Clinical Trial Application in Europe: What Will Change with the New Regulation?

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC?     

The Need for Governance by Experimentation: The Case of Biofuels

The policies of the European Union concerning the development of biofuels can be termed a lock-in. Biofuels were initially hailed as a green, sustainability technology. However evidence to the contrary quickly emerged. The European Commission proposed to alter its policies to accommodate for these effects but met with fierce resistance from a considerable number of member states who have an economic interest in these first generation biofuels. In this paper I argue that such a lock-in might have been avoided if an experimental approach to governance had been adopted. Existing approaches such as anticipation and niche management either do not reduce uncertainty sufficiently or fail to explicitly address conflicts between values motivating political and economic support for new technologies. In this paper, I suggest to apply an experimental framework to the development of sustainable biobased technologies. Such an approach builds on insights from adaptive management and transition management in that it has the stimulation of learning effects at its core. I argue that these learning effects should occur on the actual impacts of new technologies, on the institutionalisation of new technologies and most specifically on the norms and values that underly policies supporting new technologies. This approach can be relevant for other emerging technologies.     

Research in Emergency and Critical Care Settings: Debates,Obstacles and Solutions

Research is an integral part of evidence-based practice in the emergency department and critical care unit that improves patient management. It is important to understand the need and major obstacles for conducting research in emergency settings. Herein, we review the literature for the obligations, ethics and major implications of emergency research and the associated limiting factors influencing research activities in critical care and emergency settings. We reviewed research engines such as PubMed, MEDLINE, and EMBASE for the last two decades using the key words “emergency department”, “critical care”, “research”, “consent”, and “ethics” as the search terms. Research within emergency settings is slow or non-existent due to time and financial constraints as well as the lack of a research tradition. There are several barriers to conducting research studies in emergency situations such as who, what, when, and how to obtain patient consent. The emergency environment is highly pressurized, emotional, and overburdened. The time taken for research is a particular risk that could delay the desired immediate interventions. Ethical issues abound, particularly relating to informed consent. Research in emergency settings is still in its infancy. Thus, there is a strong need for extensive research in the emergency setting through community awareness, resource management, ethics, collaborations, capacity building, and the development of a research interest for the improvement of patient care and outcomes. We need to establish a well-structured plan to assess and track the decision-making capacity, consider a multistep enrolment and consent strategy, and develop an integrated approach for recruitment into studies.     

The ‘Chasing Amy’ Bias in Past Sexual Experiences: Men Can Change,Women Cannot

An extensive sexual history may deter individuals from committing to a potential romantic partner. However, the reasons for this deterrence may differ between men and women, such that women focus on practical concerns over suitability whereas men focus on reputation. Thus, individuals with extensive sexual histories, who are currently monogamous, should be more acceptable to women than they are to men. Two studies supported this hypothesis. Study 1 found that women rated male targets with a sexually experienced past with increased desirability for a long-term relationship if they reported recent shifts towards monogamy. In contrast, men rated sexually experienced female targets, with a recent shift towards monogamy, as least desirable. Study 2 extended the understanding of this effect by demonstrating that one time sexual experiences (i.e., threesome) had no effect on women’s judgments of currently monogamous men, but continued to negatively affect men’s judgments of currently monogamous women. In sum, women seem accepting of lifestyle changes in men, whereas men fixate on women’s previous experiences in spite of shifts towards monogamy.     

Bridging the HIV Divide: Stigma,Stories and Serodiscordant Sexuality in the Biomedical Age

At a time when advances in biomedicine have rendered people with HIV non-infectious under certain conditions, much public discourse on HIV remains stuck in a paradigm of ‘risk’, which does little to lessen the divide between people with and without HIV in society or challenge the way intimate relationships across this divide are typically stigmatised as undesirable and problematic. We rarely hear the stories of couples who live with mixed HIV statuses and how they themselves perceive and manage their so called ‘serodiscordance’. In this article, we examine such stories by mixed-status couples in Australia. In stark contrast to the dominant discourse, these couples invoked narratives of love, the everyday unimportance and manageability of HIV, and recent developments in HIV medicine, thereby challenging the way serodiscordant sexuality has been cast in public health research. Drawing on Ken Plummer’s work on hidden sexual stories, we consider not only the content of their stories, but the broader significance of stories to the world in which they are enacted, of storytelling as a rally for social and political recognition and legitimacy. Reflecting on our own role in the co-production of research stories, we argue that by moving marginalised sexual stories out of silence, stigmatised communities and researchers can conjointly and incrementally shape a new public discourse and new forms of ‘intimate citizenship’.     

Peat Bogs,Sperm, and Family Values: Teaching Naturalism Charitably

Introductory courses dealing with sex, gender and sexuality often assign excerpts from Thomas Aquinas as an exemplar of the naturalist view. Given that most novice students tend to side against such naturalism uncritically, they need to be exposed to a more charitable account of the biological considerations motivating a stance like Aquinas.’ With that in mind, this article presents accessible arguments aimed at restoring deliberative balance in the classroom.     

Risky Sexual Behavior of Multiple Partner Relations and Women’s Autonomy in Four Countries

Existent research reveals that inequitable gender-based power in relationships and intimate partner violence contribute to HIV rates among women in the developing world. This study uses a multi-country analysis to examine women’s autonomy in negotiating safe sex practices such as having sex with a partner with no other concurrent partner to reduce the risk of HIV/AIDS in Nigeria, Kenya, Malawi, and Nepal. The Demographic Health Survey data for Nigeria (2013), Kenya (2008–2009), Malawi (2010), and Nepal (2011) provide geographical variability as well as HIV risk variables. The sample included 16,540 women aged 15–49 years who self-identified as ever married. Factor analysis for women’s autonomy was conducted based on socio-cultural theory. Logistic regression was conducted and results identified decision-making, labor force participation, and individual autonomy as women autonomy factors significantly reduced the risk for HIV infection by having one sex partner who has only one sex partner. Other women autonomy factors related to lower risk for HIV include education, place of residence, and religion. Our study indicates that effective management of HIV transmission requires addressing women autonomy factors within the context of culture.     

Voluntary Agencies’ Responses to,and Attitudes toward Male Rape: Issues and Concerns

This paper critically explores voluntary agencies’ responses to, and attitudes toward male survivors of rape in England and Wales. There has been a gap in this area, so this paper attempts to fill this gap in knowledge by examining how these survivors experience service delivery and by examining what contributions feminist theory and research has made to understand ‘male rape’. This paper argues that feminist theory and research neglects male rape and this negligence can also be seen in voluntary organisations for survivors. Therefore, through the neglect of male rape, the gender roles of men and women are reinforced instead of being tackled. This paper contributes to knowledge by opening up a discussion on male rape in the academic setting, in feminist theory and research debates, and in research surrounding voluntary agencies. This, in turn, helps to raise awareness of such a ‘hidden’ phenomenon in policy and practice and helps to form a better understanding not only of male rape, but also of the responses and attitudes toward it by voluntary provisions and the wider society.     

Transgender Dispossession in <Emphasis Type="Italic">Transparent</Emphasis>: Coming Out as a Euphemism for Honesty

Since the 1990s, television narratives have increased visibility for LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning, Intersex, and Asexual) individuals and underscored the need for a deep exploration of the heterosexism (homophobia) that pervades much mainstream American programming (Lee and Meyer in Sex Cult 141:234–250, 2010; Manuel in Soc Semiot 19(3):275–291, 2009). One such serial, Transparent, has been credited by many major media outlets with transforming the way Americans think about transgender, gender expansive (Ehrensaft in Gender born gender made, The Experiment, New York, 2011), or trans*, individuals. Exploring Transparent through Butler and Athanasiou’s (Dispossession: the performative in the political, Polity Press, Cambridge, 2013) framework of dispossession, this essay argues that the depiction of dispossession in Transparent may serve to hypostasize the gender binary rather than to disrupt it. By severing the rhetorical act of “coming out” from the historical pathologization of non-normative sexualities and gender expansiveness in America, Transparent risks undoing the very social progress that it has the potential to further. While the show could powerfully disrupt cisgender privilege (Brydum in The true meaning of the word cisgender, 2015), as of its second season, instead, it merely illustrates how the media produced trans* “coming out” narrative all too often reifies the gender binary and cisgender privilege. Although it is tempting to praise Transparent for its representation of gender expansiveness, its problematic use of the “coming out” rhetoric should not be ignored.