A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, in partial fulfillment of the requirements for the degree Master of Science in Medicine Bioethics and Health Law, May 2015, Johannesburg / Surrogacy motherhood, an arrangement involving one woman gestating a baby to be raised by another, is still a relatively ‘new’ technology in Kenya seeing as the first surrogate birth in Kenya happened in August 2007. Being a new technology therefore, the practice is still stifled in uncertainty thereby raising a complex web of legal and ethical issues. The fact that there is no legal and ethical framework to regulate surrogacy arrangements in Kenya, exposes the practice to corruption and other exploitative activities. Lapses and lacuna in the legal framework makes it hard to standardize the practice of surrogacy in Kenya, leaving the consumers of the service (technology) at the mercy of personal interpretation of the service providers. It is therefore essential that a legal and ethical framework is formulated to not only curb the rising incidences of exploitation but to also safeguard the interests of all parties involved. It is under this background that I intend to normatively assess the current practices of surrogacy in Kenya and make recommendations based on best practices internationally to guide the development of a legal and ethical framework on surrogacy in Kenya.

Statement of the problem: Many methods for surrogate outcome validation require individual patient data which is often inaccessible by clinical trialists. Methods: A review was performed to identify statistical methods for surrogate outcome validation that may be implemented using summary data from published clinical trials. The methods were used to evaluate carotid intima-media thickness (CIMT) as a surrogate outcome for cardiovascular events in a systematic review of randomized trials of interventions for atherosclerosis. Results: the review of methods identified five procedures. At two or more years of follow-up, there was a marginally significant association of CIMT with myocardial infarction and a statistically significant association with cardiovascular mortality. At ≥ four years of follow-up, a statistically significant, negative relationship was observed between CIMT and stroke. Conclusions: CIMT may be a valid surrogate outcome for myocardial infarction and cardiovascular mortality. Additional data is needed to evaluate CIMT in specific drug classes.

Summary This paper investigates, through experiments using surrogate predators, differences in intraspecific alarm calls between familiar and unfamiliar Bronze Mannikin Spermestes cucculatus groups. Four groups of mannikins were captured with mist nets from four areas in Durban (i.e. original groups) and randomly mixed (i.e. assorted groups). These groups were exposed to latex terrestrial snakes and mounted aerial raptors, and their alarm calls and predator response behaviours recorded. The Bronze Mannikins were able to discriminate between predators of different sizes, and increased their calling rate and decreased the end frequency of the alarm call in response to larger predators. This perhaps signalled increased threat, while simultaneously decreasing the conspicuousness of the flock. When the alarm call structure of the original and assorted groups in response to both raptors and snakes was compared, birds in original groups called more often, but paused longer between calls. Anti-predator behaviour differed in that assorted groups were less vigilant and aggressive toward the predators and panicked more frequently. In these groups, a failure to transfer the predation threat information might have caused the group to stop behaving cohesively and reliably. The manipulated experiments carried out in this study indicated that Bronze Mannikins were able to communicate predator size risk to conspecifics, but not as successfully to unfamiliar group members, showing that the investment, probability through altruistic payback, is greater in stable groups.

This thesis investigates the management of information about the biological origins of individuals conceived through the use of a third party; that is, by donated gametes or surrogacy. From a review of policy reports and academic studies of families created in this way, I identify three possible management strategies: complete secrecy; openness about the means of conception coupled with third party anonymity; openness about the means of conception, coupled with releasing the identity of the third party to the individual conceived, when adult. The middle strategy is exemplified by the Report of the Committee of Inquiry into Human Fertilisation and Embryology (the 'Warnock Report', 1984). This I explore in two ways: first through a detailed analysis of the Report itself, then through a series of in-depth interviews with committee members. I conclude that although the Report can be read as a prescription for the creation of 'normal families', in which the above management strategy on origins is a device for protecting ideologically-correct but biologically-anomalous families, from the Interviews it appears that this represented a suspension of more profound difficulties experienced by members when discussing these issues. These difficulties arose from what members found to be an irresolvable dilemma over the contribution of biological factors to family life. In the final chapter I examine the nature of the contrast between the Report and the interviews; I then locate the above dilemma in broader theoretical debates and finally I suggest that the strategy of recommending anonymity between all parties exposes rather than resolves the tension between the 'biological' and the 'social' in everyday, lay, reasoning about family life. In the light of this conclusion I speculate on possible developments in the management of origins information and the likely impact of third parties being named in the future.

Statement of the problem: Many methods for surrogate outcome validation require individual patient data which is often inaccessible by clinical trialists. Methods: A review was performed to identify statistical methods for surrogate outcome validation that may be implemented using summary data from published clinical trials. The methods were used to evaluate carotid intima-media thickness (CIMT) as a surrogate outcome for cardiovascular events in a systematic review of randomized trials of interventions for atherosclerosis. Results: the review of methods identified five procedures. At two or more years of follow-up, there was a marginally significant association of CIMT with myocardial infarction and a statistically significant association with cardiovascular mortality. At ≥ four years of follow-up, a statistically significant, negative relationship was observed between CIMT and stroke. Conclusions: CIMT may be a valid surrogate outcome for myocardial infarction and cardiovascular mortality. Additional data is needed to evaluate CIMT in specific drug classes.

This thesis explores surrogate motherhood using Christian ethics within a relational framework. A surrogate mother is a woman who has a child for a commissioning couple who are usually infertile. Chapter one explores how surrogacy is presented in three secular and three Church reports by focusing upon the surrogate, the commissioning couple and the child. The key theological and ethical objections to surrogacy are briefly explored: that it undermines motherhood, involves baby selling, coercion, exploitation and commodification. Chapter two analyses motherhood according to three secular feminists and three theologians. The secular feminists are criticised for not recognising the complexity of motherhood. By contrast, motherhood in Christianity is presented as multidimensional. Chapter three analyses whether paid surrogacy commodifies, exploits and coerces the participants. Theologically the chapter explores human beings as created in the image of God and as having dignity, which can mean that payment does not always have to lead to commodification, exploitation or coercion. Chapter four explores whether paid surrogacy involves baby selling. Theologically the chapter explores the concepts of the self and other in Augustine and Aquinas. It also explores agape in Anders Nygren and Gene Outka, arguing that self-interest and altruism can co-exist with care for the self and the other in a relational framework without detriment. Comparisons are made with blood donation to suggest that paid and unpaid surrogacy can operate together without paid surrogacy being regarded as baby selling or the purchase of parenthood. Finally, chapter five outlines three models towards surrogacy: a contract model, an adoption model and my relational approach, influenced by Louis Janssens’ personalism. My relationalism aims for a more sophisticated ontology of the relationship between the self and the other and calls for various solutions in a surrogacy custody dispute.

Statement of the problem: Many methods for surrogate outcome validation require individual patient data which is often inaccessible by clinical trialists. Methods: A review was performed to identify statistical methods for surrogate outcome validation that may be implemented using summary data from published clinical trials. The methods were used to evaluate carotid intima-media thickness (CIMT) as a surrogate outcome for cardiovascular events in a systematic review of randomized trials of interventions for atherosclerosis. Results: the review of methods identified five procedures. At two or more years of follow-up, there was a marginally significant association of CIMT with myocardial infarction and a statistically significant association with cardiovascular mortality. At ≥ four years of follow-up, a statistically significant, negative relationship was observed between CIMT and stroke. Conclusions: CIMT may be a valid surrogate outcome for myocardial infarction and cardiovascular mortality. Additional data is needed to evaluate CIMT in specific drug classes.

Includes bibliographical references.

In the past few years, biomarkers such as progression free survival (PFS) and time to progression (TTP), have been increasingly used as surrogate endpoints for overall survival (OS) in clinical trials in oncology. An issue occurs when clinical trials which demonstrated statistically significant treatment effect for the surrogate marker, shows no significant effect on the true outcome of interest, OS. It is possible that this lack of concordant results was due to informative censoring. Although it is known that informative censoring may bias the observed results, it is not clear what impact informative censoring has on the surrogacy of one marker in relation to a true outcome. In this thesis, we investigated how informative censoring could affect the results of a surrogate endpoint, and how would that affect the surrogacy of that endpoint. A simulation study was conducted to evaluate the impact of informative censoring on the treatment effect on TTP and the outcomes of the surrogate validation methods relative effect (RE), surrogate threshold effect (STE), and the difference between the treatment effect on TTP and on OS (IRE). The results of the simulation showed that having informative censoring for TTP will indeed bias the treatment effect on TTP as well as the results for the validation methods, RE, STE, and IRE. Hence, we conclude that the effect of informative censoring can greatly influence the ability to validate a surrogate marker, and additionally can bias the ability to determine the efficacy of a new therapy from a clinical trial using a surrogate marker as the primary outcome. / Thesis / Master of Science (MSc)

Research about gestational surrogacy is limited from the surrogate’s perspective, yet third party reproduction is on the rise worldwide, and specifically in Canada. The experiences, relationships, and meanings of Canadian surrogate mothers are the focus of this research. Eight women’s narratives are studied to better understand the process of their gestational surrogacy experience. The purpose of this study was to learn more about surrogacy by paying attention to how surrogate mothers story/narrate their experiences. The good surrogate discourse, which influences meaning making, was uncovered when analyzing how surrogate mothers narrate their experience within gestational surrogacy positions, roles, and procedures. Further analysis focused on discourses of motherhood, gender, biomedical practice, fertility, ethics, and legislation which actively shape the stories that can be told, and limit the identities that are available. Similarly, these discourses influence relationships as surrogates monitor their need for connection with the surrogate child. Professionals in the field of child and youth care (CYC) including family practitioners, counsellors, and anyone working with children, youth, and families need to be mindful of their practice if third party reproduction is an issue as counselling support for grief and loss may be necessary. / Graduate