Abstract
In the current epidemic of opioid use disorders, there is both a scientific and ethical imperative to develop effective medical and behavioral treatments for opioid addiction. Research in subject populations with active and ongoing drug addictions bring unique ethical considerations and challenges. Sponsors, researchers, and institutional review board (IRB) members should be familiar with these unique ethical and medical issues as they design, review, and conduct research planned for this population. Issues include those of informed consent and decision-making capacity of research participants, compensation for participation and concerns about undue inducement, forces that threaten the voluntary nature of research participation including the scarcity of available drug treatment programs, and ensuring that participants are aware of and understand risks that may continue after research participation such as increased risk of overdose after research-mandated drug abstinence. This manuscript discusses the current thinking on these issues.
Highlights
Given the current opioid crisis and its impact on individuals and greater society, there is both a scientific and ethical imperative to develop effective medical and behavioral treatments for opioid dependence
Researchers, and institutional review board (IRB) members should be familiar with the unique ethical issues that are relevant to conducting research with this population
We summarize and integrate the current literature and thinking with regard to the multiple ethical complications that may arise in research involving individuals with opioid use disorder (OUD), and suggest best practices for when these complications are encountered
Summary
Given the current opioid crisis and its impact on individuals and greater society, there is both a scientific and ethical imperative to develop effective medical and behavioral treatments for opioid dependence. There is, a robust literature addressing ethical issues relevant to conducting substance abuse research. This includes a growing evidence base on best practices and data from empirical studies assessing the views and behavior of individuals with substance abuse disorders. In this narrative review, we summarize and integrate the current literature and thinking with regard to the multiple ethical complications that may arise in research involving individuals with opioid use disorder (OUD), and suggest best practices for when these complications are encountered. We intend for this review to serve as a resource for IRBs, sponsors, researchers and study teams as they design, oversee, and conduct clinical trials involving participants with OUD
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