An Ethical Exploration of Barriers to Research on Controlled Drugs

Abstract

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning.

Keywords:

• biomedical research
• confidentiality and privacy
• human subjects research
• informed consent
• institutional review board
• research ethics

Notes

1.  We limit ourselves in this article to medical indications of controversial controlled substances and do not address issues regarding their recreational use.

2.  We experienced this firsthand when our R01 NIH grant application was highly scored as exceptional to outstanding and better than 96% of all other applications in response to the PAR-12-244 on Ethical Issues in Research on HIV/AIDS and its Co-morbidities, but was not funded NIDA because investigating barriers to research on therapeutic benefits of controlled substances “doesn't fit their priorities.”

3.  Vulnerability is a separate contentious issue, which we are not addressing in this article.

4.  Could a comparison with analogous issues regarding inclusion of research subjects with a history of ethanol use be helpful? We doubt this, as the therapeutic potential of alcohol is limited to the treatment of acute methanol intoxication and disinfection.