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Ethical and Legal Issues

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. Ethical Challenges.

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Ethical and Legal Issues

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  1. 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

  2. Ethical Challenges • Confidentiality & disclosure policies • Informed consent policies • Risk-benefit assessment

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

  4. Steps for Determining Confidentiality & Disclosure Practices Investigation Deliberation & Formulation Implementation & Communication Evaluation & Modification

  5. 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

  6. 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

  7. 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

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

  9. Informed Consent Informed Voluntary Rational

  10. 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

  11. What Is Consent Capacity? Psycho-Legal Standards of Consent Communicate achoice Understand relevant information Appreciate the nature of the situation & its consequences Manipulate information rationally Appelbaum & Grisso, 1988 What is a fair standard?

  12. 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 • Child’s rights & welfare protected • Waiver does not conflict with law • Participant advocate

  13. 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

  14. 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 Research Participant’s Bill of Rights Bruzzesse & Fisher, 1999

  15. 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

  16. 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 study’s nature & purpose • Child should not be treated like "guinea pig"

  17. Community Perspectives:Substance Abuse ResearchRisks and Benefits • Community stigma • Increase risk behaviors • Personal distress • Control groups

  18. Community Perspectives:Scientific Validity • Accuracy of self and informant reports • Sampling bias • Laboratory error • Trickle down interventions • Access to drugs & government policies • Investigator bias & misuse of data

  19. Community Perspectives:Biological Basis for Adolescent Risk Behaviors • Eugenics • Self-fulfilling prophecies • Risk of preventive treatments • Fallacy of genetic factors underlying racial disparities

  20. 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

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