Ethical and bioethical issues

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Ethical and bioethical issues
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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

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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

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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

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History of bioethics

• There was little broad interest in research
  ethics before the Second World War
• Smidovichs The Confessions of a Physician (1901)
• Public concern about Walter Reeds 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

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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

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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

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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

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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

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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

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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

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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

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Other seminal events

• Henry Beechers 1959 Experimentation in Mans
  monograph
• 1960 1963 The Law-Medicine Research Institute
  of Boston Universitys survey of researhers
  attitudes and the anthology Clinical
  Investigation in Medicine
• Henry Beechers article in NEJM in 1966
  discussing 22 out 50 collected cases of unethical
  research in Americas leading universities
• 1966 - Henry Beechers 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

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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 Humphreys Tearoom Trade Study
• 1970 Zimbardos Mock Prison Research

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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

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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.

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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

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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

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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

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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

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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

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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?

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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

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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

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Utilitarianism

• There are many versions of utilitarianism, for
  example preference utilitarians argue for a
  subjective understanding of pleasure in terms of
  an individuals 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

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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?

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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)

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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

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Deontology

• Kant said a moral rule is one that can serve as a
  guide for everyones conduct
• It allows people to treat others as ends in
  themselves and not solely as a means to someone
  elses ends
• It is a rule that one can impose on oneself by
  ones 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

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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

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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

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Virtues of a researcher

• Temperance in personal life
• Justice
• Honesty
• Courage
• Compassion
• Professional competence
• Practical judgment

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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

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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 Kants 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

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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

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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

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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

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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

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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

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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

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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

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When principles conflict

• The burden of moral proof lies with those who
  seek to intervene in anothers 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

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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

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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

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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

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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

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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

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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)

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Bioethical dilemmas

• How should they be compensated

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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

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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

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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

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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