Ethical and Legal Issues

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Ethical and Legal Issues

• Research Involving Drug Abuse and Mental Health
  Co-morbidities Among Youth
• NIDA-NIMH Conference
• May 23-24, 2000

Celia B. Fisher, Ph.D. Director, Fordham
University Center for Ethics Education Department
of Psychology Bronx, NY
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Ethical Challenges

• Confidentiality disclosure policies
• Informed consent policies
• Risk-benefit assessment

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Confidentiality Myths

• Teenagers prefer confidentiality
• Disclosure policies reduce participation
• Disclosure will jeopardize data analysis
• There are few desirable reporting options

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Steps for Determining Confidentiality
Disclosure Practices

• Investigation
• Deliberation Formulation
• Implementation Communication
• Evaluation Modification

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Investigation

• Know federal, state, local reporting laws
• Identify risks that might be revealed during the
  course of research
• Evaluate the validity of risk assessments
• Identify referral/reporting criterion levels
• Investigate available services

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DELIBERATION FORMULATION

• Consult with community about potential harms of
  alternative policies
• Speak with prospective participants about child
  and parent expectations
• Consider threats to experimental validity
  recruitment
• Develop a confidentiality and disclosure policy

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Implementation Communication

• Establish appropriate relationships with referral
  sources
• Train the research team to follow the policy
• Explain the policy to prospective participants
  and guardians during informed consent
• When ever feasible, inform a participant when a
  disclosure will be made

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EVALUATION MODIFICATION

• Monitor the impact of policy on
• participant welfare
• study integrity
• recruitment
• community attitudes
• Based on the above, alter the policy when
  appropriate

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Informed Consent

• Informed
• Voluntary
• Rational

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Cash Incentives?

• Can economically deprived youth
• Be coerced into participation?
• Afford the time?
• Afford to withdraw?
• What is the message for socially disenfranchised
  youth?
• Is cash associated with drug money?
• Will teens be encouraged lie?
• Community perspectives
• Fair market value
• Alternative incentives

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What Is Consent Capacity?

• Psycho-Legal Standards of Consent
• Communicate a choice
• Understand relevant information
• Appreciate the nature of the situation
• its consequences
• Manipulate information rationally
• Appelbaum Grisso, 1988

What is a fair standard?
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Waiving Parental Consent

• Emancipated minor
• Mature minor
• Best interests of the child
• Research could not be practically carried out,
  and
• No more than minimal risk research
• Childs rights welfare protected
• Waiver does not conflict with law
• Participant advocate

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Enhancing Consent Capacity

• Simplified presentation
• Reading level (5th grade)
• Video presentation
• Sequential single-unit disclosure
• Question-answer format
• Education
• Supported decision-making
• Surrogate consent and participant assent

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Research Participants Bill of Rights

• To be fully informed
• To have all questions answered
• To freely choose to participate or to refuse
  participation
• To withdraw or not answer questions

• To privacy and confidentiality
• To be protected from harm
• To know the results of the study
• To understand these rights

Bruzzesse Fisher, 1999
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The Myth of Passive Consent

• OPRR
• Justice
• Community perspectives
• Deceptive
• Coercive teaches children to deceive
• Parents never receive the form
• Parents are afraid to sign the form

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Why do Parents Refuse to Sign Consent Forms?

• Fear others will know child's problems
• Desire for family privacy
• Experimental procedures will harm child
• Difficulty understanding the form
• Disagree with studys nature purpose
• Child should not be treated like "guinea pig"

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Community PerspectivesSubstance Abuse
ResearchRisks and Benefits

• Community stigma
• Increase risk behaviors
• Personal distress
• Control groups

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Community PerspectivesScientific Validity

• Accuracy of self and informant reports
• Sampling bias
• Laboratory error
• Trickle down interventions
• Access to drugs government policies
• Investigator bias misuse of data

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Community PerspectivesBiological Basis for
Adolescent Risk Behaviors

• Eugenics
• Self-fulfilling prophecies
• Risk of preventive treatments
• Fallacy of genetic factors underlying racial
  disparities

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The Challenge and Potential of Community Advisory
Boards

• Co-learning model
• Opinions-in-progress analysis
• Moral agency the is to ought fallacy
• Doing good well