In a challenge trial, “healthy volunteers are intentionally exposed to pathogens in a controlled environment, in order to promote understanding of the pathogenesis, transmission, prevention and treatment of infectious diseases in humans.” (WHO 2021, Preface). Intentional infection is an uncomfortable concept, and as a result there is a widely held belief amongst research ethics scholars and commentators that a significant ethical concern with challenge trials is their potential to negatively impact the public’s trust in the institution of medical research (Eyal 2022, 4). However, the relationship between public trust and the ethics of conducting and assessing challenge trials is complex and existing literature on the subject does not sufficiently clarify it. This paper will begin by examining the ethical permissibility of challenge trials. Once these trials are shown to be ethically permissible under particular circumstances, I will explore how concerns about the way these trials allegedly exacerbate public mistrust largely result from ambiguities in the terms ‘public’ and ‘trust’. After both terms are defined, I will formulate my own account of how public trust should apply to a risk/benefit analysis for the purpose of trial design selection called the community engagement account, which argues that trial design selection policy should focus on demonstrating trustworthiness rather than garnering trust. Because demonstrating trustworthiness requires meeting a set of known expectations, this account identifies local, specific publics as those whose expectations should be of concern when discussing public trust and trial design selection. To examine the expectations of these publics, this account defends community engagement as the measure which should be used to acquire evidence of harmful public mistrust towards the institution of science that could potentially result from conducting a challenge trial. / Thesis / Candidate in Philosophy / In a challenge trial, “healthy volunteers are intentionally exposed to [diseases] in a controlled environment,” to give researchers a better understanding of a disease in order to develop cures or preventative measures for it (WHO 2021, Preface). Many research ethics scholars believe that conducting challenge trials could negatively impact the public’s faith in the institution of medical research, but the relationship between public trust and conducting challenge trials is complex and existing literature on the subject does not sufficiently clarify it. This paper begins by exploring whether or not challenge trials can be ethically conducted. Once I show that they can be under particular circumstances, I examine how public trust concerns largely result from the fact that ‘public’ and ‘trust’ are not well defined. After defining them, I formulate my own account of how public trust should apply to a risk/benefit analysis for the purpose of trial design selection.

Thesis (MSc (Psychology))--University of Stellenbosch, 2006. / HIV vaccines are currently being developed and tested worldwide. This thesis reports on a qualitative study that was conducted to determine the concerns and problems regarding participation in future HIV vaccine trials. The sample for the study was selected from a peri-urban township, Masiphumelele, in Cape Town, Western Cape province, South Africa. The HIV-prevalence rate in Masiphumelele is 25%. A total of 10 participants between the ages of 19 and 30 were recruited for the present study. All participants’ first language was Xhosa and seven of them had English as a second language. Owing to a language barrier, an interpreter assisted the interviewer in conducting the interviews in the preferred language of the participants. Participants were recruited by convenience sampling and were asked to participate in two semi-structured interviews, under confidential conditions. The first interview addressed knowledge regarding HIV/AIDS, HIV vaccines and HIV clinical trials. The second interview identified the concerns and problems participants had regarding participation in future HIV vaccine trials. The interviews were recorded, transcribed and entered into Atlas ti., a computer program that assists in the analysis of textual data. The analysis of the data focused on the content of participants’ concerns about barriers to participation and their perspectives on facilitators to participation. The data collected on concerns and problems which, may influence participants’ willingness to participate in future HIV vaccine trials, was divided into two overarching themes, namely, barriers to participation and facilitators to participation. The barriers to participation included physical symptoms, stigma and discrimination, trypanophobia, distrust, psychological distress, sexual disinhibition and family responsibilities. The facilitators to participation included altruism, own protection from HIV infection, hopefulness, medical incentives, determining of HIV status, acquisition of knowledge, and equal treatment of participants in the experimental group and the placebo control group resulting from a double-blinded randomised trial. The question of participants’, recruited in the present study, willingness to participate in a future HIV vaccine trial are discussed in terms of Bronfenbrenner’s (1979) theoretical work on ecological systems, the social learning theory and the Health Belief Model (HBM). These theoretical frameworks deal with individuals, their behaviour and their environment, and how these influence one another. The significance and future direction of this line of research helps to overcome the barriers to participation and enhance the facilitators to participation. Thus, the intended result of such efforts is to maximise individuals’ participation in future HIV vaccine trials.

Some scholars argue that the principle of voluntary informed consent is rooted in the Western ethos of liberal individualism; that it would be difficult to implement this requirement in societies where the norms of decision-making emphasize collective rather than individual decision-making (for example, Sub-Saharan Africa); that it would amount to “cultural imperialism” to seek to implement the principle of voluntary informed consent in non-Western societies. This thesis rejects this skepticism about the possibility of implementing the informed consent requirement in non-Western environments and argues that applying the principle of voluntary informed consent in human subjects’ research in Sub-Saharan African communal culture could serve as an effective measure to protect vulnerable subjects from possible abuses or exploitations. The thesis proposes the “multi-step” approach to informed consent as the best approach to the implementation of the principle in the African communal setting. The thesis argues that the importance of the “multi-step” approach lies in the fact that it is one that is sensitive to local culture and customs. On the question of whether the principle of voluntary informed consent should be made compulsory in research, the thesis answers that we have no choice in the matter.

<p>A qualitative descriptive study approach was used to gather the required information. The sample for this study was drawn from an existing group of volunteers who participated in the vaccine trial at Mbeya Medical Research Centre in 2006-2007. A purposive sampling method was used to select respondents because they had had experience of being participants in a HIV vaccine trial. Twenty audio recorded in-depth interviews were conducted. The interviews were conducted at the clinic during their routine follow up visits. An open ended interview guideline was used to guide the discussion to elicit the required information from the respondents. The data was transcribed, translated and then analyzed by both content and thematic approach. Ethical procedures were observed, including getting permission from the local ethical committee in Mbeya region and participants were given an informed consent form to read and sign before starting the interview.</p>

<p>Some scholars argue that the principle of voluntary informed consent is rooted in the Western ethos of liberal individualism; that it would be difficult to implement this requirement in societies where the norms of decision-making emphasize collective rather than individual decision-making (for example, Sub-Saharan Africa); that it would amount to “cultural imperialism” to seek to implement the principle of voluntary informed consent in non-Western societies. This thesis rejects this skepticism about the possibility of implementing the informed consent requirement in non-Western environments and argues that applying the principle of voluntary informed consent in human subjects’ research in Sub-Saharan African communal culture could serve as an effective measure to protect vulnerable subjects from possible abuses or exploitations. The thesis proposes the “multi-step” approach to informed consent as the best approach to the implementation of the principle in the African communal setting. The thesis argues that the importance of the “multi-step” approach lies in the fact that it is one that is sensitive to local culture and customs. On the question of whether the principle of voluntary informed consent should be made compulsory in research, the thesis answers that we have no choice in the matter.</p>

<p>A qualitative descriptive study approach was used to gather the required information. The sample for this study was drawn from an existing group of volunteers who participated in the vaccine trial at Mbeya Medical Research Centre in 2006-2007. A purposive sampling method was used to select respondents because they had had experience of being participants in a HIV vaccine trial. Twenty audio recorded in-depth interviews were conducted. The interviews were conducted at the clinic during their routine follow up visits. An open ended interview guideline was used to guide the discussion to elicit the required information from the respondents. The data was transcribed, translated and then analyzed by both content and thematic approach. Ethical procedures were observed, including getting permission from the local ethical committee in Mbeya region and participants were given an informed consent form to read and sign before starting the interview.</p>

Magister Public Health - MPH / A qualitative descriptive study approach was used to gather the required information. The sample for this study was drawn from an existing group of volunteers who participated in the vaccine trial at Mbeya Medical Research Centre in 2006-2007. A purposive sampling method was used to select respondents because they had had experience of being participants in a HIV vaccine trial. Twenty audio recorded in-depth interviews were conducted. The interviews were conducted at the clinic during their routine follow up visits. An open ended interview guideline was used to guide the discussion to elicit the required information from the respondents. The data was transcribed, translated and then analyzed by both content and thematic approach. Ethical procedures were observed, including getting permission from the local ethical committee in Mbeya region and participants were given an informed consent form to read and sign before starting the interview. / South Africa