Ethics in Mental Health Research

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History and Principles

• Ethics in Mental Health Research

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Ethics in Mental Health Research

• Spring 2005
• Instructors
• James M. DuBois, PhD, DSc
• Jean Campbell, PhD
• Video experts

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Class AgendaDay 1 History and Principles

• Introductions
• Structure of course
• Why focus on mental health research?
• Tuskegee and its consequences
• Belmont Report and ethical principles
• Case discussion Willowbrook
• Case analysis method

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Structure of course

• Classroom (virtual or onsite)
• Normally focused on case discussion. Self-study
  preparation assists in this
• Exceptions First day-foundations Last
  day-training trainers
• Self-study DVD, textbook readings
• Adult-learning with volunteer students!

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Why focus on mental health research?

• Two main reasons
• Intrinsic challenges
• Historical Instances of unethical research and
  legacy of mistrust

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Intrinsic challenges of MH research

• Cognitive impairments may make informed consent
  more difficult to obtain
• Direct benefits to participants have proven
  difficult to provide harder to justify risks
• Risks may include relapse suicidality stigma
  attached to mental disorders makes breaches of
  confidentiality more harmful

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Excerpts from HistoryBeyond DVD

• Paul Hoch, Director of Research, New York State
  Psychiatric Institute
• gave LSD and mescaline to people with
  schizophrenia to produce delusions and
  hallucination in order to develop a model of
  psychosis in humans
• studied whether electroshock and lobotomy would
  block drug-induced psychosis
• Nobody questioned the ethics of such experiments
  Hoch was praised for his work and the exciting
  possibilities of such experiments

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Hoch, contd

• APA National Convention (1950)
• Hoch told a packed audience how the research
  subjects suffered intensely in these experiments
• Justified this type of research as helping to
  establish psychiatry as a solid fact-finding
  discipline.
• Such research was halted in the 1960s when the
  federal government decreed that psychedelic
  agents were dangerous and the NIMH discontinued
  funding

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Challenge Studies

• Symptom exacerbation experiments were accepted
  practice (1960s-2000)
• scientists provoked symptoms of people with
  schizophrenia through sensory isolation, sleep
  deprivation, and the administration of drugs that
  produced profoundly disorganized regressive
  states
• Aimed to understand underlying mechanisms

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• Veterans Administration Medical Center (1987) 28
  people with schizophrenia abruptly withdrawn from
  medication and injected with L-dopa to discover
  who would fall into a relapse the quickest
• As atypical antipsychotic medications came to
  market, researchers turned to new chemical agents
  such as ketamine, the chemical cousin of angel
  dust, to exacerbate symptoms
• Studies targeted patients in first break coming
  into ER and people who had recovered sufficiently
  to be discharged
• Even after treatment, some remained psychotic a
  year later

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Criticism of Challenge Studies

• Advocates scientists criticized challenge study
  protocols
• Response People with schizophrenia volunteered
  for these experiments
• people have a right to make a contribution to
  curing mental illness
• stigmatizing to think that people with mental
  illness cant weigh risks and decide

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Criticism of Challenge Studies

• People were misled
• Not told experiments would make them sicker
• Told experiments were to measure various brain
  hormones or to establish if regular medications
  were safe
• Risks were listed as increase in blood pressure
  or upset stomach, but no side-effects were
  anticipated at the doses administered
• No clinical benefits resulted from these studies

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DVD Discussion Group Participants

• Misunderstood nature of past abuses and current
  studies
• E.g., thought researchers infected subjects in
  Tuskegee
• Key Lessons
• Researchers need to do better in obtaining
  informed consent so that participants understand
  what is being done and not being done
• Willingness to believe that people were being
  injected with live HIV virus speaks to mistrust
  of research community

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The Tuskegee Syphilis Trial

• From 1932 through 1972, the U.S. Public Health
  Service enrolled African-American men in a
  non-therapeutic research study to observe the
  natural course of syphilis. Subjects were not
  told they had syphilis, nor were they treated for
  syphilis or any secondary problems. The study
  continued even after penicillin became the
  standard treatment for syphilis in the 1940s and
  was not ended until 1972, when a public health
  official went to the press.

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Tuskegee Legacy

• Mistrust continues today in African-American
  community
• US federal government made efforts to restore
  trust and protect participants
• National Commission Belmont Report
• Federal regulations (eventually Common Rule)
• Ongoing apology, NBAC, HIPAA, IOM,
  accreditation, education requirements, funding
  for research and education on RCR
• But note Challenge studies continued, radiation
  experiments were conducted, etc

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Regulations cannot replace ethics

• Strengths
• Can change some behaviors
• Moral statement by government prima facie duty
  to follow regulations, statutes, and case law
• Weaknesses
• Slow to adapt to needs of people (e.g., justice)
• Sets only minimum standards
• Oversight is limited
• Expertise is limited
• Shifts focus away from respect for participants
• Content of regulations can be bad

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Are There Transcultural Principles?

• The problem
• Some at PHS thought Tuskegee was unobjectionable
• Krugman always defended Willowbrook and many
  agreed with him
• Justification of paternalism in consent process
  appealed to evolution in thinking
• Additionally, we hear about how inadequate US
  rules are in international research

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The Belmont Principles

• Attempt to identify principles applicable to all
  human subjects research
• Respect for persons respect autonomous choices
  protect those lacking autonomy
• Beneficence do not harm maximize benefits,
  minimize harms
• Justice fairness in distribution treat equals
  equally

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Belmont Principles Applications

• Respect for persons implies obtain informed
  consent extra protections for those who are not
  self-determining
• Beneficence implies minimize risks, conduct
  risk/benefit assessment
• Justice implies recruit subjects to distribute
  benefits and burdens evenly dont target the
  vulnerable for convenience

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Are the Belmont Principles transcultural?

• What justification was offered for the
  principles?
• three basic principles, among those generally
  accepted in our cultural tradition, are
  particularly relevant to the ethics of research
  
• Problematic
• No claim to being transcultural bad cultural
  norms can also be widely accepted our society is
  culturally diverse and we do international
  research

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Humanizing the Principles

• Assumption we ought to work with 4 principles
  for reasons Beauchamp Childress (BC) give
• Why humanize the principles?
• To provide a foundation that
• Shows the principles arent arbitrary explains
  why common morality has embraced them
• Reminds researchers of the humanity they share
  with participants
• Provides a transcultural foundation shared
  human nature

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The Mother of All Principles

• Respect for human beings
• Respect showing regard for the worth of someone
  or something
• Worth or dignity of persons does derive from our
  nature as rational and self-determining
• But
• Were all human even if more or less actualized
• Respect cannot be reduced to respecting only the
  rational, self-determining aspect of us

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The 4 Principles Humanized

• Autonomy respect for humans as rational and
  self-determining
• Beneficence respect for humans as finite and in
  need of basic goods
• Non-maleficence respect for humans as vulnerable
  to harms
• Justice respect for the equal worth of all humans

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Limits of principles

• Strengths
• Remind us of key dimensions of person that
  deserve respect provide language and framework
  for discussion
• Weaknesses
• Principles can conflict
• Principles can be interpreted differently
• Response
• Case approach will introduce a justification
  method for resolving conflicts
• Community consultation or research can help us to
  contextualize principles

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Ethical Process

• Both content and processes matter
• Two key process issues (in addition to consent)
• Oversight
• Inclusion

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IRB Oversight

• IRBs provide review of regulatory requirements
  risk/benefit analysis justice in recruitment
  consent confidentiality safety monitoring
• Additional oversight ongoing review, may observe
  consent process, may review ongoing safety may
  halt studies

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Community Partnerships

• May enhance ethics of a study
• Show respect, clarify desired benefits and risks
  of concern
• May enhance quality of study
• Design, recruitment and retention
• But may also introduce challenges to scientific
  integrity and a new political element
• Must be aware of limitations and correct each
  other in process of dialogue

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Analyzing Cases and Justifying Decisions

• What can an analytic framework offer?
• Can help you to consider all relevant factors
• Can help you to exclude ethically unacceptable
  alternatives
• Can structure debate, provide common framework
• Can NOT guarantee youll arrive at the one right
  answer or will eliminate all disagreement

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Sources of Ethical Disagreements

• Disagreements arise when
• people have different and competing interests
• when they disagree about relevant facts e.g.,
  probabilities of benefits or magnitude of harm
• when they disagree about ethical norms e.g.,
  different ideas of whether justice requires equal
  opportunity or equal outcomes

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Analysis 4 key elements

• Stakeholders e.g., participants, researchers,
  sponsors, institutions, community
• Facts e.g., anticipated benefits and risks,
  scientific merit, feasibility of design, costs
• Norms e.g., Belmont principles, specific norms
  generated by IRBs, fair process
• Options e.g., change study design, expand
  process of review and design, add oversight
• (Mnemonic device So Far No Objections)

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Justification

• If a study infringes on a norm that the law or
  professional ethics treats as a moral absolute,
  then you should modify it
• When a study will involve overriding or
  infringing on a prima facie norm or value
• First, clearly state the goal of your action
  that is, know what goods you aim to achieve and
  state what goods or values you will be
  compromising
• Then, see if you can justify it using the
  following 5 tests

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Justification Criteria

• Effectiveness Will the study (or policy or
  action) be effective in achieving the desired
  goal?
• Necessity Is the study necessary to achieve the
  goal or is there an alternative that wont
  infringe on a competing value?
• Proportionality Is the desired goal important
  enough to justify overriding another principle or
  value?
• Least infringement Is the study designed to
  minimize infringement on the value that conflict
  with it?
• Ethical process Have you been transparent?
  Followed ethical processes, e.g., IRB review or
  community consultation?
• (Based on Childress et al 2002)