I argue for two main theses that are at odds with the positions of many clinical researchers and philosophers who write on the ethics of clinical research. The first is that certain types of clinical trials, namely, randomized clinical trials with double or triple blinding and a placebo group are generally necessary to establish that a medical intervention is effective in treating a certain type of disease or disorder. The second main thesis is that such trials are generally not ethically impermissible. My minimalist defense of clinical trials differs from most defenses of clinical trials found in the literature. I feel that the ethical permissibility of clinical trials can be judged by answering yes to the following questions: 1) Is the potential experimental subject competent to exercise his autonomy and his right of self determination in order to enroll in the clinical trial? 2) Is the potential experimental subject informed about the nature of risk and benefit involved in his participation in the clinical trial? 3) Is the trial scientifically/ epistemically valid? 4) Will the trial attempt to answer a scientific question or questions of value? I argue that competent persons have the right to enroll in scientifically valid clinical trials so long as they are informed and consent to participate.

A qualitative research study was conducted with people who had participated as healthy subjects in phase I drug trials at commercial research facilities, in order to develop a better understanding of their perspective regarding research participation. The participants were recruited using online advertisements posted on the University of Toronto student website (www.my.utoronto.ca) and NOW Magazine online. Thirty-one subjects were interviewed. The audiotaped interviews were transcribed and analyzed using grounded theory methods. A grounded theory was developed that describes the process of participation and the main factors affecting the experience of participation, from the perspective of healthy subjects. The theory, called Making Participation Work, explains how healthy subjects frame participation as an income earning opportunity, and how this framing shapes their behaviour with regard to participation. Participants expressed a range of attitudes about the experience of participation, from very positive to very negative. The main factor affecting the experience is the perceived net burden, which is in turn affected by the degree to which subjects find personal control over their participation. Net burden and finding personal control were both affected by the degree to which subjects felt valued by research staff, and by whether subjects had trust in the research enterprise. Although subjects framed participation as work, the relationship with the study doctors and nurses was viewed as clinical. Most subjects are generally trusting that participation in phase I drug trials is safe. These findings suggest that models of research participation assuming participation motivated by altruism or potential therapeutic benefit cannot accommodate the attitudes and behaviours of healthy subjects in phase I drug trials. New models must be developed which account for the framing of participation as work, while being sensitive to the trust that healthy subjects place in the research enterprise.

A qualitative research study was conducted with people who had participated as healthy subjects in phase I drug trials at commercial research facilities, in order to develop a better understanding of their perspective regarding research participation. The participants were recruited using online advertisements posted on the University of Toronto student website (www.my.utoronto.ca) and NOW Magazine online. Thirty-one subjects were interviewed. The audiotaped interviews were transcribed and analyzed using grounded theory methods. A grounded theory was developed that describes the process of participation and the main factors affecting the experience of participation, from the perspective of healthy subjects. The theory, called Making Participation Work, explains how healthy subjects frame participation as an income earning opportunity, and how this framing shapes their behaviour with regard to participation. Participants expressed a range of attitudes about the experience of participation, from very positive to very negative. The main factor affecting the experience is the perceived net burden, which is in turn affected by the degree to which subjects find personal control over their participation. Net burden and finding personal control were both affected by the degree to which subjects felt valued by research staff, and by whether subjects had trust in the research enterprise. Although subjects framed participation as work, the relationship with the study doctors and nurses was viewed as clinical. Most subjects are generally trusting that participation in phase I drug trials is safe. These findings suggest that models of research participation assuming participation motivated by altruism or potential therapeutic benefit cannot accommodate the attitudes and behaviours of healthy subjects in phase I drug trials. New models must be developed which account for the framing of participation as work, while being sensitive to the trust that healthy subjects place in the research enterprise.

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This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy

This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy

Thesis (Ph. D.)--University of Toronto, 2004. / Adviser: C.T. Patrick Diamond.

In this multi-method dissertation project I conduct policy analysis and utilize results from a discipline-wide survey (n=258) to examine the intersection of Writing Studies researchers’ disciplinary affiliation, research context, and personal disposition in relation to the local implementation of federal policy regarding human subjects research. I elaborate on the context of this project, discussing the September 2015 release of the Notice of Proposed Rulemaking (NPRM) to revise and update the Common Rule, 45.CFR Part 46, and the Conference on College Composition and Communication’s formal comment in response to the proposed rule’s provisions. I discuss the process of designing and implementing the survey used to establish a disciplinary representation of Writing Studies researchers’ perceptions of, and experiences with, IRBs. The results of this survey (Chapter 4) indicate how Writing Studies researchers presently interface with the process of local policy implementation. In Chapter 5, data from the survey are set against the Final Rule (released January 19, 2017) to provide a new taxonomy for Writing Studies researchers regarding how to interface with IRBs. Finally, the major theoretical contribution is articulated in Chapter Six: a call for human subjects researchers in Writing Studies to consider IRBs as justice-oriented, rather than positivist, in design and purpose. I argue increasingly reciprocal relationships between IRBs and Writing Studies researchers will help ensure Writing Studies research is not overly influenced by IRB review, nor that Writing Studies researchers are unwilling or unable to interface with IRBs to build more ethical and robust research agendas.

A mail survey of a nationwide sample of department heads in university departments of mechanical engineering, physiology, and psychology was conducted, in order to determine what these departments were doing to educate their Ph.D. students in research ethics. Department heads were also asked to supply names of the Ph.D. students in their departments. Based on the survey responses, departments within each discipline were then divided into those placing a relatively high versus low emphasis on teaching research ethics. Random samples of students in each emphasis category for each discipline were then surveyed and asked to rate the seriousness of 44 different hypothetical acts of misconduct, to determine if students from departments placing relatively higher emphasis on research ethics education had stricter standards than those from departments placing relatively lower emphasis on research ethics education. The two major findings of the study were (a) the majority of departments in physiology and psychology require some form of formal education in research ethics of their Ph.D. students, but only a very small percentage of mechanical engineering departments require such training; (b) the present study found no evidence that education of Ph.D. students in research ethics has any effect on the strictness of their stated ethical standards.

Yes / Research ethics review by ethics committees has grown in importance since the end of the Nuremberg trials in 1949. However, ethics committees have come under increasing criticisms either for been ‘toothless or too fierce’ (Fistein & Quilligan, 2012:224). This paper presents a personal account of my experience in obtaining ethical approval for my PhD study from a UK university and the ethical dilemmas encountered in the fieldwork in Ghana. In this paper I question whether strict adherence to ethical guidelines developed from western perspectives is useful in conducting research in non-western societies. As more academics are increasingly been mandated to undertake international research, the paper argues for more flexibility in the ethical approval process to accommodate cultural differences.