Is the legal protection for the foetus adequate in clinical trials?

In 2009 and 2010, the major drug regulatory bodies, the European Medicines Agency and the Food and Drug Administration in the USA, issued requests for the generation of information relating to the absorption, distribution, metabolism, excretion, efficacy and safety of investigational drugs in pregnant women prior to approval. In the wake of thalidomide, research involving pregnant women other than for obstetric or gynaecologic purposes became rare, and studies of investigational drugs practically unknown. Consequently, none of the legislation applicable in the UK and few of the guidelines introduced in the last 40 years properly addresses the conduct of clinical trials of investigational drugs in this population. This thesis questions whether the legal protection for the foetus is adequate in clinical trials. The answer appears to be a qualified “no”. Arguments persist regarding the moral standing of the foetus, particularly regarding abortion. That will not be the intent of such trials, and a moral case is made for the conduct of clinical trials in this population by analogy with the neonate, and the pregnant woman’s autonomy. Legally, we already recognise the foetus has ‘interests’ which crystallise upon live birth, and that compensation is recoverable for harm inflicted in utero manifesting as congenital injury. The essence of research is quite different from medical practice, and the extent to which this is understood by trial participants is unclear. The approvals processes contain a number of inadequacies which have the potential to expose the foetus to harm and affect the consent of the pregnant woman. The recovery of compensation in the event of children born injured following clinical trials during pregnancy in many ways may be more complex than other personal injury cases.. The conclusions of this thesis are that the existence of a foetus does merit recognition by the law in this setting and that morally such studies are justifiable. However, the present legislation and approval processes potentially expose the foetus to avoidable risk and may not be appropriate to enable the recovery of compensation, thereby creating potential to deter future trial participants. A proposal is made regarding an approach to simplify the process for recovery of compensation, and thereby strengthen the approval and consent processes.

Communication across cultures? An intercultural approach to customer service in the hotel industry: a study with globally branded hotels in the United Kingdom

In a professional and business-social context such as that of global hotel brands in the United Kingdom, intercultural communication, contacts and relationships are found at the heart of daily operations and of customer service. A large part of the clientele base of hotels in the United Kingdom is formed by individuals who belong to different cultural groups that travel in the country either for leisure or business. At the same time, the global workforce which is recruited in the hotel industry in the United Kingdom is a reality here to stay. Global travelling and labor work mobility are phenomena which have been generated by changes which occur on a socio-economic, cultural and political level due to the phenomenon of globalization. The hotel industry is therefore well acquainted with the essence of different cultures either to be accommodated within hotel premises, as in the case of external customers, or of diversity management where different cultures are recruited in the hotel industry, as in the case of internal customers. This thesis derives from research conducted on eight different global hotel brands in the United Kingdom in particular, with reference to three, four and five star categories. The research aimed to answer the question of how hotels are organized in order to address issues of intercultural communication during customer service and if intercultural barriers arise during the intercultural interaction of hotel staff and global customers. So as to understand how global hotel brands operate the research carried out focused in three main areas relating to each hotel: organizational culture, customer service–customer care and intercultural issues. The study utilized qualitative interviews with hotel management staff and non-management staff from different cultural backgrounds, public space observations between customers and staff during check-in and checkout in the reception area and during dining at the café-bar and restaurant. Thematic analysis was also applied to the official web page of each hotel and to job advertisements to enhance the findings from the interviews and the observations. For the process of analysis of the data interpretive (hermeneutic) phenomenology of Martin Heidegger has been applied. Generally, it was found that hotel staff quite often feel perplexed by how to deal with and how to overcome, for instance, language barriers and religious issues and how to interpret non verbal behaviors or matters on food culture relating to the intercultural aspect of customer service. In addition, it was interesting to find that attention to excellent customer service on the part of hotel staff is a top organizational value and customer care is a priority. Despite that, the participating hotel brands appear to have not yet, realized how intercultural barriers can affect the daily operation of the hotel, the job performance and the psychology of hotel staff. Employees indicated that they were keen to receive diversity training, provided by their organizations, so as to learn about different cultural needs and expand their intercultural skills. The notion of diversity training in global hotel brands is based on the sense that one of the multiple aims of diversity management as a practice and policy in the workplace of hotels is the better understanding of intercultural differences. Therefore global hotel brands can consider diversity training as a practice which will benefit their hotel staff and clientele base at the same time. This can have a distinctive organizational advantage for organizational affairs in the hotel industry, with potential to influence the effectiveness and performance of hotels.