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Bioethics Taskforce Report

This report presents guidelines for conducting substance abuse research involving children and adolescents. It addresses issues of imminent danger and radiation exposure, as well as the ethical implications of genetic research on drug addiction. Recommendations are provided to ensure participant safety and minimize stigmatization or discrimination related to genetic data.

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Bioethics Taskforce Report

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  1. Bioethics Taskforce Report Council Members: Dorothy Hatsukami, Herb Kleber, Claire Sterk, David Vlahov, Jose Szapocznik NIDA Staff: Lucinda Miner, Susan Weiss, Gaya Dowling, Rubin Baler, Kay Nimit

  2. Guidelines for Substance Abuse Research Involving Children and Adolescents • General consensus on document • Two remaining issues: • Examples of imminent danger for the purposes of permitting disclosure of confidential information • Guidelines for radiation exposure

  3. Guidelines for Substance Abuse Research Involving Children and Adolescents • Imminent danger • Insufficient data to write specific guidelines on what constitutes imminent danger • Recommended consideration of a number of factors, such as • Participant in treatment • Types and route of administration for abused drug(s) • Presence of co-morbid disorder • Age of minor

  4. Guidelines for Substance Abuse Research Involving Children and Adolescents • Imminent danger (con’t) • Judgment of investigator in consultation with IRB • Clear statement of difference between use of drugs and imminence of serious harm resulting from use of drug in consent form.

  5. Guidelines for Substance Abuse Research Involving Children and Adolescents • Radiation risk • Exposure to radiation through neuroimaging is more than minor increment over minimal risk. • Research is approvable by IRB only if participants can directly benefit from research • Otherwise, requires Department level approval (407 review) • Consideration must be given to cumulative exposure

  6. Genetics of Drug Addiction • NIDA requested National Academies to examine the ethical, behavioral and social consequences of genetics research on drug abuse. • Experts presented at a Workshop on the Genetics of Drug Addiction held November 13-14, 2003. • Summary of proceedings was prepared by the OSPC staff.

  7. Genetics of Drug Addiction • Science of genetic research: Remi Cadoret • Conducting genetic research: Marc Schuckit • IRBs and conducting genetic research: Lauren Broyles • Implications for criminal responsibility: Stephen Morse • Privacy and discrimination issue: Mark Tothstein • Field report on genetic on tobacco: Caryn Lerman

  8. Genetics of Drug Addiction • Recommendations by Bioethics Taskforce • Endorse summary document for website posting • Continue to consider ethical implications of research (Genetics Consortium) • Reproducibility of findings • Generalizability of results • Diagnostic screening • Criminal responsibility • Discrimination laws

  9. Genetics of Drug Addiction • Recommendations (con’t) • Consider supporting research in the area of communication science on genetics issues in partnership with other NIH ICs • Educate stakeholders on genetic issues to minimize stigmatization or discrimination as a result of misuse of genetic data or its misinterpretation

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