Introduction - research ethics : women, sex, and gender in biomedical research

The ethical governance of biomedical research is an area of intense international debate. Scholars argue about who should regulate and how, the appropriate role for ethics committees, what kind of research should be included, and who should be involved in monitoring compliance. A particular aspect of these debates concerns the inclusion of women as research participants and the efforts to ensure that researchers consistently investigate questions of sex and gender in health research. There is increasing evidence of the role of sex in the manifestation and course of some illnesses and their treatment. Moreover, evidence suggests that gendered expectations also affect health outcomes. This special issue investigates how researchers are addressing these issues and debates the appropriate roles of policy makers, ethicists, and lawyers in ensuring that sex and gender differences are taken into account in the development, conduct, and reporting of health research.

Biomedical research with heavy ions at the IMP accelerators

The main ion-beam acceleration facilities and research activities at the Institute of Modern Physics (IMP), Chinese Academy of Sciences are briefly introduced. Some of the biomedical research with heavy ions such as heavy-ion biological effect, basic research related to heavy-ion cancer therapy and radiation breeding at the IMP accelerators are presented.

European Union Biomedical Research Law and Policy and Citizen Science

In this chapter I focus on the EU's emerging biomedical research law and policy and examine the development of citizen science in this setting. The chapter argues that while what the analysis reveals might not be specific to the EU, attention to this organisation underlines important but often overlooked aspects of citizen science. That is, citizen science is (being) made less about promoting substantive involvement by citizens in the fashioning of biomedical trajectories and their empowerment as participants that pursue aims defined by themselves rather than others. Instead citizen science is underpinned by a more longstanding EU level approach to participation in science-based issues that sees it being harnessed, shaped and directed towards supporting the production and legitimation of organisational identity and sociotechnical order (in this case the EU’s). Within biomedical research law and policy citizen science might therefore be expected to support market-optimised biomedical futures and a dynamic internal market and economy. Citizen science is thereby implicated in the delineation of the boundaries of responsibility and accountability (and blame) for the (non-)realisation of public health priorities and objectives. In this way law and policy on participation and citizen science might support current research trajectories that do not serve all health needs.

Compositional Data in Biomedical Research

Modern methods of compositional data analysis are not well known in biomedical research. Moreover, there appear to be few mathematical and statistical researchers working on compositional biomedical problems. Like the earth and environmental sciences, biomedicine has many problems in which the relevant scienti c information is encoded in the relative abundance of key species or categories. I introduce three problems in cancer research in which analysis of compositions plays an important role. The problems involve 1) the classi cation of serum proteomic pro les for early detection of lung cancer, 2) inference of the relative amounts of di erent tissue types in a diagnostic tumor biopsy, and 3) the subcellular localization of the BRCA1 protein, and it's role in breast cancer patient prognosis. For each of these problems I outline a partial solution. However, none of these problems is \solved". I attempt to identify areas in which additional statistical development is needed with the hope of encouraging more compositional data analysts to become involved in biomedical research

TNFRSF13B Genetic variability an anthropological - evolutionary approach to Biomedical Research

In the recent years TNFRSF13B coding variants have been implicated by clinical genetics studies in Common Variable Immunodeficiency (CVID), the most common clinically relevant primary immunodeficiency in individuals of European ancestry, but their functional effects in relation to the development of the disease have not been entirely established. To examine the potential contribution of such variants to CVID, the more comprehensive perspective of an evolutionary approach was applied in this study, underling the belief that evolutionary genetics methods can play a role in dissecting the origin, causes and diffusion of human diseases, representing a powerful tool also in human health research. For this purpose, TNFRSF13B coding region was sequenced in 451 healthy individuals belonging to 26 worldwide populations, in addition to 96 control, 77 CVID and 38 Selective IgA Deficiency (IgAD) individuals from Italy, leading to the first achievement of a global picture of TNFRSF13B nucleotide diversity and haplotype structure and making suggestion of its evolutionary history possible. A slow rate of evolution, within our species and when compared to the chimpanzee, low levels of genetic diversity geographical structure and the absence of recent population specific selective pressures were observed for the examined genomic region, suggesting that geographical distribution of its variability is more plausibly related to its involvement also in innate immunity rather than in adaptive immunity only. This, together with the extremely subtle disease/healthy samples differences observed, suggests that CVID might be more likely related to still unknown environmental and genetic factors, rather than to the nature of TNFRSF13B variants only.

The Virtual Skeleton Database: An Open Access Repository for Biomedical Research and Collaboration

Background: Statistical shape models are widely used in biomedical research. They are routinely implemented for automatic image segmentation or object identification in medical images. In these fields, however, the acquisition of the large training datasets, required to develop these models, is usually a time-consuming process. Even after this effort, the collections of datasets are often lost or mishandled resulting in replication of work. Objective: To solve these problems, the Virtual Skeleton Database (VSD) is proposed as a centralized storage system where the data necessary to build statistical shape models can be stored and shared. Methods: The VSD provides an online repository system tailored to the needs of the medical research community. The processing of the most common image file types, a statistical shape model framework, and an ontology-based search provide the generic tools to store, exchange, and retrieve digital medical datasets. The hosted data are accessible to the community, and collaborative research catalyzes their productivity. Results: To illustrate the need for an online repository for medical research, three exemplary projects of the VSD are presented: (1) an international collaboration to achieve improvement in cochlear surgery and implant optimization, (2) a population-based analysis of femoral fracture risk between genders, and (3) an online application developed for the evaluation and comparison of the segmentation of brain tumors. Conclusions: The VSD is a novel system for scientific collaboration for the medical image community with a data-centric concept and semantically driven search option for anatomical structures. The repository has been proven to be a useful tool for collaborative model building, as a resource for biomechanical population studies, or to enhance segmentation algorithms.

International comparison of resource allocation in health sciences : an analysis of expenditures on biomedical research in 19 industrialized countries /

Item 507

Minority Biomedical Research Support Program : information brochure.

Mode of access: Internet.

The Canine as a biomedical research model : immunological, hematological, and oncological aspects /

"DOE/TIC-10191."

Biomedical research fellowship opportunities for foreign scientists /

Mode of access: Internet.

Towards a 21st-century roadmap for biomedical research and drug discovery: consensus report and recommendations

Decades of costly failures in translating drug candidates from preclinical disease models to human therapeutic use warrant reconsideration of the priority placed on animal models in biomedical research. Following an international workshop attended by experts from academia, government institutions, research funding bodies, and the corporate and nongovernmental organisation (NGO) sectors, in this consensus report, we analyse, as case studies, five disease areas with major unmet needs for new treatments. In view of the scientifically driven transition towards a human pathway-based paradigm in toxicology, a similar paradigm shift appears to be justified in biomedical research. There is a pressing need for an approach that strategically implements advanced, human biology-based models and tools to understand disease pathways at multiple biological scales. We present recommendations to help achieve this.