremberg trial that followed the evil that was Nazi
war experiments which were marked by unprecedented
cruelty and inferior science, focused attention on the need
for a code of research ethics
• Prosecutors argued that the experiments violated
fundamental ethical standards of civilized society
5
History of bioethics
• The Nazi war experiments were more bizarre given that in
1931, Germany had enacted strict “Richtlinien” to control
human experimentation and the use of innovative therapies
in medicine
• Two of the 14 provisions of these guidelines concerned
consent requirements
• Questions about nature of appropriate information, bona
fide consent, careful research design, special protections
for vulnerable subjects were all carefully outlined
• Experimentation on dying patients was completely
forbidden
6
History of bioethics
• No other nation had such legally and morally advanced
regulations at this time
• These regulations were in force and binding throughout
Germany from before and through the duration of the
Second World War
• They were no less comprehensive and adequate than the
more popular Nuremberg Code
• Yet, the Nazi experiments comprehensively ignored and
violated every one of the regulations
• The defendants argued that voluntary participation by
human subjects in medical experimentation was not the
norm at that time
7
Nuremberg code 1948
• The main components of the code are
• Requirement for voluntary participation
• Informed consent
• Favorable risk/benefit analysis
• Right to withdraw without penalty
• Criticized for being legalistic
• Largely ignored by medicine
• No mention of independent review or fair selection of
participants
8
1950s Wichita Jury Study
• Social science researchers from the University of Chicago
conducted a study involving secret audio taping of jury
deliberations in order to better understand decision making
process of jurors in criminal trials
• Their hypothesis was that showmanship on the part of trial
attorneys was affecting the outcome of trials
• When the results were presented in respectable academic
forums, public reaction was markedly negative
9
1950s Wichita Jury Study
• People objected to deception for research purposes in a
setting where privacy and confidentiality were critically
important
• This prompted the U.S. Congress to pass a law prohibiting
recording of jury deliberations, marking the first time that
actions of well meaning researchers will result in action to
protect people from exploitation
• Case highlighted the fact that some research questions
cannot be answered without compromising the integrity of
significant and cherished social institutions
10
1960s Thalidomide Study
• Thalidomide was introduced for the treatment of
hyperemesis gravidarum in Europe and while still
undergoing review in the U.S., an influential group of East
Coast practitioners started using it before it became clear
that it was causing a large number of birth defects
• Public outrage led to legislation that required investigators
to obtain informed consent before administering
investigational medications
11
1964 World Medical Council Declaration of
Helsinki
• This basically builds on the Nuremberg code and adds two
additional points
• That the interests of the subject should always be given
a higher priority than those of society
• That every subject in clinical research should get the
best known treatment
12
Other seminal events
• Henry Beecher’s 1959 Experimentation in Man’s
monograph
• 1960 – 1963 The Law-Medicine Research Institute of
Boston University’s survey of researhers attitudes and the
anthology “Clinical Investigation in Medicine”
• Henry Beecher’s article in NEJM in 1966 discussing 22
out 50 collected cases of unethical research in America’s
leading universities
• 1966 - Henry Beecher’s editorial in the Journal of the
American Medical Association and argument for virtue
ethics
• 1967 - M.H. Papworth – Human Guinea Pigs collected
more than 500 papers describing unethical experiments
13
Other seminal events
• 1972 Jay Katz, Alex Capron and Eleanor Glass
“Experimentation with Human Beings”
• 1973 Congressional hearings on quality of health care and
human experimentation
• Main catalyst for this was the Tuskegee Study (1932 – 1972), but
there were others, like
• 1950 Willowbrook Hepatitis Study
• 1960 Jewish Chronic Diseases Hospital Studies
• 1960 Milgram study of obedience
• 1970 San Antonio study of contraceptive pills
• 1970 Humphrey’s Tearoom Trade Study
• 1970 Zimbardo’s Mock Prison Research
14
1974 U. S. National Research Act
• This act established the modern research ethics system. The act
created U.S. federal regulations that required ethical approval
before most kinds of research involving human subjects can be
conducted, defined policy and procedures that EC must follow
when reviewing research, and established the criteria that an
EC must use to approve research conduct
• It also established the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research.
The function of the Commission is to issue recommendations
when what to do is not clear to researchers.
• In 1978, the Commission issued the Belmont Report
15
Other influences on development of bioethics
• The 60s and 70s civil rights movement in the United States
with distrust of authority, emphasis on individual rights
and autonomy
• The pace and variety of development of new health care
technology
• The Cold War and fear of any type of socialism
• The allocation, by the NHGRI, of substantial funds to
bioethics in 1989 leading to codification of the currently
predominant academic mode of discourse for bioethicists:
research concerning ethical issues as they are encountered
and resolved in society, culminating in data that is subject
to the same rigors of peer review as other social science.
16
How bioethical dilemmas are
resolved
• Ethical dilemmas continue to arise in research
• Should we select some people and expose them to an
unproven but potentially beneficial treatment so that we
can know if the rest of the population can benefit
• How should we select such people
• Who should we select
• Why
• Should such research participants be compensated
• How should they be compensated
17
How ethical dilemmas are resolved
• If the questions are clear cut, there is no dilemma
• Many times they are not and that is where the ethical
dilemma arises. To resolve this, we look for guidance
• Guidance are based on
• The arguments are conducted within an established
ethical framework
• Arguments that lead to the particular conclusions are
supported by reason
• A reasonable consensus exists about validity of the
conclusions, arising from a process of genuine debate
18
Why not rely on reason alone
• Reason alone is insufficient as there is no single
universally accepted reason-based framework within
which ethical questions can be resolved
• Nor is one likely in the future
• E.g., reason alone cannot decide between an ethical
framework that looks only at consequences and one that
considers intrinsic rightness or wrongness of actions
regardless of the consequences
• The history of discrimination against women for example
provides strong arguments against reliance on reason alone
19
The need for ethical frameworks
• The insufficiency of reason justifies the need for
established ethical frameworks
• The most widely accepted ethical frameworks in most
cultures arose within systems of religious belief but these
have limitations such as:
• A significant number of people do not accept scripture
as the source of moral thinking
• Human plurality is associated with scriptural plurality
• Many modern biotechnological issues are not addressed
in the scriptures
20
Ethical frameworks
• Despite these limitations, it is still necessary to consider
the ethical frameworks because
• Lives are not lived in isolation. We all grow up within
certain mores and traditions
• None of us derives our ethical thinking from first
principles
• Alternative ethical traditions are already accumulating,
for example about biotechnology
21
How then should we resolve bioethical
dilemmas?
• The simplest way to decide whether an action is right or
wrong is to look at the consequences
• No one can argue that we should ignore consequences of
an action before deciding whether it is right or wrong
• But we can consider the consequences of our response and
that of alternative responses
• How far can we or should we go in consideration of
consequences of specific actions?
22
Bioethical dilemmas
• Even when we are in complete agreement about a moral
question, consequences still have to be considered
• The deeper question is not whether to take consequences
into account when making ethical decisions but whether
that is all we need to do
• Are certain actions morally required, regardless of their
consequences?
• It would appear that the answer to these questions are
obvious, but this is not the case
23
Consequentialist
• Consequentialists believe that consequences alone are
sufficient to determine a course of action. Example is
utilitarianism
• Utilitarianism begins with the assumption that most actions
lead to pleasure or to happiness
• Its earliest origins can be found in the work of Mo Tzu in
5th Century BC, but the most popular exponent is Epicurus
(341 – 271 BC) who combined consequentialism with
hedonistic theory of value
24
Utilitarianism
• There are many versions of utilitarianism, for example
preference utilitarians argue for a subjective understanding
of pleasure in terms of an individual’s own perception of
his/her well-being
• Utilitarians have no moral absolutes beyond maximization
of the pleasure principle
• Rather they examine particular cases in detail to see
whether it would lead to greatest net increase in pleasure
25
Utilitarianism
• This system has 2 great strengths:
• It provides a single ethical framework for all questions
• Pleasure and Happiness are taken seriously
• Limitations
• Not always practicable. Detailed examination of every
action will soon bring all actions to a halt
• How do we measure pleasure?
26
Intrinsic Ethical Principles
• Considers intrinsic nature of the action, whether, it is right
or wrong
• There are a number of possible intrinsic ethical principles
depending on the rights and obligations to which they are
concerned
• This approach to ethics is called deontological (rights
discourse)
27
Deontology
• Deontology considers the intrinsic value of actions rather
than their consequences
• Immanuel Kant – German philosopher held that an act is
moral only if it springs from a “good will” not because it
gives us pleasure or leads to good consequences
• He constructed a formal “Categorical Imperative” as the
ultimate test of morality – “I ought never to act except in
such a way that I can also will that my maxim should
become universal law”
28
Deontology
• Kant said a moral rule is one that can serve as a guide for
everyone’s conduct
• It allows people to treat others as ends in themselves and
not solely as a means to someone else’s ends
• It is a rule that one can impose on oneself by one’s will
and not by the imposition of another
• It embodies the principles of autonomy (individual rights)
and justice (fair distribution of resources and
opportunities), and is the basis for social contract approach
in bioethics
29
Deontology
• Justice is a broader concept
• It is about fair treatment, fair distribution of resources or
opportunities
• But this is associated with considerable disagreements
• For examples, a lot of people accept that unequal
distribution of certain resources (e.g. educational
opportunities) may be fair provided certain other criteria
are satisfied (e.g. educational opportunities are purchased
with money earned or inherited)
• Others have argued that we should all be altruistic
30
Natural Law approach
• First developed by Thomas Aquinas, it states that actions
are morally right if they accord with our nature as human
beings. The attribute that is distinctively human is our
ability to reason and exercise intelligence. The theory thus
argues that we can know what is morally right through
reason
• Theory of virtue stresses the disposition of individuals to
act virtuously
31
Virtues of a researcher
•
•
•
•
•
•
•
Temperance in personal life
Justice
Honesty
Courage
Compassion
Professional competence
Practical judgment
32
Consensus?
• Much heat and little motion when proponents of one
theory or the other argue
• It has been argued that a middle level of ethics discussion
between the abstractions of ethical theories and specifics of
moral judgments are needed
• While ethicists are needed, there is a far greater need for
scientists, sociologist, psychologist, policy makers and
politicians in setting ethical policy and standards
33
Belmont principles
• Respect for persons
• Persons should be treated as autonomous agents
• Individuals with diminished autonomy deserve special
protection
• Derived moral principles
• Informed consent; incorporating information, comprehension
and voluntariness
• Truth telling. In Kant’s “The supposed right to tell lies from
benevolent motives”, he wrote that “If then, we define a lie
merely as an intentionally false declaration towards another
man, we need not add that it must injure another … for it
always injures another; if not another individual, yet mankind
generally
• Confidentiality
• Privacy
34
Belmont principles
• Beneficence
• Most well known principle to physician from the oft
quoted dictum “Primum non nocere” What Hippocrates
actually said is “I will keep (patients) from harm and
injustice; I will … remain free from intentional injustice
• Frankena arranged the components of this principle in
the following hierarchical order
•
•
•
•
I ought not to do evil or inflict harm (non-maleficence)
I ought to prevent evil or harm (beneficence)
I ought to remove evil or harm (beneficence)
I ought to do or promote good (beneficence)
• This ordering is not universally accepted
35
Belmont principles
• Justice – in the sense of what is fair and what is
deserved
• An injustice occurs when an entitlement is denied
without good reason or burden imposed unduly
• Another conception is that equals must be treated
equally.
• This plays a role in resource allocation, ensuring that no
particular group bears excessive burden on behalf of
others
• The emphasis on rights in bioethics is another
derivative of this principle
36
When principles conflict
• Conflict of principles creates a weighting or priority
problem
• Ross proposed finding the greatest duty in any
circumstance of conflict by finding the greatest balance of
right over wrong in that particular context
• He proposed a distinction between prima facie and actual
duties
• Prima facie duties are those that must always be acted
upon except they conflict with equal or stronger duties in
that particular occasion. They are always right and always
binding
37
When principles conflict
• So, though firm, they are conditional on not being
overridden or outweighed by competing moral demands
• Actual duty is therefore determined by a balance of the
respective weights of the competing prima facie duties
• Therefore duties and rights are not absolutes but rather
strong prima facie moral demands that may validly be
overiden in circumstances where stringent opposing
demands are presented by a competing moral principle
38
When principle conflict
• These ideas also apply where a single principle is leading
us to two equally attractive alternatives, only one of which
can be pursued
• They also allow us to see that there is no basis for always
reifying one principle – particularly autonomy – as is wont
to be the case in many writings on research ethics
• Justice and beneficence can override respect for autonomy
under certain circumstances – some of which are more
common in developing countries such as issues relating
rights during epidemics and disasters, community benefit,
consent in certain diseases/research and sharing of
information
39
When principles conflict
• This does not diminish the value of autonomy but let us
ask with Daniel Callahan “What would it be like to live in
a community for which autonomy was the central value”
• The arguments about duties applies to rights too
• Many philosophers no longer submit to a thesis of absolute
right to life irrespective of competing claims or social
conditions
• It is now commonly agreed that we have an exercisable
right not to have our life taken only if there is not a
sufficient moral justification to override this right
40
When principles conflict
• The right to
•
•
•
•
Life
Make autonomous decisions
Give informed consent
Decide for a child
• Is legitimately exercisable and created duties on
others if and only if the right has an overriding
status in the situation
• Therefore rights compete in many situations,
producing controversies and need for balance
41
When principles conflict
• The burden of moral proof lies with those who seek to
intervene in another’s choice, because as the need to
protect persons from harm becomes more compelling, the
weight of other principles rise and may validly override
demands to respect autonomy
• The challenge is to conceptually analyze the ethical
dilemmas and establish the relationship between principles
42
Consensus?
• Consensus?
• Based on reason
• Genuine debate
• Takes ethical traditions into account
• Open to criticism, refutation and the possibility
of change
• It is not majority opinion as it often needs to
protect the minority
• Takes time
43
Levels of ethical discussion
• Should research be allowed?
• Lesson of history
• Certain things used to be banned but are now
considered appropriate, for example, allowing women
to vote
• Alternatively certain things that were allowed are now
banned e.g. slavery
• Scientist right to autonomy of action
• Research provides the information needed for decision
making because there is a reasonable chance that research
will lead to increase in public goods
44
Bioethical dilemmas
• Should we select some people and expose them to an
unproven but potentially beneficial treatment so that we
can know if the rest of the population can benefit
• Research must be conducted on humans at some point
in their development cycle because their results are
ultimately to be used by humans and humans differ
from animals
• They can be done only in a subset of the population for
economic and ethical reasons
45
Bioethical dilemmas
• How should we select such people
• We must ensure that the people who bear the burden of
research are drawn from those who most likely to
benefit from it
• We must ensure that participants are adequately
informed about the risks of research
• We must ensure that participants know that they can
voluntarily withdraw and the procedure for such
withdrawal is set out
• We must ensure that participants know the benefits in
research and how these will be shared
46
Bioethical dilemmas
• Who should we select
• Avoid individuals who cannot comprehend the research
• Justify and ensure adequate information where
vulnerable participants are being recruited into research
• Ensure adequate community engagement
• Respect real and potential participants in research
47
Bioethical dilemmas
• Why select these people
• Research must be relevant to the health needs of the
community
• It must have social or scientific values
• Should such research participants be compensated
• Participation in research should be based on altruism
• Participation should be cost-free to participants
(including opportunity costs)
48
Bioethical dilemmas
• How should they be compensated
49
Bioethical dilemma
• Avoid undue compensation that can compromise an
individuals ability to make rational choice
• Avoid coercion
• Avoid deception
• Avoid perpetuation of injustices
• Avoid disadvantageous exploitation
50
Resolving ethical dilemmas
• No single way exists for resolving ethical debates
• However, we can arrive at valid ethical positions
• Requires education and vigorous debate as this
allows expression of opinions, clarification of
thoughts and participation
• All moral, legal, social and cultural approaches
must be considered
• Some issues require extensive debates that may
take time
51
What we must not do
• Use inappropriate tools to examine moral issues
• Fail to recognize legitimate diversity
• Disparage or reproach others who reach different
decisions/conclusions
• Assume that we can always judge the right of
individuals, societies and governments to
construct different requirements that comprise part
of moral life
• Become skeptical about morality and moral
thinking
52
Caution about perceived ethical conflicts
• Factual disagreements
• Scope of disagreements about who should be
protected by moral norms
• Which norms are relevant in particular
circumstances
• Appropriate specification
• Weight of relevant norms
• Appropriate forms of balancing
• Presence of genuine moral dilemma
• Sufficiency of information or evidence
53