Submitted in fulfilment of the degree of Doctor of Philosophy (PhD) in Bioethics and Health Law, Steve Biko Centre for Bioethics, University of the Witwatersrand. Johannesburg, November 2014 / Vulnerability, an abstract concept in health research, has concrete effects both on those who are labelled vulnerable and those who are not. It has been used increasingly as an exclusion criterion in research but has been the least examined from an ethical perspective despite being linked in most research ethics guidelines and codes, both international and local, to questions of justice and informed consent. Neither has there been an agreed upon standard for identifying and responding to vulnerability. The guidelines, despite categorizing vulnerable research participants into groups and subpopulations, do not offer a robust and comprehensive definition of vulnerability. The study aimed to analyse the notion of vulnerability in health research with a view to constructing an operational definition of the concept which would assist researchers and RECs to identify and understand vulnerabilities and strategize on maximizing protections for the participants without obstructing essential research. Using normative, metaethical and historical methods of bioethical inquiry, this research has shown that the categorization of people into vulnerable groups is not justified as it could result in obstructing research, and paternalistically excluding participants from necessary research, or inadequately protecting participants enrolled in research. The study has resulted in an appropriate operational definition of vulnerability and a Vulnerability Assessment Scale being developed to assist Research Ethics Committees and researchers identify participants with vulnerabilities and develop focused safeguards for their protections. The concept of vulnerability in health research is no longer nebulous and vague and its definition is therefore no longer an unanswered question.

There is a problem associated with the concept of vulnerability for research ethics. This problem is that we must identify populations in need of additional protections while also delineating these protections. Some have argued that the concept is too nebulous to warrant use since an increasing number of individuals may be deemed vulnerable such that virtually everyone is vulnerable in some way. In opposition to this, many have argued that that the concept of vulnerability needs to be more specific. In this thesis, I evaluate the concept of vulnerability in a number of ways. I touch on rejections of the concept, the history of the concept though both research guidelines and research ethics and seek to explore a way forward to a more useable account of vulnerability. I argue that no current account of vulnerability is adequality able to address the challenging questions posed by research trials involving human participants. A persuasive account of vulnerability should (1) have a plausible/persuasive definition of vulnerability; (2) figure out what the application of a theory of vulnerability looks like; and (3) what obligations or duties are owed to the vulnerable (and who is responsible for fulfilling these duties). In order to address this, I propose the Combined approach to vulnerability. This approach defines vulnerability as an increased likelihood to incur additional or greater wrongs. The Combined approach functions like a taxonomy and categorizes vulnerability into three groups with the use of layers and restricts the application of these layers with its formal the definition of vulnerability. This thesis marks a new novel contribution to the field of research ethics, in the way of a new theory to vulnerability that emerges from the current literature and makes progress towards a more useful concept of duties and obligations owed to the vulnerable grounded communal engagement. / Thesis / Master of Arts (MA) / Vulnerability as a concept is thoroughly debated in the field of research ethics. Some argue that the concept is useless, while others argue that the concept of vulnerability needs to be more specific about who it applies to and why. This thesis situates itself within the latter side of the debate. The Combined approach to vulnerability is my answer to this question. The Combined approach defines vulnerability as an increased likelihood to incur additional or greater wrongs. The Combined approach functions like a taxonomy and categorizes vulnerability into three groups (inherent layers, contextual layers, cascade layers) with the use of the metaphor of layers and restricts the application of these layers with its formal the definition of vulnerability. The main contributions of this approach are its novel combination as well as its new approach to the duties owed to the vulnerable.

Yes

No / This article identifies the key ethical issues that need to be addressed in any research study involving children and young people, accessed through the NHS. It makes specific reference to the Declaration of Helsinki and to additional guidance developed for researchers from a variety of disciplines, both within healthcare and in other fields of study. The focus of the paper is on defining the key ethical issues, identifying the complexities in the legislative framework underpinning research involving this patient group and offering practical advice on when, and how, ethical approval needs to be sought.

No description available.

<p> This study presents the findings revealed because of the lack of empirical research exploring police perceptions of informal accusations of racial profiling. The purpose of this qualitative descriptive single case study focused on exploring police decision-making following an informal accusation of racial profiling, in which no litigation occurred, during a police-motorist interaction. The purpose of this study included exploring police recommendations of what guidelines are necessary to reduce accusations of racial profiling. This study used a descriptive framework to explore accusations of racial profiling, feelings, perceptions, training, and leadership. Face-to-face and Skype&reg; semi-structured interviews used a purposeful and convenience approach. Eighteen police volunteers were selected for this study. Six themes emerged based on the participant&rsquo;s perceptions and experiences regarding informal accusations, responses to accusations, and police recommendations. The themes were focus on completing the task, responding professionally, fairness and respect, education, community interactions to change misperceptions, and perceptions of racial profiling. The participants advised communications between police and the community they serve is essential for reducing accusations. Implications for leadership to consider based on this study are a need for a comprehensive approach for how to interact within the community they serve, how to ensure personnel are not intentionally engaging in racial profiling, and to correct personnel actions that do not follow departmental rules. Recommendations included police-community interactions, open-forums, and better communications to allow police to explain behaviors before the media intensifying accusations.</p>

<p> Little is known about the scientist-animal relationship; therefore, the aim of this study was to learn how moments of intersubjectivity, or "oneness" are created and experienced by scientists. It is by appreciating the risks and vulnerabilities intrinsic to human-animal relationships that propel the present investigation. The current cultural bias of valuing objectification and detachment as the predominant form of scientific investigation overlooks relational subtleties intrinsic to deriving meaning from humananimal studies. By examining scientists and their descriptions of intersubjectivity with their animal participants, a greater understanding of society's philosophical and ethical deliberations on the human-animal relationship may be revealed. An exploratory, sequential mixed-method design was utilized to phenomenologically examine intersubjectivity, as well as to measure the prevalence of its dimensions within the larger academic population. Phenomenological analysis from ten interviews identified humananimal intersubjectivity as having four significant phases: <i>joint mindfulness, synchronized embodiment, intrinsic belonging </i>, and <i>transcendental awareness</i>. Spearman correlational analysis from fifty-four responses to the online survey supported these findings, as well as identified a potential link with the variables of proximity (r_s = .469, p &lt; .05, n=25), closeness (r_s = .483, p &lt; .01, n=25), similarity (r_s = .483, p &lt; .01, n=25) and embodied awareness (r_s = .421, p &lt; .01, n=25) that account for variation in the scientific population. When examining past behavior as it related to current scientific practices, gender differences emerged that resemble those reported by neuroanatomical studies. Lastly, further mixed analysis identified academic and cultural risks that were met by employing concealment and silencing strategies. These results add valuable depth in the interpretation of intersubjectivity and its relationship with scientific behavior, as well as insight into the role of intersubjectivity within ethical and philosophical debates.</p>

Background: Researchers and research ethics boards (REBs) in Toronto were unprepared for the SARS outbreak. There is a paucity of literature about how to review emergency-related protocols during a public emergency and so REBs had no guidance about how to review SARS-related protocols. Research questions: The thesis presents four related research inquiries based on the following four objectives: 1) to conduct a comprehensive evaluation of the one-year outcomes in SARS survivors; 2) to explore the ethical issues that emerged during the conduct of the SARS outcomes study; 3) to understand the impact of the SARS outbreak on research ethics review (RER) of SARS-related protocols; and 4) to propose a new framework of RER for use during public emergencies. Methods: Included in this thesis are an observational study, an analytic reflection, a grounded theory study, and a translation of the knowledge gained in the first three parts of the thesis into a framework of RER that is meaningful and actionable. Results: Part I describes the recovery made by SARS survivors from their acute illness. In part II, I explore ethical issues that arose during the conduct of the study including: social and scientific value and scientific validity of emergency research, and respect for privacy and confidentially. Part III presents a theory about how researchers, REBs and public health interacted during the outbreak and in part IV I propose ‘emergency review’ a framework for RER for use during a publicly declared emergency. Conclusions: The natural experiment that was the SARS outbreak in Toronto revealed the vulnerabilities in the structure of REBs. I highlight three conclusions which are the highest priority to provide further development in this field. These are: 1) when REBs, researchers and public health are not effectively communicating during a public emergency, the work of each group is disrupted; 2) institutional conflict of interest occurred during the research ethics review of SARS-related protocols and may be amplified during a public emergency and 3) there is a need for a multi-site review structure that could be activated on short notice to review protocols related to the emergency situation.

Background: Researchers and research ethics boards (REBs) in Toronto were unprepared for the SARS outbreak. There is a paucity of literature about how to review emergency-related protocols during a public emergency and so REBs had no guidance about how to review SARS-related protocols. Research questions: The thesis presents four related research inquiries based on the following four objectives: 1) to conduct a comprehensive evaluation of the one-year outcomes in SARS survivors; 2) to explore the ethical issues that emerged during the conduct of the SARS outcomes study; 3) to understand the impact of the SARS outbreak on research ethics review (RER) of SARS-related protocols; and 4) to propose a new framework of RER for use during public emergencies. Methods: Included in this thesis are an observational study, an analytic reflection, a grounded theory study, and a translation of the knowledge gained in the first three parts of the thesis into a framework of RER that is meaningful and actionable. Results: Part I describes the recovery made by SARS survivors from their acute illness. In part II, I explore ethical issues that arose during the conduct of the study including: social and scientific value and scientific validity of emergency research, and respect for privacy and confidentially. Part III presents a theory about how researchers, REBs and public health interacted during the outbreak and in part IV I propose ‘emergency review’ a framework for RER for use during a publicly declared emergency. Conclusions: The natural experiment that was the SARS outbreak in Toronto revealed the vulnerabilities in the structure of REBs. I highlight three conclusions which are the highest priority to provide further development in this field. These are: 1) when REBs, researchers and public health are not effectively communicating during a public emergency, the work of each group is disrupted; 2) institutional conflict of interest occurred during the research ethics review of SARS-related protocols and may be amplified during a public emergency and 3) there is a need for a multi-site review structure that could be activated on short notice to review protocols related to the emergency situation.

Discussion of manipulation as a form of undermining the consent of participants in clinical reserach, and specifically pregnant women who are HIV positive.. / I will argue that the relationship between the clinician scientist and the participant in the ACTG 076 trials involved unethically manipulative elements. My question of unethical manipulation examines the relationship between the clinician scientist and the participant. My first chapter establishes manipulation as follows, ‘A manipulates B if and only if A motivates B to make a decision or perform an action that bypasses B’s rational capacities by means of deception, emotional pressure, or exploitation of B’s ego depleted state.’ I argue that manipulation is prima facie unethical because it violates one’s autonomy. In the second chapter I examine the concerns of illness, gender roles, pregnancy, and HIV status, which can cause ego depletion and increase the participants’ vulnerability to manipulation. After analysis, I conclude that, although none of these elements can be eliminated as concerns for the clinician scientist, if they are not adequately accounted for, the clinician scientist has unethically manipulated the participant to enter and remain a part of the trial. I suggest that an adequate account would involve special consideration of how these vulnerabilities interact within the specific context of the trial. My third and final chapter will relate my conclusions to the current and upcoming research that is actively incorporating pregnant women as participants. / Thesis / Master of Arts (MA) / This thesis will examine the need to include the term “manipulation” into current ethical guidelines for Western bioethics because manipulation is a concept that is separate from concepts such as “coercion,” “force,” “exploitation,” or “undue influence” which appear in current Western bioethical guidelines. Manipulation is an unethical influence of another’s decision-making that undermines their autonomy, whereas autonomy is a key feature of Western bioethics and must be fostered rather than undermined or hindered. This thesis will discuss a clinical case in which pregnant women with HIV were enrolled in a clinical trial and I will discuss how illness, gender, pregnancy, and HIV status can cause one’s ego to be depleted so that they are more vulnerable to manipulation than other clinical participants. Finally, I will recommend that states, ethics boards, and researchers are the primary actors responsible for ensuring that participants are not manipulated in clinical research settings.