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In this article the author comments on an article of J. Perez-Rodriguez on postracial medicine and metaphysics of race. Topics discussed include psychological reality and social causation of race; influence of race on social reality; implications of socioeconomic situation and environmental factors on people's health and its implications in its race.

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations. [ABSTRACT FROM AUTHOR]

The article comments on an article on a function-based approach to shed light on the concept of informed consent in clinical research. Topics discussed include a three-step process for functional analyses of health ethics concepts, connection of functional analysis of ethical concepts to pragmatism, strategies that can be used to understand the function of an ethical concept, function enrichment and function testing.

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]

The article offers information on the clinical research is a team sport. Topics discussed include the essential trust between care providers and patients will have been lost; and also mentions that teams with an appropriate culture and an expectation of a long-term relationship with a patient and their family can also perform dual-role consent.

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.

The authors reflect on the article "The Diverse Ethics of Translational Research," by Neema Sofaer and Nir Eyal. In the article the authors offer their opinions on several arguments and assertions that are contained in Sofaer and Eyal's article and on the bioethics that are associated with post-approval research in translational science.

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.

The article offers information on the development of research ethics consultation in Canada. Research ethics consultation occur along a broad spectrum of developing field of research activities, revising or adapting methods to test the research method. Program development for research ethics consultation evolved from Stanford model, originating from an academic setting before turning into clinical setting.

The article presents a discussion over the disclosure of individual genetic research results, based on the Ravitsky and Wilfond proposed theories of "research-focused approach" and "autonomy-focused approach." The author also lays down a framework for disclosing individual results, taking into account its health implications, utilityand clinical validity.

The article discusses concealing some health information from researchers to avoid exclusion from enrolment in a study. It mentions clinicians are expected to address the health needs of patients regardless of patient behaviour, including lying and other forms of deception. It also mentions consequences on the patient are that the patient's behaviour runs the risk of imposing harms or other negative effects on others.

The article discusses conflicts between regulations and ethical principles. It mentions resolving ambiguity in favour of the ethically preferable outcome. It mentions dilemma for the ethics consultants surrounding how to integrate regulatory constraints into ethical analysis. It also mentions ethically acceptable for the investigators to resolve the dilemma they faced by relying on a commonplace.

The article discusses the importance of involving the youth in research protocol reviews. It references the study "Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part" by M. Luchtenberg et al., published within the issue. The study offers insight into the actual thoughts and experiences of young research participants. The collaboration between the institutional review board (IRB) and Youth Research Advisory Board (YRAB) in Pittsburgh, Pennsylvania is tackled.

The article discusses some dogmas used in pediatric research ethics. It references the study "Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part" by M. Luchtenberg et al., published within the issue. It is said that certain dogmas impede true child participation in clinical trials. The perception that children are a vulnerable population, are unable to give true consent, and are being genuinely heard by adults is discussed.

The article discusses young people's motivations to participate in clinical trials and its implications for research governance. It references the study "Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part" by M. Luchtenberg et al., published within the issue. The motivations cited in the study correlate with the findings of a Nuffield Council on Bioethics report. The role of clinician-patient relationship in framing research participation is discussed.

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.”

The article discusses the article "Criteria for Authorship in Bioethics," by D. B. Resnik and Z. Master. In the article the author offers his opinions on several points that are raised in Resnik and Master's article, on authorship in bioethics research and on the role that authorship guidelines in bioethics research can play in ensuring fairness and accountability in bioethics research articles.

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.

In this article the author discusses aspects of the U.S. PolyHeme clinical trial in which unconscious trauma patients received blood substitutes. The author notes a policy by the U.S. Food and Drug Administration (FDA) in which an experimental product can be given to patients without prior informed consent if a study meets FDA requirements for emergency research. An overview of the safety and ethical concerns of the policy are presented.

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.

In the article the author reflects on ethical rules concerning the use of human subjects in research. She comments on the article in this issue "The Case for Evidence-Based Rulemaking in Human Subjects Research," stating that the way in which the author assesses the rule of valid design leads to misleading issues about research methodology.

The article presenta a discussion on tiered disclosure by research subjects or participants for their autonomy and well-being. The author sides, Ravitsky and Wilfond proposed approach, that research subjects should be able to select the general circumstances for disclosure of results using a tiered process.