The issue of consent in research that administers drugs of addiction to addicted persons

Accountability in Research

Volumn 15, Issue 4, 2008, Pages 209-225

  Carter, Adrian ^a   Hall, Wayne ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Addiction; Addiction research; Informed consent; Neuroethics; Research ethics

Indexed keywords

PSYCHOTROPIC AGENT; STREET DRUG;

ADDICTION; ARTICLE; BRAIN; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; DRUG USE; ETHICS; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; MENTAL CAPACITY; NEUROSCIENCE; PATHOPHYSIOLOGY; PSYCHOLOGICAL ASPECT; RESEARCH SUBJECT; STANDARD;

BEHAVIOR, ADDICTIVE; BRAIN; DRUG USERS; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; NEUROSCIENCES; PSYCHOTROPIC DRUGS; RESEARCH SUBJECTS; STREET DRUGS; SUBSTANCE-RELATED DISORDERS;

EID: 61449558761     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620802388689     Document Type: Article

References (65)

1. Adler, M. W. (1995). Human subject issues in drug-abuse research, Drug and Alcohol Dependence, 37: 167-175.
2. American Psychiatric Association. (1994). Diagnostic and Statistical Manual of Mental Disorders: DSM-IV. Washington, DC: American Psychiatric Association.
3. Baumeister, R. F. (2003). Ego depletion and self-regulation failure: A resource model of self-control, Alcoholism, Clinical and Experimental Research, 27: 281-284.
4. Bechara, A., Dolan, S., Denburg, N., Hindes, A., Anderson, S. W., and Nathan, P. E. (2001). Decision-making deficits, linked to a dysfunctional ventromedial prefrontal cortex, revealed in alcohol and stimulant abusers, Neuropsychologia, 39: 376-389.
5. Bechara, A. (2005). Decision making, impulse control and loss of willpower to resist drugs: A neurocognitive perspective, Nature Neuroscience, 8: 1458-1463.
6. Bigelow, G. E., Brooner, R., Walsh, S., Preston, K., and Liebson, I. A. (1994). Community outcomes following research exposure to cocaine or opioids. In: Problems of Drug Dependence: Proceedings of the 56th Annual Scientific Meeting (Vol. 2). Baltimore, MD: NIDA, pp. 354.
7. Cairns, R., Maddock, C., Buchanan, A., David, A. S., Hayward, P., Richardson, G., Szmukler, G., and Hotopf, M. (2005). Prevalence and predictors of mental incapacity in psychiatric in-patients, British Journal of Psychiatry, 187: 379-385.
8. Carter, A., and Hall, W. (2008). Informed consent to opioid agonist maintenance treatment: Recommended ethical guidelines, International Journal of Drug Policy, 19: 79-89.
9. Charland, L. C. (2002). Cynthia's dilemma: Consenting to heroin prescription, American Journal of Bioethics, 2: 37-47.
10. Childress, A. R., Mozley, P. D., McElgin, W., Fitzgerald, J., Reivich, M., and O'Brien, C. P. (1999). Limbic activation during cue-induced cocaine craving, American Journal of Psychiatry, 156: 11-18.
11. Cohen, P. J. (2002). Untreated addiction imposes an ethical bar to recruiting addicts for non-therapeutic studies of addictive drugs, Journal of Law Medicine & Ethics, 30: 73-81.
12. Curran, H. V. (1991). Benzodiazepines, memory and mood: A review, Psychopharmacology (Berl), 105: 1-8.
13. Curran, H. V., Kleckham, J., Bearn, J., Strang, J., and Wanigaratne, S. (2001). Effects of methadone on cognition, mood and craving in detoxifying opiate addicts: A dose-response study, Psychopharmacology (Berl), 154: 153-160.
14. Dalrymple, T. (2006). Romancing opiates: Pharmacological lies and the addiction bureaucracy. New York: Encounter Books.
15. Dunn, L. B., and Jeste, D. V. (2001). Enhancing informed consent for research and treatment, Neuropsychopharmacology, 24: 595-607.
16. Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., and Saks, E. R. (2006). Assessing decisional capacity for clinical research or treatment: A review of instruments, American Journal of Psychiatry, 163: 1323-1334.
17. Elliott, C. (2002). Who holds the leash? American Journal of Bioethics, 2: 48.
18. Elster, J., and Skog, O.-J. (1999). Getting Hooked: Rationality and Addiction. Cambridge, UK: Cambridge University Press.
19. Epstein, D. H., Preston, K. L., Stewart, J., and Shaham, Y. (2006). Toward a model of drug relapse: An assessment of the validity of the reinstatement procedure, Psychopharmacology (Berl), 189: 1-16.
20. Faden, R. R., Beauchamp, T. L., and King, N. M. (1986). A History and Theory of Informed Consent. New York: Oxford University Press.
21. Faillace, L., Flamer, R., Imber, S., and Ward, R. (1972). Giving alcohol to alcoholics, Quarterly Journal of Studies on Alcohol, 33: 85-90.
22. Fillmore, M. T. (2003). Drug abuse as a problem of impaired control: Current approaches and findings, Behavioural and Cognitive Neuroscience Reviews, 2: 179-197.
23. Finnigan, F., and Hammerslay, R. (1992). The effect of alcohol on performance. In: Handbook of human performance, health and performance 2. (Smith, A. P., and Jones, D. M., eds.) London: Academic Press, pp. 73-126.
24. Fisch, G. S. (2007). Animal models and human neuropsychiatric disorders, Behavior Genetics, V37: 1-10.
25. Foddy, B., and Savulescu, J. (2006). Addiction and autonomy: Can addicted people consent to the prescription of their drug of addiction? Bioethics, 20: 1-15.
26. Fry, C., and Dwyer, R. (2001). For love or money? An exploratory study of why injecting drug users participate in research, Addiction, 96: 1319-1325.
27. Fureman, I., Meyers, K., McLellan, A. T., Metzger, D., and Woody, G. (1997). Evaluation of a video-supplement to informed consent: Injection drug users and preventive HIV vaccine efficacy trials, AIDS Education and Prevention, 9: 330-341.
28. Garavan, H., Lingford-Hughes, A., Jones, T., Morris, P., Rothwell, J., and Williams, S. (2007). Neuroimaging. In: Drugs and the Future: Brain Science, Addiction and Society. (Nutt, D., Robbins, T., Stimson, G., Ince, M., and Jackson, A., eds.) London: Academic Press, pp. 285-314.
29. Gerstein, D. R., and Harwood, H. J. (1990). Treating Drug Problems (vol. 1). A Study of Effectiveness and Financing of Public and Private Drug Treatment Systems. Washington DC: Institute of Medicine, National Academy Press.
30. Geyer, M. A., and Markou, A. (1995). Animal models of psychiatric disorders. In: Psychopharmacology: The fourth generation of progress. (Bloom, F. E., and Kupfer, D. J., eds.) New York: Raven, pp. 787-798.
31. Grant, S., Contoreggi, C., and London, E. D. (2000). Drug abusers show impaired performance in a laboratory test of decision making, Neuropsychologia, 38: 1180-1187.
32. Hall, W., Carter, L., and Morley, K. I. (2003). Addiction, neuroscience and ethics, Addiction, 98: 867-870.
33. Hall, W., Gartner, C. E., and Carter, A. (2008). The genetics of nicotine addiction liability: Ethical and social policy implications, Addiction, 103: 350-359.
34. Harrison, K., Vlahov, D., Jones, K., Charron, K., and Clements, M. L. (1995). Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial, Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 10: 386-390.
35. Hazelton, L. D., Sterns, G. L., and Chisholm, T. (2003). Decision-making capacity and alcohol abuse: Clinical and ethical considerations in personal care choices, General Hospital Psychiatry, 25: 130-135.
36. Hester, R., and Garavan, H. (2004). Executive dysfunction in cocaine addiction: Evidence for discordant frontal, cingulate, and cerebellar activity, Journal of Neuroscience, 24: 11017-11022.
37. Hotopf, M. (2005). The assessment of mental capacity, Clinical Medicine, 5: 580-584.
38. Iverson, L., Morris, K., and Nutt, D. (2007). Pharmacology and treatments. In: Drugs and the Future: Brain Science, Addiction and Society. (Nutt, D., Robbins, T.,Stimson, G., Ince, M., and Jackson, A., eds.) London: Academic Press, pp. 169-208.
39. Jentsch, J. D., and Taylor, J. R. (1999). Impulsivity resulting from frontostriatal dysfunction in drug abuse: Implications for the control of behavior by reward-related stimuli, Psychopharmacology, 146: 373-390.
40. Koob, G. F., and Le Moal, M. (2006). Neurobiology of Addiction. New York: Academic Press.
41. Kranzler, H. R., Dolinsky, Z., and Kaplan, R. F. (1990). Giving ethanol to alcoholics in a research setting: Its effect on compliance with disulfiram treatment, British Journal of Addiction, 85: 119-123.
42. Leshner, A. I. (1997). Addiction is a brain disease, and it matters, Science, 278: 45-47.
43. Levy, N. (2006). Autonomy and addiction, Canadian Journal of Philosophy, 36: 427-448.
44. Lubman, D. I., Yucel, M., and Hall, W. (2008). Substance use and the adolescent brain: A toxic combination, Journal of Psychopharmacology (In press).
45. Lyvers, M., and Yakimoff, M. (2003). Neuropsychological correlates of opioid dependence and withdrawal, Addictive Behaviors, 28: 605-611.
46. Mintzer, M. Z., Copersino, M. L., and Stitzer, M. L. (2005). Opioid abuse and cognitive performance, Drug and Alcohol Dependence, 78: 225-230.
47. Modell, J. G., Glaser, F. B., and Mountz, J. M. (1993). The ethics and safety of alcohol administration in the experimental setting to individuals who havechronic, severe alcohol problems, Alcohol and Alcoholism, 28: 189-197.
48. Montoya, I. D., and Haertzen, C. (1994). Reduction of psychopathology among individuals participating in non-treatment drug abuse residential studies, Journal of Addictive Disorders, 13: 89-97.
49. National Advisory Council on Alcohol Abuse and Alcoholism. (1989). Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism.
50. National Bioethics Advisory Commission. (1999). Research Involving Persons with Mental Disorders that May Affect Decision-Making Capacity. Rockville, MD: National Bioethics Advisory Commission.
51. Nutt, D., Robbins, T., Stimson, G., Ince, M., and Jackson, A. (2007). Drugs and the Future: Brain Science, Addiction and Society. London: Academic Press.
52. Perneger, T. V., Giner, F., del Rio, M., and Mino, A. (1998). Randomised trial of heroin maintenance programme for addicts who fail in conventional drug treatments, British Medical Journal, 317: 13-18.
53. Rapeli, P., Kivisaari, R., Autti, T., Kahkonen, S., Puuskari, V., Jokela, O., and Kalska, H. (2006). Cognitive function during early abstinence from opioid dependence: A comparison to age, gender, and verbal intelligence matched controls, BMC Psychiatry, 6: 9.
54. Roberts, L. W. (2002). Informed consent and the capacity for voluntarism, American Journal of Psychiatry, 159: 705-712.
55. Smith, K. L., Horton, N. J., Saitz, R., and Samet, J. H. (2006). The use of the mini-mental state examination in recruitment for substance abuse research studies, Drug and Alcohol Dependence, 82: 231-237.
56. Sugarman, J., McCrory, D. C., Powell, D., Krasny, A., Adams, B., Ball, E., and Cassell, C. (1999). Empirical research on informed consent. An annotated bibliography, Hastings Center Report, 29: S1-42.
57. Volkow, N., and Fowler, J. (2000). Addiction, a disease of compulsion and drive: Involvement of the orbitofrontal cortex, Cerebral Cortex, 10: 318.
58. Volkow, N. D., Fowler, J. S., and Wang, G. J. (2003). The addicted human brain: Insights from imaging studies, Journal of Clinical Investigation, 111: 1444-1451.
59. Volkow, N. D., and Li, T. K. (2004). Drug addiction: The neurobiology of behaviour gone awry, Nature Reviews Neuroscience, 5: 963-970.
60. Volkow, N. D., Fowler, J. S., Wang, G. J., and Swanson, J. M. (2004). Dopamine in drug abuse and addiction: Results from imaging studies and treatment implications, Molecular Psychiatry, 9: 557-569.
61. Volkow, N. D., and Li, T.-K. (2005). Drugs and alcohol: Treating and preventing abuse, addiction and their medical consequences, Pharmacology & Therapeutics, 108: 3-17.
62. Volkow, N. D., Fowler, J. S., Wang, G. J., Swanson, J. M., and Telang, F. (2007). Dopamine in drug abuse and addiction: Results of imaging studies and treatment implications, Archives of Neurology, 64: 1575-1579.
63. Walker, R., Logan, T. K., Clark, J. J., and Leukefeld, C. (2005). Informed consent to undergo treatment for substance abuse: A recommended approach, Journal of Substance Abuse Treatment, 29: 241-251.
64. Walker, T. (2008). Giving addicts their drug of choice: The problem of consent, Bioethics, 22: 314-320.
65. World Health Organization. (1993). The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research. Geneva: WHO.