title: 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.
authors.affiliation: a Albert Einstein College of Medicine.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Andreae
authors.affiliation: b Icahn School of Medicine at Mount Sinai.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Rhodes
authors.affiliation: b Icahn School of Medicine at Mount Sinai.
authors.forename: Tyler
authors.initials: T
authors.lastname: Bourgoise
authors.affiliation: c Foundation for Integrative AIDS Research.
authors.forename: George M
authors.initials: GM
authors.lastname: Carter
authors.affiliation: d Weill Cornell Medical Center.
authors.forename: Robert S
authors.initials: RS
authors.lastname: White
authors.affiliation: b Icahn School of Medicine at Mount Sinai.
authors.forename: Debbie
authors.initials: D
authors.lastname: Indyk
authors.affiliation: b Icahn School of Medicine at Mount Sinai.
authors.forename: Henry
authors.initials: H
authors.lastname: Sacks
authors.affiliation: b Icahn School of Medicine at Mount Sinai.
authors.forename: Rosamond
authors.initials: R
authors.lastname: Rhodes
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002188:Cannabis; D061891:Controlled Substances; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence* / Q000639:trends*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005610:Freedom; D003932:Heroin; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007649:Ketamine; D012935:Social Justice; D006113:United Kingdom; D014481:United States
chemical_list: D061891:Controlled Substances; D007649:Ketamine; D003932:Heroin
keywords: biomedical research; confidentiality and privacy; human subjects research; informed consent; institutional review board; research ethics