Overview of Introduction

1
Overview of Introduction

• Ethics and Compliance Competing or
  Complementary Approaches?
• In Ethical Research in Mental Health
• James M DuBois, PhD, DSc

2
Why Focus on Research Ethics in Behavioral Health?

• History
• Difficulty of finding effective tx severe nature
  of exp tx.s lack of informed consent lack of
  input from consumers
• Intrinsic
• Obstacles to informed consent e.g., cognitive
  impairments financial need
• Heightened risks loss of employment, suicide,
  stigma

3
Current Environment of Research Ethics

• Risk management approach to research ethics
  reaction to shut downs and deaths
• Remediation of shortcomings typically at level of
  IRB
• IRB as profession and industry
• Mandated training focuses on regulatory
  compliance not real ethics training
• Federally sanctioned framework for ethics
  ironically pre-empts serious ethical analysis

4
Historical Antecedents

• Willowbrook (discussed in case)
• Tuskegee syphilis trial 1932-72
• Over 400 subjects 200 controls
• Studied course of untreated syphilis
• Informed consent was deceptive and unduly
  influential (said they had bad blood, offered
  high incentives, free medical care)
• Penicillin withheld even after determined
  effective
• Secondary health problems not treated
• PHS did not respond to criticism exposé in 1972

5
Reactive Regulations

• Response
• 1974 DHEW issued regulations (NIHs policies)
• 1974 Congress created National Commission for
  the Protection of Human Subjects
• Focus was on protections
• Regulatory approach trumped arguments for
  self-regulation, educational approach, and tort
  approach (civil courts, trial law)

6
Regulations Cant Replace Ethics

• Strengths
• Can change some behaviors
• Moral statement by government
• 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

7
Overview of Chapter One

• An Ethical Framework for Research

8
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

9
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

10
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

11
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

12
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

13
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

14
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

15
Limits of principles

• Strengths
• Reminds us of key dimensions of person that
  deserve respect provides language and framework
  for discussion
• Weaknesses
• Principles can conflict
• Principles can be interpreted differently
• Case approach will introduce a justification
  method for resolving conflicts

16
Rights Talk

• Regulations speak of protecting rights does not
  clarify what rights are
• Rights statements of obligations other have
  toward us (whether legal or moral)
• Problem with IRBs considering non-legal rights
  vague anyone can claim them
• IRBs may consider more than legal rights, but
  then they go beyond regs, and should offer
  arguments

17
Virtues

• Remind us of the importance of intentions
• E.g., getting a signed consent form to comply vs.
  getting genuine informed consent out of respect
• Introduces idea that some character traits are
  needed to live according to principles
• Examples of professional virtues for researchers
  honesty, intellectual humility, competence,
  trustworthiness
• But we cant derive what is right from virtues
  need principles

18
Ethical Process

• Both content and processes matter
• Two key process issues
• Oversight
• Inclusion

19
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

20
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