Suchergebnisse

In an attempt to encourage inclusion of women, minorities, and children in clinical trials, the U.S. National Institutes of Health (NIH) requires investigators conducting NIH-sponsored research to adequately address NIH inclusion guidelines concerning recruitment of women, minorities, and children. A survey of U.S. Research Ethics Board (REB) administrators at institutions receiving NIH funding indicated awareness and implementation of the inclusion guidelines. According to the administrators, investigators and REBs address inclusion in more than half of the relevant protocols. About half of the REB administrators consider the guidelines partly responsible for increased attention to inclusion, but only about a quarter believe that there is greater inclusion as a result.

ABSTRACTWe reviewed the public comments submitted in response to the Department of Health and Human Services' (DHHS's) original and revised proposal for mandated single‐IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single‐IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site‐specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single‐IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS's final rule—and the separate rule of the National Institutes of Health—mandating single‐IRB review is needed to determine whether the single‐IRB model achieves the stated goals.

AbstractPeople acquire spatial information from many sources, including maps, verbal descriptions, and navigating in the environment. The different sources present spatial information in different ways. For example, maps can show many spatial relations simultaneously, but in a description, each spatial relation must be presented sequentially. The present research investigated how these source differences influence the mental models that children and adults form of the presented information. In Experiment 1, 8‐year‐olds, 10‐year‐olds and adults learned the layout of a six‐room space either from verbal descriptions or from a map. They then constructed the configuration and pointed to target locations. Participants who learned from the map performed significantly better than those who learned from the description. Ten‐year‐olds performed nearly as well as adults did. The 8‐year‐olds' mental models differed substantially from the older children's and adults' mental models. The younger children retained the sequential information but did not integrate the relations into a survey‐like cognitive map. Experiment 2 demonstrated that viewing the shape of the configuration, without seeing the map in full, could facilitate 8‐year‐olds' use of the verbal information and their ability to integrate the locations. The results demonstrate developmental differences in the mental representation of spatial information from descriptions. In addition, the results reveal that maps and other graphic representations can facilitate children's spatial thinking by helping them to transcend the sequential nature of language and direct experience.

Little is known about researchers' practices regarding the provision of ancillary care (AC) in public health intervention studies they have conducted and the factors that influence their decisions about whether to provide ancillary care in low-resource settings. We conducted 52 in-person in-depth interviews with public health researchers. Data analysis was iterative and led to the identification of themes and patterns among themes. We found that researchers who conduct their research in the community setting are more likely to identify and plan for the AC needs of potential research subjects before a study begins, whereas those affiliated with a permanent facility are more likely to deliver AC to research subjects on an ad hoc basis. Our findings suggest that on the whole, at least for public health intervention research in low-resource settings, researchers conducting research in the community setting confront more complex ethical and operational challenges in their decision-making about AC than do researchers conducting facility-based studies.

Community-based public health intervention research in developing countries typically takes place not in clinics but in people's homes and other living spaces. Research subjects and their communities may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic services.

"Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies"--

Although advances in treatment and diagnosis have transformed HIV into a chronic disease in high-income countries, a spectrum of structural, political, sociocultural, and health system barriers hamper early diagnosis and timely treatment of HIV in many middle- and low-income countries. In most Latin American countries, in spite of the great improvement in access to antiretroviral therapy, a large proportion of individuals infected with HIV do not know their status. In Colombia, the Joint United Nations Programme on HIV/AIDS currently estimates a much larger number of HIV cases than the number reported by Colombian authorities. Potential reasons for underdiagnosis and underreporting include sociocultural factors such as social stigma, restrictions in access to health care, a lack of public health research and robust surveillance systems, and the particular recent history and social situation related to the armed conflict the country has suffered through for several decades. Lessons from Colombia may be helpful in monitoring, understanding, and tackling the HIV epidemic in countries with long-term armed conflicts.

ABSTRACTIn the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision‐making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast‐moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.