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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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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 (2020). https://doi.org/10.1007/s43441-020-00127-1

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