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The Competence and Willingness to Consent to Research Among Patients with Heroin Dependence



Substance abuse research can raise ethical concerns about the comprehension and decision-making capacities of participants with drug dependence. In this study, the competence and willingness to consent to research participation were examined among patients with heroin dependence.


Twenty patients with heroin dependence and 24 healthy controls were asked to indicate if they would consent to participate in a low- and high-risk study. The MacArthur Competence Assessment Tool-Clinical Research was used to assess their consent capacities.


Patients with heroin dependence and healthy controls did not differ significantly in their consent capacity scores. However, the patterns that underlay their decisions to consent and decline to participate in the two fictional studies were significantly different. Specifically, patients with heroin dependence were more likely to consent to participate in both studies, irrespective of the ratio of benefits to risks. Further, patients with heroin dependence who agreed to participate in the research studies did not demonstrate poorer decision-making capacities than their nonconsenting counterparts.


Although the decision-making capacities of patients with heroin dependence and healthy controls were similar, the patterns that underlay their decisions to consent or decline to participate in the studies differed significantly between the two groups. Future studies should identify the specific factors that account for these emergent group differences.

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  1. 1.

    Verdejo-Garcia A, Chong TT, Stout JC, Yucel M, London ED. Stages of dysfunctional decision-making in addiction. Pharmacol Biochem Behav. 2018;164:99–105.

    CAS  Article  Google Scholar 

  2. 2.

    Li X, Zhang F, Zhou Y, Zhang M, Wang X, Shen M. Decision-making deficits are still present in heroin abusers after short- to long-term abstinence. Drug Alcohol Depend. 2013;130:61–7.

    Article  Google Scholar 

  3. 3.

    Saleme DM, Kluwe-Schiavon B, Soliman A, Misiak B, Frydecka D, Moustafa AA. Factors underlying risk taking in heroin-dependent individuals: Feedback processing and environmental contingencies. Behav Brain Res. 2018;350:23–30.

    CAS  Article  Google Scholar 

  4. 4.

    Stoltman JJ, Woodcock EA, Lister JJ, Lundahl LH, Greenwald MK. Heroin delay discounting: Modulation by pharmacological state, drug-use impulsivity, and intelligence. Exp Clin Psychopharmacol. 2015;23:455–63.

    CAS  Article  Google Scholar 

  5. 5.

    Jones JD, Vadhan NP, Luba RR, Comer SD. The effects of heroin administration and drug cues on impulsivity. J Clin Exp Neuropsychol. 2016;38:709–20.

    Article  Google Scholar 

  6. 6.

    Luan X, Tao J, Zhang J, et al. Increased BDNF may not be associated with cognitive impairment in heroin-dependent patients. Medicine (Baltimore). 2017;96:e6582.

    CAS  Article  Google Scholar 

  7. 7.

    Ma X, Qiu Y, Tian J, et al. Aberrant default-mode functional and structural connectivity in heroin-dependent individuals. PLoS ONE 2015;10:e0120861.

    Article  Google Scholar 

  8. 8.

    Montalvo W, Larson E. Participant comprehension of research for which they volunteer: A systematic review. J Nurs Scholarsh. 2014;46:423–31.

    Article  Google Scholar 

  9. 9.

    Aldridge J, Charles V. Researching the intoxicated: Informed consent implications for alcohol and drug research. Drug Alcohol Depend. 2008;93:191–6.

    Article  Google Scholar 

  10. 10.

    Zhao LY, Zhang XL, Shi J, Epstein DH, Lu L. Psychosocial stress after reactivation of drug-related memory impairs later recall in abstinent heroin addicts. Psychopharmacology. 2009;203:599–608.

    CAS  Article  Google Scholar 

  11. 11.

    Berg JW, Appelbaum PS, Grisso T. Constructing competence: Formulating standards of legal competence to make medical decisions. Rutgers Law Rev. 1996;48:345–71.

    CAS  PubMed  Google Scholar 

  12. 12.

    Cohen BJ, McGarvey EL, Pinkerton RC, Kryzhanivska L. Willingness and competence of depressed and schizophrenic inpatients to consent to research. J Am Acad Psychiatry Law. 2004;32:134–43.

    PubMed  Google Scholar 

  13. 13.

    Coors ME, Raymond KM, Hopfer CJ, et al. Adolescents with substance use disorder and assent/consent: Empirical data on understanding biobank risks in genomic research. Drug Alcohol Depend. 2016;159:267–71.

    Article  Google Scholar 

  14. 14.

    Zhang XL, Shi J, Zhao LY, et al. Effects of stress on decision-making deficits in formerly heroin-dependent patients after different durations of abstinence. Am J Psychiatry. 2011;168:610–6.

    Article  Google Scholar 

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Correspondence to Liyan Zhao MD or Qiang Li MD.

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The authors declare that they do not have any conflicts of interest related to the data presented in this manuscript.

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Zhao, L., Shi, H., Ying, B. et al. The Competence and Willingness to Consent to Research Among Patients with Heroin Dependence. Ther Innov Regul Sci 54, 1106–1111 (2020).

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  • Heroin dependence
  • Decision-making
  • Consent
  • Competence
  • Willingness