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In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. [ABSTRACT FROM AUTHOR]

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. 'Social context' refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. [ABSTRACT FROM AUTHOR]

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. [ABSTRACT FROM AUTHOR]

Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research. [ABSTRACT FROM AUTHOR]

In this article the author discusses aspects of the report "Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate," by J. Snyder, C. Miller, and G. Gray within the issue. The author notes the persuasiveness of Snyder and colleagues' argument regarding the use of a relative standard of minimal risk in HIV vaccine trials involving adolescents, and discusses Canadian regulations regarding minimal risk and ethical aspects of minimal risk.

The author comments on the article "Behavioral Equipoise: A Way to Resolve Ethical Stalemates in Clinical Research," by Peter A. Ubel and Robert Silbergleit. She talks about the debate on offering mammograms to women between 40 and 49 years of age. She suggests that clinical trials are not always enough to change behavior and beliefs. She comments on the use of behavioral equipoise to overcome stalemates concerning clinical practice and the state of evidence.

A letter to the editor is presented in response to the article "The Diverse Ethics of Translational Research," by N. Sofaer and N. Eyal.

The author reflects on the article "The Diverse Ethics of Translational Research," by N. Sofaer and N. Eyal. In the article the author offers his opinions on several arguments and assumptions that are contained in the article, on the importance of translational research and on the need for regulatory oversight of translational research which reflects the research's diversity.

A letter to the editor is presented in response to an article which was written by David Hunter and James Wilson.

In this article the authors discuss the article "Ethical Dilemma of Mandated Contraception in Pharmaceutical Research at Catholic Medical Institutions" by Murray Joseph Casey, Richard O'Brien, Marc Rendell and Todd Salzman. They are critical of several points which are raised in Casey et al.'s article and of the policies that Catholic medical institutions have regarding medical research.

The article discusses the article"How Good is Good Enough? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention" by Bridget Haire, John Kaldor and Christopher F. C. Jordens. In the article the author offers her opinions on several points which Haire et al. raise in their article and on the moral and ethical issues that are raised in the evaluation of new HIV prevention methods.

In this article the author discusses the article "How Good is Good Enough? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention" by Bridget Haire, John Kaldor and Christopher F. C. Jordens. She is supportive of several points which are raised in the article but is critical of points which are raised in a section of the article titled "Ethical Guidelines on Standards of Prevention and Placebo.”

In this article the author discusses aspects of the article "Social Contexts Influence Ethical Considerations of Research," by J. B. Gordon and colleagues within the issue. The study's researchers present a hypothetical case study of patients enrolled in an HIV vaccine study who will not live long enough to experience known risks. The influence of social contexts on the ethical considerations of research and the role of social media in the public discussion of research ethics is presented.

In this article the author discusses aspects of the article "Dealing With the Long-Term Social Implications of Research," by A. Fleischman and colleagues within the issue in which the study's authors propose the creation of a national advisory committee that would consider issues related to any long-range social and policy impacts of research in the protocol review process. The role and limitations of U.S. IRBs and the long-term social implications of research is discussed.

The author comments on the article "Behavioral Equipoise: A Way to Resolve Ethical Stalemates in Clinical Research," by P.A. Ubel and R. Silbergleit. He talks about research into the use of tissue plasminogen activators (t-PA) in the early treatment of stroke symptoms and questions if the study's purpose would be to increase the frequency of treating stroke with t-PA in the context of that trial. He mentions the need to ensure the trials are a means of providing additional clinical evidence.

The author reflects on the article "The Diverse Ethics of Translational Research," by N. Sofaer and N. Eyal. In the article the author offers her opinions on several arguments and assertions that are contained in Sofaer and Eyal's article and on the diverse ethics that are associated with translational research which is conducted in the developing world.

The author reflects on the article "Research Exceptionalism," by J. Wilson and D. Hunter. in the article the author offers his opinions on several arguments and assumptions that are contained in Wilson and Hunter's article and on methods that he feels could and should be used to reverse research exceptionalism.

The author reflects on the article "Research Exceptionalism," by James Wilson and David Hunter. In the article the author offers her opinions on several arguments and assertions that are contained in Wilson and Hunter's article and on the ethical imperative to limit the concept of research exceptionalism.