Argues that the War on Drugs and policies that deny convicted felons equal access to employment, housing, education and public benefits create a permanent under-caste based largely on race. Reprint. 12,500 first printing.

Heroin prescription involves the medical provision of heroin in the treatment of heroin addiction. Rudimentary clinical trials on that treatment modality have been carried out and others are currently underway or in development. However, it is questionable whether subjects considered for such trials are mentally competent to consent to them. The problem has not been sufficiently appreciated in ethical and clinical discussions of the topic. The challenges involved throw new light on the role of value and accountability in contemporary discussions (...) of mental competence. (shrink)

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining of ‘coercion’ (...) and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

(2001). The Fiction of 'Undue Inducement': Why Researchers Should Be Allowed to Pay Participants Any Amount of Money for Any Reasonable Research Project. The American Journal of Bioethics: Vol. 1, No. 2, pp. 1g-3g.

Washington, D.C.’s City Council has recently taken the first step towards legalizing the use of “medical marijuana” in accordance with the provisions of the Legalization of Marijuana for Medical Treatment Initiative of 1998. This action was not overruled by the United States Congress within the 30-day deadline imposed by the District of Columbia’s Home Rule Statute. The Council is now crafting regulations that will govern the therapeutic and palliative use of this drug with the goal of avoiding some of the (...) problems faced by the other states that have legalized medical marijuana; however, the proposed rules do not establish criteria for legitimate medical practice when medical marijuana is recommended. If the enabling regulations are passed by the D.C. Council and not rejected by the Congress, the District of Columbia will join over onequarter of the states in legalizing medical marijuana. On the other hand, if the D.C. Council fails to act favorably on the final regulations, then the effective legalization of medical marijuana will die and not be reconsidered until next year. (shrink)

Through a number of studies recently published in the psychology literature, T.D. Wilson, D.T. Gilbert, and others have demonstrated that our judgments about what our future mental states will be are contaminated by various distortions. Their studies distinguish a variety of different distortions, but they refer to them all with the generic term “affective forecasting.” The findings of their studies on normal volunteers are remarkably robust and, therefore, demonstrate that we are all vulnerable to the distortions of affective forecasting. a.

We wish to point out an additional consequence of the Catch-22 described by Andreae and colleagues (Andreae et al. 2016). The decades-long research gridlock of controlled drugs has unintentionally...

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. (shrink)

Many diseases and disease symptoms still lack effective treatment. At the same time, certain controversial Schedule I drugs, such as heroin and cannabis, have been reputed to have considerable therapeutic potential for addressing significant medical problems. Yet, there is a paucity of U.S. clinical studies on the therapeutic uses of controlled drugs. For example, people living with HIV/aids experience a variety of disease- and medication-related symptoms. Their chronic pain is intense, frequent, and difficult to treat. Nevertheless, clinical trials of compassionate (...) management for their chronic symptoms, which should be a research priority, are stymied. Stakeholders’ Views on Barriers to Research on Controlled Substances Evelyn Rhodes, Michael Andreae, Tyler Bourgiose, Debbie Indyk, Rosamond Rhodes, and Henry Sacks We employed qualitative methods to develop an understanding of the barriers to research on potential therapeutic uses of Schedule I drugs so that they might be addressed. We elicited the perspectives of key stakeholder groups that would be involved in such studies: people living with HIV/aids, clinicians, and members of institutional review boards. As we identified obstacles to research, we found that all of the stakeholder groups arrived at the same conclusion, that clinical research on the therapeutic potential of these drugs is ethically required. (shrink)