As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS /World Health Organization guidance recommends that participants in prevention trials receive ‘access to all state of the art HIV risk reduction methods’, and that decisions about adding new tools to the prevention package be (...) made in consultation with ‘all relevant stakeholders’. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process. (shrink)

Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.

Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.

Several states systematically collect data to assess whether the anesthesia administered was sufficient—the same data used by researchers to show that the concentration of sodium thiopental in the blood of executed prisoners was not enough to ensure loss of consciousness and that these inadequate levels of anesthesia were not the result of pharmacokinetic changes after death. This activity could constitute human subjects research under existing law.

America has a serious drug problem. The problem is not abuse of prescription stimulants by students cramming for the SATs, nor is it the recent spate of violent attacks associated with the use of so‐called bath salts. Rather, the problem is a shortage of critical medicines. The American Society of Health System Pharmacists reports that over two hundred drugs are in short supply. The frequency and number of drug shortages are also increasing steadily, as seen in a recent Food and (...) Drug Administration study that found that the number of reported drug shortages has nearly tripled, from sixty‐two in 2005 to 178 in 2010. There are few quick solutions to the crisis, and the long‐term effect of pending legislation and regulatory changes is unclear. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development and the US National Institutes of Health, have policies that restrict how research funds may be used. Among these are the now-rescinded Mexico City Policy, (...) elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 17-19, June 2011.