Thesis (doctoral)--Universität Frankfurt a.M., 2004. / Includes bibliographical references (p. 19-42).

Thesis (Ph. D.)--UCLA, 2008. / Vita. Includes bibliographical references (leaves 281-296).

Thesis (M.A.)--Old Dominion University, 2001. / Includes bibliographical references.

Paediatric clinical trials are crucial to ensure safety and efficacy of medicines in children. This study explored parents’ perceptions in Gaborone, Botswana, regarding children’s participation in clinical trials. One hundred participants completed a self-administered questionnaire. The results showed that 93% of the participants had a good knowledge of clinical trials; 74% thought that children would benefit from clinical trial participation; 63% would not enrol their children in clinical trials; 55% suggested that children should only be enrolled once they have reached the age of 18 years; and 71% reported that only children with an active disease should be enrolled. A large proportion (82%) reported that children’s participation should be voluntary, while joint parental consent was supported by 93% of responders. Regarding children’s assent 91% deemed respect for children’s assent essential, although 52% thought that children’s assent should not override the parental decision. There was a statistically significant correlation between finding clinical trials in general important and children’s participation in clinical trials (p=0.008, Fisher’s Exact Test), as well as the need for individual consent p<0.0001, Chi-Square). There was also a statistically significantly association between respondents, who would allow their children’s participation in clinical trials and who would encourage their family members and friends’ participation in clinical trials (p=0.0001, Chi-Square). An overwhelming 94% advocated for special regulations in Botswana to govern paediatric clinical trials. Almost all participants (99%) explicitly expressed the opinion that there should be global regulations for paediatric clinical trials. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2012.

This thesis seeks to demonstrate, by way of a multidisciplinary study, that consent is, despite its legal definition which refers to the free and enlighted expression of individual will, in fact, at times limited if not eliminated, by social considerations, arising from the medical, economic and legal context. These considerations reflect what one might call the social norm. An appropriate understanding of consent serves, therefore, to express the social norm as a constraint, which, in turn, acts as a measure of what it means to belong in society. Thus, while consent is often presented as the fundamental principle to be respected in biomedical research, it is in reality, merely one principle to respect among others. These limitations connected to consent are exacerbated in emergency situations where consent is sometimes reduced to mere signature, and in some cases it has been recognized that research can be undertaken without the subject's prior consent.

Introduction Willingness to participate in clinical trials is a crucial element in recruitment of suitable participants for intervention trials. Measurement of willingness to participate assists in determining community preparedness for clinical trials, such as HIV vaccine trials. Therefore, researchers have developed a Clinical Research Involvement Scale (CRIS) to assess willingness to participate modelled on the Theory of Reasoned Action. The CRIS was tested in the USA and was noted that it would benefit from additional testing in other populations. Aim The purpose of this study is to determine whether racial differences exist in willingness to participate and explore potential factors associated with willingness to participate in HIV prevention research. Methods A cross sectional analytic study was conducted. The CRIS was administered to university students aged 18-45 at the University of KwaZulu-Natal in South Africa. The CRIS was administered online with a demographic questionnaire to facilitate evaluation of possible associations between willingness to participate and age, gender, relationship status, parity, religion, education status, student status, employment status and access to private health care. Participation was once-off at the time of completing the scale. Results The study enrolled 636 participants, two thirds being female. An effective sample size of 509 was considered for analysis after data was cleaned for accuracy and completeness. The results indicated that all students across all race groups were willing to participate in HIV prevention research. However, when considering factors that affected willingness to participate, statistically significant differences were noted. Based on the differences amongst these factors, Black students expressed greater intention to participate compared to White and Indian students. The CRIS was deemed a reliable instrument in this population; however in its current structure it did not show strong validity. Validity improved if the factors of motivation to comply and outcome evaluations were removed in this population. Discussion The study findings are specific to students of the University of KwaZulu-Natal and cannot be generalized to other populations. The racial differences in factors that affect willingness to participate indicate differences in risk perception and seeking access to better quality healthcare. Recommendations The CRIS should be used in other student populations to assess its validity. (350 words) / Thesis (M.Med.Sc.)-University of KwaZulu-Natal, Durban, 2013.

Zugl.: Würzburg, Univ., Diss., 2006

Freie Univ., Diss. u.d.T.: Schwerin, Alexander von: Tierzucht, Strahlen und Pigmente--Berlin, 2002. / Personalbibliogr. H. Nachtsheim S. [350] - 371.

No description available.

This dissertation examines the legal position relating to the participation of children in research, especially in HIV preventive clinical research in South Africa. HIV/AIDS presents a real threat to humanity and particularly to the welfare of children. The participation of children in this type of trials is therefore vital. Children, as vulnerable participants, must also be protected from harm resulting from research. The study also considers the nature of HIV preventive clinical research, pointing to the inconsistencies in the legislation governing children’s participation in HIV preventive vaccine trials. The dissertation concludes that the question of the participation of children in HIV preventive clinical research poses many challenges, as the position in the South African law and relevant ethical guidelines are inconsistent and contradictory. The study recommends in the final instance that the relevant statutory provisions and ethical guidelines be harmonised in order to clear up the inconsistencies. / Jurisprudence / LL.M. (Legal Aspects of HIV/AIDS)